Exhibit
10.10


 


		[*]	Certain
information in this document has been omitted from this exhibit because it is both (i) not material and (ii) would be competitively harmful
if publicly disclosed.



 







 


MASTER
SERVICES AGREEMENT BETWEEN UNICYCIVE THERAPEUTICS, INC.AND ASCENT DEVELOPMENT SERVICES, INC.


 


This
Master Services Agreement (this “Agreement”) is effective as of 08 February 2021 (the “Effective Date”)
by and between Unicycive Therapeutics, Inc. a corporation organized and existing under the laws of Californa, USA and having a place
of business at 5150 El Camino Real, Suite A-32, Los Altos, CA 94022 (“Unicycive”) and Ascent Development Services,
Inc., a corporation organized under the laws of Japan having a place of business at Shibuya SOLASTA 3F, 1-21-1 Dogenzaka, Shibuya-ku,
Tokyo 150-0043, Japan (“Ascent”). Unicycive and Ascent may be referred to herein individually as a “Party”
and collectively as the “Parties.”


 


WHEREAS,
Unicycive desires to develop the investigational product Renazorb or other investigational products as agreed by the parties (the “Compound(s)”)
for clinical use in Japan and other Asian countries (“Asian Countries”) to commercialize the Compound in Asian Countries;


 


WHEREAS,
Unicycive desires to obtain the services of Ascent in connection with the Asian development of Unicycive’s Compound(s) (“Project”)
and Ascent is willing to provide such services to Unicycive under the terms and conditions of this Agreement.


 


NOW
THEREFORE, in consideration of the mutual promises hereinafter set forth, the Parties hereby agree as follows:


 


		1	SERVICES
AND STATEMENTS OF WORK.



 


		1.1	Engagement.
                                            Unicycive hereby retains Ascent to provide certain services in connection with the Projects
                                            (the “Services”), and Ascent agrees to provide the Services to Unicycive
                                            under the terms and conditions of this Agreement.



 


		1.2	Statements
of Work. This Agreement contains general terms and conditions under which Unicycive would engage Ascent and under which Ascent would
provide Services to Unicycive. Unicycive and Ascent must complete and execute a work order, project order or statement of work for each
Project referencing this Agreement (each, a “Statement of Work”) before any Services are provided. Each Statement
of Work shall describe in reasonably sufficient detail, (i) the Services to be performed, (ii) the clinical study to be conducted (if
applicable), (iii) the materials, reports, documentation or other deliverables to be provided to Unicycive (the “Deliverables”),
(iv) the specifications thereto (if applicable), (v) any special terms and conditions applicable to such Services or Deliverables, (vi)
an estimate of the costs and payments for such Services, (vii) the schedule for the provision of such Services and Deliverables, and
(viii) the project representatives for each Party. Neither Unicycive nor Ascent is obligated to execute any Statement of Work. Once executed,
each Statement of Work becomes part of this Agreement, and each such Statement of Work and this Agreement shall constitute the entire
agreement for the Services provided under such Statement of Work. The terms in a Statement of Work will apply only to Services described
in that Statement of Work.



 






     


     


    

 


		1.3	Scope
of Services. The Services to be performed by Ascent as part of a Project and pursuant to the Statement of Work for such Project may
include some or all of the following:



 


		1.3.1	Perform
market research, including interviews with key opinion leaders, industry experts, and relevant organizations; collect information concerning
current treatment practice and unmet medical need; and make key success factor and competitive analyses for the development of the Compound
in Japan;



 


		1.3.2	Build
                                            project management procedure and infrastructure necessary for implementation of the Services;



 


		1.3.3	Hire
                                            and manage analysis agencies and contract research organizations (“CROs”)
                                            to monitor and manage the progress of the Project;



 


		1.3.4	Obtain
                                            government permission required for the conduct of clinical trials and the import of the Compound
                                            and establish the system required for safekeeping and arrangement of transportation of the
                                            Compound;



 


		1.3.5	Prepare
                                            or translate the investigator's brochure, the informed consent form, and the clinical study
                                            protocol, and other documentation required for conduct of a clinical trial;



 


		1.3.6	Select
                                            and retain medical professionals and experts with relevant cumulative experience and knowledge,
                                            as necessary;



 


		1.3.7	Select
                                            medical institutions and investigators responsible for the Project and secure the number
                                            of medical institutions and trial subjects required to conduct the Project;



 






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		1.3.8	Collect
                                            and report information concerning side effects of the Compound;



 


		1.3.9	Manage
                                            the closing process of the Project;



 


		1.3.10	Construct
                                            a system for safekeeping, control, and maintenance of all the relevant documents throughout
                                            the required document-retention period;



 


		1.3.11	Report
                                            on the progress and results of the Project to Unicycive;



 


		1.3.12	Prepare
                                            and keep record of expenses incurred in performing the Services; and



 


		1.3.13	Any
                                            other services that the Parties may specify in such Statement of Work.



 


		1.4	Subcontracting.
Ascent shall not subcontract the Services, in whole or in part, to any third party without the prior written consent of Unicycive.
All permitted subcontracted Services shall be performed under the terms of a written agreement entered into between Ascent and a qualified
subcontractor or consultant; provided, however, that Ascent shall be responsible for the performance of such subcontractors and consultants.
Each such subcontract agreement shall include terms and conditions consistent with the terms and conditions of this Agreement, including
without limitation terms and conditions with respect to Inventions (as defined in Section 13.2) and Confidential Information (as defined
in Section 4.1) sufficient to secure and protect the rights of Unicycive consistent with the intent of this Agreement. Each such subcontract
agreement shall include, to the extent permitted under applicable law, a provision that makes Unicycive a third party beneficiary of
Ascent’s rights under such subcontract agreement, including without limitation the right for Unicycive to enforce the confidentiality
and intellectual property ownership provisions in such subcontract directly against such subcontractor.



 


		1.5	Changes
                                            to a Statement of Work. During the term of this Agreement, the Parties may make changes
                                            to any Statement of Work by preparing an amendment reflecting such changes, which shall be
                                            signed by both Parties (a “Change Order”). The Change Order will become
                                            effective upon the execution of the Change Order by both Parties, and Ascent will be given
                                            a reasonable period of time under the circumstances within which to implement the changes,
                                            as further detailed in the Change Order. Both Parties agree to act in good faith and promptly
                                            when considering a Change Order requested by the other Party. While the Parties negotiate
                                            a Change Order, Ascent is hereby authorized to provide additional services, the performance
                                            of which shall be subject to the terms of this Agreement; provided that such additional services
                                            and any costs associated with such additional services are specifically requested and authorized
                                            in writing by Unicycive. Unicycive hereby agrees to pay for such authorized additional services
                                            at a price mutually agreed upon in writing by the Parties regardless of whether or not a
                                            Change Order is executed
by the Parties.



 




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		1.6	Instruction;
Performance. Unicycive may give instructions to Ascent in writing concerning Ascent’s implementation and performance of the
Services from time to time when necessary, and Ascent shall take appropriate measures in accordance with the instructions given by Unicycive,
provided that, to the extent any such instructions would require a change in the applicable Statement of Work, the Parties shall execute
a Change Order pursuant to Section 1.5. Ascent shall perform all Services identified in any Statement of Work (i) in compliance with
(a) the terms, conditions and specifications set forth in the Statement of Work, including without limitation, the protocol for the applicable
Services (as may be amended or updated from time to time by Unicycive) and (b) the terms and conditions of this Agreement, (ii) in a
professional manner in accordance with accepted industry standards, and (iii) using commercially reasonable efforts to perform all Services,
and deliver all Deliverables, in accordance with the timelines set forth in the Statement of Work.



 


		2	RESPONSIBILITIES
OF ASCENT



 


		2.1	Compliance
                                            with Government Laws and Regulations. Ascent will perform the Services in compliance
                                            with any and all applicable national, provincial and local laws, rules and regulations, including
                                            without limitation any regulations promulgated by regulatory authorities which apply to the
                                            Services in any country or territory in which they are provided (collectively, “Applicable
                                            Law”).



 


		2.2	Regulatory
                                            Filings. Except as separately agreed to in writing between the Parties, Ascent shall
                                            be solely responsible, at the sole cost and expense of Unicycive, for preparing and filing
                                            any and all regulatory filings relating to the Project and the Services and shall be responsible
                                            for all interactions with regulatory authorities relating thereto. Ascent shall make available
                                            to Unicycive, or to the responsible regulatory authority, any and all relevant records, programs
                                            and data as may be reasonably requested by Unicycive for purposes relating to Unicycive’s
                                            regulatory filings.



 


		2.3	Adverse
                                            Events. In the event that under this Agreement or any Statement of Work, Ascent shall
                                            be responsible for reporting to the applicable regulatory authorities any adverse events
                                            related to the use of the Compound, Ascent shall provide Unicycive with prompt prior written
                                            notice upon becoming aware of the need to make such reports, and shall provide Unicycive
                                            with a copy of any such proposed communication with regulatory authorities for review and
                                            comment. Unicycive shall provide such comments promptly and in any event within five (5)
                                            days of receiving notice of the need for such report, and Ascent shall incorporate any reasonable
                                            comments from Unicycive in such report.



 




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		2.4	Informed
                                            Consent. Under this Agreement, Ascent may develop a standard form of informed consent
                                            (an “Informed Consent”) for each Project and require each study subject
                                            to sign such Informed Consent prior to such study subject’s participation in the applicable
                                            study. All such Informed Consents shall comply with the requirements of the study protocol
                                            and all Applicable Law. The approved form of Informed Consents shall include language intended
                                            to serve as appropriate authorization for the disclosure of protected health information
                                            of the applicable study subject, including without limitation all Personal Data (as defined
                                            in Section 6.1) to Ascent and Unicycive. Ascent will provide Unicycive with copies of all
                                            Informed Consents from the study sites for approval prior to being put into effect. The Informed
                                            Consents and any modifications thereto shall be subject to the approval of Unicycive and
                                            the relevant Institutional Review Board prior to any use thereof. Any transfer of responsibility
                                            for obtaining Informed Consent as required under Applicable Law will be set forth in the
                                            applicable Statement of Work.



 


		2.5	Study
                                            Sites. Each study site and investigator proposed by Ascent for participation in the study
                                            must be approved by Unicycive prior to initiation of any on-site study-related activities
                                            involving that study site or investigator. Following receipt of such approval by Unicycive,
                                            Ascent will assist with negotiation and execution of a clinical trial agreement with each
                                            such investigator in the form approved by Unicycive. Unless otherwise specifically requested
                                            by Unicycive in writing or required under Applicable Law, Ascent will not contract directly
                                            as a party to any clinical trial agreements with participating study sites. The clinical
                                            trial agreements and any modifications thereto shall be subject to the written approval of
                                            Unicycive prior to any use thereof.



 


		3	RESPONSIBILITIES
OF UNICYCIVE



 


		3.1	Unicycive
Supplied Materials. Unicycive shall, in accordance with the applicable Statement of Work, deliver to Ascent, at Unicycive’s
cost and expense, any and all materials, including but not limited to the Compound, identified in the Statement of Work as Unicycive’s
responsibility to deliver to Ascent or otherwise agreed to between the Parties (collectively, the “Unicycive Supplied Materials”).
Unicycive shall at all times retain title to any and all Unicycive Supplied Materials. Ascent shall provide storage of the Unicycive
Supplied Materials in accordance with the applicable specifications for such Unicycive Supplied Materials as supplied by Unicycive to
Ascent. Ascent shall only use the Unicycive Supplied Materials for the purpose of conducting the Projects and for no other purpose. Ascent
shall not allow any Unicycive Supplied Materials to be transferred to any third parties not authorized by Unicycive. If any quantity
of the Compound or any Unicycive Supplied Materials are lost, damaged, or destroyed (unless authorized by Unicycive in writing) while
in Ascent’s control due to the negligent or intentional act or omission of Ascent or its employees or agents, Ascent will promptly
provide Unicycive with appropriate documentation as to the occurrence, and, in Unicycive’s sole discretion, Ascent shall be liable
to Unicycive for the replacement cost of such Compound or such Unicycive Supplied Materials. Ascent shall maintain complete and accurate
records accounting for and documenting the use of all Unicycive Supplied Materials.



 






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		3.2	Fees
                                            and Expenses. Unicycive shall pay Ascent for the Services performed under this Agreement
                                            and any Statement of Work in accordance with the rates for such Services set forth in such
                                            Statement of Work, including any bank transfer and currency exchange fees associated with
                                            each payment. Ascent shall invoice Unicycive according to the terms in the applicable Statement
                                            of Work.



 


		3.3	Side
                                            Effects. Ascent shall notify Unicycive immediately in writing upon becoming aware of
                                            any side effects arising from the use of the Compound in relation to the Project. Unicycive
                                            shall provide Ascent with information on side effects with respect to the Compound within
                                            a reasonable period of time after Unicycive becomes aware of any such side effects.



 


		4	CONFIDENTIALITY



 


		4.1	Confidential
                                            Information. “Confidential Information” means any and all confidential or
                                            proprietary information and materials that will be or have been disclosed or otherwise provided
                                            by either Party (the “Discloser”) to the other Party (the “Recipient”)
                                            in writing, physically, orally or visually in connection with the Services, and that: (a)
                                            is identified as confidential or proprietary at the time of disclosure; or (b) by its nature
                                            should reasonably be understood by the Recipient to be confidential or proprietary. Confidential
                                            information shall include, without limitation, any and all information concerning Discloser’s
                                            know-how, data, specifications, documents, techniques, processes, protocols, formulae, chemical
                                            structures and identity, product samples, computer programs, software, apparatus, reports,
                                            trade secrets, business plans, referral sources, billing information, fee structures, identity
                                            and compensation to employees, contracts and leases, client lists, business models, technology,
                                            data, plans, specifications, study management tools, or other information, and any and all
                                            of such information that the Discloser is under an obligation to a third party to maintain
                                            as confidential.



 


		4.2	Protection
of Confidential Information. The Parties acknowledge that in the course of the work hereunder, it will be necessary for each Party
to disclose Confidential Information to the other Party. Each Party, as a Recipient, agrees not to transfer or otherwise disclose any
Confidential Information to any third party, and not to use the Confidential Information except solely to perform its obligations under
this Agreement. Each Party, as a Recipient, (i) may disclose Confidential Information solely to those of its affiliates, employees, representatives,
agents, independent consultants and advisors (collectively, “Representatives”) on a need-to-know basis who are bound
by written obligations of non-disclosure and non-use no less protective than those contained herein, and (ii) shall take the same precautions
to protect against unauthorized disclosure or use of such Confidential Information that such Party takes to protect its own confidential
information, but in no event less than a reasonable standard of care.



 






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		4.3	Exception
                                            to Confidentiality Obligation. Notwithstanding the foregoing, the confidentiality and
                                            non-use obligations set forth in this Article 4 shall not apply to:



 


		4.3.1	Information
which the Recipient can prove to have already been known to or possessed by it prior to the disclosure by Discloser, provided that the
source of such information was not known by the Recipient or its Representatives to be bound by a confidentiality obligation to the Discloser;



 


		4.3.2	Information
                                            which has already been known to the public prior to its disclosure to the Recipient by or
                                            on behalf of the Discloser;



 


		4.3.3	Information
                                            which becomes known to the public after the disclosure without any fault of the Recipient;



 


		4.3.4	Information
                                            which is lawfully received by the Recipient from a third party having legitimate authority
                                            to disclose such information and not bound by a confidentiality obligation to the Discloser;
                                            and



 


		4.3.5	Information
which is independently developed by Recipient without access to or use of the Confidential Information of the other Party.



 


		4.4	Required
                                            Disclosure of Confidential Information. The Recipient may disclose Confidential Information
                                            of the Discloser to a court or other government body of competent jurisdiction when required
                                            to do so pursuant to an order of such body or if otherwise required to do so pursuant to
                                            Applicable Law (including without limitation in connection with filings with the United States
                                            Food and Drug Administration, the United States Securities and Exchange Commission, or any
                                            other applicable governmental agency) or the rules of any securities exchange, provided it
                                            uses reasonable efforts (i) to give prompt prior notice to the Discloser to contest such
                                            order, and (ii) to limit disclosure to that which is required pursuant to Applicable Law.



 






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		4.5	Effect
of Termination.Upon termination of this Agreement, all Confidential Information (and all copies thereof) furnished to the Recipient
or its Representatives by or on behalf of the Discloser pursuant hereto, shall be, at the Discloser’s option, returned to the Discloser
or destroyed and no copy thereof shall be retained, except (i) that a single copy of all such Confidential Information may be retained
in confidence by the Recipient’s internal or outside legal counsel solely for the purposes of determining its obligations hereunder,
and (ii) the Recipient may retain one or more copies of Confidential Information if the Recipient is required to retain one or more copies
of any such Confidential Information to comply with all Applicable Law. The Recipient and its Representatives will continue to be bound
by its obligations of non-use and non- disclosure of Confidential Information of the Discloser under this Agreement for seven (7) years
after termination of this Agreement; provided, however, that the obligations of the Recipient and its Representatives with respect to
trade secrets of the Discloser shall continue perpetually after termination of this Agreement.



 


		4.6	Equitable
Relief. The Parties acknowledge that remedies at law may be inadequate to protect the Discloser against any actual or threatened
breach by the Recipient or its Representatives of the confidentiality provisions of this Agreement, and, without prejudice to any other
rights and remedies otherwise available to the Discloser, the Discloser may seek injunctive relief in the Discloser’s favor to
bar the use or disclosure of Confidential Information without proof of actual damages or requirement to post bond.



 


		5	REPRESENTATIONS
AND WARRANTIES



 


		5.1	Representations
of Each Party. Each Party represents, warrants and covenants to the other Party that:



 


		5.1.1	It
is duly authorized to execute and deliver this Agreement and to perform its obligations hereunder; and



 


		5.1.2	The
                                            terms of this Agreement are not inconsistent with, or do not constitute a violation of, any
                                            contractual or other legal obligation to which such Party is subject.



 


		5.2	Representations
of Unicycive. Unicycive represents, warrants and covenants to Ascent that:



 


		5.2.1	Unicycive
                                            shall perform its activities under this Agreement in compliance with Applicable Law; and



 


		5.2.2	All
Compound supplied by Unicycive to Ascent for use in studies as part of a Project shall be manufactured in compliance with current Good
Manufacturing Practices as required by applicable regulatory authorities.



 






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		5.3	Representations
                                            of Ascent. Ascent represents, warrants and covenants to Unicycive that:



 


		5.3.1	Ascent
                                            shall perform the Services in a professional and workmanlike manner in accordance with Applicable
                                            Laws and regulations in the countries or territories in which Services are provided as well
                                            as any clinical study protocols or standard operating procedures described in the applicable
                                            Statement of Work;



 


		5.3.2	The
                                            Deliverables shall comply with any applicable specifications set forth in the applicable
                                            Statement of Work;



 


		5.3.3	The
                                            Deliverables shall be free and clear of all liens, claims, encumbrances or demands of third
                                            parties, including any claims by any such third party of any right, title or interest in
                                            or to the Deliverables;



 


		5.3.4	Ascent
                                            is not currently employing/contracting any individual/organization who has been (i) debarred
                                            pursuant to 21 U.S.C. § 335a (a) or (b); 306(A) or 306(B) of the Generic Drug Enforcement
                                            Act of 1992, (ii) disqualified as a testing facility under C.F.R. Part 58, Subpart K, or
                                            (iii) disqualified or restricted under 21 C.F.R. 312.70 or, in each of cases (i)-(iii), under
                                            any similar laws or regulations in other countries in which Services are provided, from providing
                                            services in any capacity to a person that has an approved or pending drug product application
                                            under any Applicable Law (a “Debarred Individual”) or an employer, employee
                                            or partner of a Debarred Individual;



 


		5.3.5	Ascent
                                            has never been and is not currently a corporation, partnership or association that has been
                                            debarred by the FDA pursuant to 21 U.S.C. § 335a (a) or (b) or barred by the applicable
                                            regulatory authorities in any other country or territory pursuant to similar laws or regulations
                                            (a “Debarred Entity”) or an employee, partner, shareholder, member, subsidiary
                                            or affiliate of a Debarred Entity;



 


		5.3.6	Ascent
                                            will not use in any capacity under this Agreement the services of any individual, corporation,
                                            partnership, or association that has been (i) debarred under 21 U.S.C. § 335a (as shown
                                            in the most recently published FDA debarment list) or (ii) disqualified as a clinical investigator
                                            under the provision of 21 C.F.R. § 312.70 (as shown in the most recently published FDA
                                            debarment list) or, in each of cases (i) and (ii), any similar laws or regulations in the
                                            countries or territories in which Services are provided; and



 






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		5.3.7	If
                                            Ascent becomes aware of the debarment or disqualification of any such individual, corporation,
                                            partnership, or association providing Services under this Agreement, Ascent shall immediately
                                            notify Unicycive.



 


		6	PROTECTION
OF PERSONAL DATA



 


		6.1	Personal
                                            Data. With respect to the treatment of any personally identifiable information (“Personal
                                            Data”) that may come to the knowledge or possession of either Party in connection
                                            with any Project, any Statement of Work, the Services or otherwise under this Agreement,
                                            each Party represents and warrants to the other Party that it shall comply with the personal
                                            information protection laws, regulations and guidelines which may be applicable to the use
                                            or security of Personal Data (collectively, the “Applicable Data Privacy Laws”).



 


		6.2	Security.
Each Party shall take appropriate security measures to prevent unauthorized access to, or unauthorized disclosure, use, loss or theft
of such Personal Data from occurring in order to ensure protection of privacy of individuals, as required under Applicable Laws.



 


		6.3	Security
Breaches. If Ascent becomes aware of any breach of an Applicable Data Privacy Law relating to the Services, then it shall promptly
notify Unicycive and, if requested, assist Unicycive in meeting any obligations under Applicable Data Privacy Law to notify regulatory
authorities or other required parties at no additional cost to Unicycive.



 


		7	MONITORING



 


		7.1	Records.
                                            Ascent shall maintain all materials, information, source documents, correspondence, and
                                            data obtained or generated by Ascent or its affiliates, employees, agents, consultants, or
                                            contractors in the course of providing the Services hereunder, including without limitation
                                            all electronic media, computerized records and files (collectively “Records”)
                                            in accordance with this Agreement, the Statement(s) of Work and Applicable Law in a safe
                                            and secure manner protected from fire, theft, disclosure, and destruction.



 


		7.2	Monitoring.
Unicycive may take reasonable measures, including audit, review or inspection of the Records or any of Ascent’s facilities,
personnel, documentation, procedures, equipment, records and activities used in performing the Services (“Performance Monitoring”)
from time to time as necessary to verify that all the Services are performed properly and appropriately by Ascent in accordance with
the terms of this Agreement, the Statement(s) of Work and Applicable Law. Ascent shall cooperate with Unicycive in the Performance Monitoring.



 






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		7.3	Reporting.
                                            Upon request of Unicycive from time to time, Ascent shall report the progress of the
                                            Services, any results obtained and any other relevant information.



 


		8	DELIVERABLES



 


		8.1	Submission
                                            of Deliverables. Ascent shall submit to Unicycive all Deliverables in the form and manner
                                            and in accordance with the schedule to be mutually agreed upon in the applicable Statement
                                            of Work.



 


		8.2	Inspection
                                            of Deliverables. Upon receipt of the Deliverables, Unicycive shall have the right to
                                            inspect such Deliverables. If Unicycive finds that such Deliverables fail to comply with
                                            any applicable specification set forth in the applicable Statement of Work, or if Ascent
                                            otherwise breaches its obligations in the performance of the Services that renders the Deliverables
                                            partially or wholly invalid or unusable, Unicycive may reject such Deliverables by notifying
                                            Ascent promptly of such rejection.



 


		8.3	Correction
                                            of Deliverables. If Unicycive rejects any Deliverables under Section 8.2, Ascent shall
                                            use its best efforts to cure the breach that constitutes the basis of such rejection without
                                            cost to Unicycive. If such breach cannot be reasonably cured, Ascent shall (i) return to
                                            Unicycive any and all payments made by Unicycive to Ascent in regards to the defective Deliverable
                                            or applicable Services, and (ii) reimburse Unicycive for the actual replacement cost of any
                                            Unicycive Supplied Materials consumed during Ascent’s performance of such Services.



 


		8.4	Ownership
                                            of Deliverables. Subject to the provisions of Article 4 and Section 13.1, the Parties
                                            hereby acknowledge and agree that Unicycive shall own all right, title and interest in and
                                            to the Deliverables and that the Deliverables shall be deemed the Confidential Information
                                            of Unicycive.



 


		9	CUSTODY
OF MATERIALS



 


		9.1	Custody
                                            of Materials. Unless and until delivered by Ascent to Unicycive, Ascent shall keep in
                                            its custody any unused Unicycive Supplied Materials, the Deliverables and the Records (collectively,
                                            the “Materials”) in an appropriate manner and prevent loss, damage, theft
                                            and unauthorized use or disclosure of Materials from occurring. Ascent shall not use any
                                            part of the Materials for any purpose other than to provide the Services under this Agreement
                                            and the Statement(s) of Work.



 


		9.2	Return
or Delivery of Materials. Upon request of Unicycive, Ascent shall return or deliver to Unicycive all requested Materials, including
copies thereof, promptly. Upon any expiration or termination of this Agreement, Ascent shall promptly return to Unicycive or a third
party designated in writing by Unicycive, at Unicycive’s reasonable cost and expense, any and all Materials under Ascent’s
control, including copies thereof.



 






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		9.3	Retention
                                            by Ascent. If Unicycive requests Ascent to keep any Materials or any part thereof after
                                            the completion of Services, Ascent shall keep them in such manner and for such time as shall
                                            be agreed through consultation between the Parties.



 


		10	INVESTIGATIONS
BY REGULATORY AUTHORITIES



 


		10.1	Investigations
                                            by Regulatory Authorities. Ascent shall promptly notify Unicycive of any regulatory inspection
                                            relating to the Services by a duly authorized representative (“Inspector”)
                                            of any government agency or other regulatory entity. Ascent shall provide Unicycive with
                                            the following data as soon as practicable: (i) the purpose of the inspection, (ii) the name
                                            and credential number of the Inspector, and (iii) a copy of all materials, correspondence,
                                            statements, forms, and records received or generated pursuant to such inspection or audit.
                                            Unless otherwise required by Applicable Law, Ascent shall not permit any inspection or audit
                                            relating to the Services or Unicycive’s Confidential Information without Unicycive’s
                                            prior written approval. In the event that Ascent does not receive prior notice of such regulatory
                                            inspection or audit, Ascent shall notify Unicycive as soon as practicable after such regulatory
                                            inspection or audit, and will provide in writing to Unicycive copies of all materials, correspondence,
                                            statements, forms, and records received or generated pursuant to such inspection or audit.
                                            Unicycive shall have the primary responsibility for preparing any responses relating to the
                                            Services that may be required by the government agency or regulatory entity; provided, however,
                                            that Ascent shall have the primary responsibility for preparing any responses relating to
                                            the method of performing the Services and Ascent’s operations and procedures. Ascent
                                            shall provide any proposed correspondence with government agencies or other regulatory entities
                                            related to the Services, including without limitation any such responses, to Unicycive for
                                            Unicycive’s review and approval before submission. Ascent shall take all reasonable
                                            actions requested by Unicycive to cure any deficiencies noted during any such inspection
                                            or audit. Unicycive shall be responsible for the costs and expenses incurred in connection
                                            with preparing any responses to such investigation or audit.



 


		11	INDEMNIFICATION



 


		11.1	Unicycive
Obligations. Unicycive shall indemnify and hold harmless Ascent, its affiliates, officers, directors, representatives and employees
from and against any claims, demands, suits, actions, losses, damages, expenses and other liabilities (including without limitation court
costs, legal fees, awards or settlements) (each, a “Liability”) arising from (i) Unicycive’s negligence or willful
misconduct, (ii) Unicycive’s breach of this Agreement or any Statement of Work, or (iii) personal injury or death arising as a
result of use or administration of any Unicycive study drug or device, including the Compound, to any study subject in accordance with
the terms of the applicable Statement of Work, except to the extent that any such Liabilities are subject to Ascent’s indemnification
obligations under Section 11.2.



 






    12


     


    

 


		11.2	Ascent
                                            Obligations. Ascent shall indemnify and hold harmless Unicycive, its affiliates, officers,
                                            directors, representatives and employees from and against any Liability arising from (i)
                                            Ascent’s negligence or willful misconduct, or (ii) Ascent’s breach of this Agreement
                                            or any Statement of Work, except to the extent that any such Liabilities are subject to Unicycive’s
                                            indemnification obligations under Section 11.1.



 


		11.3	Notification.
                                            Each Party seeking indemnification under this Article 11 shall, as a condition thereto,
                                            notify the indemnifying Party promptly (such period not to exceed ten (10) days) after the
                                            receipt of notice of the Liability; provided, however, that the indemnifying Party shall
                                            not be released from its obligations under this Article 11 if any failure to promptly notify
                                            the indemnifying Party does not materially prejudice the defense of such Liability. The indemnifying
                                            Party shall have the right to select defense counsel and to direct the defense or, with the
                                            consent of the indemnified Party (which consent shall not be unreasonably withheld) settlement
                                            of, any Liability. In the event that representation of an indemnified Party and the indemnifying
                                            Party by the same counsel would be a conflict of interest for such counsel, the indemnified
                                            Party may select its own independent counsel without relieving the indemnifying Party of
                                            its obligations under this Article 11. Under no circumstances shall an indemnified Party
                                            settle or otherwise compromise any Liability without the indemnifying Party’s prior
                                            written consent.



 


		12	INSURANCE



 


		12.1	Insurance.
                                            Ascent shall maintain in force during the term of this Agreement, at its own cost and
                                            expense, insurance in quantities and types as is customary in the industry for the type of
                                            Services to render under the Agreement. Upon request by Unicycive, Ascent shall provide to
                                            Unicycive evidence of such insurance.



 


		13	INTELLECTUAL
PROPERTY RIGHTS



 


		13.1	Existing
                                            Technologies. Each Party owns and shall retain all right, title and interest in, to and
                                            under any and all intellectual property controlled by such Party prior to the Effective Date,
                                            and, except as expressly set forth in this Agreement, no right or license to such prior intellectual
                                            property is granted by either Party to the other Party. Notwithstanding the foregoing, in
                                            the event that any intellectual property owned or controlled by Ascent prior to the Effective
                                            Date, or developed and owned or controlled by Ascent after the Effective Date, without reference
                                            to or reliance upon the Compound, any Unicycive Confidential Information or any Unicycive
                                            Supplied Materials (the “Ascent IP”) is incorporated into the Deliverables,
                                            Ascent hereby grants Unicycive a non-exclusive, perpetual, royalty-free, fully paid, transferable,
                                            sublicenseable license under the Ascent IP to the extent required for Unicycive to use the
                                            Deliverables.



 






    13


     


    

 


		13.2	Inventions.
                                            Unicycive shall own all right, title and interest in and to the Compound, the Unicycive
                                            Supplied Materials and any and all materials, documents, information, protocols, and procedures
                                            generated, conceived or developed by Ascent in the course of or as a result of the Services
                                            performed hereunder, including without limitation the Deliverables, excluding any Ascent
                                            IP. Unicycive shall own all rights, title and interest in any ideas, inventions, discoveries,
                                            techniques, methods, processes, trade secrets or other know-how, whether patentable or not,
                                            that (i) relate to the Unicycive Supplied Materials (including without limitation the Compound),
                                            (ii) arise from the materials, documents, information, protocols, or procedures above described,
                                            or which are generated, conceived or developed in the course of or as a result of the Services
                                            performed under this Agreement and any Statement of Work, or (iii) arise as a result of Unicycive’s
                                            disclosure of Confidential Information to Ascent, and for each of cases (i)- (iii), any and
                                            all intellectual property therein (collectively, the “Inventions”). Ascent
                                            hereby assigns to Unicycive all of Ascent’s right, title and interest in and to the
                                            Inventions and agrees to take all reasonable actions necessary to give effect to such assignments,
                                            and Unicycive agrees to reimburse Ascent for reasonable expenses incurred in relation to
                                            such activities.



 


		13.3	Assignment
                                            by Employees. Ascent hereby represents that all employees, consultants, and any other
                                            permitted persons acting on Ascent’s behalf during its performance of the Services
                                            shall be obligated to assign to Unicycive, or obligated to assign to Ascent , and Ascent
                                            assigns to Unicycive pursuant to Section 13.2, all rights to any and all Inventions conceived
                                            or developed by such employees or other persons and to take all reasonable actions necessary
                                            to give effect to such assignments. Unicycive agrees to reimburse Ascent for reasonable expenses
                                            incurred in relation to such activities.



 


		14	TERM
AND TERMINATION



 


		14.1	Term.
                                            This Agreement shall become effective as of the Effective Date and shall continue in
                                            full force and effect until terminated by either Party in accordance with this Article 14,
                                            provided that in the event that there are Services being provided under any Statement of
                                            Work at the date of termination of this Agreement, then subject to Section 14.6, this Agreement
                                            and all such Statements of Work shall remain in force upon their terms until the completion
                                            of all Services under such Statement of Work, unless Unicycive requests in writing that Ascent
                                            also terminates the provision of Services under such Statement of Work earlier. Subject to
                                            the foregoing sentence, each Statement of Work shall be effective upon the date specified
                                            therein and shall terminate upon the later of (i) the completion of the Services to be provided
                                            thereunder; or (ii) Ascent’s receipt of all fees due under such Statement of Work,
                                            unless earlier terminated pursuant to this Article 14.



 






    14


     


    

 


		14.2	Termination
                                            for Convenience. Unicycive may, upon thirty (30) days’ prior written notice to
                                            Ascent, terminate this Agreement or any Statement of Work at any time and for any reason.
                                            Ascent may terminate this Agreement upon sixty (60) days prior written notice to Unicycive
                                            at any time, provided that such termination will not be effective with respect to any Statements
                                            of Work under which Ascent is providing Services at the date of such termination, until the
                                            completion of all Services under such Statements of Work.



 


		14.3	Termination
                                            for Insolvency. Either Party may terminate this Agreement and all Statements of Work
                                            immediately upon provision of written notice if the other Party files for insolvency or bankruptcy
                                            or equivalent proceeding in any jurisdiction, and such filing is not dismissed within sixty
                                            (60) days after such filing.



 


		14.4	Termination
                                            for Breach. In the event either Party breaches any material term of this Agreement or
                                            any Statement of Work and if such breach has not been cured within thirty (30) days after
                                            the breaching Party’s receipt of written notice of such breach from the non-breaching
                                            Party, the non-breaching Party may terminate this Agreement or the applicable Statement of
                                            Work immediately.



 


		14.5	Effects
                                            of Termination. Termination of this Agreement pursuant to this Article 14 shall not affect
                                            other remedy, statutory or contractual, otherwise available to the terminating Party, including
                                            the right to claim damages against the other Party.



 


		14.6	Payments
                                            on Termination. If this Agreement is terminated under any circumstances, Unicycive shall
                                            pay all reasonable costs, if any, actually incurred for Services performed prior to the date
                                            of termination; provided, however that Ascent shall not continue performing Services after
                                            receipt of notice of termination except to the extent specifically authorized by Unicycive.
                                            The total of such payments, including without limitation any non-cancelable costs incurred
                                            by Ascent in performing the Services, shall not exceed the aggregate maximum budgets established
                                            in all applicable Statements of Work. If an individual Statement of Work is terminated under
                                            any circumstances, Unicycive shall pay all reasonable costs, if any, actually incurred for
                                            Services performed prior to the date of termination; provided, however that Ascent shall
                                            not continue performing Services after receipt of notice of termination except to the extent
                                            specifically authorized by Unicycive. The total of such payments, including without limitation
                                            any non-cancelable costs incurred by Ascent in performing the Services, shall not exceed
                                            the maximum budget established in such Statement of Work. Ascent shall use all reasonable
                                            efforts to mitigate termination and wind down costs to Unicycive. If it is necessary for
                                            Ascent to incur additional costs not specified in a Statement of Work in winding down any
                                            Services following the date of notice of termination of this Agreement or an individual Statement
                                            of Work, Ascent shall notify Unicycive in writing of such costs and their amount, and seek
                                            Unicycive’s consent to such expenditure, such consent not to be unreasonably withheld
                                            or delayed; provided that any wind-down costs incurred as a result of termination of this
                                            Agreement or any Statement of Work for Ascent’s material breach under Section 14.4
                                            shall be the responsibility of Ascent. Unicycive shall have no liability for wind-down costs
                                            incurred without its consent. In the event of any dispute of payments hereunder, Unicycive
                                            shall pay the undisputed amounts and the parties shall work together to resolve any disputed
                                            amounts as promptly as possible. Any prepayments or overpayments by Unicycive, after subtracting
                                            any amounts owed by Unicycive to Ascent pursuant to this Section 14.6, shall be refunded
                                            in full to Unicycive, within thirty (30) days following the effective date of termination
                                            of this Agreement.



 



    15


     


    

 


		14.7	Survival.
                                            Articles 4 (Confidentiality) (for the period of time specified in Section 4.5), 6 (Protection
                                            of Personal Data), 10 (Investigations by Regulatory Authorities), 11 (Indemnification), 12
                                            (Insurance) (for the period of time specified therein), 13 (Intellectual Property Rights),
                                            15 (Disclaimer; Limitation of Liability) and 16 (Miscellaneous), and Sections 8.3 (Correction
                                            of Deliverables), 8.4 (Ownership of Deliverables), 9.1 (Custody of Materials), 9.2 (Return
                                            or Delivery of Materials), 9.3 (Retention by Ascent) (for any period of time beyond expiration
                                            or termination agreed by the Parties), 14.5 (Effects of Termination), 14.6 (Payments on Termination),
                                            and this 14.7 (Survival) of this Agreement shall survive the expiration or termination of
                                            this Agreement.



 


		15	DISCLAIMER;
LIMITATION OF LIABILITY



 


		15.1	Disclaimer.
                                            EXCEPT AS EXPRESSLY SET FORTH IN THIS AGREEMENT, NEITHER PARTY MAKES ANY, AND BOTH PARTIES
                                            HEREBY DISCLAIM ALL, REPRESENTATIONS AND WARRANTIES, WHETHER EXPRESS, IMPLIED OR STATUTORY,
                                            WRITTEN OR ORAL, INCLUDING WITHOUT LIMITATION, THE WARRANTIES OF MERCHANTABILITY, FITNESS
                                            FOR A PARTICULAR PURPOSE, TITLE AND NONINFRINGEMENT.



 


		15.2	Limitation
                                            of Liability. EXCEPT FOR BREACH OF A PARTY’S CONFIDENTIALITY OBLIGATIONS UNDER
                                            ARTICLE 4 OR ITS INDEMNIFICATION OBLIGATIONS UNDER ARTICLE 11, UNDER NO CIRCUMSTANCES WHATSOEVER
                                            WILL EITHER PARTY BE LIABLE TO THE OTHER PARTY FOR SPECIAL, INCIDENTAL OR CONSEQUENTIAL DAMAGES,
                                            INCLUDING WITHOUT LIMITATION LOST PROFITS OR LOSSES RESULTING FROM BUSINESS INTERRUPTION,
                                            EVEN IF SUCH PARTY HAS BEEN ADVISED OF THE POSSIBILITY OR LIKELIHOOD OF SUCH DAMAGES. EXCEPT
                                            FOR ITS INDEMNIFICATION OBLIGATIONS UNDER ARTICLE 11, IN NO EVENT SHALL EITHER PARTY’S
                                            LIABILITY FOR ANY AND ALL CLAIMS, LOSSES OR DAMAGES ARISING OUT OF OR RELATING TO, IN WHOLE
                                            OR IN PART, THIS AGREEMENT, ANY STATEMENT OF WORK, OR ANY SERVICES PROVIDED HEREUNDER OR
                                            THEREUNDER EXCEED THE TOTAL AMOUNT OF ALL FEES PAID BY Unicycive TO ASCENT UNDER THE STATEMENT
                                            OF WORK PURSUANT TO WHICH SUCH LIABILITY AROSE.



 



    16


     


    

 


		16	MISCELLANEOUS



 


		16.1	Governing
                                            Law and Jurisdiction. This Agreement shall be governed by the laws of Japan. The Parties
                                            hereby agree that Japan, shall have exclusive jurisdiction as a court of first instance over
                                            any dispute that may arise in connection with this Agreement which cannot be settled amicably
                                            by the Parties.



 


		16.2	Entire
                                            Agreement. This Agreement, together with any Exhibits and all executed Statements of
                                            Work, each of which are incorporated into this Agreement, sets forth the entire understanding
                                            of the Parties with respect to the subject matter hereof and supersedes all prior and contemporaneous
                                            agreements and understandings between them concerning such subject matter. If there is any
                                            conflict, discrepancy or inconsistency between the terms of this Agreement and any Statement
                                            of Work, the terms of this Agreement will control unless otherwise expressly provided in
                                            the applicable Statement of Work. Any amendment to or additions to this Agreement or any
                                            Statement(s) of Work shall not be binding unless rendered in writing and signed or sealed
                                            by the duly authorized representatives of each of the Parties.



 


		16.3	Assignment;
                                            No Third Party Beneficiaries. Neither Party shall assign this Agreement, any Statement
                                            or Work, or any rights or obligations hereunder or thereunder without the prior written approval
                                            of the other Party; provided, however, without such consent, either Party may assign this
                                            Agreement or a Statement of Work to an affiliate or a successor in interest by reason of
                                            merger, acquisition or sale of substantially all of the business to which this Agreement
                                            relates. No person or entity not a party to this Agreement (other than permitted successors
                                            and assigns) shall have any rights under or by virtue of this Agreement.



 






    17


     


    

 


		16.4	Amendment
                                            & Waiver. No change, modification, or addition or amendment to this Agreement, or
                                            waiver of any term or condition of this Agreement, is valid or enforceable unless in writing
                                            and signed and dated by the authorized officers of both Parties. No change, modification
                                            or addition or amendment to any Statement of Work, or waiver of any term or condition of
                                            any Statement of Work, is valid or enforceable unless included in a Change Order executed
                                            by both parties pursuant to Section 1.5. Any waiver of any breach of any term or condition
                                            shall not be deemed to be a waiver of any preceding or succeeding breach of the same or any
                                            other term or condition. The failure of any Party to insist upon strict performance of any
                                            term or condition hereunder shall not constitute a waiver of, or otherwise impair, such Party’s
                                            right to demand strict compliance therewith in the future.



 


		16.5	Notices.
                                            All notices and other communications required or permitted under this Agreement shall
                                            be in writing, electronic mail or by confirmed fax, and shall be deemed to have been duly
                                            given (i) upon personal delivery, (ii) upon deposit with a recognized courier with next-day
                                            delivery instructions, (iii) one (1) business day after sending, if sent by electronic mail
                                            and no delivery failure notification has been received, or (iv) upon confirmation of transmission,
                                            if sent by confirmed fax, to the address or fax number set forth below or such other address
                                            or fax number as either Party may specify by notice sent in accordance with this Section
                                            16.5:



 


	 	Unicycive:	Unicycive
    Therapeutics, Inc.
	 	 	5150
    El Camino Real, Suite A-32, 

    Los Altos, CA 94022
	 	 	Email:
    pramod.gupta@unicycive.com




 


	 	Ascent:	Ascent
    Development Services, Inc.
	 	 	Shibuya
    SOLASTA 3F, 1-21-1 Dogenzaka, Shibuya-ku,

    Tokyo 150-0043, Japan
	 	 	Attn:
    John Winebarger
	 	 	Email:
    john.winebarger@ascent-dev.com




 


		16.6	Severability.
                                            If one or more of the provisions of this Agreement is held to be invalid or unenforceable,
                                            the provision shall be considered severed from this Agreement and shall not serve to invalidate
                                            any remaining provisions hereof. The Parties shall make a good faith effort to replace any
                                            invalid or unenforceable provision with a valid and enforceable one such that the objectives
                                            contemplated by the Parties when entering this Agreement may be realized.



 






    18


     


    

 


		16.7	Force
                                            Majeure. If the performance of this Agreement or any Statement of Work by either Party
                                            is prevented, restricted, interfered with or delayed (either totally or in part) by reason
                                            of any cause beyond the reasonable control of the Party whose performance is so affected,
                                            such as acts of God, explosion, disease, extreme weather, earthquake, war, insurrection,
                                            civil strike, riots, or power failure, such affected Party shall, upon giving written notice
                                            to the other Party, be excused from such performance during the pendency, and to the extent
                                            of such prevention, restriction, interference or delay; provided, that the affected Party
                                            shall use commercially reasonable efforts to avoid or remove such causes of non-performance
                                            and shall continue performance with the utmost dispatch whenever such causes are removed.



 


		16.8	Independent
                                            Contractors. The relationship established between the Parties by this Agreement is that
                                            of independent contractors, and nothing contained herein shall be construed to (i) give either
                                            Party the power to direct and/or control the day-to-day activities of the other, (ii) constitute
                                            the Parties as partners, joint venturers, co-owners or otherwise as participants in a joint
                                            or common undertaking, or (iii) allow a Party to create or assume any obligation on behalf
                                            of the other Party, or to bind the other Party in regard of to any contract, agreement or
                                            undertaking with a third party, for any purpose whatsoever, except as contemplated by this
                                            Agreement or any Statement of Work.



 


		16.9	Counterparts;
                                            Electronic Delivery. This Agreement may be executed simultaneously in two counterparts,
                                            either one of which need not contain the signature of more than one Party but both such counterparts
                                            taken together shall constitute one and the same agreement. Signatures to this Agreement
                                            transmitted by facsimile, by email in “portable document format” (“.pdf”),
                                            or by any other electronic means intended to preserve the original graphic and pictorial
                                            appearance of this Agreement shall have the same effect as physical delivery of the paper
                                            document bearing original signature.



 


[Signature
Page Follows]


 




    19


     


    

 


IN
WITNESS WHEREOF, the Parties have caused this Agreement to be executed as of the Effective Date.


 


Unicycive
Therapeutics, Inc.


 


	Signature:	/s/
    Shalabh Gupta	 
	Name:	Shalabh
    Gupta, MD, MPA	 
	Title:	President
    & CEO	 
	Date:	Feb
    18, 2021	 



 


Ascent
Development Services, Inc.


 


	Signature:	/s/
    John Winebarger	 
	Name:	John
    Winebarger	 
	Title:	CEO	 
	Date:	2021年2月19日	 



 




    20


     


    

 


STATEMENT
OF WORK NO. 1


 


This
Statement of Work No. 1, together with the attached Appendix A (“Budget and Payment Terms”) and Appendix B (“Description
and Tentative Timeline for Services”) (collectively, this “Statement of Work”), is agreed as of 08 February
2021 (the “Effective Date”) pursuant to the Master Services Agreement (“MSA”) dated 08 February
2021, between Unicycive Therapeutics, Inc. (“Unicycive”) and Ascent Development Services, Inc. (“Ascent”).
All of the terms, covenants, and conditions set forth in the MSA are incorporated herein by reference as if the same had been set forth
herein in full. Unless otherwise defined in this Statement of Work, all capitalized terms shall have their respective meanings ascribed
to them in the MSA.


 


		1.	Project
                                            Name: Strategic Development and PMDA Informal and Formal Consultations



 


		2.	Term:
                                            The term of this Statement of Work shall begin on the Effective Date and end on or about
                                            31 December 2021.



 


		3.	Product:
                                            Renazorb



 


		4.	Unicycive
                                            Manager: Pramod Gupta, Head of Development



 


		5.	Description
                                            of and Tentative Timeline for Services: See Appendix
                                            B.



 


		6.	Maximum
                                            amount Unicycive is required to pay: *(including pass- through costs).



 


		7.	All
                                            Invoices must contain: Statement of Work Number, Product Name, Protocol Number(s) (if
                                            applicable), Unicycive contact name, Date(s) of Service, Unicycive Finance Code(s)



 


		8.	Invoices
                                            should be sent to: unicycive@bill.com



 


Unicycive
Therapeutics, Inc.

5150 El Camino Real, Suite A-32,

Los Altos, CA 94022


 




    1


     


    

 


IN
WITNESS WHEREOF, the Parties hereto have executed this Statement of Work as of the Effective Date.


 


	Unicycive
    Therapeutics, Inc.	 	Ascent
    Development Services, Inc.
	 	 	 
	By:	/s/
    Shalabh Gupta	 	By:	/s/
    John Winebarger
	Name: 
    	Shalabh
    Gupta, MD, MPA	 	Name: 	John
    Winebarger
	Title: 
    	President
    & CEO	 	Title:
    	CEO
	Date:	Feb
    18, 2021	 	Date:	2021年2月19日



 




    2


     


    

 


APPENDIX
A


 


BUDGET
AND PAYMENT TERMS


 


		1)	This
                                            entire project costs for providing the Services described in Appendix B are as follows:



 


	Total
    Direct Fees	 	 	Travel
    &
 Other Pass-Thru Costs	 	 	TOTAL
    COSTS	 
	¥	               *	 	 	¥	               *	 	 	¥	             *	 




 


		2)	Unicycive
                                            shall remit payments to Ascent according to the following schedule:



 


Upon
execution of this Statement of Work, Unicycive shall make an Upfront Payment equal to 50% of the estimated total direct costs (¥*)
and thereafter Ascent shall invoice Unicycive on a monthly time and materials basis for the time actually spent engaged in providing
the Services. Ascent shall not invoice Unicycive for direct fees in excess of ¥*. The amount of each invoice shall reflect
the Upfront Payment as a credit.


 


		3)	Ascent
                                            shall additionally invoice Unicycive on a monthly basis for various pass-through costs incurred
                                            and provide appropriate documentation of the expenses. Ascent shall obtain written approval
                                            from Unicycive prior to incurring pass-through costs in excess of the projected total of
                                            ¥*.



 


		4)	Unicycive
                                            shall make payment to Ascent immediately upon receipt of an undisputed invoice for the Upfront
                                            Payment, and within 30 days of receipt of any undisputed invoice for the remaining monthly
                                            payments consistent with the terms of the Agreement.



 




    1


     


    

 


APPENDIX
B


 


DESCRIPTION
AND TENTATIVE TIMELINE FOR SERVICES


 


Ascent
shall provide Services related to Informal and Formal PMDA Consultations for Renazorb (the “Project”).


 


		1.	PROJECT



 


		1.1.	Scope
                                            of Work



 


The
scope of activities to be conducted by Ascent related to the Project shall include but not limited to the following:


 


Informal
PMDA Meeting


 


		Ø	Informal
                                            PMDA Meeting Application Process



 


		o	US
                                            Non-clinical Data Package Review and Proposal of Japanese Non- clinical Data Package






		o	Preparation
                                            of Executive Summary for Renazorb and development strategy and creation of development/ scientific
                                            slide deck to reflect Japan strategy






		o	Discussion
                                            of Executive Summary and slide deck via TC with Unicycive to gain detailed strategic consensus






		o	Discussion
                                            of Renazorb & strategy with 1 KOL & reporting to Unicycive






		o	Application
                                            to PMDA (including Executive Summary) and maintenance of administrative communication with
                                            PMDA through meeting



 


		Ø	Informal
                                            PMDA Meeting Prep & Execution






		o	Finalization
                                            of strategy and slide deck through TCs with Unicycive






		o	Preparation
                                            for and conduct of PMDA meeting & conduct wrap up






		o	Planning
                                            for and conduct of face-to-face meeting with KOL






		o	Creation
                                            of meeting minutes for PMDA and KOL meetings



 


Formal
PMDA Meeting


 


		Ø	Formal
                                            PMDA Meeting Application Process



 


		o	Provision
                                            of guidance for Unicycive to prepare English language scientific explanation of Renazorb
                                            and its Japan development strategy based on FDA Pre-IND documentation which will be used
                                            as a guide to create the Japanese language Briefing Document (The Japanese Briefing Document
                                            will not be a literal translation)






		o	Creation
                                            of Japanese Language Briefing Document and provision of AI English back-translation



  





		Ø	Formal
                                            PMDA Meeting Preparation & Execution



		o	Submission
                                            of Briefing Document to PMDA and management of 6-week Q&A process with PMDA



		o	Conduct
                                            of preparatory meetings with Unicycive with KOL, execution of PMDA and wrap up meetings,
                                            and finalization of meeting minutes with PMDA



 






    1


     


    

 





		1.2.	Budget



 


 


	CLINICAL
    STRATEGY / INFORMAL PMDA MEETING COSTS
	Informal
    PMDA Meeting Application Process	Costs
	US
    Non-clinical Data Package Review and Proposal of Japanese Non-clincal Data Package	*
	Prepare
                                                                                                                                                                                             Executive Summary for Renazorb & development strategy and create development/ scientific slide deck (English) to reflect Japan
                                                                                                                                                                                             strategy
	*
	Discuss
    Executive Summary and slide deck via TC with Unicycive to gain detailed strategic consensus	*
	Ascent
    discusses Renazorb & strategy with 1 KOL & reports to Unicycive	*
	Create
    Executive Summary in Japanese for PMDA	*
	Apply
    to PMDA (including Executive Summary) and maintain administrative communication with PMDA through meeting	*
	Informal
    PMDA Meeting Prep & Executiveution	
	Finalize
    strategy and slide deck in English through TCs with Unicycive	*
	Translate
    final slide deck into Japanese	*
	Prepare
    for and conduct PMDA meeting & conduct wrap up	*
	Plan
    for and conduct F2F meeting with KOL	*
	Produce
    meeting minutes for PMDA and KOL meetings	*
	Subtotal
    (Direct) JPY	*
	Passthrough
    Costs	
	Meeting
    Rooms & Miscellaneous	*
	Simultaneous
    Interpreters	*
	Subtotal
    Passthrough Costs JPY	*
	TOTAL
    COST JPY (KOL/ Informal/ Strategy)	*
	CLINICAL
    FORMAL PMDA MEETING COSTS
	Formal
    PMDA Meeting Application Process	
	Ascent
                                            provides guidance for Unicycive to prepare English language scientific explanation of Renazorb
                                            and its Japan development strategy based on FDA Pre-IND documentation- which will be used
                                            as a guide to create the Japanese language Briefing Document (the Japanese Briefing Document
                                            will not be a literal

    translation)
	 

     

    *

	Create
    Japanese Language Briefing Document and provide AI English back-translation	*
	Formal
    PMDA Meeting Prep & Executiveution	
	Submit
                                            Japanese Briefing Document to PMDA and manage 6-week Q&A process with PMDA (typically
                                            3

    review
    cycles with numerous telephone and email communications, includes Slide Deck preparation for Formal Meeting)
	 

    *

	Conduct
                                            preparatory meetings with Unicycive with KOL, Executiveute PMDA and wrap up meetings, and

    finalize
    meeting minutes with PMDA
	*
	Subtotal
    (Direct) JPY	*
	Passthrough
    Costs	
	Meeting
    Rooms & Miscellaneous	*
	Simultaneous
    Interpreters	*
	PMDA
    User Fees	*
	Subtotal
    Passthrough Costs JPY	*
	TOTAL
    COST JPY (Formal PMDA Consultation)	*
	COMBINED
    INFORMAL & FORMAL PMDA MEETING COSTS
	GRAND
    TOTAL (JPY) FOR INFORMAL & FORMAL PMDA MTGS	*


 


		1.3.	Timeline



 


*


 


		1.4.	Deliverables



 


		Ø	Informal
                                            PMDA Meeting Application Form including Executive Summary of Renazorb



 






    2


     


    

 





		Ø	Presentation
                                            slide deck(s) for Informal PMDA and KOL meetings



 


		Ø	Meeting
                                            minutes for Informal PMDA and KOL meetings



 


		Ø	Formal
                                            PMDA Meeting Briefing Document and presentation slide deck of Renazorb



 


		Ø	PMDA
                                            Formal Meeting minutes



 


		2.	PROJECT
TEAM



 


		2.1.	Project
Team



 


The
following proposed Ascent team members will be responsible for the respective functional roles related to the implementation of the Project
listed below.


 


	Name	Role	Hourly
    Rate
	John
    Winebarger	Strategic
    Lead	*
	Aki
    Tsutsui	Strategic
    Communications Support	*
	Kazuhiro
    Kanmuri, PhD	Japan
    Development Lead	*
	Noboru
    Sato, PhD	Regulatory
    Lead/ Non-Clinical Assessment	*
	Yuki
    Kurai	Regulatory/
                                            Project Management

    Lead
	*
	Mikako
    Miyako	Senior
    Regulatory Associate	*
	Erika
    Zhang	Project
    Assistant	*
	Key
    Opinion Leader (Approved by Unicycive)	 	*


 


		2.2.	Project
Management



 


Overall
responsibility for Services will reside with Mr. John Winebarger. In carrying out these responsibilities Mr. Winebarger will be supported
by the team members listed above.


 


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