Document:

CONFIDENTIAL	Exhibit
4.21

 

Development
and Clinical Manufacturing Services Agreement

 

(the
“Agreement”)

 

by
and between

 

Lonza
Ltd 

Munchensteinerstrasse
38 

CH-4002
Basel 

Switzerland

 

-
hereinafter “Lonza” -

 

and

 

XORTX

 

4000
421 7th Avenue SW 

Calgary,
AB, T2P 4K9 

Canada

 

-
hereinafter “Customer” -

 

Effective
as of August 17, 2021 (the “Effective Date”)

  

    
	CONFIDENTIAL  	Page 1 of 27

 

     

    

  

CONFIDENTIAL

 

		Table
                           of Contents	Page

  

	1.   	Definitions and Interpretation	3
	 	 	 
	2.   	Performance of Services	7
	 	 	 
	3.   	Project Management / Steering Committee	9
	 	 	 
	4.   	Quality	10
	 	 	 
	5.   	Insurance	11
	 	 	 
	6.   	Ordering and Cancellation	11
	 	 	 
	7.   	Delivery and Acceptance	13
	 	 	 
	8.   	Price and Payment	14
	 	 	 
	9.   	Capital Equipment	15
	 	 	 
	10.   	Intellectual Property	15
	 	 	 
	11.   	Warranties	17
	 	 	 
	12.  	Indemnification
and Liability	18
	 	 	 
	13.   	Confidentiality	19
	 	 	 
	14.   	Term and Termination	21
	 	 	 
	15.   	Force Majeure	21
	 	 	 
	16.   	Miscellaneous	22
	 	 	 
	Appendix
    A	 
	 	 
	Appendix
    B	 

 

    
	CONFIDENTIAL  	Page 2 of 27

 

     

    

 

CONFIDENTIAL

  

Recitals

 

WHEREAS,
Customer is engaged in the development and research of certain products and requires assistance in the development and manufacture
of product;

 

WHEREAS,
Lonza and its Affiliates have expertise in the evaluation, development and manufacture of products;

 

WHEREAS,
Customer wishes to engage Lonza for Services relating to the development and clinical manufacture of the Product as described
in this Agreement; and

 

WHEREAS,
Lonza, or its Affiliate, is prepared to perform such Services for Customer on the terms and subject to the conditions set out
herein.

 

NOW,
THEREFORE, in consideration of the mutual promises contained herein, and for other good and valuable consideration, the parties
intending to be legally bound, agree as follows:

 

1.            
Definitions and Interpretation

 

	“Affiliate”	means
    any company, partnership or other entity which directly or indirectly Controls, is Controlled by or is under common Control
    with the relevant Party.  “Control” means the ownership of more than fifty percent (50%) of the issued
    share capital or the legal power to direct or cause the direction of the general management and policies of the relevant Party.
	“Agreement”	means
    this Development and Manufacturing Services Agreement incorporating all Appendices, as amended from time to time by written
    agreement of the Parties.
	“Applicable
    Laws”	means
    all relevant Canadian, U.S. and European Union federal, state and local laws, statutes, rules, and regulations which are applicable
    to the performance of the Services (as defined below) and/or the Parties’ respective obligations hereunder, including,
    without limitation, the applicable regulations and guidelines of any Regulatory Authority, Corruption laws, International
    Trade Restrictions, and all applicable cGMP together with amendments thereto.
	“Approval”	means
    the first marketing approval by the FDA, Health Canada, or EMA of Product from the Facility for commercial supply.
	“Background
    Intellectual Property”	means
    any Intellectual Property either (i) owned or controlled by a Party prior to the Effective Date or (ii) developed or acquired
    by a Party independently from the performance of the Services hereunder during the Term of this Agreement.
	“Batch”	means
    the Product derived from a single run of the Manufacturing Process.
	“Batch
    Price”	means
    the Price of each Batch.
	“Campaign”	means
    a series of no less than three (3) cGMP Batches manufactured consecutively.

 

    
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CONFIDENTIAL

 

	“Cancellation
    Fee”	has
    the meaning given in Clause 6.3.
	“Capital
    Equipment”	means
    those certain pieces of equipment described in the Project Plan used to produce the Product that are purchased by Customer
    or for which Customer reimburses Lonza, including, without limitation, the related documentation regarding the design, validation,
    operation, calibration and maintenance of such equipment.
	“Certificate
    of Analysis”	means
    a document prepared by Lonza listing tests performed by Lonza or approved External Laboratories, the Specifications and test
    results.
	“cGMP”	means
    those laws and regulations applicable in the U.S., Canada, and Europe, relating to the manufacture of medicinal products for
    human use, including, without limitation, current good manufacturing practices as specified in the ICH guidelines, including
    without limitation, ICH Q7A “ICH Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients”, US
    Federal Food Drug and Cosmetic Act at 21CFR (Chapters 210, 211, 600 and 610) and the Guide to Good Manufacturing Practices
    for Medicinal Products as promulgated under European Directive 91/356/EEC.  For the avoidance of doubt, Lonza’s
    operational quality standards are defined in internal cGMP policy documents.
	“cGMP
    Batches”	means
    any Batches which are required under the Project Plan to be manufactured in accordance with cGMP.
	“Change”	means
    any change to the Services, pricing or Scope of Work incorporated into a written amendment to the Agreement in accordance
    with clause 16.3 or effected in accordance with the Quality Agreement.
	“Commencement
    Date”	means
    the date of commencement of manufacturing activities for a Batch hereunder.
	“Confidential
    Information”	means
    all Customer Information and Lonza Information, both collectively and individually as applicable.
	“Corruption
    Laws”	means
    all anti-bribery and anti-corruption laws and regulations applicable to Lonza’s relationship with Customer, including
    but not limited to the U.S. Foreign Corrupt Practices Act, the U.K. Bribery Act 2010, and the Organization for Economic Co-operation
    and Development Convention on Combating Bribery and Foreign Public Officials in International Business Transactions.

 

    
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CONFIDENTIAL

 

	“Customer
    Information”	means
    all technical and other information not known to Lonza or in the public domain relating to the Manufacturing Process and the
    Product, from time to time supplied by the Customer to Lonza, including the Customer Materials and any other materials supplied
    by Customer to Lonza in accordance with the Project Plan and includes all New Customer Intellectual Property and all information
    that is proprietary to Customer or any Affiliate of Customer and that is maintained in confidence by Customer or any Affiliate
    of Customer and that is disclosed by Customer or any Affiliate of Customer to Lonza under or in connection with this Agreement,
    including without limitation, any and all Customer know-how and trade secrets and Customer Background Intellectual Property.
	“Customer
    Materials”	means
    any Raw Materials, components of Product, or other materials of any nature provided by Customer.
	“EMA”	means
    the European Medicines Agency, or any successor agency thereto.
	“Engineering
    Batches”	means
    a Batch that is intended to demonstrate the transfer of the Manufacturing Process to the Facility.
	“External
    Laboratories”	means
    any Third Party instructed by Lonza, with Customer’s prior consent, which is to conduct activities required to complete
    the Services.
	“Facility”	means
    Lonza’s manufacturing facilities in (i) Nansha, China, or (ii) such other Lonza facility as may be agreed upon by the
    Parties.
	“FDA”	means
    the United States Food and Drug Administration, or any successor agency thereto.
	“Governmental
    Authority”	means
    any Regulatory Authority and any national, multi-national, regional, state or local regulatory agency, department, bureau,
    or other governmental entity in the U.S., Canada, or European Union.
	“Intellectual
    Property”	means:
    (i) inventions (whether or not patentable), patents, trade secrets, copyrights, trademarks, trade names and domain names,
    rights in designs, rights in computer software, database rights, rights in confidential information (including know-how) and
    any other intellectual property rights, in each case whether registered or unregistered; (ii) all applications (or rights
    to apply) for, and renewals or extensions of, any of the rights described in the foregoing sub-clause (i); and (iii) all rights
    and applications that are similar or equivalent to the rights and application described in the foregoing sub-clauses (i) and
    (ii), which exist now, or which come to exist in the future, in any part of the world.
	“International
    Trade Restrictions”	means
    all applicable United States, United Nations, and European Union export control, trade, and financial sanctions laws, rules,
    and regulations.
	“Lonza
    Information”	means
    all information that is proprietary to Lonza or any Affiliate of Lonza and that is maintained in confidence by Lonza or any
    Affiliate of Lonza and that is disclosed by Lonza or any Affiliate of Lonza to Customer under or in connection with this Agreement,
    including without limitation, any and all Lonza know-how and trade secrets, New General Application Intellectual Property,
    and Lonza Background Intellectual Property.

 

    
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CONFIDENTIAL

 

	“Manufacturing
    Process”	means
    the production process developed by Lonza on behalf of Customer for the manufacture of Product, as such process may be improved
    or modified from time to time by agreement of the Parties in writing.
	“Master
    Batch Record”	means
    the document, proposed by Lonza and approved by Customer, which defines the manufacturing methods, test methods and other
    procedures, directions and controls associated with the manufacture and testing of Product.
	“New
    Customer Intellectual Property”	has
    the meaning given in Clause 10.2.
	“New
    General Application Intellectual Property”	has
    the meaning given in Clause 10.3.
	“Party”	means
    each of Lonza and Customer and, together, the “Parties”.
	“Product”	means
    the price for the Services and Products as set out in the applicable Project Plan.
	“Project
    Plan”	means
    the molecule identified by Customer as Oxypurinol, to be manufactured using the Manufacturing Process by Lonza for Customer
    as specified in the Project Plan.
	“Quality
    Agreement”	means
    the plan(s) describing the Services to be performed by Lonza under this Agreement, including any update and amendment of the
    Project Plan to which the Parties may agree from time to time. The initial Project Plan is attached hereto as Appendix A.
	“Raw
    Materials”	means
    the quality agreement, attached hereto as Appendix B, setting out the responsibilities of the Parties in relation to quality
    as required for compliance with cGMP.
	“Regulatory
    Authority”	means
    all ingredients, solvents, consumables, and other components of the Product required to perform the Manufacturing Process
    or Services.
	“Release”	means
    the FDA, EMA and any other similar regulatory authorities as may be agreed upon in writing by the Parties.
	“Services”	has
    the meaning given in Clause 7.1.
	“Specifications”	means
    all or any part of the services to be performed by Lonza under this Agreement (including, without limitation, process and
    analytical method transfer, process development, process optimization, validation, clinical and commercial manufacturing,
    as well as quality control and quality assurance activities), particulars of which are set out in a Project Plan.

 

    
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CONFIDENTIAL

 

	“Term”	means
    the specifications of the Product as specified in the applicable Project Plan, which may be amended from time to time in accordance
    with this Agreement.
	“Third
    Party”	means
    any party other than Customer, Lonza and their respective Affiliates.

In
this Agreement references to the Parties are to the Parties to this Agreement, headings are used for convenience only and do not
affect its interpretation, references to a statutory provision include references to the statutory provision as modified or re-enacted
or both from time to time and to any subordinate legislation made under the statutory provision, references to the singular include
the plural and vice versa, and references to the word “including” are to be construed without limitation.

 

		2.	Performance
of Services

 

		2.1	Performance
                                         of Services. Subject to Clause 2.5, Lonza shall itself and through its Affiliates,
                                         diligently carry out the Services as provided in the Project Plan and use commercially
                                         reasonable efforts to perform the Services without any material defect and according
                                         to the estimated timelines as set forth in the Project Plan. Lonza shall retain appropriately
                                         qualified and trained personnel with the requisite Knowledge and experience to perform
                                         the Services in accordance with this Agreement. Lonza may subcontract or delegate any
                                         of its rights or obligations under this Agreement to perform the Services to External
                                         Laboratories; provided, that any External Laboratories shall be subject to the same obligations
                                         and other provisions contained in this Agreement or any applicable Project Plan. Lonza
                                         shall not be responsible for analytical lab services performed by External Laboratories.

 

		2.2	Subcontractors.
                                         Lonza shall not subcontract Services as described in the Project Plan without first obtaining
                                         Customer’s prior written consent. Any agreement entered into by Lonza with a third
                                         party subcontractor shall, at a minimum, provide for ownership and allocation of Intellectual
                                         Property and for obligations of confidentiality of information, record-keeping, access,
                                         and rights to data that are consistent with the intent and terms of this Agreement. Lonza
                                         shall remain liable for the performance of any of its obligations hereunder that it delegates
                                         to a subcontractor. For the avoidance of doubt, any External Laboratories shall not be
                                         deemed to be a subcontractor of Lonza.

 

		2.3	Affiliates.
                                         Lonza, in its sole discretion, may instruct one or more of its Affiliates to perform
                                         any of Lonza’s obligations contained in this Agreement and any particular Project
                                         Plan as set forth in a Project Plan, provided, however, that Lonza shall remain fully
                                         responsible in respect of those obligations. Any of said Affiliates so used by Lonza
                                         shall be subject to all of the applicable terms and conditions applicable to Lonza under
                                         this Agreement and shall be entitled to all rights and protections afforded Lonza under
                                         this Agreement. An Affiliate of Lonza may execute a Project Plan with the Customer pursuant
                                         to this Agreement and submit invoices to the Customer under the Project Plan. In such
                                         circumstances all references in this Agreement to Lonza shall be deemed to be to the
                                         applicable Affiliate of Lonza with respect to that particular Project Plan. The Affiliate
                                         shall be entitled to enforce this Agreement with respect to such Project Plan in its
                                         own name as an intended third party beneficiary and the Affiliate shall be solely liable
                                         to the Customer for any obligations and liabilities undertaken pursuant to such Project
                                         Plan and subject to the terms of this Agreement and the Quality Agreement.

 

    
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CONFIDENTIAL

 

		2.4	Technology
                                         Transfer. If Customer is providing Customer Information to Lonza, the Parties agree
                                         that they shall work together to transfer (as described in the Project Plan) the Customer
                                         Information to the Facility, including implementing the technology transfer plan set
                                         out in the Project Plan. Customer shall fully support such technology transfer as reasonably
                                         requested by Lonza. Customer shall (by such date as agreed between the Parties) supply
                                         to Lonza all such Customer Information and Customer Materials, and other information
                                         or materials that may be reasonably required by Lonza to perform the Services. Lonza
                                         shall not be responsible for any delays arising out of Customer’s failure to provide
                                         such Customer Information, Customer Materials and/or other information and/or materials
                                         reasonably required to perform the Services to Lonza, and Customer shall be responsible
                                         for all additional costs and expenses arising out of such delay, including, if applicable,
                                         any idle Facility capacity costs.

 

		2.5	Engineering
                                         Batches. If applicable, Lonza shall manufacture Engineering Batches in accordance
                                         with the Project Plan. Customer shall have the right to make whatever further use of
                                         the non-cGMP Engineering Batches as it shall determine, provided that Customer pays for
                                         such Batches, such use is not for human use and does not violate any Applicable Laws.
                                         Lonza makes no warranty that Engineering Batches will meet cGMP or the Specifications.
                                         If Lonza determines that an Engineering Batch does meet cGMP and the Specifications,
                                         it will release such Engineering Batch as a cGMP Batch. Regardless of whether any Engineering
                                         Batch meets cGMP or the Specifications, Customer shall pay to Lonza the Price for such
                                         Engineering Batch plus the Raw Materials Fee associated with such Engineering Batches.

 

		2.6	cGMP
                                         Batches. Lonza will, in accordance with the terms of this Agreement and Quality Agreement,
                                         manufacture at the Facility and Release to Customer, cGMP Batches that comply with the
                                         Manufacturing Process, cGMP and the Specifications, together with a Certificate of Analysis;
                                         provided, however, that cGMP manufacture shall not commence until at least one (1) successful
                                         and consecutive Engineering Batch (at any given scale) has been manufactured in compliance
                                         with cGMP and Specifications. Prior to commencement of cGMP manufacturing, Lonza shall
                                         review the process assumptions. In the event that there is a material difference in the
                                         process assumptions as compared with the process results demonstrated during the manufacture
                                         of Engineering Batches, the Parties shall meet to discuss in good faith a revision to
                                         the Batch Price to reflect such difference.

 

		2.7	Stability
                                         Testing. Lonza will perform stability testing in accordance with the applicable Project
                                         Plan and the Quality Agreement, as applicable.

 

		2.8	Location
                                         of Services. All manufacturing will be done at Lonza’s Nansha Facility located
                                         at Huangge N. Ave., Guangzhou, Nansha 511455 China unless otherwise agreed with Customer.

 

		2.9	Supply
                                         of Customer Information and Customer Materials. Customer shall supply to Lonza all
                                         Customer Information and Customer Materials and other information or materials that may
                                         be reasonably required by Lonza to perform the Services. Lonza shall not be responsible
                                         for any delays arising out of Customer’s failure to provide such Customer Information,
                                         Customer Materials, or other information or materials reasonably required to perform
                                         the Services to Lonza, and Customer shall be responsible for all additional costs and
                                         expenses arising out of such delay, including, if applicable, any idle Facility capacity
                                         costs.

 

		2.10	Raw
                                         Materials. Lonza shall procure all required Raw Materials other than those Raw Materials
                                         that are Customer Materials. Quantities of Raw Materials ordered by Lonza shall be in
                                         alignment with quantities reasonably needed for planned production. Upon cancellation
                                         of any Batch or termination of the Agreement, all unused Raw Materials shall be paid
                                         for by Customer within thirty (30) days of invoice and at Customer’s option will
                                         either be (a) held by Lonza for future use for the production of Product, (b) delivered
                                         to Customer, or (c) returned to the supplier, to the extent permitted by the supplier,
                                         or (d) disposed of by Lonza. Lonza will credit Customer for any credits received by Lonza
                                         in connection with the return of Raw Materials to the supplier.

 

    
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CONFIDENTIAL

 

		2.11	Once
                                         a Product has achieved Proof of Concept (e.g. successful Phase 2a clinical study or equivalent),
                                         the Parties may negotiate in good faith a separate agreement on commercially reasonable
                                         terms and conditions for supply of commercial products.

 

3.           
Project Management / Steering Committee

 

		3.1	Project
                                         Plans. With respect to a new project to be governed by this Agreement, a new Project
                                         Plan shall be added by agreement in a writing signed by the Parties and appended to Appendix
                                         A. Each Project Plan shall include a description of the Services to be provided, the
                                         Product to be manufactured, Specifications, a schedule for completion of the Project
                                         Plan, pricing details, and such other information as is necessary for relevant Services.
                                         In the event of a conflict between the terms of a Project Plan and this Agreement, the
                                         terms of this Agreement will govern.

 

		3.2	Project
                                         Management. With respect to each Project Plan, each party will appoint a project
                                         manager who will be the party responsible for overseeing the Project Plan.

 

		3.3	Steering
                                         Committee. Each Party shall name a mutually agreed upon equal number of representatives
                                         for the Steering Committee, which shall meet twice per calendar year, or as otherwise
                                         mutually agreed by the Parties. In the event that a Steering Committee dispute cannot
                                         be resolved, such dispute shall be escalated to a senior executive of each of Customer
                                         and Lonza.

 

The
primary function of the Steering Committee is to ensure the ongoing communication between the Parties and discuss and resolve
any issues arising under this Agreement. In addition to the primary function described above, the Steering Committee shall also
take on the following responsibilities:

 

		3.3.1	discuss
                                         and seek resolution of issues around management of the Services;

 

		3.3.2	agree
                                         and monitor deadlines and milestones for the Services; and

 

		3.3.3	discuss
                                         and recommend any changes to the Services (although such changes will not take effect
                                         until they have been incorporated into a written amendment to the Project Plan which
                                         has been signed by the Parties).

 

		3.4	Facility.
                                         Lonza shall ensure that the Facility meets all the requirements of a drug establishment
                                         promulgated by the FDA at all times during the GMP-manufacture of the Product. As applicable,
                                         Lonza shall comply with all aspects required by the Quality Agreement pertaining to qualification
                                         to manufacture and ship GMP-manufactured Product.

 

		3.5	Audit.
                                         In accordance with and subject to the Parties Quality Agreement, Lonza shall notify Customer
                                         of a FDA or other regulatory audit or inspection if such audit or inspection directly
                                         relates to a GMP Product. In accordance with and subject to the Parties Quality Agreement,
                                         Lonza shall provide to Customer correspondence and reports that it receives from a governmental
                                         agency or regulatory authority in connection with a GMP Product.

 

    
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CONFIDENTIAL

 

		3.6	Person
                                         in Plant. Customer shall be permitted to have, at no additional cost, two (2) employees
                                         at the Facility as reasonably requested by Customer, at a time mutually agreed to by
                                         the Parties and during Lonza’s normal business hours, for the purpose of observing,
                                         reporting on, and consulting as to the performance of the Services as may be approved
                                         in writing in advance by Lonza. Such employee shall be subject to and agree to abide
                                         by confidentiality obligations to Third Parties and Lonza’s customary practices,
                                         operating procedures and security procedures regarding persons in plant, and such employee
                                         agrees to comply with all instructions of Lonza’s employees at the Facility. Customer’s
                                         employee(s) working at the Facility shall be and remain employees of Customer, and Customer
                                         shall be solely responsible for the payment of compensation for such Customer employee
                                         (including applicable federal, state and local withholding, FICA and other payroll taxes,
                                         workers’ compensation insurance, health insurance, and other similar statutory
                                         and fringe benefits). Customer covenants and agrees to maintain workers’ compensation
                                         benefits and employers’ liability insurance as required by applicable federal and
                                         state laws with respect to all Customer employees working at the Facility.

 

		4.	Quality

 

		4.1	Responsibility
                                         for quality assurance and quality control of Product shall be allocated between Customer
                                         and Lonza as set forth in the Quality Agreement and in Lonza standard operating procedures.
                                         If there is a conflict between the terms and conditions of this Agreement and the Quality
                                         Agreement, the terms and conditions of the Quality Agreement shall prevail concerning
                                         quality, safety and efficacy issues. If the Quality Agreement is not in place at the
                                         Effective Date, Lonza and Customer commit to enter into the Quality Agreement in a timely
                                         manner, but in no event later than the commencement of cGMP manufacturing.

 

		4.2	Provisions
                                         regarding inspections by Regulatory Authorities and audits shall be set out in the Quality
                                         Agreement.

 

		4.3	Records.
                                         Lonza will maintain accurate records for the production of the Product, as required by
                                         applicable laws and regulations or in accordance with the Quality Agreement. Lonza will
                                         retain possession of the Master Batch Record, all Batch records and Lonza Operating Documents,
                                         and will make copies of the Master Batch Record and Batch records available to Customer
                                         upon Customer’s request; Lonza will provide such copies at no cost to Customer
                                         except that Customer shall compensate Lonza for any related translation costs (such translation
                                         costs are set forth Appendix C). Lonza Operating Documents shall remain Lonza Information.
                                         Master Batch Records and executed Batch records are the property of Customer; for clarity,
                                         any Lonza Background Intellectual Property or New General Application Intellectual Property
                                         contained in any Batch records shall still be considered Lonza Information and subject
                                         to the obligations of confidentiality and non-use set forth in Section 13 of this Agreement.
                                         All Batch records shall, at Customer’s cost and request, be translated into English
                                         prior to batch release. Lonza will make Lonza Operating Documents available during site
                                         visits by Customer but Customer shall not be permitted to make copies of and/or remove
                                         Lonza Operating Documents from the Lonza site. In connection with a filing for Regulatory
                                         Approval of the Product, and securing and maintaining such approval, Lonza shall provide
                                         the Lonza Operating Documents directly to the Regulatory Authority when possible, and
                                         to the extent that Lonza cannot so provide such Lonza Operating Documents, then such
                                         documents shall be provided under strict confidentiality (subject to a separate confidentiality
                                         undertaking) to the appropriate persons (regulatory affairs) at Customer for submission
                                         to the Regulatory Authority.

 

		4.3.1	As
                                         used in this Section 4.3, “Lonza Operating Documents” means the corporate
                                         standards, standard operating procedures, standard manufacturing procedures, Lonza-customized
                                         manufacturing procedures developed prior to the Effective Date or outside the scope of
                                         this Agreement, electronic programs and files, raw material specifications, protocols,
                                         validation documentation, and supporting documentation used by Lonza, such as, without
                                         limitation, environmental monitoring, for operation and maintenance of the Facility and
                                         Lonza equipment used in the process of producing the Product, excluding any of the foregoing
                                         that are solely related to the manufacture of Product.

 

    
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CONFIDENTIAL

 

		5.	Insurance

 

		5.1	Each
                                         Party shall, during the Term and for two (2) years after delivery of the last Product
                                         manufactured or Services provided under this Agreement, obtain and maintain at its own
                                         cost and expense from a qualified insurance company, comprehensive general liability
                                         insurance including, but not limited to product liability coverage in the amount of at
                                         least two (2) million Swiss Francs (or an equivalent amount in another currency) per
                                         claim. Each Party shall provide the respective other Party with a certificate of such
                                         insurance upon reasonable request.

 

		6.	Ordering
and Cancellation

 

		6.1	Order
                                         Confirmation. Lonza shall confirm the delivery date(s) and quantity of Product to
                                         be delivered as set out in a purchase order within ten (10) business days of receipt
                                         from Customer of the relevant purchase order. Upon confirmation, a purchase order will
                                         be regarded by the Parties as a binding commitment by Lonza to manufacture and to deliver
                                         to Customer the relevant quantity of Product according to the requirements set out in
                                         such purchase order. Any delivery date set forth in Lonza’s written confirmation
                                         of a purchase order shall be an estimated delivery date only. All ordered Batches shall
                                         be scheduled in a single Campaign in each calendar year unless otherwise agreed by Lonza.
                                         Any additional or inconsistent terms or conditions of any Customer purchase order, acknowledgement
                                         or similar standardized form given or received pursuant to this Agreement shall have
                                         no effect and such terms and conditions are hereby rejected.

 

		6.2	Rescheduling.
                                         Lonza shall have the right to reschedule a Commencement Date of any Batch or Campaign
                                         upon reasonable prior written notice to Customer, provided that the rescheduled Commencement
                                         Date is no later than sixty (60) days from the Commencement Date originally estimated
                                         at the time of Lonza’s acceptance of the binding purchase order. If the Customer
                                         requests to change the Commencement Date, Lonza will make all reasonable attempts to
                                         accommodate the request; provided, however, in the event that this change would impact
                                         other projects scheduled for occupancy in the designated suite or suites, manufacture
                                         of the Customer’s Batch or Campaign may be delayed until an adequate time period
                                         is available in the Facility schedule. Any such change requested by Customer may result
                                         in a rescheduling fee. Any delay requested by Customer of more than ninety (90) days
                                         shall be considered a cancellation pursuant to Section 6.3.

 

		6.3	Cancellation
                                         of Services. Customer may cancel Services, including production of a Batch to be
                                         manufactured under a Project Plan, upon written notice to Lonza, subject to Customer’s
                                         obligation to pay for all Services rendered up to the date of cancelation, including
                                         in respect of any Product in-process, all of Lonza’s costs incurred through the
                                         date of cancelation in connection with such Services and/or Batch pursuant to the Project
                                         Plan, including any costs and handling fees for all Raw Materials used or purchased for
                                         use in connection with the Services in accordance with Section 2.9, plus the payment
                                         of a cancellation fee as calculated below (the “Cancellation Fee”):

 

Development
Services

 

		6.3.1	In
                                         the event that Customer provides written notice of cancellation to Lonza of work agreed
                                         under a Project Plan, Customer shall be responsible to reimburse Lonza for all work undertaken
                                         to that point and cost of all raw materials ordered to complete the work.

 

    
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CONFIDENTIAL

 

Manufacturing
Services for Clinical Material (for scales less than or equal to 500 L)

 

		6.3.2	In
                                         the event that Customer provides written notice of cancellation to Lonza less than or
                                         equal to three (3) months prior to the Commencement Date of one or more Batches, then
                                         seventy-five percent (75%) of the Batch Price of each such Batch cancelled is payable;

 

		6.3.3	In
                                         the event that Customer provides written notice of cancellation to Lonza more than three
                                         (3) months but less than or equal to nine (9) months prior to the Commencement Date of
                                         one or more Batches, then fifty percent (50%) of the Batch Price of each such Batch cancelled
                                         is payable; and

 

		6.3.4	In
                                         the event Customer provides written notice of cancellation more than nine (9) months
                                         prior to the Commencement Date of a subject Batch, then no Cancellation Fee is payable.

 

Manufacturing
Services for Clinical Material (for scales of more than 500L but less than or equal to 1,500 L)

 

		6.3.5	In
                                         the event that Customer provides written notice of cancellation to Lonza less than or
                                         equal to three (3) months prior to the Commencement Date of one or more Batches, then
                                         eighty-five percent (85%) of the Batch Price of each such Batch cancelled is payable;

 

		6.3.6	In
                                         the event that Customer provides written notice of cancellation to Lonza more than three
                                         (3) months but less than or equal to nine (9) months prior to the Commencement Date of
                                         one or more Batches, then sixty percent (60%) of the Batch Price of each such Batch cancelled
                                         is payable; and

 

		6.3.7	In
                                         the event that Customer provides written notice of cancellation to Lonza more than nine
                                         (9) months but less than or equal to nine (12) months prior to the Commencement Date
                                         of one or more Batches, then thirty (30%) of the Batch Price of each such Batch cancelled
                                         is payable; and

 

		6.3.8	In
                                         the event Customer provides written notice of cancellation more than twelve (12) months
                                         prior to the Commencement Date of a subject Batch, then no Cancellation Fee is payable.

 

Manufacturing
Services for Clinical Material (for scales of 10,000 L)

 

		6.3.9	In
                                         the event that Customer provides written notice of cancellation to Lonza less than or
                                         equal to six (6) months prior to the Commencement Date of one or more Batches, then one
                                         hundred percent (100%) of the Batch Price of each such Batch cancelled is payable;

 

		6.3.10	In
                                         the event that Customer provides written notice of cancellation to Lonza more than six
                                         (6) months but less than or equal to twelve (12) months prior to the Commencement Date
                                         of one or more Batches, then eighty-five percent (85%) of the Batch Price of each such
                                         Batch cancelled is payable; and

 

    
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		6.3.11	In
                                         the event Customer provides written notice of cancellation more than twelve (12) months
                                         prior to the Commencement Date of a subject Batch, then no Cancellation Fee is payable.

 

		6.4	Payment
                                         of Cancellation Fee. Any Cancellation Fee shall be payable within thirty (30) days
                                         following the written notice of cancellation associated with the cancelled Batch. Any
                                         Cancellation Fee shall include all costs associated with the cancelled Batch, including
                                         any Raw Materials in accordance with Section 2.9.

 

		6.5	Replacement
                                         Project. Notwithstanding the foregoing, Lonza will use commercially reasonable efforts
                                         to secure a new project (but excluding any project then under contract with Lonza) for
                                         the cGMP manufacturing space, and for the same dates and duration that would have been
                                         occupied by Customer, and then, in such case, the Cancellation Fee for each Batch cancelled
                                         that is replaced by a Batch of the new project shall be reduced by an amount equal to
                                         one hundred percent (100%) of the production fees associated with such replacement Batch.

 

7.            
Delivery and Acceptance

 

		7.1	Delivery.
                                         All Product shall be delivered FCA (as defined by Incoterms® 2020) the Facility.
                                         Lonza shall deliver to Customer the Certificate of Analysis and such other documentation
                                         as is reasonably required to meet all applicable regulatory requirements of the Governmental
                                         Authorities not later than the date of delivery of Batches (the “Release”).
                                         With respect to any Customer Materials, title and risk of loss shall remain with the
                                         Customer and shall not transfer to Lonza. With respect to Product, title and risk of
                                         loss shall transfer to Customer upon Release in accordance with this provision.

 

		7.2	Storage.
                                         Customer shall arrange for shipment and take delivery of such Batch from the Facility,
                                         at Customer’s expense, within (30) days after Release or pay applicable storage
                                         costs. Lonza shall provide storage on a bill and hold basis for such Batch(es) at no
                                         charge for up to thirty (30) days; provided that any additional storage beyond thirty
                                         (30) days will be subject to availability and, if available, will be charged to Customer
                                         and will be subject to a separate agreement. In addition to Section 8.2, Customer shall
                                         be responsible for all value added tax (VAT) and any other applicable taxes, levies,
                                         import, duties and fees of whatever nature imposed as a result of any storage. Notwithstanding
                                         anything to the contrary contained in this Agreement, in no event shall Lonza be required
                                         to store any Batch for more than ninety (90) calendar days after Release. Within five
                                         (5) business days following a written request from Lonza, Customer shall provide Lonza
                                         with a letter in form satisfactory to Lonza confirming the bill and hold status of each
                                         stored Batch.

 

		7.3	Acceptance/Resection
                                         of Product.

 

		7.3.1	Promptly
                                         following Release of Batches, Customer shall inspect such Batches and associated batch
                                         documentation, and shall have the right to test such Batches to determine compliance
                                         with the Specifications. Customer shall notify Lonza in writing of any rejection of a
                                         Batch based on any claim that it fails to meet Specifications within thirty (30) days
                                         of Release, after which time all unrejected Batches shall be deemed accepted. Customer
                                         shall inform Lonza in writing in case of concealed or latent defects (i.e. not discovered
                                         by routine quality control means), promptly upon discovery of such defects but no later
                                         than one (1) year after delivery of the Product.

 

    
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		7.3.2	In
                                         the event that Lonza believes that a Batch has been incorrectly rejected, Lonza may require
                                         that Customer provide to it Batch samples for testing. Lonza may retain and test the
                                         samples of such Batch. In the event of a discrepancy between Customer’s and Lonza’s
                                         test results such that Lonza’s test results fall within relevant Specifications,
                                         or there exists a dispute between the Parties over the extent to which such failure is
                                         attributable to a given Party, the Parties shall cause an independent laboratory promptly
                                         to review records, test data and perform comparative tests and analyses on samples of
                                         the Product that allegedly fails to conform to Specifications. Such independent laboratory
                                         shall be mutually agreed upon by the Parties. The independent laboratory’s results
                                         shall be in writing and shall be final and binding save for manifest error. Unless otherwise
                                         agreed to by the Parties in writing, the costs associated with such testing and review
                                         shall be borne by the Party against whom the independent laboratory rules.

 

		7.3.3	Lonza
                                         shall reprocess any Batch or, if reprocessing is not possible, replace any Batch that
                                         failed to conform with the Specifications (a “Failed Batch”), in the event
                                         that it is determined (by the Parties or the independent laboratory) that such failure
                                         was solely due to Lonza’s material breach of its obligations hereunder, negligence
                                         or intentional misconduct (“Lonza Responsibility”). Such reprocessing or
                                         replacement shall be made as promptly as practicable, in light of available manufacturing
                                         capacity, after the confirmation of Lonza Responsibility, and in any case as soon as
                                         reasonably possible after confirmation of Lonza Responsibility. Where possible, any replacement
                                         Batch shall be manufactured with the next scheduled cGMP Batch or Campaign. Customer
                                         acknowledges and agrees that its sole remedy with respect to a Failed Batch that is a
                                         Lonza Responsibility is as set forth in this Clause 7.3.3, and in furtherance thereof,
                                         Customer hereby waives all other remedies at law or in equity regarding the foregoing
                                         claims. Lonza shall not be responsible for the cost of Raw Materials or Customer Materials
                                         consumed in any Failed Batch, except to the extent set forth in this Clause 7.3.3.

 

		8.	Price
and Payment

 

		8.1	Pricing
                                         for the Services provided by Lonza are set out in, and based on the assumptions and information
                                         set out in, the applicable Project Plan. In the event of changes to the Services based
                                         on Customer’s request, Customer shall bear all additional costs.

 

		8.2	Unless
                                         otherwise indicated in writing by Lonza, all Prices and charges are exclusive of value
                                         added tax (VAT) and of any other applicable taxes, levies, import, duties and fees of
                                         whatever nature imposed by or under the authority of any government or public authority
                                         and all such charges applicable to the Services shall be paid by Customer.

 

		8.3	Lonza
                                         shall issue invoices to Customer for fifty percent (50%) of the Price for Products or
                                         Services upon commencement thereof and fifty percent (50%) upon Release of applicable
                                         Batches or deliverables, or completion of applicable Services, unless otherwise stated
                                         in the Project Plan. Charges for Raw Materials and the Raw Materials Fee for each Batch
                                         shall be invoiced upon the Release of each Batch, provided, that any Raw Materials required
                                         to be ordered more than six (6) months in advance shall be invoiced fifty percent (50%)
                                         at the time of order by Lonza and fifty percent (50%) upon Release of the Batch. All
                                         invoices are strictly net and payment must be made within thirty (30) days of date of
                                         invoice. Payment shall be made without deduction, deferment, set-off, lien or counterclaim.

 

		8.4	If
                                         in default of payment of any undisputed invoice on the due date, interest shall accrue
                                         on any amount overdue at the lesser of (i) rate of two percent (2%) per month above the
                                         London Interbank Offered Rate (LIBOR) or (ii) the maximum rate allowable by applicable
                                         law, interest to accrue on a day to day basis until full payment; and Lonza shall, at
                                         its sole discretion, and without prejudice to any other of its accrued rights, be entitled
                                         to suspend the provision of the Services and or delivery of Product until all overdue
                                         amounts have been paid in full including interest for late payments.

 

    
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		9.	Capital
Equipment

 

		9.1	Any
                                         Capital Equipment required for the performance of the Services shall be acquired on terms
                                         to be agreed by the Parties prior to commencement of the relevant Services.

 

		10.	Intellectual
Property

 

		10.1	Neither
                                         Party will, as a result of this Agreement, acquire any right, title, or interest in any
                                         Background Intellectual Property of the other Party or any of its Affiliates.

 

		10.2	Subject
                                         to Clause 10.3, Customer shall own all right, title, and interest in and to any and all
                                         Intellectual Property that Lonza and/or its Affiliates, the External Laboratories or
                                         other contractors or agents of Lonza develops, conceives, invents, first reduces to practice
                                         or makes solely or jointly with Customer or others, to the extent that it constitutes
                                         any aspect of the Manufacturing Process (excluding any Lonza Background Intellectual
                                         Property of Lonza and any New General Application Intellectual Property incorporated
                                         therein) or is both:

 

		10.2.1	a
                                         derivative of, alteration, enhancement, modification, or improvement to Customer Information,
                                         and/or Customer Background Intellectual Property; and

 

		10.2.2	severable
                                         from and does not incorporate any Lonza Background Intellectual Property, Lonza Information
                                         and/or New General Application Intellectual Property and does not disclose or reveal
                                         any unregistered Lonza Background Intellectual Property or any previously undisclosed
                                         Lonza Information;

 

(the
“New Customer Intellectual Property”). For the avoidance of doubt, “New Customer Intellectual Property”
shall include any material, processes or other items that embody, or that are claimed or covered by, any of the foregoing new
Intellectual Property, but excluding any New General Application Intellectual Property.

 

		10.3	Notwithstanding
                                         Clause 10.2, and subject to the license granted in Clause 10.5, Lonza shall own all right,
                                         title and interest in Intellectual Property that Lonza and/or its Affiliates, the External
                                         Laboratories or other contractors or agents of Lonza, solely or jointly with Customer
                                         or others, develops, conceives, invents, or first reduces to practice or makes in the
                                         course of performance of the Services that:

 

		10.3.1	is
                                         solely of general application to the development or manufacture of chemical or biological
                                         products or products components and in no way is specific to the manufacturing of the
                                         Product; or

 

		10.3.2	is
                                         an improvement of, or direct derivative of, any Lonza Background Intellectual Property
                                         or Lonza Information;

 

(the
“New General Application Intellectual Property”). For the avoidance of doubt, “New General Application Intellectual
Property” shall include any material, processes or other items that embody, or that are claimed or covered by, any of the
foregoing Intellectual Property.

 

    
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		10.4	Lonza
                                         hereby assigns to Customer all of its right, title and interest in any New Customer Intellectual
                                         Property. Lonza shall execute, and shall require its personnel as well as its Affiliates,
                                         External Laboratories or other contractors or agents and their personnel involved in
                                         the performance of the Services to execute, any documents reasonably required to confirm
                                         Customer’s ownership of the New Customer Intellectual Property, and any documents
                                         required to apply for, maintain and enforce any patent or other right in the New Customer
                                         Intellectual Property and waiver of moral rights therein. To the extent that Customer
                                         has or obtains any rights, title or interest in New General Application Intellectual
                                         Property, Customer hereby assigns to Lonza all of its right, title and interest in any
                                         New General Application Intellectual Property. Customer shall execute, and shall require
                                         its personnel as well as its Affiliates, or other contractors or agents and their personnel
                                         involved in the performance of the Services to execute, any documents reasonably required
                                         to confirm Lonza’s ownership of the New General Application Intellectual Property,
                                         and any documents required to apply for, maintain and enforce any patent or other right
                                         in the New General Application Intellectual Property.

 

		10.5	Subject
                                         to the terms and conditions set forth herein (including the payment of the Price as required
                                         above), Lonza hereby grants to Customer a non-exclusive, royalty free, world-wide, fully
                                         paid-up, perpetual, irrevocable, transferable license, under the New General Application
                                         Intellectual Property, to use, sell and import the Product (but no other products) manufactured
                                         under this Agreement.

 

		10.6	Customer
                                         hereby grants Lonza and its Affiliates, sub-contractors and the External Laboratories
                                         the non-exclusive right to use the Customer Information, Customer Background Intellectual
                                         Property, Customer Materials, New Customer Intellectual Property and any and all other
                                         intellectual property supplied by or on behalf of the Customer, during the Term solely
                                         for the purpose of fulfilling their obligations under this Agreement.

 

		10.7	Provided
                                         that (i) Customer is not in breach of this Agreement; and/or (ii) Lonza has not terminated
                                         this Agreement pursuant to Clauses 14.2.1 and/or 14.2.2, Customer will have the right
                                         to transfer the Manufacturing Process to itself and/or any Third Party (such Third Party
                                         shall be Customer’s sub-licensee), and on the basis that such transfer shall be
                                         for the manufacture of Product (but no other products); provided, however, to the extent
                                         such technology transfer includes any Lonza Information, Lonza Background Intellectual
                                         Property or New General Application Intellectual Property, such technology transfer shall
                                         be subject to a mutually agreed upon reasonable technology transfer fee based on Lonza
                                         costs for support of the transfer and on terms to be agreed by the Parties (which shall
                                         be in a separate technology transfer agreement) prior to any such transfer. Lonza shall
                                         provide reasonably necessary documents to complete such technology transfer and Customer
                                         shall reimburse Lonza for any costs (based on a full-time employee rate for such support)
                                         and expenses. For the avoidance of doubt, until such terms are agreed, Customer shall
                                         not have any right to use any Lonza Information, Lonza Background Intellectual Property
                                         or New General Application Intellectual Property nor transfer it to any Third Party.

 

		10.8	Unless
                                         the Parties expressly, mutually agree to the contrary in writing, including Without limitation
                                         by express reference to a given Other Agreement (as defined below), nothing in this Agreement
                                         (or any Project Plan entered into pursuant to this Agreement) shall supersede, amend
                                         or otherwise modify any terms or conditions or other provisions of any other agreement
                                         between the Parties that is entered into prior to or contemporaneously with the execution
                                         of this Agreement, including, without limitation, any agreement related to any gene expression
                                         system, or any intermediates of or precursors to any Product, or any services performed
                                         by Lonza or any Affiliate of Lonza for Customer, or any consumables or other products
                                         supplied by Lonza or any Affiliate to Customer (collectively, an “Other Agreement”).

 

		10.9	Lonza
                                         and Customer agree to cooperate in the filing of any patent application relating to Customer
                                         Property and Lonza Property. If any invention relates to both Customer Property and Lonza
                                         Property, and Customer and Lonza both desire to file or have filed patent applications
                                         claiming the Customer Property and the Lonza Property respectively, Customer and Lonza
                                         agree to file such applications simultaneously.

 

    
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		11.	Warranties

 

		11.1	Lonza
                                         represents and warrants that:

 

		11.1.1	it
                                         has the necessary skill and expertise to perform the Services.

 

		11.1.2	it
                                         has the full power and right to enter into this Agreement and that there are no outstanding
                                         agreements, assignments, licenses, encumbrances or rights of any kind, that would breach
                                         the provisions of this Agreement;

 

		11.1.3	the
                                         execution and delivery of this Agreement by Lonza has been authorized by all requisite
                                         corporate or company action and this Agreement is and shall remain a valid and binding
                                         obligation of Lonza, enforceable in accordance with its terms;

 

		11.1.4	to
                                         its knowledge, the conduct and the provision of the Services shall not infringe, misappropriate
                                         or violate (as the case may be) any proprietary or Intellectual Property rights of any
                                         Third Party;

 

		11.1.5	it
                                         shall promptly notify Customer in writing if it receives or is notified of a formal written
                                         claim from a Third Party that Lonza Information, Lonza Background Intellectual Property
                                         or New General Application Intellectual Property, as it relates to the Services under
                                         this Agreement, or that the use by Customer thereof, to the extent permitted under this
                                         Agreement, infringes, misappropriates or violates (as the case may be) any proprietary
                                         or Intellectual Property rights of any Third Party;

 

		11.1.6	the
                                         Services shall be performed in accordance with all Applicable Laws;

 

		11.1.7	except
                                         with respect to any development services and Engineering Batches, the manufacture of
                                         Product shall be performed in accordance with cGMP and will meet the Specifications at
                                         the date of delivery; and

 

		11.1.8	it
                                         or its Affiliates hold all necessary permits, approvals, consents and licenses to enable
                                         it to perform the Services at the Facility , except to the extent that failure to maintain
                                         such licenses, permits and approvals do not have a material adverse impact on the ability
                                         to manufacture the Product in the Facility, or on the Services provided under this Agreement.

 

		11.2	Customer
                                         warrants that:

 

		11.2.1	it
                                         has the full power and right to enter into this Agreement and that there are no outstanding
                                         agreements, assignments, licenses, encumbrances or rights of any kind, that would breach
                                         the provisions of this Agreement;

 

		11.2.2	the
                                         execution and delivery of this Agreement by Customer has been authorized by all requisite
                                         corporate or company action and this Agreement is and shall remain a valid and binding
                                         obligation of Lonza, enforceable in accordance with its terms;

 

    
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		11.2.3	all
                                         Raw Materials actually supplied by Customer shall be provided with a certificate of analysis
                                         or other relevant documentation demonstrating that such Raw Materials meet the following
                                         Lonza acceptance criteria: (i) are not contaminated, (ii) test negative for mycoplasma
                                         and bioburden (if applicable), (iii) have been manufactured in accordance with GMP (if
                                         applicable), (iv) are free from all liens, charges, or encumbrances, and (v) meet other
                                         testing requirements and/or specifications as may be agreed in writing by the Parties.
                                         In addition, Customer has provided any environmental, health and safety information related
                                         to the Raw Materials (including employee health and safety, of the handling, manufacture,
                                         distribution, use and disposal of the Raw Materials), and will update, clarify, correct,
                                         supplement and amend such information as necessary;

 

		11.2.4	it
                                         has all the rights necessary to permit Lonza and its relevant Affiliates to perform the
                                         Services without infringing the Intellectual Property rights of any Third Party and the
                                         performance of the Services, including the use of the Manufacturing Process, shall not
                                         infringe, misappropriate or violate (as the case may be) any proprietary or Intellectual
                                         Property rights of any Third Party; and

 

		11.2.5	it
                                         shall promptly notify Lonza in writing if it receives or is notified of a formal written
                                         claim from a Third Party that Customer Information and/or Customer Intellectual Property
                                         or that the use by Lonza thereof for the provision of the Services infringes , misappropriates
                                         or violates (as the case may be) any proprietary or Intellectual Property or other rights
                                         of any Third Party;

 

		11.2.6	In
                                         connection with its receipt and usage of the Services and Products, Customer shall comply
                                         with, and shall cause its Affiliates, subsidiaries, subcontractors, directors, officers,
                                         employees, agents or any other person acting on behalf of Customer (its “Relevant
                                         Agents”) to comply with, all applicable Corruption Laws and International Trade
                                         Restrictions. Customer’s receipt and usage of the Services and Products shall be
                                         in accordance with Applicable Laws; and

 

		11.3	In
                                         connection with its receipt and usage of the Services and Products, Customer shall take
                                         appropriate technical and organizational measures to ensure compliance with the GDPR.
                                         Customer shall in compliance with GDPR as well as on Lonza’s request, destroy all
                                         personal data, unless Applicable Law prevents Customer from destroying. Customer confirms
                                         that any customer personal identifiable data shared with Lonza is done in accordance
                                         with the requirements of the GDPR.

 

		11.4	DISCLAIMER:
                                         THE WARRANTIES EXPRESSLY SET FORTH IN THIS AGREEMENT ARE IN LIEU OF ALL OTHER WARRANTIES,
                                         AND ALL OTHER WARRANTIES, BOTH EXPRESS AND IMPLIED, ARE EXPRESSLY DISCLAIMED, INCLUDING
                                         WITHOUT LIMITATION ANY WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE.

 

		12.	Indemnification
and Liability

 

		12.1	Indemnification
                                         by Lonza. Lonza shall indemnify the Customer, its Affiliates, and their respective
                                         officers, employees and agents (“Customer Indemnitees”) for any loss, damage,
                                         costs and expenses (including reasonable attorney fees) that Customer Indemnitees may
                                         suffer as a result of any Third Party claim arising directly out of (i) any material
                                         breach of the warranties given by Lonza in Clause 11.1 above or (ii) any claims alleging
                                         that the Services (excluding use by Lonza of Customer Information and Customer Background
                                         Intellectual Property) infringe any Intellectual Property rights of a Third Party except,
                                         in each case, to the extent that such claims resulted from the negligence, intentional
                                         misconduct or breach of this Agreement by any Customer Indemnitees.

 

    
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		12.2	Indemnification
                                         by Customer. Customer shall indemnify Lonza, its Affiliates, and their respective
                                         officers, employees and agents (“Lonza Indemnitees”) from and against any
                                         loss, damage, costs and expenses (including reasonable attorney fees) that Lonza Indemnitees
                                         may suffer as a result of any Third Party claim arising directly out of (i) any material
                                         breach of the warranties given by Customer in Clause 11.1.1 above; or (ii) any claims
                                         alleging that the performance of Services infringes any Intellectual Property rights
                                         of third parties; or (iii) the manufacture, use, sale, or distribution of any Product,
                                         including any claims of product liability; except, in each case, to the extent that such
                                         claims resulted from the negligence, intentional misconduct or breach of this Agreement
                                         by any Lonza Indemnitees.

 

		12.3	Indemnification
                                         Procedure. If the Party to be indemnified intends to claim indemnification under
                                         this Clause 12, it shall promptly notify the indemnifying Party in writing of such claim.
                                         The indemnitor shall have the right to control the defense and settlement thereof; provided,
                                         however, that any indemnitee shall have the right to retain its own counsel at its own
                                         expense. The indemnitee, its employees and agents, shall reasonably cooperate with the
                                         indemnitor in the investigation of any liability covered by this Clause 12. The failure
                                         to deliver prompt written notice to the indemnitor of any claim, to the extent prejudicial
                                         to its ability to defend such claim, shall relieve the indemnitor of any obligation to
                                         the indemnitee under this Clause 12.

 

		12.4	DISCLAIMER
                                         OF CONSEQUENTIAL DAMAGES. IN NO EVENT SHALL EITHER PARTY BE LIABLE TO THE OTHER PARTY
                                         FOR INCIDENTAL, INDIRECT, SPECIAL, PUNITIVE OR CONSEQUENTIAL DAMAGES, LOST PROFITS OR
                                         LOST REVENUES ARISING FROM OR RELATED TO THIS AGREEMENT, EXCEPT TO THE EXTENT RESULTING
                                         FROM FRAUD, GROSS NEGLIGENCE OR INTENTIONAL MISCONDUCT.

 

		12.5	LIMITATION
                                         OF LIABILITY. LONZA’S LIABILITY UNDER THIS AGREEMENT SHALL IN NO EVENT EXCEED,
                                         IN THE AGGREGATE, THE TOTAL AMOUNTS PAID BY CUSTOMER TO LONZA UNDER THE PROJECT PLAN
                                         GIVING RISE TO SUCH CLAIM FOR DAMAGES, EXCEPT TO THE EXTENT RESULTING FROM LONZA’S
                                         FRAUD, GROSS NEGLIGENCE OR INTENTIONAL MISCONDUCT.

 

		13.	Confidentiality

 

		13.1	A
                                         Party receiving Confidential Information (the “Receiving Party”) agrees to
                                         strictly keep secret any and all Confidential Information received during the Term from
                                         or on behalf of the other Party (the “Disclosing Party”) using at least the
                                         same level of measures as it uses to protect its own Confidential Information, but in
                                         any case at least commercially reasonable and customary efforts. Confidential Information
                                         shall include information disclosed in any form including but not limited to in writing,
                                         orally, graphically or in electronic or other form to the Receiving Party, observed by
                                         the Receiving Party or its employees, agents, consultants, or representatives, or otherwise
                                         learned by the Receiving Party under this Agreement, which the Receiving Party knows
                                         or reasonably should know is confidential or proprietary.

 

		13.2	Notwithstanding
                                         the foregoing, Receiving Party may disclose to any courts and/or other authorities Confidential
                                         Information which is or will be required pursuant to applicable governmental or administrative
                                         or public law, rule, regulation or order. In such case the Party that received the Confidential
                                         Information will, to the extent legally permitted, inform the other Party promptly in
                                         writing and cooperate with the Disclosing Party in seeking to minimize the extent of
                                         Confidential Information which is required to be disclosed to the courts and/or authorities.

 

    
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		13.3	The
                                         obligation to maintain confidentiality under this Agreement does not apply to Confidential
                                         Information, which:

 

		13.3.1	at
                                         the time of disclosure was publicly available; or

 

		13.3.2	is
                                         or becomes publicly available other than as a result of a breach of this Agreement by
                                         the Receiving Party; or

 

		13.3.3	as
                                         the Receiving Party can establish by competent proof, was rightfully in its possession
                                         at the time of disclosure by the Disclosing Party and had not been received from or on
                                         behalf of Disclosing Party; or

 

		13.3.4	is
                                         supplied to a Party by a Third Party which was not in breach of an obligation of confidentiality
                                         to Disclosing Party or any other party; or

 

		13.3.5	is
                                         developed by the Receiving Party independently from and without use of the Confidential
                                         Information, as evidenced by contemporaneous written records.

 

		13.4	The
                                         Receiving Party will use Confidential Information only for the purposes of this Agreement
                                         and will not make any use of the Confidential Information for its own separate benefit
                                         or the benefit of any Third Party including, without limitation, with respect to research
                                         or product development or any reverse engineering or similar testing. The Receiving Party
                                         agrees to return or destroy promptly (and certify such destruction) on Disclosing Party’s
                                         request all written or tangible Confidential Information of the Disclosing Party, except
                                         that one copy of such Confidential Information may be kept by the Receiving Party in
                                         its confidential files for record keeping purposes only.

 

		13.5	Each
                                         Party will restrict the disclosure of Confidential Information to such officers, employees,
                                         consultants and representatives of itself and its Affiliates who have been informed of
                                         the confidential nature of the Confidential Information and who have a need to know such
                                         Confidential Information for the purpose of this Agreement. Prior to disclosure to such
                                         persons, the Receiving Party shall bind its and its Affiliates’ officers, employees,
                                         consultants and representatives to confidentiality and non-use obligations no less stringent
                                         than those set forth herein. The Receiving Party shall notify the Disclosing Party as
                                         promptly as practicable of any unauthorized use or disclosure of the Confidential Information.

 

		13.6	The
                                         Receiving Party shall at any time be fully liable for any and all breaches of the confidentiality
                                         obligations in this Clause 13 by any of its Affiliates or the employees, consultants
                                         and representatives of itself or its Affiliates.

 

		13.7	Each
                                         Party hereto expressly agrees that any breach or threatened breach of the undertakings
                                         of confidentiality provided under this Clause 13 by a Party may cause irreparable harm
                                         to the other Party and that money damages may not provide a sufficient remedy to the
                                         non-breaching Party for any breach or threatened breach. In the event of any breach and/or
                                         threatened breach, then, in addition to all other remedies available at law or in equity,
                                         the non-breaching Party shall be entitled to seek injunctive relief and any other relief
                                         deemed appropriate by the non-breaching Party.

 

		13.8	All
                                         obligations of confidentiality under this Clause 13 will terminate seven (7) years after
                                         the expiration or termination of the Term; provided however that the obligations of confidentiality
                                         for Confidential Information identified as a trade secret will survive indefinitely until
                                         such trade secret information no longer qualifies as a trade secret.

 

    
	CONFIDENTIAL  	Page 20 of 27

 

     

    

 

CONFIDENTIAL

 

		14.	Term
and Termination

 

		14.1	Term.
                                         This Agreement shall commence on the Effective Date and shall end on the third (3rd)
                                         anniversary of the Effective Date unless terminated earlier as provided herein or extended
                                         by mutual written consent of the Parties (the “Term”). Notwithstanding the
                                         foregoing, each Project Plan may have separate term and termination provisions so long
                                         as the term of any Project Plan does not extend beyond the Term.

 

		14.2	Termination.
                                         This Agreement may be terminated as follows:

 

		14.2.1	by
                                         either Party if the other Party breaches a material provision of this Agreement or a
                                         Project Plan and fails to cure such breach to the reasonable satisfaction of the non-breaching
                                         Party within ninety (90) days ten (10) days for non-payment) following written notification
                                         of such breach from the non-breaching party to the breaching party; provided, however,
                                         that such ninety (90) day period shall be extended as agreed by the Parties if the identified
                                         breach is incapable of cure within ninety (90) days and if the breaching Party provides
                                         a plan and timeline to cure the breach, promptly commences efforts to cure the breach
                                         and diligently prosecutes such cure (it being understood that this extended period shall
                                         be unavailable for any breach regarding non-payment);

 

		14.2.2	by
                                         either Party, immediately, if the other Party becomes insolvent, is dissolved or liquidated,
                                         makes a general assignment for the benefit of its creditors, or files or has filed against
                                         it, a petition in bankruptcy or has a receiver appointed for a substantial part of its
                                         assets; or

 

		14.2.3	by
                                         either Party pursuant to Clause 15.

 

		14.3	Consequences
                                         of Termination. In the event of termination hereunder, Lonza shall be compensated
                                         for (i) Services rendered up to the date of termination, including in respect of any
                                         Product in-process; (ii) subject to Section 2.9, all costs incurred through the date
                                         of termination, including Raw Materials costs and Raw Materials Fees for Raw Materials
                                         used or purchased for use in connection with the Project Plan; (iii) all unreimbursed
                                         Capital Equipment and related decommissioning charges incurred pursuant to Clause 9;
                                         and (iv) any applicable Cancellation Fees. In the case of termination by Lonza for Customer’s
                                         material breach, Cancellation Fees shall be calculated as of the date of written notice
                                         of termination.

 

		14.4	Survival.
                                         The rights and obligations of each Party which by their nature survive the termination
                                         or expiration of this Agreement shall survive the termination or expiration of this Agreement,
                                         including, as applicable, Clauses 5 (insurance), 8.3, 8.4, 10 (intellectual property),
                                         12 (indemnification and liability), 13 (confidentiality), 14.3, and 16 (to the extent
                                         relevant).

 

		15.	Force
Majeure

 

		15.1	If
                                         Lonza is prevented or delayed in the performance of any of its obligations under the
                                         Agreement by Force Majeure and gives written notice thereof to Customer specifying the
                                         matters constituting Force Majeure together with such evidence as Lonza reasonably can
                                         give and specifying the period for which it is estimated that such prevention or delay
                                         will continue, Lonza shall be excused from the performance or the punctual performance
                                         of such obligations as the case may be from the date of such notice for so long as such
                                         cause of prevention or delay shall continue. Provided that, if such Force Majeure persists
                                         for a period of six (6) months or more, Customer may terminate this Agreement by delivering
                                         written notice to Lonza.

 

    
	CONFIDENTIAL  	Page 21 of 27

 

     

    

 

CONFIDENTIAL

 

		15.2	“Force
                                         Majeure” shall be deemed to include any reason or cause beyond Lonza’s reasonable
                                         control affecting the performance by Lonza of its obligations under the Agreement, including,
                                         but not limited to, any cause arising from or attributable to acts of God, strike, lockouts,
                                         labor troubles, restrictive governmental orders or decrees, riots, insurrection, war,
                                         terrorists acts, or the inability of Lonza to obtain any required raw material, energy
                                         source, equipment, labor or transportation, at prices and on terms deemed by Lonza to
                                         be reasonably practicable, from Lonza’s usual sources of supply.

 

		15.3	With
                                         regard to Lonza, any such event of Force Majeure affecting services or production at
                                         its Affiliates or suppliers shall be regarded as an event of Force Majeure.

 

		16.	Miscellaneous

 

		16.1	Non-Solicitation.
                                         During the term of this Agreement and for two (2) years thereafter, Customer agrees not
                                         to seek to induce or solicit any employee of Lonza to discontinue his or her employment
                                         with Lonza in order to become an employee or an independent contractor of Customer or
                                         its Affiliates; provided, however, that Customer shall be in violation of this Section
                                         16.1 as a result of making a general solicitation for employees or independent contractors.
                                         For the avoidance of doubt, the publication of an advertisement shall not constitute
                                         solicitation or inducement.

 

		16.2	Severability.
                                         If any provision hereof is or becomes at any time illegal, invalid or unenforceable in
                                         any respect, neither the legality, validity nor enforceability of the remaining provisions
                                         hereof shall in any way be affected or impaired thereby. The Parties hereto undertake
                                         to substitute any illegal, invalid or unenforceable provision by a provision which is
                                         as far as possible commercially equivalent considering the legal interests and the Purpose.

 

		16.3	Amendments/Assignment.
                                         Modifications and/or amendments of this Agreement must be in writing and signed by the
                                         Parties. Lonza shall be entitled to instruct one or more of its Affiliates to perform
                                         any of Lonza’s obligations contained in this Agreement, but Lonza shall remain
                                         fully responsible in respect of those obligations. Subject thereto, neither Party may
                                         assign its interest under this Agreement without the prior written consent of the other
                                         Party, such consent not to be unreasonably withheld, conditioned or delayed, provided,
                                         however that (a) Lonza may assign this Agreement to (i) any Affiliate of Lonza or (ii)
                                         any third party in connection with the sale or transfer (by whatever method) of all or
                                         substantially all of the assets of the business related to the Facility or providing
                                         the Services, and (b) Lonza shall be entitled to sell, assign and/or transfer its trade
                                         receivables resulting from this Agreement without the consent of the Customer. For purposes
                                         of this Clause 16.3, the terms “assign” and “assignment” shall
                                         include, without limitation (i) the sale of fifty percent (50%) or more of the outstanding
                                         stock of such Party to an Affiliate of such Party or an unrelated entity or natural person,
                                         (ii) the sale or transfer or other assignment of all or substantially all of the assets
                                         of the Party or the line of business or Product to which this Agreement relates, and
                                         (iii) a merger, consolidation, acquisition or other form of business combination. Any
                                         purported assignment without a required consent shall be void. No assignment shall relieve
                                         any Party of responsibility for the performance of any obligation that accrued prior
                                         to the effective date of such assignment.

 

		16.4	Notice.
                                         All notices must be written and sent to the address of the Party first set forth above.
                                         All notices must be given (a) by personal delivery, with receipt acknowledged, (b) by
                                         facsimile followed by hard copy delivered by the methods under (c) or (d), (c) by prepaid
                                         certified or registered mail, return receipt requested, or (d) by prepaid recognized
                                         next business day delivery service. Notices will be effective upon receipt or at a later
                                         date stated in the notice.

 

    
	CONFIDENTIAL  	Page 22 of 27

 

     

    

 

CONFIDENTIAL

 

		16.5	Governing
                                         Law/Jurisdiction. This Agreement is governed in all respects by the laws of the State
                                         of New York, USA. The Parties agree to submit to the jurisdiction of the state and federal
                                         courts of the State of New York, USA.

 

		16.6	Entire
                                         Agreement. This Agreement contains the entire agreement between the Parties as to
                                         the subject matter hereof and supersedes all prior and contemporaneous agreements with
                                         respect to the subject matter hereof. This Agreement may be executed in any number of
                                         counterparts, each of which shall be deemed to be an original, and all of which together
                                         shall constitute one and the same document. Each party acknowledges that an original
                                         signature or a copy thereof transmitted by facsimile or by .pdf shall constitute an original
                                         signature for purposes of this Agreement.

 

[Signature
page follows.]

 

    
	CONFIDENTIAL  	Page 23 of 27

 

     

    

 

CONFIDENTIAL

 

IN
WITNESS WHEREOF, each of the Parties hereto has caused this Development and Manufacturing Services Agreement to be executed by
its duly authorized representative as of the Effective Date.

 

	 	LONZA LTD
	 	 	 	 
	 	By:	/s/
    Bart van Aarnhem 
	 	Name: 	Bart van Aarnhem
	 	Title: 	Associate General Counsel

  

	 	By:	/s/
    Marie Leblanc
	 	Name: 	Marie Leblanc
	 	Title: 	Head of Sales EMEA, Small Molecues
	 	 	 	 

	 	XORTX
	 	 	 
	 	By:	/s/ Allen
    Davidoff 
	 	 	Allen Davidoff
	 	 	CEO

 

    
	CONFIDENTIAL  	Page 24 of 27

 

     

    

  

APPENDIX
A

Project Plan A -1 

 

Project
Plan titled “GMP Manufacture of 14kg Oxypurinol”, dated March 31, 2021

 

(Lonza
Reference: PN-036484)

 

    
	CONFIDENTIAL  	Page 25 of 27

 

     

    

 

APPENDIX
B

Quality Agreement

 

[To
be attached once finalized]

 

    
	CONFIDENTIAL  	Page 26 of 27

 

     

    

  

APPENDIX
C

 

Translation
Costs

 

As
of the Effective Date, Lonza’s cost of translation that is referenced in Section 4.3 of the Agreement is as follows:

 

		●	$1,500
                                         (One Thousand Five Hundred USD) per executed Batch record.

 

    
	CONFIDENTIAL  	Page 27 of 27Exhibit
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;

 

    2 

     

    

 

		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.

 

    3 

     

    

 

		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.

 

    4 

     

    

 

		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.

 

    5 

     

    

 

		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.

 

    6 

     

    

 

		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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