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”)


  






    
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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	 



 



    
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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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	“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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	“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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	“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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	“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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		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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		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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		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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		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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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
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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.



 






    
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		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.



 






    
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		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.



 



    
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		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.]


 




    
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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









 




    
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APPENDIX
A

Project Plan A -1 


 


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


 


(Lonza
Reference: PN-036484)


 




    
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APPENDIX
B

Quality Agreement


 


[To
be attached once finalized]


 




    
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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.



 








    
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