Document:

EX-10.16

 Exhibit 10.16 

 

			
	

	  	

 Master Agreement for 

Clinical Trials Services 

This Master Agreement for Clinical Trials Management Services (the “Agreement”) is made and entered into on April 2nd, 2020, (the “Effective Date”), 
 by and between 

inRegen, a Cayman Islands company, with offices at 

10 Market Street #688 Camana Bay 

Grand Cayman Islands, KY1-9006 

(hereinafter referred to as “Sponsor”) 

and 
 Frenova, LLC d/b/a Frenova
Renal Research, 920 Winter Street, 
 Waltham, Massachusetts 02451-1457 

(hereinafter referred to as “Frenova”). 

Each is sometimes referred to as “Party” 

Sponsor is engaged in the business of developing and marketing cell-based products and desires to engage Frenova to perform services in connection with
certain clinical trials under development by or under control of Sponsor. 
 Frenova, among other things, is engaged in the business of providing certain
services related to the implementation and management of clinical development programs for the pharmaceutical, biotechnology and medical device industries, which may include certain contract research organization related services. This Agreement
sets forth terms under which Sponsor will engage Frenova to provide such services and is comprised of the following Articles: 
  

	 	1.	 Definitions 

  

	 	2.	 Services and Standards 

 

	 	3.	 Financial Terms and Conditions 

 

	 	4.	 Term and Termination 

 

	 	5.	 Confidentiality and Proprietary Rights 

 

	 	6.	 Representations and Warranties 

 

	 	7.	 Indemnification and Insurance 

 

	 	8.	 Miscellaneous Clauses 

By signing below, each Party agrees to the terms of this Agreement. 
  

			
	Frenova, LLC	  	inRegen
		
	 /s/ Franklin W. Maddux
	  	 /s/ Timothy A. Bertram

	Name: Franklin W. Maddux, MD, FACP	  	Name: Timothy A. Bertram
	Title: Global Chief Medical Officer	  	Title: CEO inRegen/TCBIO
	Date: April 2, 2020	  	Date: 02 April 2020

			
	

	  	

  

	1.0	 RECITALS AND DEFINITIONS 

 

	 	1.1	 Definitions 

  

	 	1.1.1	 Affiliates: With respect to either Party, an Affiliate is an entity that is controlled by, controls or
is under common control with such Party. A person, corporation or other entity will be regarded as in control of another corporation or entity if such first person, corporation or other entity owns or directly or indirectly controls more than fifty
percent (50%) of the voting stock or other ownership interest of the other corporation or entity, or if such first person, corporation or other entity possesses, directly or indirectly, the power to direct or cause the direction of the management
and policies of the other corporation or other entity or the power to elect or appoint fifty percent (50%) or more of the members of the governing body of the other corporation or other entity. 

 

	 	1.1.2	 Amendment: A written specification of changes to a Statement of Work signed by each Party’s
authorized representatives. 

  

	 	1.1.3	 Case Report Form (“CRF”): The printed, optical, or electronic document designed to record all
the Protocol required information to be reported to Sponsor on each Study Subject. 

  

	 	1.1.4	 Facility: The location at which the clinical trial is actually conducted (e.g., end stage renal disease
facility or, if applicable, for certain studies this may reference a medical practice) under the supervision of an Investigator. 

  

	 	1.1.5	 Frenova Project Manager: The Frenova representative assigned to lead the Frenova project team, act as
the principal liaison between Frenova and Sponsor, and provide general oversight in the delivery of Services with regard to a specific Statement of Work. 

  

	 	1.1.6	 Good Clinical Practice (“GCP”): The standard defined in the ICH Harmonised Tripartite
Guideline For Good Clinical Practice E6(R1) Current Step 4 version dated 10 June 1996 (including the Post Step 4 corrections) and applicable EU regulations, e.g. EU Directive 2001/20/EC and Regulation (EU) No. 536/2014 and DIN ISO 14155
and the Federal Food, Drug and Cosmetic Act, 21 U.S.C. §§ 301 et seq., 21 C.F.R. Parts 11, 50, 54, 56, and 312; the Good Clinical Practices adopted as guidance by the U.S. Food and Drug Administration; or comparable state, federal or local
law. 

  
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	 	1.1.7	 HIPAA: means the United States Health Insurance Portability and Accountability Act of 1996 as amended by
the Health Information Technology for Economic and Clinical Health (HITECH) Act, enacted as part of the American Recovery and Reinvestment Act of 2009 and its applicable regulations. 

 

	 	1.1.8	 Institutional Review Board (“IRB”): Any board, committee, or other group formally designated
by an institution to review, to approve the initiation of, and to conduct periodic review of, biomedical research involving human subjects constituted in accordance with and in compliance with 21 C.F.R. Part 56, EU Directive 2001/20/EC Art. 2 k) and
Regulation (EU) No. 536/2014 Art. 2 (11). The primary purpose of such review is to assure the protection of the rights and welfare of human subjects. An IRB may also be referred to as an independent ethics committee or ethics committee.

  

	 	1.1.9	 Invention: Inventions or discoveries, whether patentable or not, which are conceived or first actually
reduced to practice in the performance of the Study or the Services including any related patent, trade secret, copyright or other proprietary right. For the purpose of clarity, conception of an invention shall be dictated by inventorship in
accordance with United States patent law. 

  

	 	1.1.10	 Investigator: A person responsible for the conduct of the clinical trial at a Facility. If a trial is
conducted by a team of individuals at a Trial Site, the Investigator is the responsible leader of the team and may be called the Principal Investigator. 

  

	 	1.1.11	 Investigator Budget: A subset of the Pass-Through Budget which sets forth the estimated costs related to
the services to be provided by the Investigator in conducting the Study as set forth in the Statement of Work. 

  

	 	1.1.12	 Key Personnel: The Frenova Project Manager and other key Frenova personnel assigned to the Services as
set forth in a Statement of Work. 

  

	 	1.1.13	 Pass-Through Budget: The estimated costs of Pass-Through expenses for goods and materials incurred by
Frenova on behalf of Sponsor, in connection with the performance of the Services as set forth in a Statement of Work. 

  

	 	1.1.14	 Payment Schedule: The schedule of payments due to be made for Services delivered and Pass-Through
expenses incurred, as set forth in a Statement of Work. 

  
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	 	1.1.15	 Project Specifications: The specific Services to be provided, statement of assumptions used in preparing
the Services Budget, Pass-Through Budget, and assignment of project-related responsibilities between the Parties as set forth in a Statement of Work. 

  

	 	1.1.16	 Protocol: A written document that describes a Study and sets forth specific activities to be performed
in accordance with 21 C.F.R. Section 312.23(a)(6), 21 C.F.R. 812.25(b), EU Directive 2001/20/EC Art. 2 h) or Regulation (EU) No. 536/2014 Art. 2 (22), as may be amended from time to time. 

 

	 	1.1.17	 Services: The services to be provided by Frenova, its Affiliates and its Subcontractors (if applicable)
under this Agreement as specifically outlined in a Statement of Work, Amendment or winding down plan. 

  

	 	1.1.18	 Services Budget: The estimated cost of the Services, based upon the Project Specifications as set forth
in a Statement of Work. 

  

	 	1.1.19	 Statement of Work: A written specification of Services to be performed by Frenova under this Agreement,
including the Project Specifications, Contact Information, Services Budget, Pass-Through Budget, Investigator Budget and Payment Schedule. 

  

	 	1.1.20	 Study: A clinical trial performed at one or more Trial Sites under the supervision of one or more
Investigator(s) pursuant to a study Protocol. 

  

	 	1.1.21	 Study Agent: The drug(s), biologic(s) or device(s), if any, that are the subject of the Study as
specified in the Protocol. 

  

	 	1.1.22	 Study Subject: individuals who are screened for a Study and/or are participating in a Study.

  

	 	1.1.23	 Subcontractor: An individual or company engaged by Frenova to conduct some elements of a Statement of
Work, such as clinical laboratories, patient recruitment services, interactive voice recognition systems and other services, which shall exclude reference to contract employees as set forth in Section 2.3.3. 

 

	 	1.1.24	 Trial Site(s): Any public or private entity or agency specifically identified related to or pursuant to
Statement of Work which performs clinical research, and is engaged to perform a Study by Frenova or Sponsor and the location(s) where trial-related activities are actually conducted. 

  
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	2.0	 SERVICES AND STANDARDS 

The Parties will agree on all Services to be provided and the performance of those Services will be authorized in writing through the execution of a Statement
of Work. Frenova will not begin work on any Services without an executed Statement of Work or other written document authorizing commencement of the Services, except with respect to an agreed upon letter of agreement which may executed between the
parties to permit Frenova to perform preliminary work involving a Study as the specific Statement of Work for such Study is being negotiated and finalized and signed by the Parties. Statements of Work may be entered into by Frenova or any of its
Affiliates, which by execution of such a Statement of Work, will agree to be bound to the terms of this Agreement. Each and every Statement of Work is subject to the agreement of both Parties and each Party reserves the right to decline to enter any
Statement of Work. 
  

	 	2.1	 Statements of Work 

Frenova will provide Services as specified in one or more Statements of Work. 
  

	 	2.1.1	 Project Specifications. The Statement of Work will include Project Specifications, which may include
items such as a description of the Study Protocol, Trial Sites, Facilities, subjects, CRFs, reports and Services to be provided by Frenova, including potential Facilities, potential Trial Sites and potential Investigators. 

 

	 	2.1.2	 Services Budget. Each Statement of Work will include a Services Budget and will include the costs
related to the Services to be provided. Frenova will not exceed the total cost outlined in the Services Budget without the prior written approval of Sponsor, unless specifically authorized by an Amendment, as set out in Section 2.2 below.
Sponsor agrees that the Services Budget presented in each Statement of Work is an estimate based upon the Project Specifications. Any changes to the Project Specifications, including without limitation, a request by Sponsor for compression of the
timelines or extensions of the timelines for any reason, may result in changes to the Statement of Work, which will be documented in accordance with Section 2.2 below. 

 

	 	2.1.3	 Pass-Through Budget. Each Statement of Work may include a Pass-Through Budget, which will contain an
estimate of anticipated Pass-Through expenses to be incurred on Sponsor’s behalf in connection with performance of the Services. Sponsor agrees that the Pass-Through Budget contains an estimate based on the Project Specifications, and
information supplied by third party suppliers, and that such costs cannot be predicted with complete certainty at the outset of a Study. Sponsor will reimburse all of Frenova’s actual direct costs for Pass-Through expenses incurred in
performance of the Services, in accordance with Article 3 below. Frenova will notify Sponsor in writing of any increases or decreases in the Pass-Through Budget upon receipt of such information from third party suppliers or other sources, as the
case may be, and such information will be included in an Amendment to the applicable Statement of Work. 

  
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	 	2.1.4	 Investigator Budget. While a subset of the Pass-Through Budget, each Statement of Work may include an
Investigator Budget including the costs related to the services to be provided by the Investigator in conducting the Study which will be the basis of the budget attached to the clinical trial agreements to be executed with Investigators. Sponsor
agrees that the Investigator Budget generally contains a per procedure fee structure based on the specific Study protocol schedule of events, prorated according to Study Subject participation, and that such costs may be subject to change in the
event of changes to the Study protocol. Sponsor will reimburse all of Frenova’s actual direct costs for the expenses incurred by the Investigator in performance of the Study, in accordance with Article 3 below. Frenova will notify Sponsor in
writing of any increases or decreases in the Investigator Budget upon receipt of such information from Investigators or other sources, as the case may be, and such information will be included in an Amendment to the applicable Statement of Work.

  

	 	2.1.5	 Payment Schedule. Each Statement of Work will contain a Payment Schedule, which will specify the manner
and timing of all payments for Services and pass-through expenses described in the Statement of Work. Any changes to the Project Specifications, and corresponding changes to the Services Budget or Pass-Through Budget, will be reflected in a
corresponding change in the Payment Schedule. 

  

	 	2.1.6	 Contact Information and Designation of Key Personnel. Each Statement of Work will identify the Key
Personnel as the Parties may agree are to be included and their contact information. 

  

	 	2.1.7	 Territory-Specific Requirements. A Statement of Work may contain terms and conditions supplemental to or
different from the terms and conditions set forth in this Agreement, as are necessary for territory-specific matters. In such case, the Statement of Work shall explicitly state that it will govern with respect to such terms and such
territory-specific terms shall take precedence over this Agreement with respect to such terms in such territory. 

  

	 	2.2	 Amendments 

Any changes to a Statement of Work, including but not limited to changes to the Project Specifications, Services Budget, Pass-Through Budget or Investigator
Budget, will be agreed upon by the Parties and documented in an Amendment to the Statement of Work. Sponsor agrees that Frenova will not perform any out-of-scope work
described in an Amendment until it is approved in writing by both Parties. 

  
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	 	2.2.1	 Unanticipated Changes. Sponsor agrees that changes in costs resulting from, for example, changes to
Project Specifications due to modifications to the Study Protocol, delays in receipt of Study Agent from Sponsor, changes in amounts charged by third party suppliers or poor subject enrollment due to changes in clinical practices, cannot be
reasonably anticipated in advance. Upon identification by either Party of changes to the Project assumptions or other unanticipated changes to the Project Specifications, the Parties will prepare an Amendment to accommodate increases or decreases to
the Project Budget (including the Services Budget and Pass-Through Budget, or Payment Schedule that are reasonably associated with any such adjustments. Such unanticipated changes may include, but are not limited to, any of the following:

  

	 	2.2.1.1	 delays in receiving from Sponsor technical information or Sponsor’s acceptance of documents submitted by
Frenova in the performance of its duties under this Agreement or any Statement of Work, or any other delay on the part of Sponsor; 

  

	 	2.2.1.2	 delay in receipt of regulatory approval from a regulatory agency, IRB or Ethics Committee;

  

	 	2.2.1.3	 delay in performance by a Subcontractor not selected by Frenova; 

 

	 	2.2.1.4	 delay in shipment of Study Agent, clinical samples and/or clinical supplies to Trial Sites;

  

	 	2.2.1.5	 delay due to changes in standard of care imposed by law, regulation or changes in medical practice affecting
participating Trial Sites; or Facilities; 

  

	 	2.2.1.6	 commencement of a new clinical trial with the same target patient population as the Study which is undertaken
by Frenova on behalf of Sponsor; 

  

	 	2.2.1.7	 delay by reason of force majeure as defined herein; 

 

	 	2.2.1.8	 Sponsor requested changes to the Services or Protocol; 

 

	 	2.2.1.9	 delays due to questions received by either Party from regulatory agencies or ethics committees regarding
submission materials that relate to characteristics of the Study Agent or Protocol design; 

  

	 	2.2.1.10	 delays due to any changes in applicable law or regulatory environment; or 

 

	 	2.2.1.11	 changes for any other reason agreed upon in writing by Sponsor. 

  
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	 	2.3	 Project Staffing 

In performing the Services, Frenova will reasonably allocate personnel who are adequately trained, qualified and experienced to conduct the work as specified
in a Statement of Work. Sponsor will have the right, before executing a Statement of Work to review the qualifications of any Key Personnel and raise any concerns which Sponsor may have in that regard and, if such concerns cannot be sufficiently
addressed to both parties satisfaction, then such Statement of Work shall not be executed by the parties. In the event that Sponsor has concerns regarding the performance of any Key Personnel, Sponsor shall raise such concerns to Frenova, and the
parties shall in good faith seek to resolve such concerns. 
  

	 	2.3.1	 Key Personnel. Frenova will assign a Frenova Project Manager and/or other employees whose participation
in a project is expected for the duration of the project, who will serve as Key Personnel. Frenova will use reasonable efforts to seek the continuity of Key Personnel’s participation in a project for the duration of the project. Frenova will
provide thirty (30) days’ notice to Sponsor, whenever practical, of any changes to the Key Personnel. Frenova will provide project-specific training to replacement Key Personnel at its own expense. Sponsor will have the right to review the
qualifications of any Key Personnel replacements and raise any reasonable concerns which Sponsor may have in that regard and, both parties shall seek in good faith to address such concerns.  

 

	 	2.3.2	 Project Team. Frenova will assign non-Key Personnel at its sole
discretion, as needed to perform the Services in accordance with the Statement of Work. 

  

	 	2.3.3	 Use of Contract Employees. Frenova may, at its own discretion, assign some elements of the Services to
contract employees. Frenova agrees that any contract employees used to perform the Services will be adequately qualified, experienced and trained as required to perform the Services in the same manner as Frenova qualifies and trains its own
employees. Frenova will remain responsible for satisfactory performance of all Services performed by contract employees. 

  

	 	2.4	 Use of Subcontractors 

Frenova may use Subcontractors to conduct some elements of a Statement of Work. Frenova will notify Sponsor in advance of its use of Subcontractors. In the
event that Sponsor objects, for reasonable cause, to any such Frenova Subcontractors, Frenova will replace the Subcontractor within a mutually agreeable timeframe. 
  

	 	2.4.1	 Sponsor-Selected Subcontractors. In the event that Sponsor requires Frenova to use a specific
Subcontractor that is not otherwise agreeable to Frenova, Frenova will not be responsible for the performance of the Subcontractor, and Sponsor will manage the performance of the Subcontractor and be responsible for any delays or changes to the
Project Budget that result from the performance of the Subcontractor. Frenova will notify Sponsor promptly of any performance issues arising out of the use of any such Subcontractors. If Sponsor engages a Subcontractor, but requires that Frenova
manage or oversee the performance of the Subcontractor, then Sponsor will supply Frenova with a copy of the relevant contract with the Subcontractor. 

  
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	 	2.4.2	 Frenova-Selected Subcontractors. For Subcontractors selected and contracted directly by Frenova, Frenova
will manage the performance of the Subcontractor in coordination with Frenova. 

  

	 	2.5	 Engagement of Trial Sites and Investigators 

If required in the terms of a Statement of Work, Frenova will coordinate execution of contracts with Trial Sites and Principal Investigators for the
performance of each Study (which may include, by example, clinical trial agreements and facility use agreements) using templates mutually agreeable to Frenova and Sponsor. Unless otherwise agreed upon in any Statement of Work, if an Investigator or
other relevant party insists upon any material changes to any provisions of the applicable template agreement(s), then Frenova shall submit the proposed material change to Sponsor, and Sponsor shall promptly review, comment on, reject and/or approve
such proposed changes. Each such contract will include terms, to the extent applicable, pertaining to Confidentiality, Proprietary Rights, Inspections and any other pertinent matters as the Parties may decide, which shall be no less restrictive than
those of this Agreement without the consent of Sponsor. 
  

	 	2.6	 Applicable Standards 

Frenova shall perform Services pursuant to this Agreement any Statement of Work in compliance with the specifications of that Statement of Work, GCP and
applicable United States, EU laws and regulations, and/or laws of regulations of the specific territories where Services are being performed. The Statement of Work shall specify to what extent Frenova or Sponsor shall provide standard operation
procedures in the performance of the Services. 
  

	 	2.7	 Sponsor-Provided Systems 

2.7.1 In the event that Sponsor requires Frenova to use Sponsor’s information systems and associated processes pursuant to a Statement of
Work, Sponsor will be responsible for all costs associated with installation and operation of the systems, including costs for hardware and software licenses, and for training of Frenova personnel assigned to the project in the use of Sponsor
system(s). Sponsor shall allow Frenova to access the EDC System (defined below) to review and approve Trial Site visit activity for the purpose of processing payments to the Trial Sites. 

2.7.2 Sponsor acknowledges that Frenova shall contract with and/or license from an electronic data capture vendor (“EDC Vendor”)
such that Sponsor may utilize the EDC Vendor software applications to serve as Sponsor’s electronic data capture system for any particular Study. Sponsor’s rights to use such EDC Vendor software, including, but not limited to, any
derivative works, modifications, updates and enhancements thereto, and/or services (“EDC System”) for purposes of electronic data capture are subject to Sponsor’s compliance with the following terms and conditions: 

  
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	 	a.	 Only Sponsor’s employees and contractors conducting or performing services directly related to the Study
pursuant to a Statement of Work and/or clinical trial agreement executed thereto (the “Authorized Users”) may access the EDC System on behalf of Sponsor. 

 

	 	b.	 Sponsor shall use the EDC System only for lawful purposes and in accordance with this Agreement, the Statement
of Work (including clinical trial agreements executed thereto), consistent with industry standards, and for purposes related to a Study. Any data that Sponsor plans to collect in the EDC System that is the proprietary information of Fresenius
Medical Care Holdings, Inc. and any of its Affiliates, shall be subject to approval by Frenova, which shall not be unreasonably withheld. 

  

	 	c.	 Sponsor acknowledges that the EDC System is proprietary to the EDC Vendor, and such EDC Vendor owns all right,
title and interest in the EDC System, including, but not limited to, any derivative works, modifications, updates and enhancements. The Authorized Users shall protect and treat the EDC System and materials as confidential using the same care as
required under the Agreement with respect to Sponsor’s Confidential Information, but no less than reasonable care. Sponsor understands and agrees that the EDC System may only be used by Sponsor and its Authorized Users in accordance with the
terms set forth above and that Sponsor will not (1) modify, copy or create derivative works based on the EDC System, or (2) reverse engineer, disassemble or decompile the EDC System or any portion thereof in any manner. Sponsor agrees to
execute any additional documentation as Frenova’s and/or EDC Vendor’s request setting forth any such additional obligations or use restrictions as may be required for Authorized Users to access and/or utilize the EDC System.

  

	 	d.	 Sponsor acknowledges that errors may exist or occur in any software program. Frenova makes no warranty or
representation that the EDC System shall operate uninterrupted or be error-free and assumes no responsibility for obsolescence of the EDC System. 

2.7.3 Frenova shall in good faith seek to enforce on behalf of Sponsor, at Sponsor’s expense, warranties which Frenova may hold pursuant
to Frenova’s license and/or contractual arrangement with the EDC Vendor. 
 Except as otherwise stated in this Agreement, the EDC SYSTEM, THE SERVICES
PROVIDED IN CONNECTION WITH THE EDC SYSTEM, AND THE DELIVERABLES DELIVERED THROUGH USE OF THE EDC SYSTEM ARE PROVIDED AND DISTRIBUTED ON AN “AS IS” BASIS WITHOUT WARRANTIES OF ANY KIND, EITHER EXPRESS OR IMPLIED, INCLUDING BUT NOT LIMITED
TO WARRANTIES OF TITLE, NON-INFRINGEMENT, MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE. 

2.7.4 EDC Vendor shall provide to Sponsor at the completion of the Study a download of the Study data contained in the EDC System for such
Study. Frenova shall in good faith seek to facilitate the execution of additional documentation as to the nature, timing, and extent of such download of Study data by and among Frenova, EDC Vendor and Sponsor as may be reasonably requested. 

  
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 2.7.5 To the extent that Frenova utilizes, or Sponsor otherwise requires the use of,
additional software services or an additional software vendor in additional that provided by the EDC Vendor, then the provisions with respect to the use and scope of services to be provided pursuant to such software services or software vendor shall
be addressed in the applicable Statement of Work. 
  

	 	2.8	 Inspections 

  

	 	2.8.1	 Inspection by Sponsor: During the term of this Agreement, Frenova will permit representatives of
Sponsor who are not competitors of Frenova in the dialysis services business to examine, at Sponsor’s cost, at a reasonable time during normal business hours and subject to at least ten (10) business days prior written notice to Frenova:
(i) the facilities where the Services are being, will be or have been conducted; (ii) documentation directly related to the conduct of the Study as necessary for Sponsor to confirm that the Services are being or will be or have been
conducted in conformance with applicable specific Statements of Work, this Agreement and in compliance with applicable laws and regulations. Frenova may exclude from any such inspection any of its proprietary or confidential information that is not
otherwise required to be provided to Sponsor in connection with this Agreement. 

  

	 	2.8.2	 Inspection by Regulatory Authorities: Sponsor acknowledges that Frenova may respond independently
to any correspondence, inquiry or inspection request from a regulatory authority in which Frenova or its Affiliates is named if it is not practicable to inform and work cooperate with Sponsor in such regard. To the extent any such request is related
to a Study, Frenova shall: (i) notify Sponsor promptly of any regulatory authority inspection or inquiry, including, but not limited to, inspections of Trial Sites, Facilities, subcontractors or laboratories; (ii) forward to Sponsor
copies of any correspondence from any regulatory authority relating to such inspection or inquiry, including, but not limited to, FDA Form 483 notices, and FDA refusal to file, rejection or warning letters; (iii) notify Sponsor of the results
of any such inspection or inquiry, including requested or required improvements, changes or modifications to Frenova’s operations; and (iv) notify Sponsor of any actions taken in response to or anticipation of such an inspection or
inquiry. Where reasonably practicable, Frenova will give Sponsor the opportunity to have a representative present during an inspection by a regulatory authority. Sponsor, however, acknowledges that it may not direct the manner in which Frenova
fulfills its obligations to permit inspection by regulatory authorities. 

  
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	 	2.8.3	 Inspections of Trial Site(s) by Frenova: To the extent required pursuant to the Statement of Work and/or
in connection with Frenova’s provision of Services as specified in this Agreement and any associated Statement of Work, Frenova may conduct monitoring visits and/or inspections of participating Trial Sites, and Facilities. Based on
Frenova’s observations during such Trial Site or Facility visits and inspections, Frenova may decide: (i) that enrollment should be suspended at the Trial Site or Facility; (ii) that a Trial Site’s or Facility’s non-compliance needs to be reported to Sponsor and/or regulatory authorities; and/or (iii) Trial Site’s or Facility’s participation in a Study needs to be terminated. Upon such a determination,
Frenova will present to Sponsor a basis for its decision. If Sponsor disagrees with the basis for Frenova’s decision, Frenova will assign its contract with the Trial Site or Facility to Sponsor and Sponsor agrees to accept such assignment and
to be responsible for all contractual duties and obligations to the Trial Site and/or Facility. 

  

	 	2.9	 Steering Committee 

Both Parties hereby may, upon mutual agreement, establish a joint review committee (“Joint Review Committee”) which shall be responsible for
reviewing and discussing operational, clinical quality, implementation of current and potential clinical trials. If established, each Party shall appoint two representatives (or more, upon mutual agreement) to the Joint Review Committee, which
representatives shall include appropriate leadership for both Parties. The Joint Review Committee shall convene quarterly at mutually agreeable dates and times. Agendas for the Joint Review Committee meetings can include, but not be limited to,
discussions of issues related to operations, quality, strategy, and future opportunities. 
  

	 	2.10	 Participation in Protocol Review 

Because of Frenova expertise in the conduct and administration of clinical trials involving patients with end stage renal disease or other patients with kidney
disease, Sponsor may include as part of the Statement of Work Frenova’ review, consultation and advisement on the Protocol for improving implementation and administration to the target subject population and potentially Study design, as
applicable. 
  

	 	2.11	 Potential Trial Sites/Investigators Generally 

Frenova as part of the Services pursuant to a Statement of Work, may routinely provide to Sponsor a list of potential Trial Sites and potential Investigators
(including potential Facilities). Consistent with Section 5, such potential Trial Site(s) and potential Investigators and potential Facilities are deemed Confidential Information of Frenova. Sponsor hereby agrees that it shall not knowingly
seek to directly contract with any potential Trial Site or any potential Investigator that are contractually obligated to facilitate Frenova’s involvement for any clinical trial that he/she would conduct for Sponsor at least in part at a
facility owned or operated by Frenova or its Affiliates. 

  
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	3.0	 FINANCIAL TERMS AND CONDITIONS 

The Parties agree that the fees and other reimbursements that Frenova will receive for performing the Services hereunder will be outlined in each Statement of
Work and are subject to the following terms and conditions. 
  

	 	3.1	 Compensation for Services 

For Services provided, Sponsor will pay Frenova in accordance with the terms in this section of the Agreement and each applicable Statement of Work. The timing
and frequency of payments will be governed by the Payment Schedule detailed in each Statement of Work. 
  

	 	3.2	 Services Budget 

All fees for Services shall be paid in the amounts and at the times indicated in the Payment Schedule. 

 

	 	3.3	 Pass-Through Budget 

In order to provide funding for Pass-Through expenses, exclusive of Trial Site/Investigator payments described below, Sponsor will make an advance payment to
Frenova of an amount to be specified in each Statement of Work. Frenova will submit to Sponsor detailed monthly invoices for amounts incurred during the relevant billing period. The advance payment will be retained by Frenova until the completion of
the Services, at which time a reconciliation of expenses will be done to ensure that Sponsor pays for only those expenses actually incurred. The advance payment will then be applied to the final invoice, if unpaid, and any remaining advance payment
will be refunded to Sponsor within thirty (30) days from the date of the final reconciliation. 
  

	 	3.4	 Trial Site/Investigator Payments and Reconciliation 

In order to provide for timely payments to Trial Sites/Investigators, Sponsor will make an initial advance payment to Frenova of an amount to be determined in
each Statement of Work. The Statement of Work shall specify, as the parties may mutually agree, any additional advance payments shall be made from Sponsor to Frenova and the process of invoicing and reconciliation of such advance payments, to the
extent applicable. In the event Frenova has any remaining advance payment upon the completion of Services, Frenova shall apply such advanced payment to the final invoice, if unpaid, and any remaining advance payment will be refunded to Sponsor
within thirty (30) days from the date of the final reconciliation. 
  

	 	3.5	 Invoices 

  

	 	3.5.1	 Invoices for Services and Pass-Through expenses will be submitted in accordance with the Payment Schedule
associated with the relevant Statement of Work and will be prepared monthly, or as frequently as necessary. 

  
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	 	3.5.2	 All invoices under this Agreement will be forwarded to the Sponsor representative designated in the relevant
Statement of Work. 

  

	 	3.5.3	 All payments under this Agreement will be remitted to the Frenova Affiliate named in the Statement of Work, to
the address and in the manner set forth in the Payment Schedule of the applicable Statement of Work. 

  

	 	3.6	 Payment Terms 

Sponsor agrees to pay for Services and Pass-Through expenses in accordance with the Payment Schedule outlined in each Statement of Work or associated
Amendment. Sponsor will pay for all Services, Pass-Through expenses and other correctly invoiced items within forty-five (45) days of receipt of invoice. All payments will be made in the currency noted in the Payment Schedule of the Statement
of Work. All fees for Services and Pass-Through expenses are exclusive of VAT (including non-refundable VAT) and other local taxes (excluding taxes based on Frenova’s income), which Sponsor will pay when
applicable. All Frenova invoices are payable within forty-five (45) days of receipt by Sponsor. Undisputed payments from Sponsor which are received 30 days past due will incur a 1.0% penalty per month calculated daily and compounded monthly or,
if lower, the highest rate permitted under applicable law. Sponsor will use reasonable efforts to inform Frenova in writing of any claimed errors on the invoice or invoice items being disputed within fifteen (15) business days of Sponsor’s
receipt of the invoices and the basis of such dispute (“disputed items”) (payment of undisputed items shall be required consistent with this Section). Sponsor acknowledges and agrees that any discrepancies identified through verification
of Study documentation that may result in an adjustment to payment must be resolved in a timely and satisfactory manner The parties shall in good faith seek to resolve any disputed items within thirty (30) days of any such items being deemed
“disputed” as set forth above. If the parties cannot resolve such disputed items within such time frame, then a party may pursue all of its rights in law and equity with respect to such disputed items.     

 

	 	3.7	 Final Payments 

Any final payments specified in a Statement of Work will be invoiced upon completion of the Services and delivery to Sponsor of any final Study databases,
reports or other deliverables as specified in the Statement of Work. If a final payment is specified in a Statement of Work, it will be due within forty-five (45) days of Sponsor’s receipt of invoice unless Sponsor notifies Frenova in
writing of any deficiencies in the Services. Frenova will correct any such deficiencies within thirty (30) days of notice and will resubmit the final invoice to Sponsor immediately upon final shipment of the corrected project deliverable(s).

  

	 	3.8	 Currency Management 

The Parties agree that all amounts to be paid to Frenova for Services rendered and all Pass-Through expenses, including Trial Site/Investigator payments, shall
be paid in U. S. Dollars unless otherwise set forth in an applicable Statement of Work. 

  
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	4.0	 TERM AND TERMINATION 

 

	 	4.1	 Term 

Unless earlier terminated according to Section 4.2, 4.3, or 4.4 below, this Agreement will remain in effect for an initial term of five (5) years
from the Effective Date, and thereafter will renew automatically for successive terms of one (1) year unless either Party notifies the other Party of termination of the Agreement no later than sixty (60) days prior to renewal hereof. In
the event of non-renewal by either Party, the term of this Agreement applicable under any outstanding Statement of Work will continue until completion of the Services described in such Statement of Work or
appropriate termination of the Statement of Work. 
  

	 	4.2	 Termination by Sponsor 

 

	 	4.2.1	 Sponsor may terminate this Agreement or any Statement of Work upon sixty (60) days prior written notice to
Frenova for any reason. Sponsor will pay Frenova for all Services properly rendered and Pass-Through expenses, including Trial Site/Investigator/Facility expenses incurred pursuant to this Agreement or any terminated Statement of Work. Sponsor will
also pay for Services and Pass-Through expenses, including Trial Site/Investigator/Facility expenses, necessary to conduct an orderly winding down of the administration of this Agreement, or any terminated Statement of Work, which amount will not
exceed the remaining unpaid balance of the Project Budget of the Statement of Work, unless special circumstances warrant otherwise. 

  

	 	4.2.2	 As soon as practicable following receipt of notice of termination under this Section 4.2, Frenova will
submit an itemized accounting of Pass-Through expenses and costs incurred, costs anticipated, and payments received in order to determine a balance to be paid by either Party to the other. Such balance will be paid by Sponsor or Frenova within
thirty (30) days of completion of work. 

  

	 	4.3	 Termination by Frenova 

 

	 	4.3.1	 Failure of Sponsor to comply with any of the material terms or conditions of this Agreement or to
respond to Frenova’s inquiries or requests for information will entitle Frenova to give written notice of default of this Agreement or a Statement of Work via certified/return receipt mail or overnight courier to ensure receipt by Sponsor. If
Sponsor does not cure the default within sixty (60) days of receipt of notice (or for such reasonable amount of time thereafter, if the default is not susceptible of cure within sixty (60) days), this Agreement or the affected Statement of
Work may be terminated by Frenova, which will 

  
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cease performance of Services. The cessation of Services in accordance with this Section will not be a default of performance obligations by Frenova, nor will it be a breach of this Agreement or
any Statement of Work. Sponsor will pay to Frenova all amounts due and owing for Services performed, Pass-Through expenses (including Trial Site/Investigator expenses) incurred, costs associated with winding up activities described in
Section 4.2 above, as well as any late fees which may be due, pursuant to Section 3.6 above. 

  

	 	4.3.2	 Additionally, Frenova may terminate any Statement of Work upon thirty (30) days prior written notice if:
(i) Sponsor cancels or materially delays the requested Services; (ii) unanticipated material changes to the project assumptions or project specifications cannot be addressed to both Parties’ satisfaction through an Amendment;
(iii) changes to the Study Protocol cause enrollment targets to become commercially unreasonable; (iv) Sponsor is unable to make timely payments to Frenova resulting in Frenova lacking funds to process payments to Trial Sites.

  

	 	4.4	 Termination for Other Reasons 

 

	 	4.4.1	 If in the reasonable assessment of Frenova or Sponsor, the continued performance of the Services contemplated
by this Agreement or any Statement of Work could constitute a potential or actual violation of legal, regulatory, ethical or scientific standards and/or patient safety and welfare is jeopardized, then either Party may terminate this Agreement or any
Statement of Work by giving written notice stating the effective date of such termination and notice period, if any. The parties shall use all reasonable efforts to rectify the alleged violation prior to the end of the notice period, if any.

  

	 	4.4.2	 Either Party may terminate this Agreement and all Statements of Work hereunder, effective immediately upon
written notice to the other Party, if the other Party: (i) files a voluntary petition in bankruptcy or has an involuntary bankruptcy petition filed against it, which is not dismissed within thirty (30) days after its institution,
(ii) is adjudged as bankrupt, (iii) becomes insolvent, (iv) has a receiver, trustee, conservator or liquidator appointed for all or a substantial part of its assets, (v) ceases to do business, (vi) commences any dissolution,
liquidation or winding up, (vii) makes an assignment of its assets for the benefit of its creditors, (viii) is excluded, suspended, sanctioned or otherwise restricted from participating in federal health care programs, including but not
limited to, Medicare or Medicaid, or is (ix) is convicted of a felony. 

  
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	 	4.5	 Survival 

Expiration or termination of this Agreement will not relieve the Parties of any obligation accruing prior to such expiration or termination. In addition, the
following sections: Financial Terms and Conditions, Term and Termination, Confidentiality and Proprietary Rights, Representations and Warranties, Indemnification and Insurance, Non-Solicitation of Employees,
Governing Law, as well as any other sections which by their nature should survive, will survive expiration or termination of this Agreement indefinitely, or for the period of time noted in the specific clause. 

 

	5.0	 CONFIDENTIALITY AND PROPRIETARY RIGHTS 

5.1 During the term of this Agreement and thereafter, the Parties and their Representatives (as defined below) shall neither disclose
nor use for any purpose except as expressly provided in this Agreement below, Confidential Information (as defined below) that is provided by Sponsor or Frenova (including without limitation their affiliates, customers, and licensors), directly or
indirectly, pursuant to this Agreement, whether oral or in written form, or other tangible medium, and whether or not marked confidential. “Confidential Information” means all Sponsor or Frenova (including without limitation their
Affiliates, customers and licensors) information and data, including, but not limited to, technical data, trade secrets, know-how, ideas, research, prototypes, samples, formulas, compounds, methods, plans,
specifications, characteristics, raw material data, software, inventions, discoveries, processes, designs, drawings, schematics whether or not patentable, and information concerning Sponsor’s or Frenova’s financial condition, product
plans, services, customers, potential customers, potential Trial Site lists and potential Investigator lists, distribution systems, suppliers, markets, business, technology, marketing plans, sales, manufacturing, purchasing and accounting methods,
strategy, budgets, contracts, grants, costs, profits, employees and consultants, plans for future development, and other information of a similar nature. For the sake of clarity, the potential Trial Site list(s), potential Investigator’s
list(s), and potential Facility list(s) developed by Frenova, including but not limited to the identity and contact information for potential Investigators, is confidential and proprietary and, subject to 5.3, shall be deemed as Frenova Confidential
Information. Notwithstanding any provision herein to the contrary, the medical records of any Study Subject used in the care and treatment of such patient shall be owned by the medical provider(s), as applicable, and their applicable Affiliates, and
in no event will this Section 5 be construed to place restrictions on the use of and disclosure of such medical information. 

5.2 In consideration of any access the Parties may have to Sponsor’s or Frenova’s Confidential Information hereunder, during
the term of this Agreement and thereafter, the Parties shall: 
  

	 	5.2.1	 in the case of Frenova, not use such Confidential Information except in the performance of Study related
Services in accordance with the applicable Statement of Work; 

  

	 	5.2.2	 hold the Confidential Information in strict confidence and shall protect such Confidential Information from
disclosure and shall use the same degree of care to avoid disclosure of such Confidential Information as the parties employ with respect to their own confidential information of like importance, but in no event less than a reasonable amount of care;

  
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	 	5.2.3	 not, without the express written permission of Sponsor or Frenova, as applicable, divulge any such Confidential
Information to others, except to persons who are (i) employees of the Parties or their Affiliates used in accordance with Section 8.8 or represent a Party or their Affiliate used in accordance with Section 8.8 in a professional
capacity; (ii) are bound by obligations of confidentiality and nonuse at least as restrictive as those set forth herein; and (iii) who have a bona fide need to know Confidential Information in connection with the Study related Services
(collectively, “Representatives”); 

  

	 	5.2.4	 not use for its own benefit or the benefit of its Representatives or any person or entity, other than the Party
owning the information, any such Confidential Information; and 

  

	 	5.2.5	 not copy, create derivative works of or reverse engineer any such Confidential Information, except such
duplication as is necessary in the performance of the Study related Services, or in the case of Sponsor, for the use of the Services. 

5.3 Confidential Information shall not include information that the receiving Party can show: 

 

	 	5.3.1	 was already in their possession without obligation to keep it confidential as evidenced by its written records
prepared or received prior to the disclosure; 

  

	 	5.3.2	 is lawfully disclosed to them by a third party, provided such information was not obtained by such third party
directly or indirectly from either Sponsor or Frenova (including without limitation their Affiliates, customers and licensors) on a confidential basis as evidenced by its written records; 

 

	 	5.3.3	 is independently developed by them (including without limitation their Affiliates) without access to or use of
the Confidential Information as evidenced by its written records prepared contemporaneously with the development; or 

  

	 	5.3.4	 is generally known to the public without violation hereof. 

  
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 5.4 A Party may make disclosures of the other Party’s Confidential Information as
required by law or regulation or by an order of a governmental agency, legislative body or court of competent jurisdiction, provided that the Party required to disclose such information: (i) provides the other Party, as applicable, with prompt
written notice of such requirement, (ii) cooperates with the other Party, as applicable, in connection with such Party’s actions to obtain a protective order and/or confidential treatment for such Confidential Information, and
(iii) limits such disclosure of Confidential Information to the fullest extent permitted under applicable law. 
 5.5
Notwithstanding any language to the contrary in this Agreement, the Parties shall be responsible for any disclosure or use of the other Party’s Confidential Information or other prohibited activity involving the other Party’s Confidential
Information by any of their respective Representatives, person or entity to which the other Party’s Confidential Information is disclosed. Each Party shall notify the other in writing immediately upon becoming aware of the occurrence of any
unauthorized release of the other Party’s Confidential Information or other breach of this Agreement. The Parties each acknowledge and agree that due to the unique nature of the Confidential Information there is no adequate remedy at law for
any breach of its or its Representatives’ obligations hereunder and that any breach would result in irreparable harm to Sponsor or Frenova, as applicable. Therefore, upon any such breach, Sponsor or Frenova, as applicable, shall be entitled to
obtain appropriate equitable relief in addition to its remedies at law. 
 5.6 Nothing contained in this Agreement shall be construed
as granting or conveying to Sponsor or Frenova, or their Representatives, by implication, license, estoppel or otherwise, any right, title or interest in or to the Confidential Information. None of the Confidential Information which may be disclosed
hereunder shall constitute any representation, warranty, assurance, guarantee, or inducement by Sponsor or Frenova as to the non-infringement of patents, trademarks, copyrights or any intellectual property
rights or other rights of third parties. All Confidential Information and other written data provided by Sponsor or Frenova hereunder shall be and remain the property of Sponsor or Frenova, as applicable. 

5.7 In the event Sponsor shall come into contact with any Subject’s medical records, Sponsor shall hold in confidence the identity
of such Subject and shall comply with all applicable law(s) and contractual obligations regarding the confidentiality of such Subject’s records. 

5.8 Sponsor and Frenova each agree to hold the terms of this Agreement in confidence. Notwithstanding anything in this Agreement to the
contrary, Frenova may, however, disclose such Confidential Information to potential Principal Investigator(s) or Principal Investigator(s) and/or their designees, provided that such parties have agreed to protect the confidential nature of the
information disclosed to them. 
  

	 	5.9	 Return or Destruction of Information 

Upon a Party’s written request, Sponsor or Frenova shall promptly deliver to the other or to destroy if so requested, as applicable, all originals,
copies, and summaries of documents, materials, and other tangible manifestations of Confidential Information and any other property of Sponsor or Frenova, as applicable, that the Party shall have in its possession or under their control, in whatever
media; provided, however, that each Party shall be entitled to retain in confidence under this Agreement, including without limitation (i) one (1) archived copy of the other Party’s Confidential Information and all materials created by
such Party and containing the other Party’s Confidential Information, including without limitation notes and memoranda, solely for the purpose of administering a Party’s obligations under this Agreement; and (ii) Confidential
Information contained in such Party’s electronic back-up files that are created and maintained in the normal course of business pursuant to such Party’s standard protocol for preserving its
electronic backup records. 

  
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	 	5.10	 Proprietary Rights 

 

	 	5.10.1	 The entire right, title and interest in and to any Invention that is related to an indication, use, formulation
or dosage, or to the manufacture, of the Study Agent shall be the property of Sponsor (“Sponsor Inventions”). Frenova hereby assigns and agrees to assign all Sponsor Inventions to Sponsor. Any Inventions that are related to dialysis
devices and processes (including disposables related thereto) shall be owned by Frenova or its designee (“Frenova Inventions”). Sponsor hereby assigns and agrees to assign all Frenova Inventions to Frenova. 

 

	 	5.10.2	 The parties hereto acknowledge and agree that the inventions and technologies of Sponsor and Frenova or their
respective Affiliates that pre-exist this Agreement or are made or conceived independently of a Study and the Services are their separate property, respectively, and are not affected by this Agreement and no
Party hereto shall have any claims to or rights in such pre-existing or independently made or conceived inventions and technologies. The Sponsor and Frenova shall not be deemed to transfer or grant to another
Party hereto any rights except insofar as necessary to permit the parties to conduct Study related Services, and as expressly provided in this Agreement. 

  

	 	5.10.3	 Subject to Section 5.10.1 above, title to any other Inventions made or conceived (i) solely by
Sponsor employees or consultants shall be solely owned by Sponsor; (ii) solely by Frenova employees or consultants shall be solely owned by Frenova; and (iii) jointly by Sponsor employees or consultants and/or Frenova employees or
consultants shall be jointly owned by the respective employers (“Joint Inventions”). 

  

	 	5.10.4	 The Parties understand and agree that Frenova is in the business of providing dialysis care through its
clinics. As such, the Parties agree that with respect to data and results arising out of the performance of the Study related Services, Frenova retains a right to use the Study data in connection with the treatment of patients. Frenova agrees to
hold the Study data in confidence and to maintain the Study data as Confidential Information as defined by this Agreement. 

  

	 	5.10.5	 Each Party hereto agrees to assist the other Party hereto in their efforts to establish and perfect its rights
acquired under this Section 5.10, and to execute any documents reasonably necessary to do the same. The Party requesting such assistance shall reimburse the other Party for reasonable expenses incurred in satisfying the obligations under the
immediately preceding sentence. 

  
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	 	5.10.6	 With respect to Joint Inventions, Frenova and Sponsor shall each own a
one-half undivided interest in the Joint Inventions and, subject to the terms of this Agreement, can sell, license or otherwise transfer its rights to the Joint Inventions without a duty of accounting to the
other Party. Each Party hereby grants to the other Party all permissions, consents and waivers with respect to, and all licenses under, such Joint Inventions, throughout the world, necessary to provide the other Party with such rights of practice,
use and other exploitation, and will execute documents as necessary to accomplish the foregoing. In addition, the Parties shall cooperate in good faith in connection with (i) preparing, filing and prosecuting patent applications (including
reissue, continuing, continuation-in-part, provisional, divisional, and substitute applications and any foreign counterparts thereof); (ii) maintaining any resulting
patents; (iii) managing any interference or opposition proceedings relating to the foregoing; and (iv) bringing, pursuing and settling infringement claims against third parties. 

 

	 	5.11	 Publicity 

Except as may be required by law, a Party shall not use the other Party’s name or any of the name of any of the other Party’s Affiliates, in any
press release, publicity, advertising, or other disclosure without the named party’s prior written consent. Furthermore, no Party to this Agreement shall use the names, trade names, trademarks, service marks, logos or other brand-source indicia
(“Trademarks”) of any other Party in any advertising, promotional or sales literature or in any publicity without the prior written approval of the Party whose Trademarks are to be used. Further, either Party may make such public
disclosures as it determines, based on advice of counsel, are reasonably necessary to comply with laws or regulations. 
  

	 	5.12	 Publications 

Frenova shall not publish any articles or make any presentations relating to the Services, Sponsor Confidential Information or referring to data generated
pursuant to any Statement of Work issued hereunder, without the prior written consent of Sponsor. Sponsor shall not publish any articles or make any presentations including Frenova Confidential Information, without the prior written consent of
Frenova. Nothing in this Section 5.12 will prevent Sponsor from publishing any results of any Study. 

  
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	6.0	 REPRESENTATIONS AND WARRANTIES 

 

	 	6.1	 Acknowledgements 

Sponsor acknowledges and agrees that there can be no assurance, representation or warranty by Frenova that a Study Agent which is the subject of research in
any Study to which the Services are related, either during the term of this Agreement or thereafter, will be successfully developed or, if so developed, will receive the required approval by the United States Food and Drug Administration
(“FDA”) or other regulatory authority. 
  

	 	6.2	 Representations and Warranties of Sponsor 

 

	 	6.2.1	 Sponsor represents and warrants to Frenova as of the Effective Date that, to Sponsor’s knowledge,
performance of obligations required of Frenova hereunder will not infringe or violate the intellectual property rights of any third party including but not limited to trademark, trade secrets, copyright, patent, proprietary information rights.

  

	 	6.2.2	 Sponsor represents and warrants that neither any assignment nor task requested by Sponsor nor the conduct
thereof as provided in this Agreement would necessarily violate any applicable law or regulation. Sponsor shall notify Frenova immediately upon learning of any potential violation of this Agreement or of applicable law pertaining to the Study.

  

	 	6.2.3	 Sponsor represents and warrants that it has the right, title and interest in the Study Agent which is the
subject of research covered by this Agreement or any Statement of Work (whether such right, title and interest is held solely by Sponsor or jointly with others) and that it has the legal right, authority and power to enter into this Agreement, and
to perform any clinical trial which is the subject of a Statement of Work issued hereunder. 

  

	 	6.2.4	 Sponsor represents and warrants it will provide Frenova with copies of any monitoring visit follow-up letters sent to the Trial Sites, provided that Frenova agrees to limit their use of these monitoring visit follow-up letters to the provision of the Services.

  

	 	6.3	 Representations and Warranties of Frenova 

 

	 	6.3.1	 Frenova represents and warrants that the personnel assigned to perform Services rendered under this Agreement
will be capable professionally, and that it will perform its obligations hereunder in accordance with all applicable federal, international, state or local law or regulation, the terms of this Agreement and any Statement of Work issued hereunder.

  
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	 	6.3.2	 Frenova further represents and warrants that it will make available to Sponsor or to the responsible regulatory
authority relevant records, programs, and data as may be reasonably requested by Sponsor for purposes related to filing and prosecution of Sponsor’s related applications for any regulatory approvals. 

 

	 	6.3.3	 Frenova’s sole obligation for material breach of a representation and warranty set out in this Section
will be, at Sponsor’s option, to correct or re-perform, or refund all amounts paid for that portion of the Services that fails to materially conform thereto. 

 

	 	6.4	 Debarment Certification 

 

	 	6.4.1	 Frenova certifies that it has not been debarred under Section 306 of the Federal Food, Drug, and Cosmetic
Act, 21 U.S.C. §335a(a) or (b) or any equivalent local law or regulation. In the event that Frenova becomes debarred, Frenova agrees to notify Sponsor immediately. 

 

	 	6.4.2	 Frenova certifies that no individual or entity providing Services hereunder has been or will be debarred under
Section 306 of the Federal Food, Drug and Cosmetic Act, 21 U.S.C §335a (a) or (b) or any equivalent local law or regulation. In the event that Frenova becomes aware of or receives notice of the debarment of any individual or entity
providing Services hereunder, Frenova agrees to notify Sponsor immediately. 

  

	 	6.5	 No Suspension or Exclusion from Federal Health Care Programs 

Each Party represents and warrants that it has not been and will not be excluded, suspended, sanctioned or otherwise restricted from participating in federal
health care programs in the U.S., including but not limited to, Medicare or Medicaid.    In the event that a Party becomes aware of or receives notice of its exclusion, suspension, sanction or restriction from participating in
federal health care programs in the U.S., such Party shall notify the other Party immediately. 
  

	 	6.6	 No Other Warranties 

The Parties’ warranties and representations contained in this Agreement are in lieu of all other warranties expressed or implied. 

 

	7.0	 INDEMNIFICATION AND INSURANCE 

 

	 	7.1	 Indemnification by Sponsor 

 

	 	7.1.1	 Sponsor will indemnify, defend and hold harmless Frenova, its Affiliates, and their officers, directors,
agents, employees, and independent contractors (each an “Indemnitee”) against any and all losses, damages, liabilities, costs and expenses, settlement payments, judgments, fines, fees, penalties or other charges, including
reasonable 

  
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attorneys and professional fees (collectively “Losses”) resulting from any claims, causes of action or suits, proceeding, arbitration, pending or threatened, and in each case by a third
party (each a “Claim”) against Indemnitees arising out of the authorized use or disclosure of Sponsor’s Confidential Information by the Indemnitee or their respective Representatives, the Study, the Services and other work
conducted under this Agreement, in each case subject to Section 7.1.3. Frenova will promptly notify Sponsor upon receipt of notice of any Claim (provided that the failure to give such notice will not relieve Sponsor of its obligations under
this Section except to the extent, if at all, it is prejudiced thereby) and will permit Sponsor’s attorneys and personnel, at Sponsor’s discretion and cost, to handle and control the defense of any such Claim. Frenova may participate in
the defense using its own independent counsel, at Frenova’s expense, without relieving Sponsor of its obligations under this Section. 

  

	 	7.1.2	 Under no circumstances, however, will Sponsor accept liability, settle or otherwise compromise any Claims
without prior written consent of Frenova, which will not be unreasonably withheld. Frenova will fully cooperate and aid in any such defense. 

  

	 	7.1.3	 Sponsor will not be obligated to indemnify, defend, or hold harmless Frenova against any Claim to the extent
that such Claim arose as a result of Frenova’s negligence, intentional misconduct or breach of this Agreement or any Statement of Work hereunder. If Sponsor incurs reasonable defense costs that it is not responsible for pursuant to this
Section 7.1.3, Frenova will repay to Sponsor all such costs. 

  

	 	7.2	 Indemnification by Frenova 

 

	 	7.2.1	 Frenova will indemnify, defend and hold harmless Sponsor and its employees, officers, and directors against any
and all Losses, resulting from any Claim arising from the authorized use or disclosure of Frenova’s Confidential Information by Sponsor or their respective Representatives, Frenova’s negligence, intentional misconduct, or breach of this
Agreement or any Statement of Work hereunder. Sponsor will promptly notify Frenova upon receipt of notice of any Claim for which it intends to seek indemnification hereunder, provided that the failure to give such notice will not relieve Frenova of
its obligations under this Section except to the extent, if at all, it is prejudiced thereby. Sponsor will permit Frenova’s attorneys and personnel, at Frenova’s discretion and cost, to handle and control the defense of any such Claim.
Sponsor may participate in the defense using its own independent counsel, at Sponsor’s expense, without relieving Frenova of its obligations under this Section. 

  
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	 	7.2.2	 Under no circumstances, however, will Frenova accept liability, settle or otherwise compromise any Claims
subject to indemnification under this Section without prior written consent of Sponsor, which will not be unreasonably withheld. Sponsor will fully cooperate and aid in any such defense. 

 

	 	7.2.3	 Frenova will not be obligated to indemnify, defend or hold harmless Sponsor against any Claim to the extent
that such claim arose as a result of Sponsor’s negligence, intentional misconduct or breach of this Agreement or any Statement of Work hereunder. If Frenova incurs reasonable defense costs that it is not responsible for pursuant to this
Section 7.2.3, Sponsor will repay to Frenova all such costs. 

  

	 	7.3	 Limits of Liability 

Frenova’s liability for direct damages hereunder will not exceed the total fees for Services payable by Sponsor to Frenova under the applicable Statement
of Work. Except for any breach of provisions related to Confidential Information in Section 5, in no event will a Party be liable to the other Party for any indirect, incidental, special, consequential, punitive, exemplary damages of any kind
(including without limitation, lost profits, lost savings, loss of data, loss of business opportunities) arising out of or related to this Agreement, any Statement of Work, or the transactions contemplated by this Agreement, however caused, under
any theory of liability, even if any or all of the Parties have been advised of the possibility of such damages. Nothing in this Section 7.3 will limit a Party’s liability pursuant to Sections 7.1 or 7.2. 

 

	 	7.4	 Insurance 

Sponsor represents and warrants that it maintains a policy or program of insurance or at levels sufficient to support the Sponsor’s Indemnification and
obligations and duties assumed under this Agreement. This includes: 
  

	 	(1)	 General liability insurance for bodily injury, including death, and property damage; 

 

	 	(2)	 Workers’ compensation insurance in the amount required by the law of the state in which the
Institution’s employees are located; and 

  

	 	(3)	 Clinical trial insurance policy or similar systems for compensation for any damage suffered by a subject
resulting from participation in a clinical trial conducted in the EU. 

 Sponsor shall provide to Frenova, upon request, evidence of its
insurance of the types specified in this Section or self-insurance. 
 Frenova represents and warrants that it maintains a policy or program of insurance or
self-insurance at levels sufficient to support the Frenova’s Indemnification and obligations and duties assumed under this Agreement. For Services performed within the United States of America, this includes: 

 

	 	(1)	 General liability insurance for bodily injury, including death, and property damage; 

  
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	 	(2)	 Workers’ compensation insurance in the amount required by the law of the state in which the
Institution’s employees are located; 

  

	 	(3)	 Professional liability insurance. 

For Services performed outside of the United States of America, this includes: 
  

	 	(1)	 General and Product liability insurance for bodily injury, including death, and property damage.

 Frenova shall provide to Sponsor, upon request, evidence of its insurance of the types specified in this Section or self-insurance. 

 

	8.0	 MISCELLANEOUS CLAUSES 

 

	 	8.1	 Independent contractor relationship 

Frenova and Sponsor are independent contractors. Nothing in this Agreement will be construed to create the relationship of partners, joint venturers, or
employer and employee between Frenova and Sponsor or Frenova’s employees. Neither Party, nor its employees, or independent contractors will have authority to act on behalf of or bind the other Party in any manner whatsoever unless otherwise
authorized in this Agreement or a specific Statement of Work or in a separate writing signed by both Parties. 
  

	 	8.2	 Nonsolicitation of Employees 

Neither Party, during the term of this Agreement and for twelve (12) months thereafter, will, without the prior written consent of the other Party,
directly or indirectly solicit for employment or contract, attempt to employ or contract with or assist any other entity in employing, contracting with or soliciting for employment or contract any employee or executive who is at that time
employed/contracted by the other Party or an Affiliate used in accordance with Section 8.8 and who had been employed/contracted by the other Party or an Affiliate used in accordance with Section 8.8 in connection with one or more
Statements of Work issued hereunder. Provided, however, that the foregoing provision will not prevent either Party from conducting solicitation via a general advertisement for employment that is not specifically directed to any such employee or from
employing any such person who responds to such solicitation. 
  

	 	8.3	 Notices 

Except as otherwise provided, all communications and notices required under this Agreement will be mailed by first class mail or sent via nationally
recognized overnight courier to the addresses set forth below, or to such other addresses as the Parties from time to time specify in writing. 

  
 26 

			
	

	  	

  

			
	If to Sponsor:	  	If to Frenova:
		
	 inRegen
 c/o Twin City Bio LLC

3929 WestPoint BLVD
 Suite G

Winston-Salem, NC 27103
 Attn: Tim Bertram
	  	 Frenova, LLC
 920 Winter Street

Waltham, MA 02451
 Attention: Business Operations

 
 with a copy to:

 
 Frenova, LLC

c/o FMCNA
 920 Winter Street

Waltham, MA 02451
 Attention: Corporate Law
Department

  

	 	8.4	 Anti-Bribery; Anti-Corruption 

As stated in the Fresenius Medical Care Code of Ethics and Business Conduct, Frenova upholds the values of quality, honesty and integrity, innovation and
improvement, respect and dignity, as well as lawful conduct, especially with regard to anti-bribery and anti-corruption. Frenova upholds these values in its own operations, as well as in its relationships with business partners. Frenova’s
continued success and reputation depends on a common commitment to act accordingly. Together with Frenova, Sponsor is committed to uphold these fundamental values by adherence to applicable laws and regulations. 

 

	 	8.5	 Force Majeure 

If the performance of this Agreement by Frenova or Sponsor is prevented, restricted, interfered with or delayed (either totally or in part) by reason of any
cause beyond the control of the Parties (including, but not limited to, acts of God, explosion, disease, weather, war, insurrection, terrorism, civil strike, riots or extensive power failure), the Party so affected will, upon giving notice to the
other Party as soon as is practical, be excused from such performance to the extent of such prevention, restriction, interference or delay, provided that the affected Party will use reasonable efforts to avoid or remove such causes of non-performance and will continue performance whenever such causes are removed. 
  

	 	8.6	 Governing Law 

This Agreement will be governed in all respects by the laws of New York, United States of America or the laws of Germany, as applicable to where the Services
are performed, without regard to its conflict of laws principles. 
  

	 	8.7	 Severability 

If any of the provisions or a portion of any provision of this Agreement is held to be unenforceable or invalid by a court of competent jurisdiction, the
validity and enforceability of the enforceable portion of any such provision and/or the remaining provisions will not be affected thereby. 

  
 27 

			
	

	  	

  

	 	8.8	 Assignment 

Neither Party may assign this Agreement without the prior written consent of the other Party, which consent will not be unreasonably withheld; provided,
however, that either Party may assign this Agreement without consent to a successor in interest to substantially all of the business of that Party to which the subject matter of this Agreement relates upon delivery to the other Party of notice of
such assignment. Additionally, Frenova may use the services of its corporate Affiliates to fulfill its obligations under this Agreement and any Statement of Work provided that Frenova shall also remain fully responsible for such obligations
regardless of whether Frenova or one of its Affiliates has signed the Statement of Work. Frenova shall ensure that any Affiliate so used shall be acts according to all of the terms and conditions applicable to Frenova under this Agreement or any
Statement of Work, and the Affiliate shall be entitled to all rights and protections afforded Frenova under this Agreement and any Statement of Work. Any such Affiliate of Frenova may execute a Statement of Work directly. 

 

	 	8.9	 Waiver 

No waiver of any term, provision or condition of this Agreement whether by conduct or otherwise in any one or more instances will be deemed to be construed as
a further or continuing waiver of such term, provision or condition or of any other term, provision or condition of this Agreement. 
  

	 	8.10	 Entire Agreement; Incorporation by Reference; Conflict 

This Agreement and all Statements of Work (including any Protocols and Study Specifications) contains the full understanding of the Parties
with respect to the Services and supersedes all existing agreements and all other oral, written or other communications between the Parties concerning the subject matter hereof. This Agreement will not be modified in any way except in writing and
signed by a duly authorized representative of Sponsor and an authorized officer of Frenova. In the event of a conflict between the terms and conditions this Agreement or those of any Statement of Work, the terms of this Agreement will take
precedence and control unless the provisions of a Statement of Work expressly provide otherwise. 
  

	 	8.11	 English Language 

The Parties hereto confirm that this Agreement as well as any other documents relating hereto, including notices, have been and shall be drawn up in the
English language only. 
  

	 	8.12	 Counterparts; Facsimile Signatures 

This Agreement may be executed in any number of counterparts with the same effect as if all the parties had signed the same document. Such executions may be
transmitted to the parties by facsimile, or in graphical-image form by email or other electronic transmission (collectively, “facsimile evidenced signature”), is to be deemed for all purposes to have been executed and delivered by that
party to the other party and such facsimile evidenced signature shall have the full force and effect of an original signature. All fully executed counterparts, whether original or facsimile evidenced signature or a combination of both, shall be
construed together and shall constitute one and the same agreement. 

  
 28 

			
	

	  	

  

	 	8.13	 Dispute Resolution 

In the event a dispute relating to this Agreement or any Statement of Work arises between the Parties, the Parties will use all reasonable efforts to resolve
the dispute through direct discussions for a period of thirty (30) business days. The senior management of each Party is committed to respond to any such dispute. Should such effort to amicably settle the dispute fail, the Parties may proceed
to file an action in court. 
  

	 	8.13	 No Requirement for Referrals; Fair Market Value. 

The Parties agree that the benefits to the parties hereunder do not require, are not payment for and are not in any way contingent upon the referral of
patients or business or any other arrangement between the Parties. The Parties represent that the compensation negotiated and agreed upon is fair market value for the services rendered based upon arm’s length bargaining. Furthermore, the
parties represent that the compensation is not and has not been determined in a manner that takes into account the volume or value of any referrals or business otherwise generated between the Parties for which payment may be made in whole or in part
under Medicare or any other federal health care program. The parties further represent that nothing contained in this Agreement and no amount paid hereunder is intended or shall be construed as an inducement for the Parties to refer or admit any
patients to, or order any goods or services from any Parties, or any of their respective Affiliates. 
  

	 	8.14	 Non-Exclusivity; Other Interests. 

The Parties acknowledge and agree that this Agreement is non-exclusive. Additionally, nothing in this Agreement shall
limit, restrict or prevent each Party from pursuing, developing, engaging, or providing products or services that are or may be competitive with the products or services of the other Party including, but not limited, providing products or services
to a competitor; provided, however, that the confidentiality obligations hereunder remain in full force and effect with respect to each Party. 

  
 29EX-10.17

 Exhibit 10.17 

MASTER SERVICES AGREEMENT 

THIS MASTER SERVICES AGREEMENT (the
“Agreement”) is effective as of May 1, 2019 (the “Effective Date”) by and between PPD DEVELOPMENT, L.P., a Delaware limited partnership, with its principal executive offices located at 929
North Front Street, Wilmington, North Carolina (“PPD”) and inRegen, a Cayman Islands exempted company with its principal executive offices located at 10 Market St., #688 Camana Bay, Grand Cayman KY1-9006 Cayman Islands (“Sponsor”). 
 WHEREAS, Sponsor is engaged in the
development, manufacture, distribution and sale of pharmaceutical products; and 
 WHEREAS, PPD is a clinical research organization engaged
in the business of managing clinical research programs and providing clinical development and other related services; and 
 WHEREAS,
Sponsor may wish to retain the services of PPD from time to time to perform clinical development services in connection with certain clinical research programs Sponsor is conducting (individually, a “Project”), in which case
the terms and conditions for each such Project shall be set forth in a project addendum to be attached to this Agreement and incorporated herein by reference (individually, a “Project Addendum” and collectively, the
“Project Addenda”); and 
 WHEREAS, PPD is willing to provide such services to Sponsor in accordance with the terms
and conditions of this Agreement and the attached Project Addenda. 
 NOW, THEREFORE, for good and valuable consideration contained herein,
the exchange, receipt and sufficiency of which are acknowledged, the parties agree as follows: 
  

	1.	 SERVICES. 

1.1 Services to be Provided by PPD. PPD hereby agrees to provide to Sponsor the services identified and described in the Services
section of each Project Addendum attached to this Agreement (the “Services”). PPD shall perform the Services for each Project set forth in the applicable Project Addendum in compliance with (i) the protocol for the
Project (“Protocol”), which may be attached to and made a part of the applicable Project Addendum, as amended or updated from time to time, (ii) the terms and conditions of this Agreement, (iii) the terms and
conditions of the applicable Project Addendum, (iv) PPD’s standard operating procedures (“SOPs”), which will be available for Sponsor’s review upon written request, and (v) all applicable laws, rules and
regulations. Sponsor agrees that PPD is responsible only for those Services set forth on a properly executed Project Addendum. 
 1.2
Project Addendum. In the event that the parties hereto shall reach agreement with respect to the provision of Services for a Project, PPD, or a PPD Affiliate, and Sponsor, or an affiliate of Sponsor, shall execute a Project Addendum
evidencing such Services. Each Project Addendum shall be attached to this Agreement and incorporated into and made a part of this Agreement by reference, and each such Project Addendum and this Agreement shall constitute the entire agreement for the
applicable Project. To the extent any terms set forth in a Project Addendum conflict with the terms set forth in this Agreement, the terms of the Project Addendum shall control. 

1.3 Sponsor Cooperation. Sponsor will, and will cause its affiliates and their respective representatives, agents, employees and
contractors (collectively referred to as “Sponsor’s Representatives”) to, cooperate with PPD and its Affiliates in providing accurate and up to date information, taking action and executing documents, as appropriate, to
perform the Services or regulatory obligations delegated to PPD under a Project Addendum or achieve the objectives of this Agreement and any Project Addendum executed under this Agreement. Sponsor acknowledges and agrees that PPD’s performance
under this Agreement is dependent on Sponsor’s and Sponsor’s Representatives’ timely and effective cooperation with PPD and its Affiliates. Accordingly, Sponsor acknowledges that any delay by

  

	
	Page 1

 PPD PROPRIETARY AND CONFIDENTIAL 

 
  

 Sponsor or Sponsor’s Representatives may result in PPD being released from an obligation or schedule
deadline or in Sponsor having to pay extra fees in order for PPD to meet a specific obligation or deadline despite the delay. In the event of any such delays, the study timelines will be revised accordingly. 

1.4 Compliance with Law. Sponsor shall comply with all Applicable Laws in its performance of its obligations under, and subject matter
of, this Agreement. PPD will comply with all Applicable Laws in the performance of the Services and its obligations under this Agreement 

1.5 Operating Guideline, Safety Plan or Safety and Medical Management Plan. Notwithstanding anything to the contrary herein, in
the event PPD and Sponsor agree upon operating guidelines, safety plans or safety and medical management plans (each shall be referred as a “Project- Specific Plan”), the parties shall comply with the terms and conditions of
any such Project-Specific Plan. In the event of any conflict between the terms and conditions of a Project-Specific Plan and the relevant Project Addendum, the terms and conditions of the Project-Specific Plan shall control. Sponsor shall be
responsible for any additional costs associated with compliance with the Project-Specific Plan, which will be captured in Contract Modification to the relevant Project Addendum. 

1.6 Patient Enrollment. The parties agree that enrollment numbers are good faith estimates and that various factors outside of
PPD’s control can affect the rate of enrollment. PPD shall exercise all reasonable efforts to meet such enrollment estimates but cannot guarantee that enrollment numbers or enrollment timelines will be met. 

1.7 Final Protocol. PPD shall not be liable or responsible for the final review, approval, adoption, and content of the Protocol, and,
accordingly, Sponsor shall be solely liable and responsible in this regard. 
 1.8 Definitions. “Affiliate”
means an entity which that controls, is controlled by or is under common control with a party or, with respect to PPD, PPD’s parent company Pharmaceutical Product Development, LLC. “Applicable Laws” means any applicable
federal, national (U.S. or foreign), supranational, state, provincial, territorial, local, municipal, regulatory, self-regulatory or similar statute, constitution, resolution, law, ordinance, regulation, rule or code, administrative order or
requirement, judgment, decree or other restriction enacted, adopted, issued, implemented or promulgated or otherwise put into effect by or under the authority of any governmental entity or common law. 

 

	2.	 COMPENSATION AND PAYMENT.

 2.1 Charges for Services. Sponsor shall pay PPD for all Services performed under this Agreement and any
Project Addendum (“Direct Fees”) in accordance with the rates for such Services set forth in such Project Addendum, CNF or Contract Modification thereto. Upon signature of a Project Addendum, PPD shall invoice Sponsor an
initial amount equal to twelve percent (12%) of the total Direct Fees budget for that Project. Each Project Addendum will detail the payment schedule, inclusive of said advance, through which PPD shall be compensated for Services performed. 

2.2 Charges for Pass Through Costs. Sponsor shall also reimburse PPD for all out-of-pocket expenses incurred in connection with the performance of the Services with respect to a Project, including, without limitation, investigator grants and fees, travel expenses, shipping and postage
costs, copying and printing fees, copyright fees, third party drug storage and distribution fees, required Institutional Review Board or similar board or committee fees, and other “pass through” expenses, each as set forth in the Project
Addendum or pre-approved in writing by Sponsor and incurred in connection with performing the Services (collectively, the “Pass Through Costs”). Upon signature of a Project Addendum,
PPD shall invoice Sponsor a mutually pre-agreed initial amount of the total estimated Pass Through Costs, exclusive of investigator fees, which are addressed separately in Section 2.3 below. This initial
payment will be used to offset PPD’s payment of Pass Through Costs on Sponsor’s behalf. After this initial payment, PPD will invoice Sponsor monthly in arrears reflecting all actual Pass Through Costs incurred by PPD. 

  
  

Page 2 

 PPD PROPRIETARY AND CONFIDENTIAL 

 
  

 Where PPD incurs Pass Through Costs in a currency other than the currency as stated in the
contract (“Contract Currency”), PPD shall, for Sponsor invoicing and payment purposes, convert such costs to the Contract Currency based on an average exchange rate between the local currency and the Contract Currency for the month in
which such costs were incurred. This average exchange rate will be based on the monthly average of the daily exchange rates as published in the Wall Street Journal. 

2.3 Charges for Investigator Fees. At the beginning of each study Sponsor shall advance PPD a
pre-agreed amount of the total investigator fee budget for the sole purpose of paying investigator fees. PPD will then invoice Sponsor monthly for reimbursement for all payments made to investigators during
the invoice period using funds received in the advance payment, and Sponsor agrees to pay such invoices in accordance with the terms of this Section 2. For Sponsor invoicing and payment purposes, PPD shall convert all investigator fees that are
to be paid in a currency other than the Contract Currency to the Contract Currency based on the average exchange rate between the currencies for the month prior to the month the invoice is raised. PPD shall have no obligation to pay vendor costs, or
investigator payments to any vendor or investigator site for conduct of services related to a Project until PPD has received payment of such Pass-Through Costs from Sponsor. Notwithstanding anything to the contrary contained herein, Sponsor
acknowledges and agrees that certain vendor contracts, including without limitation, contracts for investigator meetings, comparator drug purchase and patient recruitment services, must be advanced and paid up front by Sponsor. 

2.4 Payment Terms. Sponsor shall pay (meaning PPD shall receive cleared funds into its account(s)) each invoice within forty-five
(45) days of receipt of said invoice. In the event Sponsor disputes an invoice, or any portion of an invoice, such a dispute should be made, in writing (e-mail is sufficient) within forty-five
(45) days of receipt of said invoice, together with documentation supporting Sponsor’s dispute. Notwithstanding the foregoing, all undisputed invoices and all undisputed portions of any invoice shall continue to be payable forty-five
(45) days from receipt of said invoice. PPD and Sponsor shall use commercially reasonable efforts to resolve the dispute in good faith and as expeditiously as reasonably possible. Upon resolution of any such dispute, Sponsor shall make the
agreed upon payment within fifteen (15) days of such resolution. If payment is not received within the timeframes set forth in this Section 2.4, in addition to any other rights and remedies available to PPD, such amounts shall be considered
late and will be subject to interest at the rate of one per cent (1.0%) per month (or the maximum amount permitted by applicable law if less than 1.0% per month) from the due date of the applicable invoice and lasting until the date of actual and
full payment of the outstanding amounts. Furthermore, in the event any undisputed amounts remain unpaid for ten (10) business days after Sponsor’s receipt of written notice from PPD of such amount, PPD shall have the right, in its sole
discretion, to (i) suspend performance of the Services until PPD receives full payment of all outstanding and undisputed amounts. In no event will PPD have the right to withhold safety reports or patient data from Sponsor. 

2.6 Purchase Orders. In the event Sponsor utilizes a purchase ordering system with its suppliers, Sponsor shall provide PPD the
applicable purchase order number (“PO”) for the Project on or before the date on which the Project Addendum or any amendment, is executed (whichever is earlier in time). Should Sponsor fail to provide the PO within the above
timeframe, PPD may invoice for Services performed and Pass Through Costs incurred. Sponsor will pay such invoices in accordance with the payment terms set forth in this Agreement irrespective of whether the invoice includes the Project PO. 

2.7 Payment after Termination. Upon termination of any Project Addendum or this Agreement, Sponsor shall pay PPD: (i) all Direct
Fees for all Services performed; (ii) all Pass Through Costs incurred; (iii) any other costs or expenses payable by Sponsor pursuant to the terms of this Agreement or the Project Addendum, including any costs specified for wind down activities;
and (iv) all future non-cancelable obligations incurred (where such obligations were created as a result of a Project being authorized by Sponsor). If no sums are outstanding from Sponsor to PPD, any
funds held by PPD, determined to be unearned (taking into account any wind down activities), shall be returned to Sponsor within sixty (60) days following completion of the final reconciliation Project budget. 

2.9 Pre-Execution Services. In the event Sponsor requests in writing PPD to begin providing the
Services for a Project prior to the execution by Sponsor of a Project Addendum, Sponsor agrees that PPD shall be compensated for Services performed pursuant to such written request in accordance with the payment terms contained herein and the PPD
Proposal for Services. 

  
  

Page 3 

 PPD PROPRIETARY AND CONFIDENTIAL 

 
  

 2.10 Taxes. All fees stated in this Agreement or any Project Addendum are exclusive of
Value Added Tax (“VAT”) or similar taxes. If any VAT or similar taxes are due, these will be payable by Sponsor in addition to the fees paid to PPD. 

2.11 Payments. Unless otherwise set forth in a Project Addendum, all payments to PPD under this Agreement or any Project Addendum shall
be made as follows: 
  

			
	payment wired to:	  	JPMorgan Chase
		  	Acct: 500002360
		  	R/T Number: 021000021 (ACH & Wire)
		  	SWIFT/BIC: CHASUS33
		  	Beneficiary: PPD Development, L.P.

 Any changes to the payee information set forth above require a writing signed by PPD’s treasurer or chief financial
officer. 
  

	3.	 TERM AND TERMINATION.

 3.1 Term. The term of this Agreement shall commence on the Effective Date and shall continue for a period of
five (5) years unless extended by mutual written agreement by the parties. Each Project Addendum shall be effective upon the date set forth in such Project Addendum and shall terminate upon (i) the completion of the Services to be provided
thereunder, and (ii) PPD’s receipt of all Direct Fees, Pass Through Costs, and any other payments due to PPD related to the Services provided thereunder, unless earlier terminated pursuant to the terms of this Agreement or the Project
Addendum, as applicable. 
 3.2 Early Termination. Any Project Addendum may be terminated without cause by Sponsor upon thirty
(30) days prior written notice. PPD or Sponsor may terminate any Project Addendum in the event of the other party’s breach of Agreement or Project Addendum upon thirty (30) days prior written notice, provided that such breach is not
cured within such thirty (30) day period. 
 3.3 Insolvency. Either party hereto may terminate this Agreement or any Project
Addendum hereunder immediately upon the occurrence of an “Insolvency Event” with respect to the other party. For purposes of this Agreement, “Insolvency Event” shall mean (1) a party, a party’s parent
organisation or any of the party’s subsidiaries shall commence a voluntary proceeding seeking liquidation, reorganization or other relief with respect to itself or its debts under any bankruptcy, insolvency or other similar law or seeking the
appointment of a trustee, receiver, liquidator, custodian or other similar official of it or any substantial part of its property, or shall consent to any such relief or to the appointment of or taking possession by any such official in an
involuntary case or other proceeding commenced against it, or shall make a general assignment for the benefit of creditors, or ceases to be solvent, or suspends business, or shall fail generally to pay its debts as they become due, or shall take any
action to authorize any of the foregoing; (2) an involuntary case or other proceeding shall be commenced against a party, a party’s parent organisation or any of the party’s subsidiaries seeking liquidation, reorganization or other
relief with respect to it or its debts under bankruptcy, insolvency or other similar law or seeking the appointment of a trustee, receiver, liquidator, custodian or other similar official of it or any substantial part of its property, and such
involuntary case or other proceeding shall remain undismissed and unstayed for a period of sixty (60) days; or (3) an order for relief shall be entered against a party, a party’s parent organisation or any of the party’s
subsidiaries under the federal bankruptcy laws now or hereafter in effect. 
 3.4 Effect of Termination. The termination of this
Agreement by either party shall not automatically terminate all Project Addenda, unless otherwise agreed in writing. In the event of termination or expiration of this Agreement, the terms and conditions of this Agreement shall continue to apply to
all Project Addenda still in effect after such termination or expiration. 

  
  

Page 4 

 PPD PROPRIETARY AND CONFIDENTIAL 

 
  

 3.5 Wind Down. Upon the termination of this Agreement or a Project Addendum, PPD shall
reasonably cooperate with Sponsor to provide for an orderly wind-down or transfer of the Services provided by PPD hereunder, which, shall include the prompt provision of all data and results belonging to Sponsor of any Project to Sponsor in a
mutually acceptable format. Costs associated with such wind-down or transfer activities shall be billed to Sponsor on a time and materials basis, based on the then-current PPD rates. 

3.6 Provisions Surviving Termination. The expiration, termination or cancellation of this Agreement will not extinguish the rights of
either party that accrue prior to expiration, termination or cancellation or any obligations that extend beyond expiration, termination or cancellation, either by their inherent nature or by their express terms, including, without limitation, the
obligations contained in Sections 2 (Compensation and Payment), 3.4 (Effect of Termination), 3.5 (Wind Down), 3.6 (Provisions Surviving Termination), 5 (Confidentiality), 6 (Data Privacy), 7 (Intellectual Property), 8 (Indemnification), 9
(Limitation of Liability), 10 (Insurance) 11.2 (Record Maintenance after Expiration or Termination), 13.2 (Publicity), 13.5 (Notices), 13.6 (Governing Law), 13.7 (Severability), 13.10 (Assignment), 13.11 (Subcontracting), 13.12 (Arbitration), 13.13
(Construction) and 13.18 (Clinical Trial Supply), hereof and herein shall survive termination of this Agreement. 
  

	4.	 PERSONNEL. 

4.1 Project Management. The Services with respect to each Project shall be performed by PPD under the direction of the person identified
as the operational lead in the applicable Project Addendum or such other person acceptable to Sponsor as PPD may from time to time designate as the Project Manager, such Sponsor acceptance of the designated Project Manager not to be unreasonably
withheld or delayed in all instances. 
 4.2 Covenant Not to Interfere. During the term of a Project Addendum, neither party will
knowingly solicit for employment any employee of the other party who is conducting the Project under that Project Addendum. As used in this section “solicit” means the initiation by a party or its agent of a contact with any
of the other party’s then current employees who are conducting the Project under that Project Addendum for the purpose of offering employment to such employees, but shall not include the circumstance where any such employee initiates a contact
with the other party for the purpose of obtaining employment whether in response to a general advertisement of employment or where such contact is initiated by a third party who was not instructed to contact such employee by the hiring party. 

4.3 Personnel Retention. In the event of delays in the performance of the Project, i.e., after PPD is authorized to commence work,
which are beyond the control of PPD or caused by or are the responsibility of Sponsor, and where Sponsor desires for PPD to keep PPD Project personnel assigned to the Project, in addition to any other sums payable to PPD hereunder, Sponsor shall pay
a personnel fee calculated on an FTE-day basis rate agreed upon by both parties. Said personnel fees shall be invoiced by PPD on a monthly basis and shall be due and payable by Sponsor within forty-five
(45) days of receipt of invoice. 
  

	5	 CONFIDENTIALITY. 

5.1 Sponsor Confidential Information. PPD shall treat all of Sponsor’s information, including information generated by or as a
result of the Services or otherwise provided to PPD by or on behalf of Sponsor (“Sponsor Confidential Information”) as the confidential and exclusive property of Sponsor. 

5.2 PPD Confidential Information. Sponsor shall treat all information of PPD or any of PPD’s Affiliates including, without
limitation, any PPD bids or proposals, standard operating procedures, third party confidential information, personnel information, all PPD Property (as defined below) (“PPD Confidential Information”) as the confidential and
exclusive property of PPD. Further, with the exception of Sponsor Confidential Information, any information disclosed, obtained, or observed by Sponsor or any affiliate of Sponsor during an audit of PPD or an Affiliate of PPD, or the facilities of
either shall be deemed to be PPD Confidential Information. Sponsor Confidential Information and PPD Confidential Information shall collectively be referred to as “Confidential Information.” 

  
  

Page 5 

 PPD PROPRIETARY AND CONFIDENTIAL 

 
  

 5.3 Use of Confidential Information. Each party shall use the other’s
Confidential Information solely for the purposes contemplated by this Agreement and for no other purpose without the prior written consent of the other party. Neither party shall publish, disseminate or otherwise disclose Confidential Information of
the other to any third party without first obtaining the written consent of such other party; provided however that (i) each party may disseminate or otherwise disclose the other’s Confidential Information within its organization to only
those Affiliates, employees, agents, representatives and advisors (collectively “Associates”) and Subcontractors who have a need to know; and (ii) PPD may disclose Sponsor’s Confidential Information to investigator
sites performing Services in respect of the applicable Project to the extent reasonably required to perform the Services or the Project. Furthermore, each party shall ensure that its Associates and Subcontractors are aware of this Agreement and
bound by terms of confidentiality no less stringent than those stated herein. In addition, prior to providing any Confidential Information to a permitted third party other than an Associate, the receiving party will ensure that such third parties
are bound to written obligations of confidentiality that are not less stringent than those contained herein. Each Party will remain responsible for the acts or omissions of its Associates and Subcontractors in connection with the Confidential
Information. 
 5.4 Exceptions to Confidential Information. The above provisions of confidentiality shall not apply to that part of
disclosing party’s Confidential Information which the receiving party is able to demonstrate by documentary evidence: (i) was in the receiving party’s possession prior to receipt from the disclosing party or is independently developed
by or for the receiving party, as shown by the receiving party’s contemporaneous written records; (ii) was in the public domain at the time of receipt from disclosing party; (iii) subsequently becomes a part of the public domain
through no fault of the receiving party, its affiliates or its Associates and Subcontractors; or (iv) is lawfully received by the receiving party from a third party having a right of further disclosure. 

5.5 Disclosure Required by Law. The receiving party may disclose Confidential Information to the extent required pursuant to any
judicial action, order of the court or other governmental agency; provided, however, that the receiving party shall make all reasonable efforts to notify the disclosing party prior to the disclosure of Confidential Information and allow the
disclosing party the opportunity to contest and avoid such disclosure, and further provided that the receiving party shall disclose only that portion of such Confidential Information that it is legally required to disclose. To the extent permitted
by law the receiving party will request any disclosures made under this section be maintained confidential by the court or agency involved. 

5.6 Return of Information. Upon termination or expiration of this Agreement and subject to the terms of Section 11.2 or at the
disclosing party’s earlier written request, the receiving party shall return, and shall cause its affiliates and Associates and Subcontractors to return, all documentary, electronic or other tangible forms of Confidential Information provided
by the disclosing party including, without limitation, any and all copies thereof, or, at the disclosing party’s request, destroy all or such parts of the disclosing party’s Confidential Information as the disclosing party shall direct.
Notwithstanding the foregoing, the receiving party may retain copies of such of the disclosing party’s Confidential Information as is reasonably necessary for regulatory purposes and one copy for legal archival purposes, subject to the ongoing
obligations of non- use and confidentiality. 
 5.7 Remedy. Each party agrees that its
obligations hereunder are necessary and reasonable in order to protect the other party and the other party’s business, and expressly agrees that monetary damages would be inadequate to compensate the other party for any breach of the terms of
this Agreement or a Project Addendum. Accordingly, each party agrees and acknowledges that any such violation or threatened violation will cause irreparable injury to the other party, and that, in addition to any other remedies that may be available
in law, in equity or otherwise, the other party shall be entitled to seek injunctive relief against the threatened breach of this Agreement or a Project Addendum or the continuation of any such breach, without the necessity of proving actual
damages. 
 5.8 Survival. The obligations contained herein shall survive for a period of ten (10) years from the date of the
disclosure of the Confidential Information. 

  
  

Page 6 

 PPD PROPRIETARY AND CONFIDENTIAL 

 
  

	6.	 DATA PRIVACY. 

6.1 Definitions. “Data Protection and Privacy Laws” means all applicable laws, regulations and regulatory requirement and
guidance relating to data protection and privacy globally, including: (a) the U.S. Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) Privacy and Security Rules, 45 C.F.R. Parts
160-164; (b) any other U.S. state or federal laws or regulations governing the privacy or security of personal data; (c) the EU Data Protection Directive 95/46/EC (“the Directive”), superseded
by the General Data Protection Regulation (“Regulation”) on 25 May 2018, or any related legislation of any member state in the European Economic Area (“EEA”); or (d) any other law now in force or that may in future come
into force governing the Processing of Personal Data applicable to any party to this Agreement, and including those relating to security breaches, identity theft, and unauthorized disclosures of Personal Data. “Personal Data”,
“Process/Processing”, “Controller”, “Processor” and “Data Subject” shall have the same meaning as under the Regulation and shall also include these terms, or corresponding terms, as defined under any other
Data Protection and Privacy Laws. In particular, “Personal Data” shall also include “personal information”, “health information”, and “protected health information” as defined by Data Protection and Privacy
Laws, including HIPAA. “Data Subject” shall also include a “person” or “individual” as defined by Data Protection and Privacy Laws, including an “individual” as defined by HIPAA. 

6.2 Compliance. Each party warrants to the other that it will Process Personal Data in compliance with all Data Protection and Privacy
Laws, as well as applicable regulatory guidance, including the International Conference on Harmonisation Guideline for Good Clinical Practice (ICH-GCP) and Good Laboratory Practice (GLP). 

6.3 Respective Roles of the Parties. Sponsor and PPD acknowledge that Sponsor is the Controller and PPD is the Processor with respect
to the Processing of Personal Data on behalf of the Sponsor pursuant to Services provided by PPD under this Agreement. In the event that the Services are performed by any PPD Affiliate then such PPD Affiliate shall be a sub-Processor. Where Sponsor is the Controller, PPD shall Process the Personal Data only in accordance with instructions from Sponsor, unless restricted in doing so by a law to which PPD is subject. In such case,
PPD shall inform the Sponsor of this legal restriction before the Processing begins, unless prevented from doing so by law. (The instructions referred to in this paragraph may be specific instructions or instructions of a general nature as set out
in this Agreement, a Project Addendum, Protocol, SOP or Project-Specific Plan or as otherwise documented by Sponsor to PPD during the term of this Agreement). 

6.4 Representative. If Sponsor needs to appoint a representative to comply with Data Protection and Privacy Laws in any EU Member State
pursuant to Article 4 of the Directive or Article 27 of the Regulation, and PPD is willing to provide such services to Sponsor, Sponsor and PPD may enter into a mutually acceptable agreement for such representative purposes. Unless and until such an
agreement is entered into, PPD shall not be deemed to be a representative under any Data Protection and Privacy Laws. 
 6.5 Data
Processing Obligations. PPD shall implement appropriate technical and organisational measures to protect Personal Data as required by ICH-GCP and/or GLP and Data Protection and Privacy Laws, and in
particular shall implement measures to assist Sponsor in meeting its information security obligations under Articles 32 to 36 of the Regulation. PPD shall in particular ensure that persons authorized to Process Personal Data have committed
themselves to confidentiality or are under an appropriate statutory obligation of confidentiality. PPD shall make available to Sponsor all information necessary to demonstrate compliance with its data protection obligations pursuant to this
Agreement and any Project Addendum and contribute to audits conducted by Sponsor or another auditor mandated by Sponsor, subject to the provisions of Section 11.3 of this Agreement regarding audits. 

6.6 Privacy and Security Incidents. If PPD becomes aware of any unauthorized access, acquisition, use, disclosure, loss, destruction,
or alteration of Personal Data resulting in a compromise of the confidentiality, integrity, or availability of the Personal Data, and a risk of harm to the Data Subjects (“Security Breach”), then it shall notify Sponsor without undue
delay, and in any event within two (2) 

  
  

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 business days, and, if requested, assist Sponsor in meeting its obligations to notify Data Subjects,
regulatory authorities or other required parties. Such required notifications shall be at Sponsor’s sole cost and expense, except to the extent PPD or its Associate or Subcontractor was responsible for such Security Breach. 

6.7 Data Protection Requests. PPD shall promptly notify Sponsor in writing if, in the context of the Services, it receives any
communication from a Data Subject (in particular where the Data Subject wishes to exercise their data protection rights), a privacy supervisory authority or other regulatory authority in each case in respect of data protection, and provide Sponsor
with cooperation and assistance in relation to any such communication. PPD shall be entitled to charge Sponsor for such assistance at a mutually agreed upon hourly rate, unless the communication relates to a breach or violation by PPD or a PPD
Affiliate of its obligations under this Section 6. However, PPD and Sponsor recognize that any fees charged to the requesting party must comply with Data Protection and Privacy Laws. 

6.8 Processors and Data Transfers. In providing Services, it may be necessary to sub-contract
certain Personal Data Processing tasks to one or more third party sub-Processors. An up-to-date list of appointed sub-Processors is available from the Sponsor’s PPD business contact. It may also be necessary to transfer Personal Data to PPD Affiliates based outside the EEA (member states of the European Union plus, Norway,
Iceland & Liechtenstein) and Switzerland or sub-contract certain tasks to one or more third party sub-Processors, including cloud-based service providers, whose
servers may be located outside the EEA and Switzerland. Transfers of Personal Data to PPD Affiliates and sub-Processors outside the EEA and Switzerland shall be variously protected by EU Standard Contractual
Clauses “Controller to Processor” 2010, or otherwise proceed on the basis of Data Subject consent. For the avoidance of doubt, Sponsor consents to the transfer of Personal Data to PPD’s Affiliates and
sub-Processors, including those outside the EEA and Switzerland using the above transfer mechanisms, where such transfers are necessary to perform the Services in accordance with this Agreement, any Project
Addendum, Protocol, SOP or Project- Specific Plan. 
 6.9 Termination Obligations. On any termination or expiry of this Agreement or
when instructed by Sponsor in writing, PPD shall cease all operations on Personal Data and shall promptly, at Sponsor’s direction, cost and expense, return and/or irretrievably delete all Personal Data Processed by PPD under this Agreement and
in a format agreed by the Parties and instruct its subcontractors to do the same. Should PPD be prevented by its national law or local regulator from destroying or returning all or part of such data, the data shall be kept confidential and not be
actively processed for any purpose, and shall be deleted promptly upon the expiration or such legal or regulatory obligation. 
  

	7.	 INTELLECTUAL PROPERTY. 

7.1 No License. Neither anything contained herein, nor the delivery of any information to a party hereto, shall be deemed to grant the
receiving party any right or license under any patent or patent application or to any know-how, technology or invention of the disclosing party. 

7.2 Sponsor Property. Subject to Section 7.3 below, PPD hereby assigns to Sponsor all rights PPD, PPD Affiliates or its Associates
and Subcontractors may have in any invention, technology, know- how or other intellectual property relating to the drug or therapeutic product, which is the subject of the Project, or Protocol and which is either: (i) the result of PPD’s
provision of the Services and is contracted as part of the Services; (ii) incorporates, references, requires the use of, or is a derivative work of Sponsor’s Confidential Information; or (ii) specifically set forth as a deliverable
under a Project Addendum (“Sponsor Property”). PPD shall assist Sponsor, at Sponsor’s sole cost and expense, in obtaining or extending protection therefor. PPD warrants that it has and will continue to have agreements with its
Associates and Subcontractors to effect the terms of this Section 7.2. 
 7.3 PPD Property. PPD and PPD Affiliates possess, and
in the future may possess certain processes, technology, know-how, methodologies trade secrets, improvements, and other intellectual property, which has been independently developed without the benefit of any
information provided by Sponsor or in connection with the Services, does not incorporate, require the use of, or constitute derivative 

  
  

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 works of any Sponsor Confidential Information (collectively, “PPD Inventions”). Sponsor and PPD
agree that (i) any PPD Inventions; (ii) any literature reviews and analyses based on publicly available databases conducted by PPD in the performing the Services; and (iii) revisions, improvements, upgrades, or enhancements to each of
(i)-(ii) set forth in this section (collectively, “PPD Property”) shall, in each case, be the sole and exclusive property of PPD. PPD hereby grants to Sponsor a non-exclusive, royalty-free,
worldwide, irrevocable (except in the event Sponsor breaches its licensing obligations herein), nontransferable (except in connection with the transfer of the product to which the Services or deliverable relate, and in no event to a competitor of
PPD), sublicensable (except to a competitor of PPD), perpetual license to use and exploit any PPD Property that is incorporated in any deliverable or other material provided by PPD pursuant to this Agreement, but only to the extent necessary for
Sponsor to use of the deliverables or the Services. In the event that Sponsor transfers its license or sublicenses as permitted in this Section 7.3, Sponsor agrees that it will (i) first have written confidentiality agreements in place
with such third party in accordance with Section 5 above, (ii) have such third parties bound to licensing obligations that are no less stringent than the terms of this Section 7.3, with no further right to sublicense, and
(iii) remain liable and responsible to PPD for any third party’s breach of the confidentiality and licensing terms required herein. 

7.4 Third Party Materials. In the event any Third Party Materials (as hereinafter defined) are used by PPD or its Affiliates to perform
the Services, Sponsor acknowledges and agrees that any such Third Party Materials are the sole and exclusive property of the applicable third party providing such Third Party Materials. Sponsor shall obtain no right, title or interest in any Third
Party Materials except as expressly provided herein. To the extent that a deliverable contains any Third Party Materials, PPD shall secure for Sponsor a fully paid up, royalty-free, non-exclusive license (PPD
will use commercially reasonable efforts to secure a license that is sublicensable and transferable in connection with any license or transfer of the drug product to which the Services Relate) to use such Third Party Materials solely to the extent
necessary to use such deliverable, provided that in no event may Sponsor use, offer, sell, commercialize or otherwise dispose of such Third Party Materials separate from such deliverable or on a stand-alone basis. “Third Party Materials”
means any data or other materials obtained by PPD or its Associates and Subcontractors from third parties or proprietary databases maintained by third parties, scales, or copies of published articles. 

 

	8.	 INDEMNIFICATION. 

8.1 Sponsor Indemnity. Sponsor shall indemnify, defend, and hold harmless PPD and its Associates (“PPD
Indemnitees”) from and against any and all damages, liabilities, losses, fines, penalties, settlement amounts, costs and expenses of any kind or nature whatsoever, including, without limitation, reasonable attorneys’ fees,
expert witness fees, court costs, and amounts (collectively, “Losses”) incurred by PPD Indemnitees as a result of any third party claim, demand, action, proceeding, investigation or hearing (collectively, a
“Claim”) to the extent arising from this Agreement or any Services provided by PPD Indemnitees hereunder, including but not limited to, Project related services provided by PPD at the request of Sponsor yet prior to
finalization of the relevant Project Addendum; provided however, that Sponsor shall have no obligation of indemnity hereunder with respect to any Claim to the extent such Claim arises from the negligence, intentional misconduct or breach of this
Agreement on the part of PPD or its Associates. 
 8.2 PPD Indemnity. PPD shall indemnify, defend and hold harmless Sponsor and its
Associates (“Sponsor Indemnitees”) from and against any and all Losses incurred by Sponsor Indemnitees as a result of any Claim to the extent arising from the negligence, intentional misconduct, or breach of Agreement of PPD, PPD
Affiliates or its Associates; provided however, that PPD shall have no obligation of indemnity hereunder with respect to any Claim which arose from the negligence, intentional misconduct or material breach of this Agreement on the part of Sponsor or
its Associates. 
 8.3 Indemnification Procedure. Each indemnified party shall give the indemnifying party prompt notice of any Claim
for which indemnification is sought hereunder. The indemnifying party shall have the right to control the defense and settlement of a Claim, at its sole expense, provided the indemnifying party shall act reasonably and in good faith with respect to
all matters relating to the settlement or disposition of the Claim, and the indemnified party shall reasonably cooperate in the investigation, 

  
  

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 defense and settlement of such Claim at the indemnifying party’s expense. Neither party will enter into
any settlement agreement that attributes fault or negligence to the other party, requires any payment by the other party, or restricts the future actions or activities of the other party, without the other party’s prior written consent, which
shall not be unreasonably withheld. Any indemnified party shall have the right to participate in, but not control, the defense and settlement of a Claim and to employ separate legal counsel of its own choice; provided, however, that such employment
shall be at the indemnified party’s own expense, unless the indemnifying party has failed to assume the defense and employ counsel (in which case the indemnified party shall control the defense and settlement of such Claim). 

 

	9.	 LIMITATION OF LIABILITY.

 9.1 EXCEPT FOR LIABILITY ARISING FROM A PARTY’S BREACH OF SECTIONS 5, OR 6 OR A PARTY’S OBLIGATION OF
INDEMNIFICATION UNDER SECTION 8, NEITHER PARTY SHALL BE LIABLE FOR ANY SPECIAL, CONSEQUENTIAL, INCIDENTAL OR INDIRECT DAMAGES ARISING OUT OF OR IN CONNECTION WITH THIS AGREEMENT (OR THE TERMINATION HEREOF) OR ANY PROJECT ADDENDUM, INCLUDING, WITHOUT
LIMITATION, LOSS OF PROFITS OR ANTICIPATED SALES, EVEN IF THE PARTY HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES. 
 9.2 TO
THE FULLEST EXTENT PERMITTED BY LAW, AND EXCEPT FOR PPD’S LIABILITY FOR: (I) ITS BREACH OF SECTIONS 5 OR 6; (II) ITS INDEMNIFICATION OBLIGATIONS UNDER SECTION 8.2; OR (III) GROSS NEGLIGENCE, WILLFUL MISCONDUCT OR FRAUD, THE TOTAL
LIABILITY, IN THE AGGREGATE, OF PPD, PPD ASSOCIATES, AND ANY OF THEM, TO SPONSOR AND ANYONE CLAIMING BY OR THROUGH SPONSOR, FOR ANY AND ALL CLAIMS, LOSSES, COSTS OR DAMAGES, INCLUDING WITHOUT LIMITATION, ATTORNEYS’ FEES AND COSTS AND
EXPERT-WITNESS FEES AND COSTS OF ANY NATURE WHATSOEVER OR CLAIMS EXPENSES RESULTING FROM OR IN ANY WAY RELATED TO THIS AGREEMENT OR ANY PROJECT ADDENDUM FROM ANY CAUSE OR CAUSES SHALL NOT EXCEED ONE MILLION U.S. DOLLARS ($1,000,000) OR THREE TIMES
THE TOTAL DIRECT FEES, WHICHEVER IS GREATER, RECEIVED BY PPD UNDER THE APPLICABLE PROJECT ADDENDUM, WHICH IS THE SUBJECT OF THE CLAIM. 

9.3 TO THE FULLEST EXTENT PERMITTED BY LAW, THE TOTAL LIABILITY, IN THE AGGREGATE, OF EACH PARTY, ITS ASSOCIATES, AND ANY OF THEM, TO THE
OTHER PARTY AND ANYONE CLAIMING BY OR THROUGH THE OTHER PARTY, FOR ANY AND ALL SPECIAL, CONSEQUENTIAL, INCIDENTAL OR INDIRECT DAMAGES UNDER SECTION 9.1 ABOVE, AND RESULTING FROM ITS BREACH OF SECTIONS 5 OR 6 SHALL NOT EXCEED (I) EIGHT MILLION
U.S. DOLLARS ($8,000,000) IF THE DIRECT FEES PAYABLE UNDER THE PROJECT ADDENDUM GIVING RISE TO THE BREACH TOTAL TWO MILLION U.S. DOLLARS ($2,000,000) OR LESS, OR (II) FOUR TIMES (4X) THE TOTAL DIRECTS FEES PAYABLE UNDER THE PROJECT ADDENDUM OR
TWENTY- FIVE MILLION U.S. DOLLARS ($25,000,000), WHICHEVER IS LESS, WHERE SUCH DIRECT FEES ARE GREATER THAN TWO MILLION US DOLLARS ($2,000,000). 

9.4 TO THE FULLEST EXTENT PERMITTED BY LAW, THE TOTAL LIABILITY, IN THE AGGREGATE, OF PPD, PPD ASSOCIATES, AND ANY OF THEM, TO SPONSOR AND
ANYONE CLAIMING BY OR THROUGH SPONSOR, FOR ANY AND ALL CLAIMS, LOSSES, COSTS OR DAMAGES, INCLUDING WITHOUT LIMITATION, ATTORNEYS’ FEES AND COSTS AND EXPERT- WITNESS FEES AND COSTS OF ANY NATURE WHATSOEVER OR CLAIMS EXPENSES RESULTING FROM ITS
GROSS NEGLIGENCE SHALL NOT EXCEED (I) EIGHT MILLION U.S. DOLLARS ($8,000,000) IF THE DIRECT FEES PAYABLE UNDER THE PROJECT ADDENDUM GIVING RISE TO THE BREACH TOTAL TWO MILLION U.S. DOLLARS ($2,000,000) OR LESS, OR (II) FOUR TIMES (4X) THE
TOTAL DIRECTS FEES PAYABLE UNDER THE PROJECT ADDENDUM OR TWENTY-FIVE MILLION U.S. DOLLARS ($25,000,000), WHICHEVER IS LESS, WHERE SUCH DIRECT FEES ARE GREATER THAN TWO MILLION US DOLLARS ($2,000,000). 

  
  

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	10.	 INSURANCE. 

10.1 Sponsor and PPD will each undertake to purchase and maintain insurance of such types and amounts reasonably adequate to cover any
liabilities arising out of its obligations hereunder. Sponsor further undertakes to purchase and maintain insurance of such types and amounts and coverage reasonably adequate (including but not limited to that required by law) to cover any
liabilities arising in relation to all clinical trials contracted to PPD pursuant to this Agreement. The following sets forth the minimum thresholds of insurance each party will maintain: 

10.2 PPD Insurance. PPD shall, at its own cost and expense, obtain and thereafter maintain in full force and effect and with properly
licensed and financially secure insurers (AM Best rating of A-VII in the United States and reasonably equivalent in countries outside the United States) the following insurance during the term of this
Agreement and for a period of not less than three (3) years following termination of this Agreement: 
  

	 	(i)	 Worker’s Compensation. In amounts as required by applicable law; 

 

	 	(ii)	 Automobile Liability Insurance. One Million US Dollars ($1,000,000) per occurrence covering all owned, leased
and hired vehicles; 

  

	 	(iii)	 General Commercial Liability Insurance. One Million US Dollars ($1,000,000) per occurrence and Three Million US
Dollars ($3,000,000) in the annual aggregate; and 

  

	 	(iv)	 Professional Liability Insurance. Five Million US Dollars ($5,000,000) per occurrence and Five Million US
Dollars ($5,000,000) in the annual aggregate. 

 10.3 Sponsor Insurance. Sponsor shall, at its own cost and
expense, obtain and thereafter maintain in full force and effect, and with properly licensed and financially secure insurers (AM Best rating of A-VII in the United States and reasonably equivalent in countries
outside the United States) the following insurance during the term of this Agreement and for a period of not less than three (3) years following termination of this Agreement: 

 

	 	(i)	 Worker’s Compensation. In amounts as required by applicable law; 

 

	 	(ii)	 General Commercial Liability Insurance. One Million US Dollars ($1,000,000) per occurrence and Three Million US
Dollars ($3,000,000) in the annual aggregate; 

  

	 	(iii)	 Products Liability Insurance, including coverage for bodily injury suffered in the context of a clinical trial,
with a minimum limit of Ten Million US Dollars ($10,000,000) per occurrence and Ten Million US Dollars ($10,000,000) in the annual aggregate; and 

  

	 	(iv)	 Clinical Trials Insurance. In amounts as required by applicable law. 

10.4 Sponsor and PPD will each undertake, upon request, to provide the other party a certificate (or certificates) of insurance setting forth
the liability limits, exclusions and deductibles of the insurance such party is required to carry pursuant to this Agreement. Each party shall obtain the prior written consent of the other party before implementing any material change or
cancellation of the insurance coverage agreed upon herein. Neither party will make any material changes to coverage thresholds that bring such party’s required coverage below the minimum requirements stated in this Agreement. Unapproved
reductions in any coverage threshold is a breach of this Agreement and at the non-breaching party’s option, can result in termination of this Agreement. 

  
  

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	11.	 RECORD STORAGE, AUDITS, AND
INSPECTIONS. 

 11.1 Record Maintenance during Project. During the term of the
applicable Project Addendum, PPD shall maintain all materials and all other data obtained or generated by PPD in the course of providing the Services thereunder, including all computerized records and files. 

11.2 Record Maintenance after Expiration or Termination. Subject to the terms of this Section 11.2, upon the expiration or
termination of the applicable Project Addendum, the continued retention of all materials and data directly relating to the Protocol and/or applicable drug product and obtained or generated by PPD in the course of providing the Services under the
applicable Project Addendum (collectively, the “Records”) is the Sponsor’s responsibility. Upon completion of Sponsor’s payment obligations hereunder, PPD shall (at Sponsor’s risk, cost and expense), deliver
the Records to Sponsor at its offices identified herein in such form as is then currently in the possession of PPD. Notwithstanding the foregoing, PPD shall be entitled at its expense to retain copies of the Records reasonably necessary for
regulatory and business purposes and in accordance with PPD’s corporate records retention schedule, all subject to the confidentiality obligations set forth in Section 5 above. Upon the expiration of PPD’s retention period, PPD may
dispose of all such copies; provided however that, prior to any such disposal, PPD shall provide Sponsor with ninety (90) days written notice and shall offer Sponsor, at Sponsor’s risk, cost and expense, the opportunity to request that PPD
deliver such copies to Sponsor. 
 11.3 Sponsor conducted Services Audits. During the term of the applicable Project Addendum, at
mutually agreeable dates and times and upon reasonable prior written notice to PPD, representatives of Sponsor (who shall not be competitors of PPD) shall be permitted to review, on site at PPD’s facilities, all documents, information, data and
materials in the possession of PPD directly relating to the applicable Project conducted hereunder for the sole purpose of determining the compliance of the Services with the: (i) standard of performance and specifications set forth in the
applicable Project Addendum; and (ii) applicable laws, regulations, guidelines and rules governing the Services. PPD and Sponsor agree to one (1) no-cost Services audit per year, to include no more than
three (3) days on-site at PPD’s facilities. In instances where an audit is deemed necessary by Sponsor due to a significant quality concern or investigation (For Cause Audit), PPD and Sponsor agree
to no-cost audits as needed. All other Services audits shall be charged according to PPD’s personnel billable rates. All Sponsor representatives shall, in advance of such audit, execute a mutually
agreeable confidentiality and non-disclosure agreement with PPD. Notwithstanding the foregoing, Sponsor shall not be permitted to review information that is subject to third party confidentiality obligations,
privileged, or not directly related to the performance of the applicable Services. Sponsor and its agents and consultants shall observe all confidentiality obligations concerning all documents, information, data or materials that it comes in contact
with in connection with the audit. 
 11.4 Regulatory Inspections. 

 

	 	a.	 Inspections of Investigator Sites. Both parties shall promptly notify the other party of any regulatory
inspections of investigator sites of which it becomes aware. Where reasonably practicable and permitted by the relevant regulatory authority, Sponsor will have the right to be present at any inspections which are directly related to the Services.
PPD shall reasonably act to secure the cooperation of investigators with respect to regulatory review. 

  

	 	b.	 Inspections of PPD. PPD agrees to promptly notify Sponsor of a regulatory inspection of PPD in which
Sponsor’s project is the scope of the inspection. Sponsor agrees to provide PPD support during the inspection as needed relative to the Services contracted and Project. PPD agrees to provide updates to Sponsor as to the progress of the
inspection relative to the Services and Sponsor project. 

  

	 	c.	 Inspection of Sponsor. Sponsor agrees to notify PPD of a regulatory inspection of Sponsor which are
directly related to the Services. PPD agrees to provide Sponsor with support relative to the Services. Sponsor agrees to provide PPD with updates of inspection activities relative to the Services. The parties shall review costs associated with
participation and shall agree to a reasonable rate of compensation in advance of the performance of any regulatory services. 

  
  

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 11.5 Suspected Scientific Misconduct. Both parties agree to notify the other party of
instances of suspected scientific misconduct as it relates to the Services. 
 11.6
Non-Compliance of Clinical Investigators and Related Parties. Notwithstanding anything to the contrary herein, in the event PPD or Sponsor identify continued
non-compliance on the part of the clinical investigator/institution or related supporting staff, Sponsor agrees to support all actions required by PPD procedures/actions to secure compliance. Should the
decision be made to terminate or suspend the trial as a result of serious and persistent non-compliance by these parties, Sponsor agrees to report the clinical investigator according to applicable regulatory
requirement and authorizes PPD to report in the absence of such appropriate Sponsor action. 
  

	12.	 DEBARMENT. 

PPD represents that, consistent with Section 306(a) and Section 306(b) of the Federal Food, Drug and Cosmetic Act (21 U.S.C. § 335a (a) and
335a (b)), neither it nor any of its Associates and Subcontractors engaged in the performance of Services hereunder, is debarred and PPD will not knowingly hire any debarred individual to perform Services. PPD further warrants that neither it nor
any of its Associates and Subcontractors engaged in the performance of Services hereunder, will use in any capacity in connection with the Services, any person who to its knowledge is the subject of a conviction described in 42 U.S.C. § 1320a-7(a) for which a person can be debarred, suspended, or excluded. PPD will Sponsor in writing promptly if it is debarred or it becomes aware of the fact that any of its Associates and Subcontractors performing
Services is debarred or is the subject of a conviction described in 42 U.S.C. § 1320a-7(a), or if it is aware of any action, suit, claim, investigation or legal or administrative proceeding is pending,
relating to the debarment, suspension, exclusion or conviction of PPD or its Associates and Subcontractors providing Services hereunder. 
  

	13.	 MISCELLANEOUS. 

13.1 Independent Contractor Relationship. The parties hereto are independent contractors, and nothing contained in this Agreement is
intended, and shall not be construed, to place the parties in the relationship of partners, principal and agent, employer/employee or joint venturer. Neither party shall have any right, power or authority to bind or obligate the other, nor shall
either hold itself out as having such right, power or authority. 
 13.2 Publicity. Neither party shall mention or otherwise use the
name, insignia, symbol, trademark, trade name or logotype of the other party (or any abbreviation or adaptation thereof) in any publication, press release, promotional material or other form of publicity without the prior written approval of the
other party in each instance. The restrictions imposed by this Section shall not prohibit a party from making any disclosure identifying the other party that is required by any Applicable Law. 

13.3 Publication. PPD may not publish any articles or make any presentations relating to the Services provided to Sponsor hereunder
with respect to a Project or referring to data, information or materials generated as part of the Services without the prior written consent of Sponsor. 

13.4 Force Majeure. If either party shall be delayed, hindered, or prevented from the performance of any act required hereunder by
reason of strike, lockouts, labor troubles, restrictive governmental or judicial orders or decrees, riots, insurrection, war, acts of God, inclement weather, or other cause beyond such party’s reasonable control (each, a
“Disability”), then performance of such act shall be excused for the length of time necessary to cure such Disability and resume performance. A party shall not be liable for any delays resulting from a Disability, and any
affected timelines may be extended for a period at least equal to that of the Disability. The party incurring the Disability shall provide notice to the other of the commencement and termination of the Disability and reasonably cooperate with the
unaffected party to mitigate any potential delay. 

  
  

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 13.5 Notices. Any notice required or permitted to be given hereunder by either party
hereto shall be in writing and shall be deemed effectively given or delivered: (i) on the date delivered if delivered personally, (ii) on the first business day after the date sent if sent by recognized overnight courier, (iii) on the
date transmitted if sent via facsimile (with confirmation of receipt generated by the transmitting machine), or (iv) on the second business day after the date deposited if mailed by certified mail, return receipt requested, postage prepaid. All
notices to each party shall be sent to the address for said party set forth in the applicable Project Addendum. If no address is provided in the Project Addendum, then notices shall be sent to the following address: 

 

					
		 	If to PPD:	  	 PPD Development, L.P.
 929 North Front
Street

		 		  	 Wilmington, North Carolina 28401

Attention: CEO

		 		  	Tel: (910) 251-0081
		 		  	Fax: (910) 558-5820
			
		 	If to Sponsor:	  	inRegen
		 		  	 c/o Twin City Bio LLC
 3929 WestPoint
BLVD
 Suite G

		 		  	 Winston-Salem, NC 27103
 Attn: Tim
Bertram

 A party desiring to change its address for notice must give notice of the change to the other party hereto in the form and
manner provided in this Section 13.5. Upon the failure of a party to notify the other Party of any change to or discontinuance of an address, any notices sent to the original or discontinued address shall be deemed to have been effectively
given. 
 13.6 Governing Law. This Agreement and the rights and obligations of the parties hereunder shall be governed by and
construed in accordance with the laws of the State of New York without reference to its conflicts of laws provisions. 
 13.7
Severability. If any provision of this Agreement or any Project Addendum is held to be illegal, invalid or unenforceable under any present or future law, and if the rights or obligations of any party hereto under this Agreement or such
Project Addendum will not be materially or adversely affected thereby, (a) such provision will be fully severable, (b) this Agreement or such Project Addendum will be construed and enforced as if such illegal, invalid or unenforceable provision
had never compromised a part hereof, (c) the remaining provisions of this Agreement or such Project Addendum will remain in full force and effect and will not be affected by the illegal, invalid or unenforceable provision or by its severance
herefrom, and (d) in lieu of such illegal, invalid or unenforceable provision, there will be added automatically as a part of this Agreement or such Project Addendum, a legal, valid and enforceable provision as similar in terms as to such illegal,
invalid or unenforceable provision as may be possible and reasonably acceptable to the parties herein. 
 13.8 Waiver. Any term or
condition of this Agreement or a Project Addendum may be waived at any time by the party that is entitled to the benefit thereof, but no such waiver shall be effective unless set forth in a written instrument duly executed by or on behalf of the
party waiving such term or condition. No waiver by any party hereto of any term or condition of this Agreement or a Project Addendum, in any one or more instances, shall be deemed to be or construed as a waiver of the same or any other term or
condition of this Agreement or such Project Addendum on any future occasion. 
 13.9 Amendments. No amendment, change or modification
to this Agreement or any Project Addendum shall be effective unless in writing and executed by the parties hereto. 

  
  

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 13.10 Assignment. This Agreement and any Project Addendum may not be assigned by
either party without the prior written consent of the other party; provided, however, that a party hereto may assign this Agreement or a Project Addendum hereunder to (i) a
successor-in-interest to the party’s business or (ii) an Affiliate. 

13.11 Subcontracting. In the event that PPD subcontracts all or part of the Services under a Project Addendum to a third party
Subcontractor, PPD shall be responsible and retain primary liability for the performance of all obligations of Subcontractors (as defined below). When used in this Agreement, the term “Subcontractor” shall mean and refer to any third party
selected, managed and contracted by PPD or to whom PPD has subcontracted or delegated PPD’s obligation to perform any portion of the Services hereunder, but shall exclude (i) investigators and investigative site personnel involved in the
performance of a Project; (ii) a third party serving as a member on a data and safety monitoring board or data monitoring committee hereunder; and (iii) third party providers used by PPD at the written request of Sponsor despite the fact
that PPD has the ability to perform the subcontracted service either itself or through a PPD Affiliate. Regarding Sponsor-requested subcontractors, PPD shall be liable to Sponsor only to the extent that PPD was negligent in fulfilling any
contracting, validation, management and/or oversight responsibilities in respect to such third-party. Sponsor shall have the ability to approve PPD’s use of any subcontractor prior to the assignment of any such Services by PPD. 

13.12 Arbitration. Except for disputes regarding breaches of Section 5 and the right to pursue the remedies set forth in
Section 5.7 above, the parties may submit any dispute arising hereunder to binding arbitration pursuant to the Commercial Arbitration Rules of the American Arbitration Association (“AAA”). The arbitration shall be conducted in
Winston-Salem, North Carolina. The decision of the arbitrator or arbitration panel shall be final and binding upon the parties hereto and shall be enforceable by any court of competent jurisdiction. By agreeing to arbitration, the parties do not
intend to deprive any competent court of such court’s jurisdiction to issue a pre-arbitral injunction, pre-arbitral attachment or other order in aid of the
arbitration proceedings and the enforcement of any award or judgment. Without prejudice to such provisional remedies in aid of arbitration as may be available under the jurisdiction of a national court, the court of arbitration shall have full
authority to grant provisional remedies and to award damages for failure of any party to respect the court of arbitration’s order to that effect. The parties will keep the arbitration confidential and that the existence of the arbitration
proceeding and any element of it (including but not limited to any pleadings, briefs or other documents submitted or exchanged, any testimony or other oral submissions, and any awards) shall not be disclosed beyond the tribunal, the AAA, the
parties, their counsel, accountants and auditors, insurers and re-insurers, and any person or entity necessary to the conduct of the proceeding. The confidentiality obligations in this Section 13.12 shall
not apply (i) if disclosure is required by law, or in judicial or administrative proceedings, or (ii) as far as disclosure is necessary to enforce the rights arising out of the arbitration award. Without otherwise limiting the requirements
imposed by this Section 13.12, a party may seek from any court having jurisdiction any interim or provisional relief that may be necessary to protect its interests hereunder, pending the resolution of any dispute in accordance with this
Section 13.12. 
 13.13 Construction. Except where the context otherwise requires, wherever used the singular shall include the
plural, the plural the singular, the use of any gender shall be applicable to all genders, the word “or” is used in the inclusive sense, and “including” means including, without limitation. The captions of this Agreement are for
convenience of reference only and in no way define, describe, extend or limit the scope or intent of this Agreement or the intent of any provision contained in this Agreement. The language of this Agreement shall be deemed to be the language
mutually chosen by the parties and no rule of strict construction shall be applied against either party hereto. 
 13.14 MedDRA and
WHODrug Dictionary License. The parties acknowledge that MedDRA and Uppsala Monitoring Centre product licenses are required by all parties who wish to distribute or receive MedDRA or WHODrug dictionary terminology. Each party represents and
warrants that it possesses a current MedDRA and/or Uppsala Monitoring Centre product license. In the event Sponsor requests that PPD perform services which require PPD to distribute MedDRA terminology or WHODrug dictionary to third parties, Sponsor
shall be responsible for ensuring that all such third parties possess the necessary MedDRA and/or Uppsala Monitoring Centre product licenses. 

  
  

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 13.15 Counterparts and Electronic Signatures. This Agreement, any Project Addendum
hereunder, and all associated amendments may be executed in counterparts, each of which shall be deemed an original and all of which together shall constitute one and the same instrument. Each party may execute this Agreement, any Project Addendum,
and all amendments by electronic signature (whatever form the electronic signature takes) or in Portable Document Format (or other file format) sent by electronic means. Signatures of authorized signatories of the parties completed by electronic
signature or sent by electronic means in Portable Document Format shall have the same force and effect as manual signatures, shall be valid and binding, and, upon delivery, shall constitute due execution of this Agreement, any Project Addendum, or
any amendments hereunder. 
 13.16 Representative. With regard to any Project conducted under this Agreement, Sponsor shall not name
any PPD employee, contractor, or other PPD representative on Line 16 of Form FDA 1571. Sponsor acknowledges and understands that if Sponsor desires that any PPD employee, contractor, or other PPD representative be named as the Senior Medical Officer
in Canada on Line 89 of Form HC/SC 3011 or in any similar capacity for clinical trials conducted in other countries, Sponsor must first submit such a request to PPD in writing for the performance of services pursuant to such naming, including,
without limitation, responsibility for review and evaluation of information relevant to the safety of the study drug. If PPD agrees to perform such services, the parties shall enter into good faith negotiations and enter into either a separate
agreement or written amendment to the applicable Project Addendum prior to PPD initiating the services. 
 13.17 Economic Sanctions and
Trade Embargoes. Sponsor represents and warrants that (i) neither Sponsor nor Sponsor’s directors or officers are subject to economic sanctions and trade embargoes; (ii) Sponsor is not 50% or more owned, directly or indirectly, by
individuals or entities that are subject to economic sanctions or trade embargoes; and (iii) Sponsor will not request PPD to provide any services that would cause PPD to violate any economic sanctions or trade embargoes. PPD represents and
warrants that (i) neither PPD nor its Affiliates, nor its or their directors or officers are subject to economic sanctions and trade embargoes; (ii) PPD is not 50% or more owned, directly or indirectly, by individuals or entities that are
subject to economic sanctions or trade embargoes; and (iii) PPD will not violate any economic sanctions or trade embargoes in connection with the Services. 

13.18 Clinical Trial Supply. Sponsor acknowledges that in certain jurisdictions PPD may, at Sponsor’s request, act as importer of
record (“IoR”) for the study by the operation of the laws or regulations or engaged by Sponsor to provide clinical trial supply management services. Where PPD acts as the IoR, clinical trial supply process shall follow PPD’s
guidelines and the Incoterms for the goods arriving into a jurisdiction shall be decided by PPD. If Sponsor uses its own logistics vendors for the study, Sponsor shall make sure its logistics vendors follow PPD’s guidelines and adopt the
Incoterms as designated by PPD. Sponsor shall bear or reimburse PPD for all the costs PPD may incur as IoR including without limitation all applicable customs duties, taxes, and government levies. 

Where PPD recovers import VAT (or other tax) on behalf of Sponsor, fees shall be charged to Sponsor net of such VAT (or such other tax). Notwithstanding the
foregoing, Sponsor agrees that if such import VAT (or other tax) is subsequently determined by a tax authority, during an audit or otherwise, to not be recoverable by PPD, Sponsor agrees that it will indemnify PPD and hold PPD harmless for all
losses, claims and demands (including but not limited to such irrecoverable tax) in connection thereto, except to the extent arising out of PPD’s negligence or willful misconduct or fraud. The indemnity under this clause shall survive the
expiration or early termination of this Agreement. 
 13.19 Entire Agreement. This Agreement constitutes the entire agreement between
the parties and supersedes all prior negotiations, representations or agreements, either written or oral, with respect to the subject matter hereof 

  
  

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 IN WITNESS WHEREOF, this Agreement has been executed and delivered by the parties hereto by their duly
authorized officers as of the date of last signature below. 
  

									
	 PPD DEVELOPMENT, L.P.
 BY:
PPD GP, LLC
	 		 	INREGEN
	ITS: GENERAL PARTNER	 		 	
					
	By:	 	/s/ William Sharbaugh	 		 	By:	 	/s/ Timothy A Bertram
	Name:	 	William Sharbaugh	 		 	Name:	 	Timothy A Bertram
	Title:	 	Chief Operating Officer	 		 	Title:	 	CEO
	Date:	 	01-May-2019	 		 	Date:	 	30 April 2019

  
  

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