Document:

Exhibit 10.5

      

      
        

        

      

      MERCEDES-BENZ AUTO LEASE TRUST 2019-A,

      as Issuer,

       

        

      MERCEDES-BENZ FINANCIAL SERVICES USA LLC,

      as Servicer and Administrator,

       

        

      and

       

        

      CLAYTON FIXED INCOME SERVICES LLC,

      as Asset Representations Reviewer

       

        

      
        

      

      ASSET REPRESENTATIONS

      REVIEW AGREEMENT

      

      

      Dated as of January 1, 2019

      
        

        

        
          

        

        

      

      
        
          

      

      
      TABLE OF CONTENTS

      

      

      	 	
              Page

            
	
              ARTICLE One

            	 
	
              USAGE AND DEFINITIONS

            	 
	 	 	 
	
              Section 1.01.

            	
              Capitalized Terms; Rules of Usage

            	
              1

            
	 	 	 
	
              ARTICLE Two

            	 
	
              ENGAGEMENT; ACCEPTANCE

            	 
	 	 
	
              Section 2.01.

            	
              Engagement; Acceptance

            	
              4

            
	
              Section 2.02.

            	
              Confirmation of Status

            	
              4

            
	 	 	 
	
              ARTICLE Three

            	 
	
              ASSET REPRESENTATIONS REVIEW PROCESS

            	 
	 	 
	
              Section 3.01

            	
              . Review Notices and Identification of Review Assets

            	
              4

            
	
              Section 3.02.

            	
              Review Materials

            	
              4

            
	
              Section 3.03.

            	
              Performance of Reviews

            	
              5

            
	
              Section 3.04.

            	
              Review Report

            	
              5

            
	
              Section 3.05.

            	
              Review Representatives

            	
              6

            
	
              Section 3.06.

            	
              Dispute Resolution

            	
              6

            
	
              Section 3.07.

            	
              Limitations on Review Obligations

            	
              6

            
	 	 	 
	
              ARTICLE Four

            	 
	
              ASSET REPRESENTATIONS REVIEWER

            	 
	 	 
	
              Section 4.01.

            	
              Representations and Warranties of the Asset Representations Reviewer

            	
              7

            
	
              Section 4.02.

            	
              Covenants

            	
              8

            
	
              Section 4.03.

            	
              Fees and Expenses

            	
              8

            
	
              Section 4.04.

            	
              Limitation on Liability

            	
              10

            
	
              Section 4.05.

            	
              Indemnification by Asset Representations Reviewer

            	
              10

            
	
              Section 4.06.

            	
              Indemnification of Asset Representations Reviewer

            	
              10

            
	
              Section 4.07.

            	
              Inspections of Asset Representations Reviewer

            	
              11

            
	
              Section 4.08.

            	
              Delegation of Obligations

            	
              11

            
	
              Section 4.09.

            	
              Confidential Information

            	
              11

            
	
              Section 4.10.

            	
              Personally Identifiable Information

            	
              12

            
	 	 	 
	
              ARTICLE Five

            	 
	
              REMOVAL, RESIGNATION

            	 
	 	 
	
              Section 5.01.

            	
              Eligibility of the Asset Representations Reviewer

            	
              14

            
	
              Section 5.02.

            	
              Resignation and Removal of Asset Representations Reviewer

            	
              14

            
	
              Section 5.03.

            	
              Successor Asset Representations Reviewer

            	
              15

            
	
              Section 5.04.

            	
              Merger, Consolidation or Succession

            	
              16

            
	 	 	 
	
              ARTICLE Six

            	 
	
              OTHER AGREEMENTS

            	 
	 	 
	
              Section 6.01.

            	
              Independence of the Asset Representations Reviewer

            	
              16

            

      

      

      
        i

        
          

      

      
      	 	 	
              Page

            
	 	 	 
	
              Section 6.02.

            	
              No Petition

            	
              16

            
	
              Section 6.03.

            	
              Limitation of Liability of Owner Trustee

            	
              16

            
	
              Section 6.04.

            	
              Termination of Agreement

            	
              17

            
	 	 	 
	
              ARTICLE Seven

            	 
	
              MISCELLANEOUS PROVISIONS

            	 
	 	 
	
              Section 7.01.

            	
              Amendments

            	
              17

            
	
              Section 7.02.

            	
              Assignment; Benefit of Agreement; Third Party Beneficiaries

            	
              17

            
	
              Section 7.03.

            	
              Notices

            	
              18

            
	
              Section 7.04.

            	
              GOVERNING LAW

            	
              18

            
	
              Section 7.05.

            	
              WAIVER OF JURY TRIAL

            	
              19

            
	
              Section 7.06.

            	
              No Waiver; Remedies

            	
              19

            
	
              Section 7.07.

            	
              Severability

            	
              19

            
	
              Section 7.08.

            	
              Table of Contents and Headings

            	
              19

            
	
              Section 7.09.

            	
              Counterparts

            	
              19

            
	
              Schedule A – Representations and Warranties, Review Materials and Tests

            	
              SA-1

            

       

      

      
        ii

        
          

      

      
        
          This ASSET REPRESENTATIONS REVIEW AGREEMENT, dated as of January 1, 2019 (as amended, restated, supplemented or otherwise modified from time to
            time, this “Agreement”), is among MERCEDES-BENZ AUTO LEASE TRUST 2019-A, a Delaware statutory trust (the “Issuer”), MERCEDES-BENZ FINANCIAL SERVICES USA LLC, a Delaware limited liability company, as servicer and administrator (in such
            capacities, the “Servicer” and the “Administrator”, respectively) and CLAYTON FIXED INCOME SERVICES LLC, a Delaware limited liability company, (the “Asset Representations Reviewer”).

           

          RECITALS

           

          WHEREAS, the Issuer will engage the Asset Representations Reviewer to perform a review of certain motor vehicle leases and leased
              vehicles for compliance with certain representations and warranties made with respect thereto; and

           

          WHEREAS, the Asset Representations Reviewer desires to perform such review in accordance with the terms of this Agreement.

           

          NOW, THEREFORE, in consideration of the premises and other good and valuable consideration, the receipt and sufficiency of which are
              hereby acknowledged, the parties hereto agree as follows:

           

          ARTICLE ONE

           

          USAGE AND DEFINITIONS

           

          Section 1.01.  Capitalized Terms; Rules of Usage.  Capitalized

              terms used in this Agreement that are not otherwise defined shall have the meanings ascribed thereto in Appendix 1 to the 2019-A Servicing Supplement or, if not defined therein, in Appendix A to the Basic Collateral Agency Agreement, which
              Appendices are hereby incorporated into and made a part of this Agreement.  Appendix 1 also contains rules of usage applicable to this Agreement.  Whenever used herein, unless the context otherwise requires, the following words and phrases
              shall have the respective meanings set forth below for all purposes of this Agreement.  In the event of any conflict between a definition appearing below and any other 2019-A Basic Document, the definition appearing below shall control for
              purposes of this Agreement.

           

          “2019-A Servicing Supplement” means the 2019-A Servicing
              Supplement, dated as of January 1, 2019, to the Basic Servicing Agreement, among the Servicer, MBFS USA, as Lender, Daimler Trust, as titling trust, and Daimler Title Co., as collateral agent.

           

          “Annual Fee” has the meaning stated in Section 4.03(a).

           

          “Annual Period” means each annual period commencing on
              the 2019-A Closing Date, in the case of the first such period, and otherwise on the most recent anniversary of the 2019-A Closing Date and ending on the next anniversary of the 2019-A Closing Date.

           

          “ARR Indemnified Person” means each of the Asset
              Representations Reviewer and its officers, directors, employees and agents.

           

          
            
              

          

          
          “Basic Collateral Agency Agreement” means the Amended
              and Restated Basic Collateral Agency Agreement, dated as of March 1, 2009, among Daimler Trust, the Administrative Agent, Daimler Title Co., as collateral agent, and MBFS USA, as lender and as servicer.

           

          “Confidential Information” means oral, written and
              electronic materials (irrespective of its source or form of communication) furnished before, on or after the date of this Agreement to the Asset Representations Reviewer for the purposes contemplated by this Agreement, including (i) lists of
              Review Assets and any related Review Materials, (ii) origination and servicing guidelines, policies and procedures, and form contracts and (iii) notes, analyses, compilations, studies or other documents or records prepared by the Servicer,
              which contain information supplied by or on behalf of the Servicer or its representatives; provided,   that Confidential Information will not include information that (a) is or becomes generally available to the public other than as a result
              of disclosure by the Information Recipients, (b) was available to, or becomes available to, the Information Recipients on a non-confidential basis from a Person or entity other than the Issuer or the Servicer before its disclosure to the
              Information Recipients who, to the knowledge of the Information Recipient is not bound by a confidentiality agreement with the Issuer or the Servicer and is not prohibited from transmitting the information to the Information Recipients, (c)
              is independently developed by the Information Recipients without the use of the Confidential Information, as shown by the Information Recipients’ files and records or other evidence in the Information Recipients’ possession or (d) the Issuer
              or the Servicer provides permission to the applicable Information Recipients to release.

           

          “Eligible Representations” shall mean those
              representations identified within the “Tests” included in Schedule A.

           

          “Information Recipients” means the Asset Representations
              Reviewer and its officers, directors, employees, agents, representatives or affiliates, including legal counsel.

           

          “Issuer PII” means PII furnished by the Issuer, the
              Servicer or their Affiliates to the Asset Representations Reviewer and PII developed or otherwise collected or acquired by the Asset Representations Reviewer in performing its obligations under this Agreement.

           

          “Personally Identifiable Information”  or “PII” means information in any format about an identifiable individual, including, name, address, phone number, e-mail address, account number(s), identification
              number(s), any other actual or assigned attribute associated with or identifiable to an individual and any information that when used separately or in combination with other information could identify an individual.

           

          “Review” means the completion by the Asset
              Representations Reviewer of the procedures listed under “Tests” in Schedule A for each Review Asset as described in Section 3.03.

           

          “Review Assets” means those 2019-A Leases and 2019-A
              Leased Vehicles identified by the Servicer as requiring a Review by the Asset Representations Reviewer following receipt of a Review Notice according to Section 3.01.

           

          “Review Fee” has the meaning stated in Section 4.03(b).

           

          
            2

            
              

          

          “Review Materials” means the documents, data, and other
              information required for each “Test” in Schedule A.

           

          “Review Notice” means a notice delivered to the Asset
              Representations Reviewer by the Indenture Trustee pursuant to Section 7.02 of the Indenture.

           

          “Review Report” means the report prepared and delivered
              by the Asset Representations Reviewer pursuant to Section 3.04, which will, among other things, (i) indicate for each Review Asset whether there was a Test Pass, Test Fail or Test Complete for each related Test, (ii) include, for each Test
              Fail or Test Complete, the related reason for such Test Fail or Test Complete, including (for example) whether the Review Asset was a Test Fail as a result of missing or incomplete Review Materials and (iii) contain a summary of the Review
              results to be included in the Issuer’s Form 10-D report for the Collection Period in which the Review Report is received.

           

          “Test Complete” has the meaning stated in Section
              3.03(c).

           

          “Test Fail” has the meaning stated in Section 3.03(a).

           

          “Test Pass” has the meaning stated in Section 3.03(a).

           

          “Tests” mean the procedures listed in Schedule A, as
              applied to the process described in Section 3.03.

           

          
            3

            
              

          

          ARTICLE TWO

           

          ENGAGEMENT; ACCEPTANCE

           

          Section 2.01.  Engagement; Acceptance.  The Issuer
              hereby engages Clayton Fixed Income Services LLC to act as the Asset Representations Reviewer for the Issuer.  Clayton Fixed Income Services LLC accepts the engagement and agrees to perform the obligations of the Asset Representations
              Reviewer on the terms stated in this Agreement.

           

          Section 2.02.  Confirmation of Status.  The parties
              confirm that the Asset Representations Reviewer is not responsible for (i) reviewing the 2019-A Leases and 2019-A Leased Vehicles for compliance with the representations and warranties under the 2019-A Servicing Supplement, except as
              described in this Agreement or (ii) determining whether noncompliance with the representations or warranties constitutes a breach of the 2019-A Servicing Supplement.

           

          ARTICLE THREE

           

          ASSET REPRESENTATIONS REVIEW PROCESS

           

          Section 3.01.  Review Notices and Identification of Review Assets. 

              On receipt of a Review Notice from the Indenture Trustee pursuant to Section 7.02 of the Indenture, the Asset Representations Reviewer will start a Review.  Once a Review Notice has been issued, the Servicer will provide the list of Review
              Assets to the Asset Representations Reviewer within ten Business Days.

           

          The Asset Representations Reviewer will not be obligated to start a Review until a Review Notice and the related list of Review
              Assets is received.  The Asset Representations Reviewer is not obligated to verify (i) whether the Indenture Trustee properly determined that a Review Notice was required or (ii) the accuracy or completeness of the list of Review Assets
              provided by the Servicer.

           

          Section 3.02.  Review Materials.

           

          (a)          Access to Review Materials.  Within 60 days of the delivery of a Review Notice, the Servicer will provide the Asset Representations Reviewer with access to the Review Materials for all Review Assets in one or more
              of the following ways: (i) by providing access to the Servicer’s systems, either remotely or at an office of the Servicer, (ii) by electronic posting to a password-protected website to which the Asset Representations Reviewer has access,
              (iii) by providing originals or photocopies at an office of the Servicer or (iv) in another manner agreed by the Servicer and the Asset Representations Reviewer.  The Servicer may redact or remove Personally Identifiable Information from the
              Review Materials without changing the meaning or usefulness of the Review Materials.  The Asset Representations Reviewer shall be entitled to rely in good faith, without independent investigation or verification, that the Review Materials are
              accurate and complete in all material respects, and not misleading in any material respect.

           

          (b)          Missing or Insufficient Review Materials.  The Asset Representations Reviewer will review the Review Materials to determine if any Review Materials are missing or insufficient for the Asset Representations
              Reviewer to perform any Test.  If the Asset Representations Reviewer determines any missing or insufficient Review Materials, the Asset Representations Reviewer will notify the Servicer promptly, and in any event no less than 30 days before
              completing the Review.  The Servicer will have 60 days to give the Asset Representations Reviewer access to the missing Review Materials or other documents or information to correct the insufficiency.  If the missing Review Materials or other
              documents have not been provided by the Servicer within 60 days, the related Review Report will report a Test Fail for each Test that requires use of the missing or insufficient Review Materials.

           

          
            4

            
              

          

          Section 3.03.  Performance of Reviews.

           

          (a)          Test Procedures.  For a Review, the Asset Representations Reviewer will perform, for each Review Asset, the Tests for each Eligible Representation.  In the course of its review, the Asset Representations Reviewer
              will use the Review Materials listed in Schedule A.  For each Test and Review Asset, the Asset Representations Reviewer will determine if the Test has been satisfied (a “Test Pass”) or if the Test has not been satisfied (a “Test Fail”).

           

          (b)          Review Period.  The Asset Representations Reviewer will complete the Review within 60 days of receiving access to the Review Materials.  However, if additional Review Materials are provided to the Asset
              Representations Reviewer as described in Section 3.02(b), the Review period will be extended for an additional 30 days.

           

          (c)          Completion of Review for Certain Review Assets.  Following the delivery of the list of the Review Assets and before the delivery of the Review Report by the Asset Representations Reviewer, the Servicer may notify
              the Asset Representations Reviewer if a Review Asset has been paid in full by the related Lessee or purchased from the Issuer in accordance with the terms of the 2019-A Servicing Agreement.  On receipt of such notice, the Asset
              Representations Reviewer will immediately terminate all Tests of the related Review Asset, and the Review of such Review Assets will be considered complete (a “Test Complete”).  In this case, the related Review Report will indicate a Test
              Complete for such Review Asset and the related reason.

           

          (d)          Duplicative Tests.  If the same Test is required for more than one representation and warranty, the Asset Representations Reviewer will only perform the Test once for each Review Asset, but will report the results
              of the Test for each applicable representation and warranty on the Review Report.

           

          (e)          Termination of Review.  If a Review is in process and the Notes will be paid in full on the next Payment Date, the Servicer will notify the Asset Representations Reviewer no less than five days before that Payment
              Date.  On receipt of such notice, the Asset Representations Reviewer will terminate the Review immediately and will not be obligated to deliver a Review Report.

           

          Section 3.04.  Review Report.  Within five Business
              Days after the end of the applicable Review period under Section 3.03(b), the Asset Representations Reviewer will deliver to the Issuer, the Servicer and the Indenture Trustee a Review Report.  The Asset Representations Reviewer will ensure
              that the Review Report does not contain any Personally Identifiable Information.  On reasonable request of the Servicer, the Asset Representations Reviewer will provide additional details on the Test results.

           

          
            5

            
              

          

          Section 3.05.  Review Representatives.

           

          (a)          Servicer Representative.  The Servicer will designate one or more representatives who will be available to assist the Asset Representations Reviewer in performing the Review, including responding to requests and
              answering questions from the Asset Representations Reviewer about access to Review Materials on the Servicer’s originations, leases or other systems, obtaining missing or insufficient Review Materials and/or providing clarification of any
              Review Materials or Tests.

           

          (b)          Asset Representations Review Representative.  The Asset Representations Reviewer will designate one or more representatives who will be available to the Issuer, the Servicer and the Administrator during the
              performance of a Review.

           

          (c)          Questions About Review.  The Asset Representations Reviewer will make appropriate personnel available to respond in writing to written questions or requests for clarification of any Review Report from the
              Indenture Trustee or the Servicer until the earlier of (i) the payment in full of the Notes and (ii) one year after the delivery of the Review Report.  The Asset Representations Reviewer will not be obligated to respond to questions or
              requests for clarification from Noteholders or any other Person and will direct such Persons to submit written questions or requests to the Servicer.

           

          Section 3.06.  Dispute Resolution.  If a Review Asset
              that was the subject of a Review becomes the subject of a dispute resolution proceeding under Section 3.11 of the 2019-A Servicing Supplement, the Asset Representations Reviewer will participate in the dispute resolution proceeding on request
              of a party to the proceeding.  The reasonable out-of-pocket expenses of the Asset Representations Reviewer for its participation in any dispute resolution proceeding will be considered expenses of the requesting party for the dispute
              resolution and will be paid, in the case of (i) an arbitration, by a party to the dispute resolution as determined by the arbitrator for the dispute resolution, and (ii) a mediation, as the parties shall mutually determine, in each case
              according to Section 3.11 of the 2019-A Servicing Supplement.  If not paid by a party to the dispute resolution, the expenses will be reimbursed by the Issuer pursuant to Section 4.03(d).

           

          Section 3.07.  Limitations on Review Obligations.

           

          (a)          Review Process Limitations.  The Asset Representations Reviewer will have no obligation (i) to determine whether a Delinquency Trigger has occurred or whether the required percentage of Noteholders has voted to
              direct a Review under the Indenture; (ii) to determine which 2019-A Leases and 2019-A Leased Vehicles are subject to a Review, (iii) to obtain or confirm the validity of the Review Materials, (iv) to obtain missing or insufficient Review
              Materials, (v) to take any action or cause any other party to take any action under any of the 2019-A Basic Documents to enforce any remedies for breaches of representations or warranties about the Eligible Representations, (vi) to determine
              the reason for the delinquency of any Review Asset, the creditworthiness of any Lessee, the overall quality of any Review Asset or the compliance by the Servicer with its covenants with respect to the servicing of such Review Asset, or (vii)
              to establish cause, materiality or recourse for any failed Test.

           

          
            6

            
              

          

          (b)          Testing Procedure Limitations.  The Asset Representations Reviewer will only be required to perform the Tests listed under Schedule A, and will not be obligated to perform additional procedures on any Review Asset
              or to provide any information other than a Review Report.  However, the Asset Representations Reviewer may provide additional information in a Review Report about any Review Asset that it determines in good faith to be material to the Review.

           

          ARTICLE FOUR

           

          ASSET REPRESENTATIONS REVIEWER

           

          Section 4.01.  Representations and Warranties of the Asset
                  Representations Reviewer.  The Asset Representations Reviewer hereby makes the following representations and warranties as of the 2019-A Closing Date:

           

          (a)          Organization and Qualification.  The Asset Representations Reviewer is duly organized and validly existing as a limited liability company in good standing under the laws of State of Delaware. 
              The Asset Representations Reviewer is qualified as a foreign limited liability company in good standing and has obtained all necessary licenses and approvals in all jurisdictions in which the ownership or lease of its properties or the
              conduct of its activities requires the qualification, license or approval, unless the failure to obtain the qualifications, licenses or approvals would not reasonably be expected to have a material adverse effect on the Asset Representations
              Reviewer’s ability to perform its obligations under this Agreement.

           

          (b)          Power, Authority and Enforceability.  The Asset Representations Reviewer has the power and authority to execute, deliver and perform its obligations under this Agreement.  The Asset
              Representations Reviewer has authorized the execution, delivery and performance of this Agreement.  This Agreement is the legal, valid and binding obligation of the Asset Representations Reviewer enforceable against the Asset Representations
              Reviewer, except as may be limited by insolvency, bankruptcy, reorganization or other laws relating to the enforcement of creditors’ rights or by general equitable principles.

           

          (c)          No Conflicts and No Violation.  The completion of the transactions  contemplated by this Agreement and the performance of the Asset Representations Reviewer’s obligations under this Agreement
              will not (i) conflict with, or be a breach or default under, any indenture, mortgage, deed of trust, loan agreement, guarantee or similar document under which the Asset Representations Reviewer is a debtor or guarantor, (ii) result in the
              creation or imposition of a Lien on the properties or assets of the Asset Representations Reviewer under the terms of any indenture, mortgage, deed of trust, loan agreement, guarantee or similar document, (iii) violate the organizational
              documents of the Asset Representations Reviewer or (iv) violate a law or, to the Asset Representations Reviewer’s knowledge, an order, rule or regulation of a federal or State court, regulatory body, administrative agency or other
              governmental instrumentality having jurisdiction over the Asset Representations Reviewer or its properties that applies to the Asset Representations Reviewer, which, in each case, would reasonably be expected to have a material adverse effect
              on the Asset Representations Reviewer’s ability to perform its obligations under this Agreement.

           

          
            7

            
              

          

          (d)          No Proceedings.  To the Asset Representations Reviewer’s knowledge, there are no proceedings or investigations pending or threatened in writing before a federal or State court, regulatory body,
              administrative agency or other governmental instrumentality having jurisdiction over the Asset Representations Reviewer or its properties (i) asserting the invalidity of this Agreement, (ii) seeking to prevent the completion of the
              transactions contemplated by this Agreement or (iii) seeking any determination or ruling that would reasonably be expected to have a material adverse effect on the Asset Representations Reviewer’s ability to perform its obligations under, or
              the validity or enforceability of, this Agreement.

           

          (e)          Eligibility.  The Asset Representations Reviewer meets the eligibility requirements in Section 5.01.

           

          Section 4.02.  Covenants.  The Asset Representations Reviewer
                  covenants and agrees that:

           

          (a)          Eligibility.  It will notify the Issuer and the Servicer promptly if it no longer meets, or reasonably expects that it will no longer meet, the eligibility requirements in Section 5.01.

           

          (b)          Review Systems; Personnel.  It will maintain business process management and/or other systems necessary to ensure that it can perform each Test and, on execution of this Agreement, will load
              each Test into these systems.  The Asset Representations Reviewer will ensure that these systems allow for each Review Asset and the related Review Materials to be individually tracked and stored as contemplated by this Agreement.  The Asset
              Representations Reviewer will maintain adequate staff that is properly trained to conduct Reviews as required by this Agreement.

           

          (c)          Maintenance of Review Materials.  It will maintain copies of any Review Materials, Review Reports and other documents relating to a Review, including internal correspondence and work papers,
              for a period of at least two years after any termination of this Agreement.

           

          Section 4.03.  Fees and Expenses.

           

          (a)          Annual Fee.  As compensation for its activities hereunder, the Asset Representations Reviewer shall be entitled to receive an annual fee (the “Annual Fee”) with respect to each Annual Period prior to the
              termination of the Issuer, in an amount equal to $5,000.  The Annual Fee will be paid by the Issuer on the 2019-A Closing Date and on each anniversary of the 2019-A Closing Date until this Agreement is terminated; provided, however, that if
              the Asset Representations Reviewer resigns or is removed in accordance with Section 5.02, then the Asset Representations Reviewer shall refund to the Issuer a portion of the Annual Fee attributable to the portion of the annual period during
              which the Asset Representations Reviewer will no longer act as the Asset Representations Reviewer, assuming for purposes of such calculation that the Annual Fee for each day during the annual period is an amount equal to the Annual Fee
              divided by 365.

           

          
            8

            
              

          

          (b)          Review Fee.  Following the completion of a Review and the delivery of the related Review Report pursuant to Section 3.04, or the termination of a Review according to Section 3.03(e), and the delivery to the
              Indenture Trustee and the Servicer of a detailed invoice, the Asset Representations Reviewer will be entitled to a fee of $175 for each Review Asset for which the Review was started (the “Review Fee”), payable by the Issuer.  However, no
              Review Fee will be charged for any Review Asset which was included in a prior Review or for which no Tests were completed prior to the Asset Representations Reviewer being notified of a termination of the Review according to Section 3.03(c)
              or due to missing or insufficient Review Materials under Section 3.02(b).  If the detailed invoice is submitted on or before the first day of a month, the Review Fee will be paid by the Issuer according to the priority of payments in the
              Indenture on the Payment Date in that month.  However, if a Review is terminated according to Section 3.03(e), the Asset Representations Reviewer must submit its invoice for the Review Fee for the terminated Review no later than ten Business
              Days before the final Payment Date to be reimbursed on such final Payment Date.

           

          (c)          Reimbursement of Travel Expenses.  If the Servicer provides access to the Review Materials at one of its properties, the Issuer will reimburse the Asset Representations Reviewer for its reasonable travel expenses
              incurred in connection with the Review upon receipt of a detailed invoice.

           

          (d)          Dispute Resolution Expenses.  If the Asset Representations Reviewer participates in a dispute resolution proceeding under Section 3.06 and its reasonable out-of-pocket expenses for participating in the proceeding
              are not paid by a party to the dispute resolution within 90 days after the end of the proceeding, the Issuer will reimburse the Asset Representations Reviewer for such expenses upon receipt of a detailed invoice.

           

          (e)          Payment of Invoices.  When applicable pursuant to this Section, the fees and expenses of the Asset Representations Reviewer are to be paid via the priority of payments described in Section 5.04(b) or 8.03 of the
              Indenture, as applicable.  The Asset Representations Reviewer will issue invoices to the Issuer at the notices addresses set forth in Section 11.04 of the Indenture and Issuer shall pay all invoices submitted by the Asset Representations
              Reviewer within 30 days following the receipt by the Issuer, in accordance with the priority of payments described in Section 5.04(b) or 8.03 of the Indenture, as applicable.  The Administrator shall promptly pay to the Asset Representations
              Reviewer the amount of any fees, expenses and indemnification amounts not otherwise paid or reimbursed by the Issuer on any Payment Date in accordance with the terms of Section 5.04(b) or 8.03 of the Indenture, as applicable; provided that
              the Asset Representations Reviewer shall promptly reimburse the Administrator for any such amounts to the extent it subsequently receives payment or reimbursement in respect thereof from the Issuer in accordance with the terms of such
              Sections.  For the avoidance of doubt, the aggregate limit on the Asset Representations Reviewer fees, expenses and indemnities specified in Section 8.03 of the Indenture shall not apply to payments made or to be made by the Administrator to
              the Asset Representations Reviewer pursuant to this subsection.

           

          
            9

            
              

          

          Section 4.04.  Limitation on Liability.  The Asset
              Representations Reviewer will not be liable to any Person for any action taken, or not taken, in good faith under this Agreement or for errors in judgment.  The Asset Representations Reviewer will, however, be liable for its willful
              misconduct, bad faith or negligence in performing its obligations under this Agreement, but in no event will it be liable for special, indirect or consequential losses or damages (including lost profit), even if it has been advised of the
              likelihood of the loss or damage and regardless of the form of action.

           

          Section 4.05.  Indemnification by Asset Representations Reviewer. 

              The Asset Representations Reviewer will indemnify each of the Issuer, the Seller, the Servicer, the Administrator, the Owner Trustee and the Indenture Trustee and their respective directors, officers, employees and agents for all fees,
              expenses, losses, damages and liabilities, including any legal fees or expenses incurred in connection with the enforcement of the Asset Representations Reviewer’s indemnification or other obligations hereunder, resulting from the Asset
              Representations Reviewer’s (i) willful misconduct, bad faith or negligence in performing its obligations under this Agreement and (ii) breach of any of its representations or warranties in this Agreement.  The Asset Representations Reviewer’s
              obligations under this Section will survive the termination of this Agreement, the termination of the Issuer and the resignation or removal of the Asset Representations Reviewer.

           

          Section 4.06.  Indemnification of Asset Representations Reviewer.

           

          (a)          Indemnification.  The Issuer will, or will cause the Administrator to, indemnify each ARR Indemnified Person for all costs, expenses, losses, damages and liabilities resulting from the performance of its
              obligations under this Agreement (including the fees and expenses of defending itself against any loss, damage or liability), but excluding any cost, expense, loss, damage or liability resulting from the Asset Representations Reviewer’s (i)
              willful misconduct, bad faith or negligence or (ii) breach of any of its representations or warranties in this Agreement.

           

          (b)          Proceedings.  Promptly on receipt by an ARR Indemnified Person of notice of a Proceeding against it, such ARR Indemnified Person will, if a claim is to be made under Section 4.06(a), notify the Issuer and the
              Administrator of the Proceeding.  The Issuer and/or the Administrator may participate in and assume the defense and settlement of a Proceeding at its expense.  If the Issuer or the Administrator notifies an ARR Indemnified Person of its
              intention to assume the defense of the Proceeding with counsel reasonably satisfactory to such ARR Indemnified Person, and so long as the Issuer, the Servicer or the Administrator assumes the defense of the Proceeding in a manner reasonably
              satisfactory to such ARR Indemnified Person, the Issuer and the Administrator will not be liable for fees and expenses of counsel to such ARR Indemnified Person unless there is a conflict between the interests of the Issuer or the
              Administrator, as applicable, and an ARR Indemnified Person.  If there is a conflict, the Issuer, the Servicer or the Administrator will pay for the reasonable fees and expenses of separate counsel to the ARR Indemnified Person.  No
              settlement of a Proceeding may be made without the approval of the Issuer and the Administrator and the ARR Indemnified Person, which approval will not be unreasonably withheld, conditioned or delayed.

           

          
            10

            
              

          

          (c)          Survival of Obligations.  The Issuer’s and the Administrator’s obligations under this Section will survive the resignation or removal of the Asset Representations Reviewer and the termination of this Agreement.

           

          (d)          Repayment.  If the Issuer or the Administrator makes any payment under this Section and an ARR Indemnified Person later collects any of the amounts for which the payments were made to it from others, such ARR
              Indemnified Person will promptly repay the amounts to the Issuer or the Administrator, as applicable.

           

          Section 4.07.  Inspections of Asset Representations Reviewer. 

              The Asset Representations Reviewer agrees that, with reasonable advance notice not more than once during any year, it will permit authorized representatives of the Issuer, the Servicer or the Administrator, during the Asset Representations
              Reviewer’s normal business hours, to examine and review its books of account, records, reports and other documents and materials relating to (a) the performance of its obligations under this Agreement, (b) payments of its fees and expenses
              for its performance of its obligations under this Agreement and (c) a claim made by it under this Agreement.  In addition, the Asset Representations Reviewer will permit representatives of the Issuer, the Servicer or the Administrator to make
              copies and extracts of any of those documents and to discuss them with the Asset Representations Reviewer’s officers and employees.  Each of the Issuer, the Servicer and the Administrator will, and will cause its authorized representatives
              to, hold in confidence the foregoing information except if disclosure may be required by Applicable Law or if the Issuer, the Servicer or the Administrator reasonably determines that it is required to make the disclosure under this Agreement
              or the other 2019-A Basic Documents.  The Asset Representations Reviewer will maintain all relevant books, records, reports and other documents and materials for a period of at least two years after the termination of its obligations under
              this Agreement.

           

          Section 4.08.  Delegation of Obligations.  The Asset
              Representations Reviewer may not delegate or subcontract its obligations under this Agreement to any Person without the prior written consent of the Issuer and the Servicer.

           

          Section 4.09.  Confidential Information.

           

          (a)          Treatment.  The Asset Representations Reviewer agrees to hold and treat Confidential Information given to it under this Agreement in confidence and under the terms and conditions of this Section, and will
              implement and maintain safeguards to further assure the confidentiality of the Confidential Information.  The Confidential Information will not, without the prior written consent of the Issuer and the Servicer, be disclosed or used by any
              Information Recipient other than for the purposes of performing Reviews of Review Assets or performing its obligations under this Agreement.  The Asset Representations Reviewer agrees that it will not, and will cause its Affiliates to not (i)
              purchase or sell securities issued by the Servicer or its Affiliates or special purpose entities on the basis of Confidential Information or (ii) use the Confidential Information for the preparation of research reports, newsletters or other
              publications or similar communications.

           

          (b)          Protection.  The Asset Representations Reviewer will take reasonable measures to protect the secrecy of and avoid disclosure and unauthorized use of Confidential Information, including those measures that it takes
              to protect its own confidential information and not less than a reasonable standard of care.  The Asset Representations Reviewer acknowledges that Personally Identifiable Information is also subject to the additional requirements in Section
              4.10.

           

          
            11

            
              

          

          (c)          Disclosure.  If the Asset Representations Reviewer is required by applicable law, regulation, rule or order issued by a Governmental Authority to disclose part of the Confidential Information, it may disclose the
              Confidential Information.  However, before a required disclosure, the Asset Representations Reviewer, if permitted by law, regulation, rule or order, will use its reasonable efforts to provide the Issuer and the Servicer with notice of the
              requirement and will cooperate, at the Servicer’s expense, in the Issuer’s and the Servicer’s pursuit of a proper protective order or other relief for the disclosure of the Confidential Information.  If the Issuer and the Servicer are unable
              to obtain a protective order or other proper remedy by the date that the information is required to be disclosed, the Asset Representations Reviewer will disclose only that part of the Confidential Information that it is advised by its legal
              counsel it is legally required to disclose.

           

          (d)          Responsibility for Information Recipients.  The Asset Representations Reviewer will be responsible for a breach of this Section by its Information Recipients.

           

          (e)          Violation.  The Asset Representations Reviewer agrees that a violation of this Agreement may cause irreparable injury to the Issuer and the Servicer and the Issuer and the Servicer may seek injunctive relief in
              addition to legal remedies.  If an action is initiated by the Issuer or the Servicer to enforce this Section, the prevailing party will be reimbursed for its fees and expenses, including reasonable attorney’s fees, incurred for the
              enforcement.

           

          Section 4.10.  Personally Identifiable Information.

           

          (a)          Use of Issuer PII.  The Issuer does not grant the Asset Representations Reviewer any rights to Issuer PII except as otherwise provided in this Agreement.  The Asset Representations Reviewer will use Issuer PII
              only to perform its obligations under this Agreement or as specifically directed in writing by the Issuer and will only reproduce Issuer PII to the extent necessary for these purposes.  The Asset Representations Reviewer must comply with all
              laws applicable to PII, Issuer PII and the Asset Representations Reviewer’s business, including any legally required codes of conduct, including those relating to privacy, security and data protection.  The Asset Representations Reviewer will
              protect and secure Issuer PII.  The Asset Representations Reviewer will implement privacy or data protection policies and procedures that comply with applicable law and this Agreement.  The Asset Representations Reviewer will implement and
              maintain reasonable and appropriate practices, procedures and systems, including administrative, technical and physical safeguards to (i) protect the security, confidentiality and integrity of Issuer PII, (ii) ensure against anticipated
              threats or hazards to the security or integrity of Issuer PII, (iii) protect against unauthorized access to or use of Issuer PII and (iv) otherwise comply with its obligations under this Agreement.  These safeguards include a written data
              security plan, employee training, information access controls, restricted disclosures, systems protections (e.g., intrusion protection, data storage protection and data transmission protection) and physical security measures.

           

          
            12

            
              

          

          (b)          Additional Limitations.  In addition to the use and protection requirements described in Section 4.10(a), the Asset Representations Reviewer’s disclosure of Issuer PII is also subject to the following
              requirements:

           

          (i)          The Asset
              Representations Reviewer will not disclose Issuer PII to its personnel or allow its personnel access to Issuer PII except (A) for the Asset Representations Reviewer personnel who require Issuer PII to perform a Review, (B) with the prior
              consent of the Issuer or (C) as required by applicable law.  When permitted, the disclosure of or access to Issuer PII will be limited to the specific information necessary for the individual to complete the assigned task.  The Asset
              Representations Reviewer will inform personnel with access to Issuer PII of the confidentiality requirements in this Agreement and train its personnel with access to Issuer PII on the proper use and protection of Issuer PII.

           

          (ii)          The Asset
              Representations Reviewer will not sell, disclose, provide or exchange Issuer PII with or to any third party without the prior consent of the Issuer.

           

          (c)          Notice of Breach.  The Asset Representations Reviewer will notify the Issuer promptly in the event of an actual or reasonably suspected security breach, unauthorized access, misappropriation or other compromise of
              the security, confidentiality or integrity of Issuer PII and, where applicable, immediately take action to prevent any further breach.

           

          (d)          Return or Disposal of Issuer PII.  Except where return or disposal is prohibited by applicable law, promptly on the earlier of the completion of the Review or the request of the Issuer, all Issuer PII in any
              medium in the Asset Representations Reviewer’s possession or under its control will be (i) destroyed in a manner that prevents its recovery or restoration or (ii) if so directed by the Issuer, returned to the Issuer without the Asset
              Representations Reviewer retaining any actual or recoverable copies, in both cases, without charge to the Issuer.  Where the Asset Representations Reviewer retains Issuer PII, the Asset Representations Reviewer will limit the Asset
              Representations Reviewer’s further use or disclosure of Issuer PII to that required by applicable law.

           

          (e)          Compliance; Modification.  The Asset Representations Reviewer will cooperate with and provide information to the Issuer regarding the Asset Representations Reviewer’s compliance with this Section.  The Asset
              Representations Reviewer and the Issuer agree to modify this Section as necessary for either party to comply with applicable law.

           

          (f)          Audit of Asset Representations Reviewer.  The Asset Representations Reviewer will permit the Issuer and its authorized representatives to audit the Asset Representations Reviewer’s compliance with this Section
              during the Asset Representations Reviewer’s normal business hours on reasonable advance notice to the Asset Representations Reviewer, and not more than once during any year unless circumstances necessitate additional audits.  The Issuer
              agrees to make reasonable efforts to schedule any audit described in this Section with the inspections described in Section 4.07.  The Asset Representations Reviewer will also permit the Issuer during normal business hours on reasonable
              advance notice to audit any service providers used by the Asset Representations Reviewer to fulfill the Asset Representations Reviewer’s obligations under this Agreement.

           

          
            13

            
              

          

          (g)          Affiliates and Third Parties.  If the Asset Representations Reviewer processes the PII of the Issuer’s Affiliates or a third party when performing a Review, and if such Affiliate or third party is identified to
              the Asset Representations Reviewer, such Affiliate or third party is an intended third-party beneficiary of this Section, and this Agreement is intended to benefit the Affiliate or third party.  The Affiliate or third party may enforce the
              PII related terms of this Section against the Asset Representations Reviewer as if each were a signatory to this Agreement.

           

          ARTICLE FIVE

           

          REMOVAL, RESIGNATION

           

          Section 5.01.  Eligibility of the Asset Representations Reviewer. 

              The Asset Representations Reviewer must be a Person who (i) is not Affiliated with the Issuer, the Depositor, the Servicer, the Indenture Trustee, the Owner Trustee or any of their Affiliates and (ii) was not, and is not Affiliated with a
              Person that was, engaged by the Issuer, the Depositor, the Servicer or any Underwriter to perform any due diligence on the 2019-A Leases and 2019-A Leased Vehicles prior to the 2019-A Closing Date.

           

          Section 5.02.  Resignation and Removal of Asset Representations
                  Reviewer.

           

          (a)          No Resignation.  The Asset Representations Reviewer will not resign as Asset Representations Reviewer unless it determines it is legally unable to perform its obligations under this Agreement and there is no
              reasonable action that it could take to make the performance of its obligations under this Agreement permitted under applicable law.  In such event, the Asset Representations Reviewer will deliver a notice of its resignation to the Issuer and
              the Servicer, together with an Opinion of Counsel supporting its determination.

           

          (b)          Removal.  If any of the following events occur, the Issuer, by notice to the Asset Representations Reviewer, may remove the Asset Representations Reviewer and terminate its rights and obligations under this
              Agreement:

           

          (i)           the
              Asset Representations Reviewer no longer meets the eligibility requirements in Section 5.01;

           

          (ii)          the
              Asset Representations Reviewer breaches of any of its representations, warranties, covenants or obligations in this Agreement; or

           

          (iii)          an 
              Insolvency Event of the Asset Representations Reviewer occurs.

           

          (c)          Notice of Resignation or Removal.  The Issuer will notify the Servicer and the Indenture Trustee of any resignation or removal of the Asset Representations Reviewer.

           

          (d)          Continue to Perform After Resignation or Removal.  The Asset Representations Reviewer will continue to perform its obligations under this Agreement until a successor Asset Representations Reviewer has accepted its
              engagement according to Section 5.03(b).

           

          
            14

            
              

          

          Section 5.03.  Successor Asset Representations Reviewer.

           

          (a)          Engagement of Successor Asset Representations Reviewer.  Following the resignation or removal of the Asset Representations Reviewer, the Issuer will engage a successor Asset Representations Reviewer who meets the
              eligibility requirements of Section 5.01.

           

          (b)          Effectiveness of Resignation or Removal.  No resignation or removal of the Asset Representations Reviewer will be effective until a successor Asset Representations Reviewer has executed and delivered to the Issuer
              and the Servicer an agreement accepting its engagement and agreeing to perform the obligations of the Asset Representations Reviewer under this Agreement or entering into a new agreement with the Issuer on substantially the same terms as this
              Agreement.

           

          (c)          Transition and Expenses.  If the Asset Representations Reviewer resigns or is removed, it will cooperate with the Issuer and the Servicer and take all actions reasonably requested to assist the Issuer in making an
              orderly transition of its rights and obligations under this Agreement to the successor Asset Representations Reviewer.  The Asset Representations Reviewer will pay the reasonable expenses of transitioning its obligations under this Agreement
              and preparing the successor Asset Representations Reviewer to take on the obligations on receipt of an invoice with reasonable detail of the expenses from the Issuer and the Servicer or the successor Asset Representations Reviewer.

           

          
            15

            
              

          

          Section 5.04.  Merger, Consolidation or Succession. 
              Any Person (i) into which the Asset Representations Reviewer is merged or consolidated, (ii) resulting from any merger or consolidation to which the Asset Representations Reviewer is a party or (iii) succeeding to the business of the Asset
              Representations Reviewer, if that Person meets the eligibility requirements in Section 5.01, will be the successor to the Asset Representations Reviewer under this Agreement.  Such Person will execute and deliver to the Issuer, the Servicer
              and the Administrator an agreement to assume the Asset Representations Reviewer’s obligations under this Agreement (unless the assumption happens by operation of law).

           

          ARTICLE SIX

           

          OTHER AGREEMENTS

           

          Section 6.01.  Independence of the Asset Representations Reviewer. 

              The Asset Representations Reviewer will be an independent contractor and will not be subject to the supervision of the Issuer for the manner in which it accomplishes the performance of its obligations under this Agreement.  Unless expressly
              authorized by the Issuer, the Asset Representations Reviewer will have no authority to act for or represent the Issuer and will not be considered an agent of the Issuer.  Nothing in this Agreement will make the Asset Representations Reviewer
              and the Issuer members of any partnership, joint venture or other separate entity or impose any liability as such on any of them.  For the avoidance of doubt, the Indenture Trustee will not be responsible for monitoring the performance by the
              Asset Representations Reviewer of its obligations under this Agreement.

           

          Section 6.02.  No Petition.  Each of the parties to
              this Agreement covenants and agrees that for a period of one year and one day (or, if longer, any applicable preference period) after payment in full of all Exchange Notes and all outstanding Securities, it will not institute against, or join
              any Person in instituting against, the Titling Trust, the Initial Beneficiary, the Issuer or the Transferor any bankruptcy, reorganization, arrangement, insolvency or liquidation Proceedings, or other Proceedings under any Insolvency Law in
              connection with any obligations relating to the 2019-A ABS Notes, the 2019-A Exchange Note or the 2019-A Basic Documents and agrees that it will not cooperate with or encourage others to institute any such Proceeding.

           

          Section 6.03.  Limitation of Liability of Owner Trustee. 

              It is expressly understood and agreed by the parties hereto that (i) this Agreement is executed and delivered by WTNA, not individually or personally but solely as Owner Trustee of the Issuer, in the exercise of the powers and authority
              conferred and vested in it, (ii) each of the representations, undertakings and agreements herein made on the part of the Issuer is made and intended not as personal representations, undertakings and agreements by WTNA but is made and intended
              for the purpose of binding only the Issuer, (iii) nothing herein contained shall be construed as creating any liability on WTNA, individually or personally, to perform any covenant either expressed or implied contained herein of the Issuer,
              all such liability, if any, being expressly waived by the parties hereto and by any Person claiming by, through or under the parties hereto, (iv) WTNA has not verified and has made no investigation as to the accuracy or completeness of any
              representations and warranties made by the Issuer in this Agreement and (v) under no circumstances shall WTNA be personally liable for the payment of any indebtedness or expenses of the Issuer or be liable for the breach or failure of any
              obligation, representation, warranty or covenant made or undertaken by the Issuer under this Agreement or any other related documents.

           

          
            16

            
              

          

          Section 6.04.  Termination of Agreement.  This
              Agreement will terminate, except for the obligations under Section 4.05, on the earlier of (i) the payment in full of all outstanding Notes and the satisfaction and discharge of the Indenture and (ii) the date the Issuer is terminated under
              the Trust Agreement.

           

          ARTICLE SEVEN

           

          MISCELLANEOUS PROVISIONS

           

          Section 7.01.  Amendments.

           

          (a)          The parties may amend this Agreement:

           

          (i)           to
              clarify an ambiguity, correct an error or correct or supplement any term of this Agreement that may be defective or inconsistent with the other terms of this Agreement or to provide for, or facilitate the acceptance of this Agreement by, a
              successor Asset Representations Reviewer, in each case without the consent of the Noteholders or any other Person;

           

          (ii)          to add,
              change or eliminate terms of this Agreement, in each case without the consent of the Noteholders or any other Person, if the Administrator delivers an Officer’s Certificate to the Issuer, the Owner Trustee and the Indenture Trustee stating
              that the amendment will not have a material adverse effect on the Noteholders; or

           

          (iii)         to add,
              change or eliminate terms of this Agreement for which an Officer’s Certificate is not or cannot be delivered under Section 7.01(a)(ii), with the consent of the Majority Noteholders.

           

          (b)          Notwithstanding anything to the contrary in this
              Section, any amendment to this Agreement that affects the rights or the obligation of either the Indenture Trustee or the Owner Trustee will require the consent of the Indenture Trustee or the Owner Trustee, as applicable.

           

          Section 7.02.  Assignment; Benefit of Agreement; Third Party
                  Beneficiaries.

           

          (a)          Assignment.  Except as stated in Section 5.04, this Agreement may not be assigned by the Asset Representations Reviewer without the consent of the Issuer and the Servicer.

           

          (b)          Benefit of Agreement; Third-Party Beneficiaries.  This Agreement is for the benefit of and will be binding on the parties and their permitted successors and assigns.  The Owner Trustee and the Indenture Trustee,
              for the benefit of the Noteholders, will be third-party beneficiaries of this Agreement and may enforce this Agreement against the Asset Representations Reviewer and the Servicer.  No other Person will have any right or obligation under this
              Agreement.

           

          
            17

            
              

          

          Section 7.03.  Notices.

           

          (a)          Notices to Parties.  Unless otherwise expressly specified or permitted by the terms hereof, all notices, requests, demands, consents, waivers or other communications to or from the parties to this Agreement will
              be in writing.  Notices, requests, demands, consents and other communications will be deemed to have been given and made, (i) upon delivery or, in the case of a letter mailed via registered first class mail, postage prepaid, three days after
              deposit in the mail and (ii) in the case of (a) a facsimile, when receipt is confirmed by telephone or by reply e-mail or reply facsimile from the recipient, (b) an e-mail, when receipt is confirmed by telephone or by reply e‐mail from the
              recipient and (c) an electronic posting to a password-protected website, upon printed confirmation of the recipient’s access to such password-protected website, or when notification of such electronic posting is confirmed in accordance with
              clauses (ii)(b) and (ii)(c) above.

           

          (b)          Notice Addresses.  Any notice, request, demand, consent, waiver or other communication will be addressed as stated in the 2019-A Administration Agreement or this  Agreement, as applicable, or to another address as
              a party may give by notice to the other parties.

           

          In the case of the Asset Representations Reviewer, all such notices, including Review Notices, shall be sent to:

           

          Via electronic mail to ARRNotices@clayton.com

           

          and to:

           

          Clayton Fixed Income Services LLC

          2638 South Falkenburg Road

          Riverview, Florida 33578

          Attn: SVP

          

          

          with a copy to:

           

          Clayton Fixed Income Services LLC, c/o Clayton Holdings LLC

          1500 Market Street, West Tower Suite 2050

          Philadelphia, Pennsylvania 19102

          Attn: General Counsel

          

          

          In the case the Administrator or the Servicer, all such notices shall be sent to:

           

          Mercedes-Benz Financial Services USA LLC

          36455 Corporate Drive

          Farmington Hills, Michigan 48331

          Attention:  Steven C. Poling (e-mail: steven.c.poling@daimler.com)

          

          

          Section 7.04.  GOVERNING LAW.

           

          (a)          THIS AGREEMENT SHALL BE GOVERNED BY AND CONSTRUED IN ACCORDANCE WITH THE LAWS OF THE STATE OF NEW YORK, WITHOUT REGARD TO ANY OTHERWISE APPLICABLE PRINCIPLES OF CONFLICTS OF LAWS (OTHER THAN SECTION 5-1401 OF
                THE NEW YORK GENERAL OBLIGATIONS LAW), AND THE OBLIGATIONS, RIGHTS AND REMEDIES OF THE PARTIES HEREUNDER SHALL BE DETERMINED IN ACCORDANCE WITH SUCH LAWS.

           

          
            18

            
              

          

          Section 7.05.  WAIVER OF JURY TRIAL.  EACH PARTY TO THIS AGREEMENT IRREVOCABLY WAIVES, TO THE FULLEST EXTENT PERMITTED BY APPLICABLE LAW, ANY AND ALL RIGHT TO TRIAL BY JURY IN ANY LEGAL PROCEEDING
                RELATING TO THIS AGREEMENT OR THE TRANSACTIONS CONTEMPLATED BY ANY 2019-A BASIC DOCUMENT.

           

          Section 7.06.  No Waiver; Remedies.  No party’s failure
              or delay in exercising a power, right or remedy under this Agreement will operate as a waiver.  No single or partial exercise of a power, right or remedy will preclude any other or further exercise of the power, right or remedy or the
              exercise of any other power, right or remedy.  The powers, rights and remedies under this Agreement are in addition to any powers, rights and remedies under law.

           

          Section 7.07.  Severability.  If any one or more of the
              covenants, agreements, provisions or terms of this Agreement is held invalid, illegal or unenforceable, then such covenants, agreements, provisions or terms will be deemed severable from the remaining covenants, agreements, provisions and
              terms of this Agreement, and will in no way affect the validity, legality or enforceability of the other covenants, agreements, provisions and terms of this Agreement.

           

          Section
                  7.08.  Table of Contents and Headings.  The Table of Contents and the various headings in this Agreement are included for convenience only and will not affect the meaning or interpretation of any provision of this
              Agreement.

           

          Section 7.09.  Counterparts.  This Agreement may be
              executed in any number of counterparts, each of which will be an original, and all of which will together constitute one and the same instrument.

           

          
            19

            
              

          

          IN WITNESS WHEREOF, the parties hereto have caused this Agreement to be duly executed by their respective officers duly authorized as
              of the day and year first above written

           

          	 	
                  MERCEDES-BENZ AUTO LEASE TRUST 2019-A,

                
	 	 	
                  as Issuer

                
	 	 	 
	 	
                  By:

                	
                  WILMINGTON TRUST, NATIONAL ASSOCIATION, not in its individual capacity, but solely as Owner Trustee

                
	 	 	 
	 	
                  By:

                	 
	 	 	
                  Name:

                
	 	 	
                  Title:

                
	 	 
	 	
                  MERCEDES-BENZ FINANCIAL SERVICES USA LLC,

                
	 	 	
                  as Servicer and Administrator

                
	 	 	 
	 	
                  By:

                	 
	 	 	
                  Name:

                
	 	 	
                  Title:

                
	 	 
	 	
                  CLAYTON FIXED INCOME SERVICES LLC,

                
	 	 	
                  as Asset Representations Reviewer

                
	 	 	 
	 	
                  By:

                	 
	 	 	
                  Name:

                
	 	 	
                  Title:

                

          

          

          
            
              

          

          
          SCHEDULE A

           

          REPRESENTATIONS AND WARRANTIES, REVIEW MATERIALS AND TESTS

          Representation (1) - Origination

           

          The 2019-A Lease is a Stand-Alone Lease that was originated (a) by a Dealer, (b) on or after July 2014, (c) pursuant to an agreement
              which allows for recourse to the Dealer in the event of certain defects in the 2019-A Lease (but not for a default by the related Lessee) and (d) in substantial compliance with the Credit and Collection Policy.

           

          Review Materials

           

          
            
              	

                    	-	
                      Lease agreement

                    

            

          

           

          Procedures to be Performed

           

          (i)           Confirm
              the lease agreement was signed by the Lessee and the Lessor

           

          (ii)          Confirm
              the lease agreement form number and revision date are on the List of Approved Contract Forms

           

          (iii)         Confirm
              the lease agreement is dated on or after July 2014

            

           

          (iv)         Confirm
              the dealer agreement contains provisions which allow for recourse to the Dealer in the event of certain defects in the Lease, outside of  default by the related Lessee

           

          (v)          Confirm
              there is no evidence the lease agreement is not in compliance with the Credit and Collection Policy

           

          (vi)         If section
              (i) through (v) are confirmed, then Test Pass

           

          Representation (2) - Leases

           

          The 2019-A Lease constitutes “tangible chattel paper” or “electronic chattel paper” within the meaning of Section 9-102 of the UCC.

           

          Review Materials

           

          
            
              	

                    	-	
                      Lease agreement

                    

            

          

           

          
            
              	

                    	-	
                      Title documents

                    

            

          

           

          Procedures to be Performed

           

          (i)           Confirm
              there is a signature under the appropriate Lessee, Co-lessee and Lessor signature lines within the lease agreement

           

          
            SA-1

            
              

          

          (ii)          Confirm
              the lease agreement reports a monetary obligation greater than zero

           

          (iii)         Confirm
              the assignment section of the lease agreement lists the  Titling Trust as the sole assignee

           

          (iv)         If
              sections (i) through (iii) are confirmed, then Test Pass

           

          Representation (3) – Leased Vehicle

           

          The related 2019-A Vehicle is a Mercedes-Benz passenger car or sport utility vehicle that was new at the time of the origination of
              the related 2019-A Lease and is not powered by a diesel engine.

           

          Review Materials

           

          
            
              	

                    	-	
                      Lease agreement

                    

            

          

           

          Procedures to be Performed

           

          (i)           Confirm
              the vehicle description section of the lease agreement reports that the leased vehicle is a new vehicle

           

          (ii)          Confirm

              the vehicle description section of the lease agreement reports that the leased vehicle is a Mercedes-Benz passenger car, sport utility vehicle or a smart automobile and is not powered by a diesel engine

           

          (iii)         If
              sections (i) and (ii) are confirmed, then Test Pass

           

          Representation (4) – Certificate of Title and Lienholder

           

          Each 2019-A Vehicle was titled, or the Servicer has started procedures that will result in the 2019-A Vehicle being titled, in one of
              the 50 states of the United States or the District of Columbia and the Collateral Agent is or will be noted as lienholder of the 2019-A Vehicle (other than in Kansas, Missouri, Nebraska, Nevada or South Dakota) and such lien is a perfected
              first priority security interst.

           

          Review Materials

           

          
            
              	

                    	-	
                      Lease agreement

                    

            

          

           

          
            
              	

                    	-	
                      Title documents

                    

            

          

           

          
            
              	

                    	-	
                      Lease file

                    

            

          

           

          Procedures to be Performed

           

          (i)           Confirm
              the title lists the Collateral Agent as the first priority lienholder or evidence of an application for such title is present

           

          
            SA-2

            
              

          

          (ii)          Confirm
              the Vehicle Identification Number (VIN) listed on the title matches the VIN number on the lease agreement

           

          (iii)         Confirm
              there is no evidence of any lien that would take priority over the Collateral Agent’s security interest

           

          (iv)         If
              sections (i) through (iii) are confirmed, then Test Pass

           

          Representation (5) - Lessee

           

          The related Lessee is a Person other than MBFS USA, any Affiliate thereof or a Governmental Authority and, at the time of origination
              of the 2019-A Lease, based on information provided by the Lessee, the Lessee is located in and has a billing address within a State.

           

          Review Materials

           

          
            
              	

                    	-	
                      Lease agreement

                    

            

          

           

          Procedures to be Performed

           

          (i)           Confirm
              the Lessee is not reported as MBFS USA, an affiliate or a governmental authority

           

          (ii)          Confirm
              the Lessee’s address as reported on the lease agreement is located within the United States

           

          (iii)         If
              sections (i) and (ii) are confirmed, then Test Pass

           

          Representation (6) – Closed-End Lease; Payment in Dollars

           

          The 2019-A Lease is payable solely in Dollars in the United States and is a closed-end lease that provides for equal monthly payments
              by the Lessee, which scheduled payments, if made when due, fully amortize to an amount equal to the Booked Residual Value of the related 2019-A Vehicle based upon the related Contract Rate.

           

          Review Materials

           

          
            
              	

                    	-	
                      Lease agreement

                    

            

          

           

          Procedures to be Performed

           

          (i)          Confirm the
              lease agreement represents a closed end lease

           

          (ii)          Confirm
              the lease agreement is denominated in US dollars

           

          (iii)         Confirm
              the monthly payments section of the lease agreement calls for level monthly payments over the entire lease term with the possible exception of the first and last payment

           

          
            SA-3

            
              

          

          (iv)          Calculate
              the product of the level monthly payment with the number of payments due over the lease term and confirm this amount fully amortizes to the Booked Residual Value of the related 2019-A Vehicle based upon the related Contract Rate

           

          (v)          If sections
              (i) through (iv) are confirmed, then Test Pass

           

          Representation (7) – One Original

           

          There is only one original executed copy or authoritative copy, as applicable, of the 2019-A Lease.  The Servicer, or its custodian,
              has possession or control of such original or authoritative copy, as applicable, which does not have any marks or notations indicating that it has been pledged, assigned or otherwise conveyed to any Person other than the Titling Trust.

           

          Review Materials

           

          
            
              	

                    	-	
                      Lease agreement

                    

            

          

           

          Procedures to be Performed

           

          (i)           Confirm
              that the lease agreement is marked as the original copy or authoritative copy, as applicable

           

          (ii)          Confirm
              there is no evidence that the lease agreement has been pledged, assigned or otherwise conveyed to any Person other than the Titling Trust

           

          (iii)         If
              sections (i) and (ii) are confirmed, then Test Pass

           

          Representation (8) – Compliance with Law

           

          The 2019-A Lease complied in all material respects at the time it was originated and, as of the 2019-A Cutoff Date, will comply in
              all material respects with all requirements of federal, State and local laws.

           

          Review Materials

           

          
            
              	

                    	-	
                      Lease agreement

                    

            

          

           

          Procedures to be Performed

           

          (i)           Confirm
              the lease agreement form number and revision date are on the List of Approved Contract Forms

           

          (ii)          Confirm
              the following sections of the contract are present and completed:

           

          
            
              	

                    	(a)	
                      Name and address of Lessor

                    

            

          

          
            
              	

                    	(b)	
                      Name and address of Lessee and Co-lessee (if applicable)

                    

            

          

          
            
              	

                    	(c)	
                      Vehicle description

                    

            

          

          
            
              	

                    	(d)	
                      Amount due at lease signing

                    

            

          

          
            
              	

                    	(e)	
                      Amount of monthly payment

                    

            

          

           

          
            SA-4

            
              

          

          
            
              	

                    	(f)	
                      Number of monthly payments

                    

            

          

          
            
              	

                    	(g)	
                      Other charges

                    

            

          

          
            
              	

                    	(h)	
                      Total of Payments

                    

            

          

           

          (iii)         Confirm
              there is an itemization of the amount due at lease signing

           

          (iv)         Confirm
              there is an itemization of the monthly payment

           

          (v)          Confirm the
              following disclosures are included on the contract

           

          
            
              	

                    	(a)	
                      Early termination

                    

            

          

          
            
              	

                    	(b)	
                      Excessive wear

                    

            

          

          
            
              	

                    	(c)	
                      Purchase option

                    

            

          

          
            
              	

                    	(d)	
                      Insurance requirements

                    

            

          

          
            
              	

                    	(e)	
                      Late charges

                    

            

          

           

          (vi)         If
              sections (i) through (v) are confirmed, then Test Pass

           

          Representation (9) - Enforceability

           

          The 2019-A Lease was fully and properly executed by the parties thereto and such 2019-A Lease represents the legal, valid and binding
              full-recourse payment obligation of the related Lessee, enforceable against such Lessee in accordance with its terms, except as enforceability is subject to or limited by bankruptcy, reorganization, insolvency, fraudulent conveyance,
              moratorium and other similar laws affecting the enforcement of creditors’ rights in general or principles of equity (whether considered in a suit at law or in equity).

           

          Review Materials

           

          
            
              	

                    	-	
                      Lease agreement

                    

            

          

           

          Procedures to be Performed

           

          (i)           Confirm
              the lease agreement was signed by the Lessor, Lessee and Co-lessee (if applicable)

           

          (ii)          Confirm
              the lease agreement form number and revision date are on the List of Approved Contract Forms

           

          (iii)         If
              sections (i) and (ii) are confirmed, then Test Pass

           

          Representation (10) – Title to the Lease and Leased Vehicle

           

          Neither the 2019-A Lease nor the 2019-A Vehicle has been sold, transferred, assigned, pledged or granted by any Dealer to any Person
              other than the Titling Trust.  The Titling Trust has good and marketable title to such 2019-A Lease and 2019-A Vehicle, free and clear of any Liens (other than Permitted Liens), participations and rights of others, including, to the knowledge
              of the Servicer, Liens (other than Permitted Liens) or claims for work, labor or material relating to such 2019-A Vehicle.

           

          
            SA-5

            
              

          

          Review Materials

           

          
            
              	

                    	-	
                      Lease agreement

                    

            

          

           

          
            
              	

                    	-	
                      Title documents

                    

            

          

           

          
            
              	

                    	-	
                      Lease file

                    

            

          

           

          Procedures to be Performed

           

          (i)           Confirm
              the assignment section of the lease agreement has been signed by the Dealer and lists the Titling Trust as the assignee

           

          (ii)          Confirm
              there is no evidence within the lease file that the Lease has been sold, transferred, assigned, pledged or granted by any Dealer to any Person other than the Title Trust

           

          (iii)         Confirm
              the title shows that the Titling Trust is the owner of the Lease vehicle

           

          (iv)         Confirm
              the title document does not indicate any additional liens (other than permitted liens)

           

          (v)          If sections
              (i) through (iv) are confirmed, then Test Pass

           

          Representation (11) – Lease in Full Force and Effect; No Waiver

           

          The 2019-A Lease is in full force and effect and not satisfied, subordinated or rescinded and no provision of the 2019-A Lease has
              been waived in any manner that causes or could cause such 2019-A Lease to not qualify with the other criteria set forth herein.

           

          Review Materials

           

          
            
              	

                    	-	
                      Lease agreement

                    

            

          

           

          
            
              	

                    	-	
                      Data tape

                    

            

          

           

          
            
              	

                    	-	
                      Lease file

                    

            

          

           

          Procedures to be Performed

           

          (i)           Confirm
              the lease agreement form number and revision date are on the List of Approved Contracts

           

          (ii)          Confirm
              within the data tape that the lease has not been paid off as of the 2019-A Cutoff Date

           

          
            SA-6

            
              

          

          (iii)         Confirm
              there is no evidence within the lease file that the Lease has been satisfied, subordinated or rescinded

           

          (iv)         Confirm
              there is no evidence within the lease file that any provision of the lease has been waived in any manner that would cause the Lease to become invalid

           

          (v)          If sections
              (i) through (iv) are confirmed, then Test Pass

           

          Representation (12) – No Defenses

           

          The 2019-A Lease is not subject to any right of rescission, cancellation, setoff, claim, counterclaim or any other defense (including
              defenses arising out of violations of usury laws) of the related Lessee to payment of the amounts due thereunder, and no such right of rescission, cancellation, set-off, claim, counterclaim or any other defense (including defenses arising out
              of violations of usury laws) has been asserted or threatened.

           

          Review Materials

           

          
            
              	

                    	-	
                      Lease file

                    

            

          

           

          Procedures to be Performed

           

          (i)           Confirm
              there is no indication within the lease file that the Lease is subject to any right of rescission, cancellation, setoff, claim or counterclaim that could cause the Lease to become invalid

           

          (ii)          Confirm
              there is no indication within the lease file of any threats of rescission, cancellation, setoff, claim or counterclaim that could cause the Lease to become invalid

           

          (iii)         If
              sections (i) and (ii) are confirmed, then Test Pass

           

          Representation (13) - Assignability

           

          The 2019-A Lease is fully assignable and does not require the consent of the related Lessee or any other Person as a condition to any
              transfer, sale or assignment of the rights thereunder to the Titling Trust.

           

          Review Materials

           

          
            
              	

                    	-	
                      Lease agreement

                    

            

          

           

          Procedures to be Performed

           

          (i)           Confirm
              the lease agreement form number and revision date are on the List of Approved Contracts

           

          
            SA-7

            
              

          

          (ii)          Confirm
              the lease agreement contains language allowing the sale, transfer, assignment, conveyance or pledge of the Lease without the consent of the related Lessee or any other Person

           

          (iii)         If
              sections (i) and (ii) are confirmed, then Test Pass

           

          Representation (14) – Lease Term

           

          As of its origination date, the 2019-A Lease had an original Lease Term of no less than 12 months and no more than 60 months.

           

          Review Materials

           

          
            
              	

                    	-	
                      Lease agreement

                    

            

          

           

          Procedures to be Performed

           

          (i)           Confirm
              the number of payments as stated on the lease agreement are within the allowable lease term limits

           

          (ii)          If
              section (i) is confirmed, then Test Pass

           

          Representation (15) - Insurance

           

          As of the time of origination of the 2019-A Lease, the related lease agreement required the related Lessee to obtain physical damage
              insurance covering the related 2019-A Vehicle.

           

          Review Materials

           

          
            
              	

                    	-	
                      Lease agreement

                    

            

          

           

          Procedures to be Performed

           

          (i)           Confirm
              the lease agreement contains language that required the Lessee to obtain and maintain physical damage insurance to the related Leased Vehicle

           

          (ii)          If section
              (i) is confirmed, then Test Pass

           

          Representation (16) – No Bankruptcy

           

          As of the 2019-A Cutoff Date, the Servicer has not received actual notice that the Lessee on any 2019-A Lease is a debtor in a
              bankruptcy proceeding.

           

          Review Materials

           

          
            
              	

                    	-	
                      Lease file

                    

            

          

           

          
            SA-8

            
              

          

          Procedures to be Performed

           

          (i)           Confirm
              the lease file does not contain evidence that the related Lessee or Lease is the subject of any bankruptcy proceeding or insolvency proceeding as of the 2019-A Cutoff Date

           

          (ii)          If section
              (i) is confirmed, then Test Pass

           

          Representation (17) – No Extensions

           

          The 2019-A Lease has not been extended or otherwise been deferred, but may have been modified in accordance with the Credit and
              Collection Policy so long as such modification did not cause such 2019-A Lease to not qualify with the other criteria set forth herein.

           

          Review Materials

           

          
            
              	

                    	-	
                      Lease agreement

                    

            

          

           

          
            
              	

                    	-	
                      Data file

                    

            

          

           

          
            
              	

                    	-	
                      Lease file

                    

            

          

           

          Procedures to be Performed

           

          (i)           Confirm
              the Lease has not been extended, deferred or modified as of the 2019-A Cutoff Date

           

          (ii)          If the
              Lease has been extended, deferred or modified, confirm that (a) there is no evidence that the extension, deferment or modification violated the Credit and Collection Policy and (b) the Lease, as extended, deferred or modified, meets all other
              representations

           

          (iii)         If
              section (i) or section (ii) is confirmed, then Test Pass

           

          Representation (18) – Delinquencies; No Payment Default

           

          As of the 2019-A Cutoff Date, none of the 2019-A Leases is Delinquent by more than 30 days.  As of the 2019-A Cutoff Date, none of
              the 2019-A Leases is a Defaulted Lease.

           

          Review Materials

           

          
            
              	

                    	-	
                      Data tape

                    

            

          

           

          Procedures to be Performed

           

          (i)           Confirm
              the data tape does not indicate that 10% or more of the Base Monthly Payment required to be paid on the Lease was more than 30 days past due as of the 2019-A Cutoff Date

           

            

          
            SA-9

            
              

          

          (ii)          If section
              (i) is confirmed, then Test Pass

           

          Representation (19) – Securitization Value

           

          As of the 2019-A Cutoff Date, each 2019-A Lease had a Securitization Value not less than $15,000 and no more than $250,000.

           

          Review Materials

           

          
            
              	

                    	-	
                      Lease file

                    

            

          

           

          Procedures to be Performed

           

          (i)           Confirm
              the Lease has a Securitization Value that is greater than or equal to $15,000.00

           

          (ii)          Confirm
              the Lease has a Securitization Value that is less than or equal to $250,000.00

           

          (iii)         If
              sections (i) and (ii) are confirmed, then Test pass

           

          Representation (20) – FICO Score

           

          As of its origination date, the Lessee under the 2019-A Lease had a FICO score of not less than 651.

           

          Review Materials

           

          
            
              	

                    	-	
                      Lease file

                    

            

          

           

          Procedures to be Performed

           

          (i)           Confirm
              the related Lessee’s FICO score was greater than or equal to 651

           

          (ii)          If section
              (i) is confirmed, then Test Pass

           

          Representation (21) – No Allocation to Other Specified Interest

           

          The 2019-A Lease and the related 2019-A Vehicle allocated to the 2019-A Reference Pool has not been allocated to any Reference Pool
              other than the 2019-A Reference Pool.

           

          Review Materials

           

          
            
              	

                    	-	
                      Lease file

                    

            

          

           

          Procedures to be Performed

           

          (i)           Confirm
              the lease file indicates that the related Lease and Leased Vehicle were allocated to the 2019-A Reference Pool

           

          
            SA-10

            
              

          

          (ii)          Confirm
              the related Lease and Leased Vehicle have not been re-allocated to any other reference pool other than the 2019-A Reference Pool

           

          (iii)         If
              section (i) and (ii) are confirmed, then Test Pass

           

          Representation (22) – Model Year

           

          The related 2019-A Vehicle has a model year between 2015 and 2019, inclusive.

           

          Review Materials

           

          
            
              	

                    	-	
                      Lease agreement

                    

            

          

           

          Procedures to be Performed  

           

          (i)           Confirm
              the vehicle description of the lease agreement indicates that the Leased Vehicle is of a model year between 2015 and 2019

           

          (ii)          If section
              (i) is confirmed, then Test Pass

           

           

          

           SA-11Exhibit 10.24

        

         

          

        Portions of this Exhibit have been redacted pursuant to a request for confidential treatment under Rule83 of the General Rules and Regulations under the Securities Act of 1933, as amended. 
          Such redacted portions have been replaced with “***” in this Exhibit.  An unredacted version of this document has been filed separately with the Securities and Exchange Commission along with the confidential treatment.

         

           

      

       

        
         

        

        Execution Version

      

       

      

      CLINICAL TRIAL COLLABORATION AND SUPPLY AGREEMENT

      

      

      by and between

      

      

      NISD International GmbH

      

      

      and

      

      

      PDS Biotechnology Corporation

      

      

      Dated:  May 19, 2017

      

      

      
        
          

      

      
      TABLE OF CONTENTS

       

        

      	 	 	
              Page

            
	 	 	 
	
              1.

            	
              Definitions

            	
              1

            
	
              2.

            	
              Scope of the Agreement

            	
              8

            
	
              3.

            	
              Conduct of the Study

            	
              9

            
	
              4.

            	
              Protocol and Informed Consent; Certain Covenants

            	
              14

            
	
              5.

            	
              Adverse Event Reporting

            	
              16

            
	
              6.

            	
              Term and Termination

            	
              16

            
	
              7.

            	
              Costs of Study

            	
              18

            
	
              8.

            	
              Supply and Use of the Compounds

            	
              19

            
	
              9.

            	
              Confidentiality

            	
              23

            
	
              10.

            	
              Intellectual Property

            	
              24

            
	
              11.

            	
              Reprints; Rights of Cross-Reference

            	
              27

            
	
              12.

            	
              Publications; Press Releases

            	
              27

            
	
              13.

            	
              Representations and Warranties; Disclaimers

            	
              28

            
	
              14.

            	
              Insurance; Indemnification; Limitation of Liability

            	
              31

            
	
              15.

            	
              Use of Name

            	
              32

            
	
              16.

            	
              Force Majeure

            	
              32

            
	
              17.

            	
              Entire Agreement; Amendment; Waiver

            	
              32

            
	
              18.

            	
              Assignment and Affiliates

            	
              33

            
	
              19.

            	
              Invalid Provision

            	
              33

            
	
              20.

            	
              No Additional Obligations

            	
              33

            
	
              21.

            	
              Governing Law; Dispute Resolution

            	
              33

            
	
              22.

            	
              Notices

            	
              34

            
	
              23.

            	
              Relationship of the Parties

            	
              34

            
	
              24.

            	
              Counterparts and Due Execution

            	
              35

            
	
              25.

            	
              Construction

            	
              35

            

      

      

      	
              Appendices

            	 	 
	
              Appendix A

            	
              

              

            	
              A1-A14

            
	
              Appendix B

            	
              

              

            	
              B-1

            
	
              Appendix C

            	
              

              

            	
              C-1

            
	 	 	 
	
              Schedules

            	 	 
	
              Schedule 1

            	
              

              

            	
              SCH-1

            

      

      

      
        i

        
          

        
          	
                   

                	
                  Execution Version

                

        

      

      CLINICAL TRIAL COLLABORATION AND SUPPLY AGREEMENT

      

      

      This CLINICAL TRIAL COLLABORATION AND SUPPLY AGREEMENT (this “Agreement”), made as of May 19, 2017 (the “Effective Date”), is by and between MSD International GmbH, having a place of
          business at Weystrasse 20,`6000 Luzern 6, Switzerland (“Merck”), and PDS Biotechnology Corporation having a place of business at Commercialization Center for
          Innovative Technologies, 675 US Highway One, North Brunswick, NJ 08902 USA (“PDS”).  Merck, and PDS are each referred to herein individually as “Party” and
          collectively as “Parties”.

      

      

      RECITALS

      

      

      A.          Merck holds intellectual property rights with respect to the Merck
          Compound (as defined below).

      

      

      B.          PDS is developing the PDS Compound (as defined below) for the treatment
          of certain tumor types.

      

      

      C.          Merck is developing the Merck Compound for the treatment of certain
          tumor types.

      

      

      D.          PDS desires to sponsor a clinical trial in which the PDS Compound and
          the Merck Compound would be dosed concurrently or in combination.

      

      

      E.         Merck and PDS, consistent with the terms of this Agreement, desire to
          collaborate as more fully described herein, including by providing the Merck Compound and the PDS Compound for the Study (as defined below).

      

      

      NOW, THEREFORE, in consideration of the premises and of the following mutual promises, covenants and conditions, the Parties,
          intending to be legally bound, mutually agree as follows:

      

      

      1.           Definitions.

      

      

      For all purposes of this Agreement, the capitalized terms defined in this Article I and throughout this Agreement shall have the meanings herein specified.

      

      

      1.1         “Affiliate” means, with respect to either Party, a firm, corporation or other entity which directly or indirectly owns
          or controls said Party, or is owned or controlled by said Party, or is under common ownership or control with said Party.  The word “control”
          as used in this definition means (i) the direct or indirect ownership of fifty percent (50%) or more of the outstanding voting securities of a legal entity, or (ii) possession, directly or indirectly, of the power to direct the management or
          policies of a legal entity, whether through the ownership of voting securities, contract rights, voting rights, corporate governance or otherwise.

      

      

      1.2         “Agreement” means this agreement, as amended by the Parties from
          time to time, and as set forth in the preamble.

      

      

      1.3         “Alliance Manager” has the meaning set forth in Section 3.10.

       

        

      
        
          

        
          	
                   

                	
                  Execution Version

                

        

      

      
      1.4        ‘‘Applicable Law” means all federal, state, local, national and regional statutes, laws, rules, regulations and directives applicable to a particular activity hereunder, including performance of clinical trials, medical
          treatment and the processing and protection of personal and medical data, that may be in effect from time to time, including those promulgated by the United States Food and Drug Administration (“FDA”), national regulatory authorities, the European Medicines Agency (“EMA”) and any successor
          agency to the FDA or EMA or any agency or authority performing some or all of the functions of the FDA or EMA in any jurisdiction outside the United States or the European Union (each a “Regulatory

            Authority” and collectively, “Regulatory Authorities”), and including cGMP and GCP (each as defined below); all data protection requirements such as
          those specified in the EU Data Protection Directive and the regulations issued under the United States Health Insurance Portability and Accountability Act of 1996 (“HIPAA”);

          export control and economic sanctions regulations which prohibit the shipment of United States origin products and technology to certain restricted countries, entities and individuals; anti-bribery and anti-corruption laws pertaining to
          interactions with government agents, officials and representatives; laws and regulations governing payments to healthcare providers; and any United States or other country’s or jurisdiction’s successor or replacement statutes, laws, rules,
          regulations and directives relating to the foregoing.

      

      

      1.5         “Business Day” means any day other than a Saturday, Sunday, or a day on which commercial banks located in the
          country where the applicable obligations are to be performed are authorized or required by law to be closed.

      

      

      1.6        “cGMP” means the current Good Manufacturing Practices officially published and interpreted by EMA, FDA and other applicable Regulatory Authorities that may be in
          effect from time to time and are applicable to the Manufacture of the Compounds.

      

      

      1.7         “Clinical

            Data” means all data (including raw data) and results generated by or on behalf of either Party or at either Party’s direction, or by or on behalf of the Panics together or at their direction, in the course of each such Party’s
          performance of the Study; provided however***.

       
      

         

       
      1.8         “Clinical Quality Agreement” has the meaning set forth in Section 8.2.

      

      

      1.9         “CMC”
          means “Chemistry Manufacturing and Controls” as such term of art is used in the pharmaceutical industry.

      

      

      1.10        “Combination” means the use or method of using the PDS Compound and the
          Merck Compound in concomitant or sequential administration.

      

      

      1.11       “Compounds” means the PDS Compound and the Merck Compound.  A ‘Compound” means either the PDS Compound or the Merck Compound, as applicable.

      

      

      1.12      “Confidential

            Information” means any information, Know-How, or other proprietary information or materials furnished to one Party (“Receiving Party”) by or on
          behalf of the other Party (“Disclosing Party”) pursuant to this
          Agreement, except to the extent that such information or materials:  (a) was already known to the Receiving Party, other than under an obligation of confidentiality, at the time of disclosure by the Disclosing Party, as demonstrated by competent
          evidence; (b) was generally available to the public or otherwise part of the public domain at the time of its disclosure to the Receiving Party; (c) became generally available to the public or otherwise part of the public domain after its
          disclosure and other than through any act or omission of the Receiving Party in breach of this Agreement; (d) was disclosed to the Receiving Party by a Third Party who had no obligation to the Disclosing Party not to disclose such information to
          others; or (e) was subsequently developed by the Receiving Party without use of the Disclosing Party Confidential Information, as demonstrated by competent evidence.

       

        

       

        

    

     

      
       

        

       

        

       

        

       

        

       

        

       

        

       *** Portions of this page have been omitted pursuant to a request for Confidential Treatment filled separately with the Commission.

        

      

      

      
        2

        
          

        
          	
                   

                	
                  Execution Version

                

        

      

      1.13       “Continuing

            Party” has the meaning set forth in Section 10.1.3.

      

      

      1.14       “Control”
          or “Controlled” means, with respect to particular information or intellectual property, that the applicable Party owns or has a license to such information
          or intellectual property and has the ability to grant a right, license or sublicense to the other Party as provided for herein without violating the terms of any agreement or other arrangement with any Third Party.

      

      

      1.15       “CTA”
          means an application to a Regulatory Authority for purposes of requesting the ability to start or continue a clinical trial.

      

      

      1.16       “Data

            Sharing and Sample Testing Schedule” means the schedule attached hereto as Schedule

              I.

      

      

      1.17       “Defending

            Party” has the meaning set forth in Section 14.2.3.

      

      

      1.18       “Delivery”
          with restore to the Merck Compound has the meaning set forth in Section 8.4.1, and with respect to the PDS Compound, the meaning set forth in Section 8.4.2.

      

      

      1.19       “Direct

            Manufacturing Costs” has the meaning set forth in Section 6.11.

      

      

      1.20       “Disclosing

            Party” has the meaning set forth in the definition of Confidential Information.

      

      

      1.21       “Disposition

            Package” has the meaning set forth in Section 8.8.1.

      

      

      1.22       “Dispute”
          has the meaning set forth in Section 21.1.

      

      

      1.23       “Effective

            Date” has the meaning set forth in the preamble.

      

      

      1.24       “EMA”
          has the meaning set forth in the definition of Applicable Law.

      

      

      1.25       “Exclusions

            List” has the meaning set forth in the definition of Violation.

      

      

      1.26       “FDA”
          has the meaning set forth in the definition of Applicable Law.

      

      

      1.27       “Filing

            Party” has the meaning set forth in Section 10.1.3.

      

      

      1.28       “Force

            Majeure” has the meaning set forth Section 16.

      

      

      1.29       “GAAP”
          has the meaning set forth in Section 6.11.

      

      

      
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      1.30       “GCP”
          means the Good Clinical Practices officially published by EMA, FDA and the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) that may be in effect from time to time and are
          applicable to the testing of the Compounds.

      

      

      1.31      “Government

            Official” means:  (a) any officer or employee of a government or any department, agency or instrument of a government; (b) any Person acting in an official capacity for or on behalf of a government or any department, agency, or
          instrument of a government; (c) any officer or employee of a company or business owned in whole or part by a government; (d) any officer or employee of a public international organization such as the World Bank or United Nations; (e) any officer
          or employee of a political party or any Person acting in an official capacity on behalf of a political party; and/or (f) any candidate for political office; who, when such Government Official is acting in an official capacity, or in an official
          decision-making role, has responsibility for performing regulatory inspections, government authorizations or licenses, or otherwise has the capacity to make decisions with the potential to affect the business of either of the Parties.

      

      

      1.32       “HIPAA” has the meaning set forth in the definition of Applicable Law.

      

      

      1.33      “IND”
          means any Investigational New Drug Application filed or to be filed with the FDA as described in Title 21 of the U.S. Code of Federal Regulations, Part 312, and the equivalent application in the jurisdictions outside the United States, including
          an “Investigational Medicinal Product Dossier” filed or to be filed with Regulatory Authorities in the European Union.

      

      

      1.34       “Indirect

            Manufacturing Costs” has the meaning set forth in Section 6.11.

      

      

      1.35       “Inventions”
          means all inventions and discoveries, whether or not patentable, that are made, conceived, or first actually reduced to practice by or on behalf of a Party, or by or on behalf of the Parties together, (i) in the design or performance of the Study
          or in the design pc performance of any Subsequent Study performed pursuant to Section 3.14 or (ii) through use of unpublished Clinical Data.

      

      

      1.36       “Joint

            Development Committee” or “JDC” has the meaning set forth in Section 3.10.

      

      

      1.37       “Joint

            Patent Application” has the meaning set forth in Section 10.1.3.

      

      

      1.38       “Joint

            Patent” means a patent that issues from a Joint Patent Application.

      

      

      1.39       “Jointly

            Owned Invention” has the meaning set forth in Section 10.1.1.

      

      

      1.40     “Know-How”
          means any proprietary invention, innovation, improvement, development, discovery, computer program, device, trade secret, method, know-how, process, technique or the like, including manufacturing, use, process, structural, operational and other
          data and information, whether or not written or otherwise fixed in any form or medium.  regardless of the media on which contained and whether or not patentable or copyrightable, that is not generally known or otherwise in the public domain.

      

      

      
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      1.41       “Liability”
          has the meaning set forth in Section 14.2.1.

      

      

      1.42       “Manufacture,”

          “Manufactured,” or “Manufacturing” means all activities related to
          the manufacture of a Compound, including planning, purchasing, manufacture, processing, compounding, storage, filling, packaging, waste disposal, labeling, leafleting, testing, quality assurance, sample retention, stability testing, release,
          dispatch and supply, as applicable.

      

      

      1.43       “Manufacturer’s

            Release” or “Release” has the meaning ascribed to such term in the Clinical Quality Agreement.

      

      

      1.44       “Manufacturing

            Site” means the facilities where a Compound is Manufactured by or on behalf of a Party, as such Manufacturing Site may change from time to time in accordance with Section
              8.7.

      

      

      1.45       “Merck”
          has the meaning set forth in the preamble.

      

      

      1.46       “Merck

            Background Patents” has the meaning set forth in Section 10.4.2.

      

      

      1.47       “Merck

            Compound” means pembrolizumab, a humanized anti-human PD-1 monoclonal antibody, excluding, ***.

        

      

      

      1.48       “Merck

            Inventions” has the meaning set forth in Section 10.3.

      

      

      1.49      “NDA”
          means a New Drug Application, Biologics License Application, Marketing Authorization Application, filing pursuant to Section 510(k) of the United States Federal Food, Drug and Cosmetic Act, or similar application or submission for a marketing
          authorization of a product filed with a Regulatory Authority to obtain marketing approval for a biological, pharmaceutical or diagnostic product in that country or in that group of countries.

      

      

      1.50     “Non-Conformance”
          means, with respect to a given unit of Compound.  (i) an event that deviates from an approved cGMP requirement with respect to the applicable Compound, such as a procedure, Specification, or operating parameter, or that requires an investigation
          to assess impact to the quality of the applicable Compound or (ii) that such Compound failed to meet the applicable representations and warranties set forth in Section 2.3. 

          Classification of the Non-Conformance is detailed in the Clinical Quality Agreement.

      

      

      1.51       “Non-Filing

            Party” has the meaning set forth in Section 10.1.3.

      

      

      1.52       “Other

            Party” has the meaning set forth in Section 14.2.3.

      

      

      1.53       “Opting-out

            Party” has the meaning set forth in Section 10.1.3.

      

      

      1.54       “Party”
          has the meaning set forth in the preamble.

      

      

      1.55       “PD-1

            Antagonist” means any ***.

      

      

      

      

      

      

      

      

      

      

      

      

      

      

      

      

      

      

      

      

      
         

          

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      1.56       “PDS”
          has the meaning set forth in the preamble.

      

      

      1.57       “PDS

            Background Patents” has the meaning set forth in Section 10.4.1.

      

      

      1.58       “PDS

            Class Compound” means a ***.

      

      

      1.59       “PDS

            Compound” means PDS0101, a cationic lipid-based therapeutic vaccine encapsulating HPV peptides, excluding, however, any biosimilar version of other than a biosimilar version Controlled by PDS or its Affiliate.

      

      

      1.60       “PDS

            Inventions” has the meaning set forth in Section 10.2.

      

      

      1.61      “Person”
          means any individual, sole proprietorship, partnership, corporation, business trust, joint stock company, trust, unincorporated organization, association, limited liability company, institution, public benefit corporation, joint venture, entity
          or governmental entity.

      

      

      1.62       “Pharmacovigilance

            Agreement” has the meaning set forth in Section 5.1.

      

      

      1.63       “Project

            Manager” has the meaning set forth in Section 3.10.

      

      

      1.64       “Protocol”
          means the written documentation that describes the Study and sets forth specific activities to be performed as part of the conduct of the Study, a summary of which is attached hereto as Appendix A.

      

      

      1.65       “Receiving Party” has the meaning set forth in the definition of Confidential Information.

      

      

      1.66       “Regulatory

            Approvals” means, with respect to a Compound, any and all permissions (other than the Manufacturing approvals) required to be obtained from Regulatory Authorities and any other competent authority for the development, registration,
          importation and distribution of such Compound in the United States, Europe or other applicable jurisdictions for use in the Study.

      

      

      1.67       “Regulatory

            Authorities” has the meaning set forth in the definition of Applicable Law.

      

      

      1.68       “Regulatory

            Documentation” means, with respect to the Compounds, all submissions to Regulatory Authorities in connection with the development of such Compounds, including all INDs and amendments thereto, NDAs and amendments thereto, drug master
          files, correspondence with regulatory agencies, periodic safety update reports, adverse event files, complaint files, inspection reports and manufacturing records, in each case together with all supporting documents (including documents that
          include Clinical Data).

      

      

      1.69       “Related

            Agreements” means the Pharmacovigilance Agreement, the Clinical Quality Agreement and the agreement referenced in Section 4.3 (Financial Disclosure).

       

        

       

        

       

        

       

        

       

        

       

        

       

        

       

        

       

        

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      1.70     ‘‘Right

            of Reference” means the “right of reference” defined in 21 CFR 314.3(b), including with regard to a Party, allowing the applicable Regulatory Authority in a country to have access to relevant information (by cross-reference,
          incorporation by reference or otherwise) contained in Regulatory Documentation (and any data contained therein) filed with such Regulatory Authority with respect to a Party’s Compound, only to the extent necessary for the conduct of the Study in
          such country or as otherwise expressly permitted or required under this Agreement to enable a Party to exercise its rights or perform its obligations hereunder.

      

      

      1.71       “SAEs”
          has the meaning set forth in Section 5.2.

      

      

      1.72       “Samples”
          means biological specimens collected from subjects participating in the Study, including urine, blood and tissue samples.

      

      

      1.73       “Sample

            Testing” means the analyses to be performed by each Party using the applicable Samples, as described in the Data Sharing and Sample Testing Schedule.

      

      

      1.74       “Sample

            Testing Results” means those data and results arising from the Sample Testing performed by a Party.

      

      

      1.75       “Specifications”
          means, with respect to a given Compound, the set of requirements for such Compound as set forth in the Clinical Quality Agreement.

      

      

      1.76      “Study”
          means the Phase II clinical trial described in the Protocol to evaluate the safety, and preliminary efficacy of the concomitant and/or sequenced administration of the combination of the Merck Compound and the PDS Compound in patients with
          recurrent or meta-static head and neck cancer and high-risk human papillomavirus-16 (HPV16) infection after failure with platinum-based chemotherapy (see attached protocol).

      

      

      1.77       “Study

            Completion” has the meaning set forth in Section 3.11.

      

      

      1.78       “Subcontractors”
          has the meaning set forth in Section 2.4.

      

      

      1.79       “Term”
          has the meaning set forth in Section 6.1.

      

      

      1.80       “Territory”
          means anywhere in the world.

      

      

      1.81       “Third

            Party” means any Person or entity other than PDS, Merck or their respective Affiliates.

      

      

      1.82       “Toxicity

            & Safety Data” means all clinical adverse event information and/or patient-related safety data included in the Clinical Data, as more fully described in the Phannacovigi lance Agreement.

      

      

      1.83       “VAT”
          has the meaning set forth in Section 8.16.

      

      

      1.84      “Violation”
          means that a Party or any of its officers or directors or any other personnel (or other permitted agents of a Party performing activities hereunder) has been:  (1) convicted of any of the felonies identified among the exclusion authorities listed
          on the U.S. Department of Health and Human Services, Office of Inspector General (OIG) website, including 42 U.S.C. 1320a-7(a) (http://oig.hhs.gov/exclusions/authorities.asp); (2) identified in the GIG List of Excluded Individuals/Entities (LEIE)
          database (http://exclusions.oig.hhs.gov/) or listed as having an active exclusion in the System for Award Management (http://www.sam.gov); or (3) listed by any US Federal agency as being suspended, proposed for debannent, debarred, excluded or
          otherwise ineligible to participate in Federal procurement or non-procurement programs, including under 21 U.S.C. 335a (http://vvww.fda.gov/ora/compliance_ref/debar/) ((1), (2) and (3) collectively the “Exclusions Lists”).

      

      

      
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      2.           Scope

              of the Agreement.

      

      

      2.1        Generally.  Each Party shall:  (a) contribute to the Study such re-sources as are necessary to fulfill its obligations set forth in this Agreement; and (b) act in good faith in performing its
          obligations under this Agreement and each Related Agreement to which it is a Party.

      

      

      2.2         Manufacturing Delay.  Each Party shall notify the other Party as promptly as possible in the event of any Manufacturing delay that is likely to adversely affect supply of its Compound as
          contemplated by this Agreement.

      

      

      2.3         Compound Commitments.

      

      

      2.3.1      PDS agrees to Manufacture and supply the PDS
          Compound for purposes of the Study in accordance with Article 8, and PDS hereby represents and warrants to Merck that, at the time of Delivery of the PDS Compound, such PDS Compound shall have been Manufactured and supplied in compliance with: 
          (i) the Specifications for the PDS Compound:  (ii) the Clinical Quality Agreement; and (iii) all Applicable Law, including cGMP and health, safety and environmental protections.

      

      

      2.3.2     Merck agrees to Manufacture and supply the Merck
          Compound for purposes of the Study in accordance with Article 8, and Merck hereby represents and warrants to PDS that, at the time of Delivery of the Merck Compound, such Merck Compound shall have been Manufactured and supplied in compliance
          with:  (i) the Specifications for the Merck Compound; (ii) the Clinical Quality Agreement; and (iii) all Applicable Law, including cGMP and health, safety and environmental protections.

      

      

      2.3.3     Without limiting the foregoing, each Party is
          responsible for obtaining all regulatory approvals (including facility licenses) that are required to Manufacture its Compound in accordance with Applicable Law (provided

          that, for clarity, PDS shall be responsible for obtaining Regulatory Approvals for the Study as set forth in Section 3.4).

      

      

      2.4        Delegation of Obligations.  Each Party shall have the right to delegate any portion of its obligations hereunder as follows:  (a) to such Party’s Affiliates; (b) to contract re-search organizations
          or other Third Parties that (i) are conducting clinical trials of such Party’s Compound as of the Effective Date and are set forth in the Protocol as performing such Study activities, or (ii) are conducting Sample Testing for such Party; (c)
          without restriction to the extent related to the Manufacture of such Party’s Compound; and (d) upon the written consent of the other Party.  Any and all Third Parties to whom a Party delegates any of its obligations hereunder are referred to as “Subcontractors”.  Notwithstanding any delegation of its obligations hereunder, each Party shall remain solely and fully liable for the performance of its
          Affiliates and Subcontractors to which such Party delegates the performance of its obligations under this Agreement.  Each Party shall use diligent efforts to ensure that each of its Affiliates and Subcontractors performs such Party’s obligations
          pursuant to the terms of this Agreement, including the Appendices and Schedules attached hereto such diligent efforts shall include, but are not limited to, the vetting and providing active monitoring of any Affiliates or Subcontractor engaged by
          such Party to perform its obligations.  Each Party shall use reasonable efforts to obtain and maintain copies of documents relating to the obligations performed by such Affiliates ° and Subcontractors that are required to be provided to the other
          Party under this Agreement.

      

      

      
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      2.5         Compounds.  Except as expressly set forth in Section 3.14, this Agreement does not create any obligation on the part of
          Merck to provide the Merck Compound for any activities other than the Study, nor does it create any obligation on the part of PDS to provide the PDS Compound for any activities other than the Study.

      

      

      3.           Conduct

              of the Study.

      

      

      3.1         Sponsor.  PDS shall act as the sponsor of the Study under its existing ND for the PDS Compound with a Right of Reference to the IND of the Merck Compound as further described in Section 3.4:  provided, however, that in no event shall PDS file an additional ND for the Study unless required by Regulatory Authorities to
          do so.  If a Regulatory Authority requests an additional IND for the Study the Parties shall meet and mutually agree on an approach to address such requirement.

      

      

      3.2         Performance.  PDS shall use diligent efforts to ensure that the Study is performed in accordance with this Agreement, the Protocol and all Applicable Law, including GCP which diligent efforts shall
          include, but are not limited to, the vetting and providing active monitoring of any Affiliate or Subcontractors engaged by PDS to perform its obligations.

      

      

      3.3        Debarred Personnel:  Exclusions Lists.  Notwithstanding anything to the contrary contained herein, PDS shall not to its knowledge, after diligent investigation, employ or subcontract with any
          Person that is excluded, debarred, suspended, proposed for suspension or debarment, in Violation or otherwise ineligible for government programs for the performance of the Study or any other activities under this Agreement or the Related
          Agreements.  PDS hereby certifies that to its knowledge, after diligent investigation, it has not employed or otherwise used in any capacity and will not employ or otherwise use in any capacity, the services of any Person suspended, proposed for
          debarment, or debarred under United States law, including 21 USC 335a, or any foreign equivalent thereof, in performing any portion of the Study or other activities under this Agreement or the Related Agreements and that PDS has, as of the
          Effective Date, screened itself, and its officers and directors, against the Exclusions Lists and that it has informed Merck whether it or any of its officers or directors has been in Violation.  PDS shall notify Merck in writing immediately if
          any such suspension, proposed debarment, debarment or Violation occurs or comes to its attention, and shall, with respect to any Person so suspended, proposed for debarment, debarred or in Violation, promptly remove such Person from performing
          activities, function or capacity related to the Study or otherwise related to activities under this Agreement or the Related Agreements.

      

      

      
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      3.4         Regulatory Matters.  PDS shall:  (a) obtain, prior to initiating the Study, all Regulatory Approvals from all Regulatory Authorities, ethics committees and/or institutional review boards with
          jurisdiction over the Study prior to initiating the Study; and (b) follow all directions from any such Regulatory Authorities, ethics committees and/or institutional review boards.  Merck shall have the right (but not the obligation) to
          participate in any discussions with a Regulatory Authority regarding matters related to the Merck Compound and to collaborate on questions posed to Regulatory Authorities regarding the design and conduct of the Study.  Each Party shall provide to
          the other, as necessary, a cross-reference letter or similar communication to the applicable Regulatory Authority to effectuate the Right of Reference.  Notwithstanding anything to the contrary in this Agreement, neither Party shall have any
          right to access the other Party’s CMC data with respect to its Compound.  Merck shall authorize FDA and other applicable Regulatory Authorities to cross-reference the appropriate Merck Compound INDs and CTAs to provide data access to PDS
          sufficient to support conduct of the Study.  If Merck’s CTA is not available in a given country, Merck will file its CMC data with the Regulatory Authority for such country, referencing PDS’ CTA as appropriate (however, PDS shall have no right to
          directly access the CMC data).

      

      

      3.5       Documentation.  PDS shall maintain reports and all related documentation in good scientific manner and in compliance with Applicable Law.  PDS shall provide to Merck all Study information and
          documentation reasonably requested by Merck to enable Merck to (a) comply with any of its legal, regulatory and/or contractual obligations, or any request by any Regulatory Authority, related to the Merck Compound and (b) determine whether the
          Study has been performed in accordance with this Agreement.

      

      

      3.6         Copies.  PDS shall provide to Merck copies of all Clinical Data, in electronic form or other mutually agreeable alternate form and on the timelines specified in the Data Sharing and Sample Testing
          Schedule (if applicable) or upon mutually agreeable timelines; provided, however, that a complete copy of the Clinical Data shall be provided to Merck no later than *** days following Study Completion.  PDS shall use diligent efforts to require that all patient authorizations and consents required
          under HIPAA, the EU Data Protection Directive or any other similar Applicable Law in connection with the Study permit such sharing of Clinical Data with Merck such diligent efforts shall include, but are not limited to, actively monitoring any
          authorizations and consents utilized by Affiliates and Subcontractors and immediately notifying Merck of any failure to comply with such Applicable Laws.

      

      

      3.7         Samples.

      

      

      3.7.1      PDS shall provide Samples to Merck as specified in
          the Protocol or as agreed to by the Joint Development Committee.  Each Party shall use the Samples only for the Sample Testing and each Party shall conduct the Sample Testing solely in accordance with the Data Sharing and Sample Testing Schedule
          and the Protocol.  Merck shall ***.  Merck shall provide to PDS the Sample Testing Results for the Sample Testing conducted by or on behalf of Merck, in electronic form or other mutually agreeable alternate form, to the extent specified on the
          Data Sharing and Sample Testing Schedule and on the timelines specified in the Data Sharing and Sample Testing Schedule or as otherwise mutually agreed.

       

        

       

        

       

        

       

        

       

        

       

        

       

        

       

        

       

        

       

        

      

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      3.7.2    PDS shall ***.  PDS shall provide to Merck the Sample
          Testing Results for the Sample Testing conducted by or on behalf of PDS, in electronic form or other mutually agreeable alternate form, to the extent specified on the Data Sharing and Sample Testing Schedule and on the timelines specified in the
          Data Sharing and Sample Testing Schedule or as otherwise mutually agreed.

      

      

      3.7.3     Except to the extent otherwise agreed in a writing
          signed by authorized representatives of each Party, each Party may use and disclose the Sample Testing Results owned by the other Party only for the purposes of (i) seeking Regulatory Approval for the use of its respective Compound in the
          Combination and (ii) filing and prosecuting patent applications for Jointly Owned Inventions and enforcing any resulting patents in accordance with Article 10.

      

      

      3.8         Ownership and Use of Clinical Data.

      

      

      3.8.1     All Clinical Data shall ***.  Merck hereby ***.  PDS
          hereby ***.  *** hereby grants ***.  PDS shall maintain the Clinical Data in its internal database; provided, however, that at all times during the Term, PDS shall grant Merck access to all Clinical Data and any
          portions of PDS’ database that include Clinical Data.

      

      

      3.8.2      Notwithstanding the foregoing, and subject to the
          remaining provisions of this Section 3.8, before publication of the Clinical Data in accordance Article 12, neither Party may disclose the Clinical Data publicly or to
          a Third Party (other than as permitted under this Agreement) without the consent of the other Party and each Party’s use of such unpublished Clinical Data is restricted to:  (1) *** ;(2) *** ;(3) ***; and (4) ***; provided, however, that the foregoing shall not limit or restrict either Party’s ability to
          (A) use or disclose the Clinical Data as may be necessary to comply with Applicable Law or with such Party’s internal policies and procedures with respect to pharmacovigilance and adverse event reporting or (B) share with Third Parties or
          Affiliates Toxicity and Safety Data where because of severity, frequency or lack of reversibility either Party needs to use such Toxicity and Safety Data with respect to its own Compound or the Combination to ensure patient safety.

      

      

      3.9          Regulatory Submission.  It is understood and acknowledged by the Parties that positive Clinical Data could be used to obtain label changes for the Compounds, and each Party may propose a subsequent
          Study (as defined below) in connection therewith in accordance with Section 3.14.

      

      

      

      

      

      

      

      

      

      

      

      

      

      

      

      

      

      

      

      

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      3.10        Joint Development Committee; Alliance Managers.

      

      

      3.10.1   The Parties shall form a joint development committee
          (the “Joint Development Committee” or “JDC”) made up of an equal
          number of representatives of Merck and PDS, which shall have responsibility for coordinating all regulatory and other activities under, and pursuant to, this Agreement.  The JDC will review and finalize the Protocol in accordance with Section 4.1 to the extent it is not final as of the Effective Date.  Each Party shall designate a project manager (the “Project

            Manager”) who shall be responsible for implementing and coordinating activities and facilitating the exchange of information between the Parties
          with respect to the Study and shall be a member of the JDC.  Other JDC members will be agreed by both Parties.

      

      

      3.10.2    The JDC shall meet as soon as practicable after the
          Effective Date and then no less than ***, and more often as reasonably considered necessary at the request of either Party, to provide an update on the progress of the Study.  The JDC may meet in person or by means of teleconference, Internet
          conference, videoconference or other similar communications equipment.  Prior to any such meeting, the PDS Project Manager shall provide an update in writing to the Merck Project Manager, which update shall contain information about the overall
          progress of the Study, recruitment status, interim analysis (if results available), final analysis and other information relevant to the conduct of the Study.

      

      

      3.10.3    In addition to a Project Manager, each Party shall
          designate an alliance manager (the “Alliance Manager”), who shall endeavor to ensure clear and responsive communication between the Parties and the effective exchange of information and shall serve as the primary point of contact for any issues arising under this Agreement.  The Alliance Managers shall
          have the right to attend all JDC meetings and may bring to the attention of the JDC any matters or issues either of them reasonably believes should be discussed and shall have such other responsibilities as the Parties may mutually agree in
          writing.  In the event that an issue arises and the Alliance Managers cannot or do not, after good faith efforts, reach agreement on such issue, or if there is a decision to be made by the JDC on which the members of the JDC cannot unanimously
          agree, the issue shall be elevated to the *** for Merck and the Chief Executive Officer for PDS.  In the event such escalation does not result in resolution or consensus:  (a) Merck shall ***; and (b) ***.

      

      

      3.11       Final Study Report.  PDS shall provide Merck with an electronic draft of the final study report promptly following Study Completion, and Merck shall have *** days after receipt of such draft to
          provide comments thereon.  PDS shall consider in good faith any comments provided by Merck on the draft final study report and shall not include any statements relating to the Merck Compound that have not been approved by Merck.  PDS shall
          deliver to Merck a final version of the final study report promptly following finalization thereof (the “Final Study Report”).  “Study Completion” shall occur upon database lock of the Study results.

      

      

      3.12      Relationship.  Except as expressly set forth in this Agreement, nothing in this Agreement shall:  (a) ***; or (b) create an exclusive relationship between the Parties with respect to any Compound. 
          Each Party acknowledges and agrees that nothing in this Agreement shall be construed as a representation or inference that the other Party will not develop for itself, or enter into business relationships with other Third Parties regarding, any
          products, programs, studies (including combination studies), technologies or processes that are similar to or that may compete with the Combination or any other product, program, technology or process, including ***, provided that the Clinical Data, Confidential Information, Jointly Owned Inventions and Sample Testing Results are not used or disclosed in, connection therewith in violation of
          this Agreement.

       

        

       

        

       

        

       

        

       

        

       

        

       

        

       

        

       

        

      

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      3.13       Licensing.  Nothing in this Agreement shall prohibit or restrict a Party from licensing, assigning or otherwise transferring to an Affiliate or Third Party its Compound and the related Clinical
          Data, Confidential Information, Jointly Owned Inventions or Sample Testing Results; provided, however, that in the case of any such license, assignment or transfer, the licensee, assignee or transferee shall agree in
          writing to be bound by the terms of this Agreement with respect to such Clinical Data, Confidential.  Information, Jointly Owned Inventions or Sample Testing Results.  For purposes of clarity, any assignment or transfer of this Agreement must
          comply with Section 18 of this Agreement.

      

      

      3.14       Subsequent Study.

      

      

      3.14.1   During the Term and for a period of *** months after
          Study Completion, either Party shall have the option to propose amending this Agreement and the Related Agreements or negotiating a new agreement (a “Subsequent
            Study Agreement”), as appropriate, for the purpose of conducting a registration study for the Combination in the same indication as the Study (each a “Subsequent

            Study”) by sending a written proposal to the other Party.  PDS must ***.  For clarity, if the Parties ***, neither Party shall ***.

      

      

      3.14.2    If the receiving Party desires to *** the Parties
          shall ***:

      

      

      (a)          the Party that ***;

      

      

      (b)          ***;

      

      

      (c)          ***,

       

        

       

        

       

        

       

        

       

        

       

        

       

        

       

        

       

        

       

        

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        (d)         that the Parties will ***; and

        

        

        (e)          that the Parties shall ***.

        

        

      

      4.           Protocol

              and Informed Consent; Certain Covenants.

      

      

      4.1         Protocol.  A synopsis of the initial Protocol has been agreed to by the Parties as of the Effective Date and is attached hereto as Appendix

              A.  Through the JDC, PDS shall:  (a) provide a draft of any subsequent revisions to the Protocol to Merck for Merck’s review and comment; (b) consider in good faith any further changes to the draft of the Protocol requested by
          Merck; (c) incorporate any changes, requested by Merck with respect to Merck Compound; and, (d) once a final version of the Protocol, incorporating all comments is ready, submit the revised Protocol to the JDC for final approval.  To the extent
          the JDC cannot agree unanimously regarding the contents of the Protocol for final approval:  (i) PDS shall have final decision-making authority with respect to matters in the Protocol related to the PDS Compound; (ii) Merck shall have final
          decision-making authority with respect to matters in the Protocol related to the Merck Compound (including with respect to the quantities and/or presentations of Merck Compound to be provided for the Study and/or the timing for Delivery thereof);
          and (iii) all other matters in respect of the Protocol on which the JDC cannot agree shall be resolved in accordance with Section 3.10.3.  Once the final Protocol has
          been approved in accordance with this Section 4.l, any material changes to such approved final Protocol (other than material changes relating solely to the PDS
          Compound) and any changes to the final Protocol (whether or not material) relating to the Merck Compound shall require Merck’s prior written consent.  Any such proposed changes will be sent in writing to Merck’s Project Manager and Merck’s
          Alliance Manager.  Merck will provide such consent, or a written explanation for why such consent is being withheld, within *** Business Days after Merck receives a copy of PDS’ requested changes.

      

      

      4.1.1     Notwithstanding anything to the contrary contained
          herein, Merck, in its sole discretion(other than the dose and dosing regimen agreed to by the Parties in the final approved Protocol, shall have the sole right to determine the dose and dosing regimen for the Merck Compound and shall have the
          final decision on all matters relating to the Merck Compound (including quantities of Merck Compound to be supplied pursuant to Article 8) and any information regarding the Merck Compound included in the Protocol.

      

      

      4.1.2      Notwithstanding anything to the contrary contained
          herein, PDS, in its sole discretion, shall have the sole right to determine the dose and dosing regimen for the PDS Compound and shall have the final decision on all matters relating to the PDS Compound (including quantities of PDS Compound to be
          supplied pursuant to Article 8) and any information regarding the PDS Compound included in the Protocol.

      

      

      4.2        Informed Consent.  PDS shall prepare the patient informed consent form for the Study (which shall include provisions regarding the use of Samples in Sample Testing) in consultation with Merck (it
          being understood and agreed that the portion of the informed consent form relating to the Sample Testing of the Merck Compound shall be provided to PDS by Merck).  Any proposed changes to such form that relate to the Merck Compound, including
          Sample Testing of the Merck Compound, shall be subject to Merck’s prior written consent.  Any such proposed changes will be sent in writing to Merck’s Project Manager and Merck’s Alliance Manager.  Merck will provide such consent, or a written
          explanation for why such consent is being withheld, within *** Business Days after Merck receives a copy of PDS’ requested changes.

       

        

       

        

       

        

       

        

       

        

       

        

       

        

       

        

       

        

       

        

       

        

       

        

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      4.3         Financial Disclosure.  PDS shall (a) track and collect financial disclosure information from all “clinical investigators” involved in the Study and (b) prepare and submit the certification and/or
          disclosure of the same in accordance with all Applicable Law, including, but not limited to, Part 54 of Title 21 of the United States Code of Federal Regulations (Financial Disclosure by Clinical Investigators) and related FDA Guidance
          Documents.  Prior to the initiation of clinical activities coder the Study, but in any event within *** days after the Effective Date, the Parties shall determine whether PDS shall track and collect from all “clinical investigators” involved, in
          the Study separate certification and/or disclosure forms for each of Merck and PDS or one (1) “combined” certification and/or disclosure form for both Merck and PDS.  For purposes of this Section 4.3, the term “clinical investigators” shall have
          the meaning set forth in Part 54.2(d) of Title 21 of the United States Code of Federal Regulations.

      

      

      4.4         Transparency Reporting.

      

      

      4.4.1     With respect to any annual reporting period in which
          PDS is not an entity that is required to make a Transparency Report under Applicable Law, PDS will:  (a) notify Merck, in writing, within *** days after the commencement of such reporting period that PDS is not so required; and (b) during such
          reporting period PDS will track and provide to Merck data regarding “indirect” payments or other transfers of value by PDS to such health care professionals to the extent such payments or other transfers of value were required, instructed,
          directed or otherwise caused by Merck pursuant to this Agreement in the format requested by Merck and provided on a basis to be agreed upon by both Parties.  PDS represents and warrants that any data provided by PDS to Merck pursuant to Section
          4.4.1(b) above will be complete and accurate to the best of PDS’s knowledge.

      

      

      4.4.2     With respect to any annual reporting period in which
          PDS is required to make a Transparency Report tinder Applicable Law, PDS will provide to Merck, in writing, PDS’s point of contact for purposes of receiving information from Merck pursuant to this Section 4.4, along with such contact’s full name,
          email address, and telephone number.  PDS may update such contact from time to time by notifying Merck in writing pursuant to Section 22 (Notices).  Where applicable, Merck will provide to such PDS contact all information regarding the value of
          the Merck Compound provided for use in the Study required for such reporting.  In the event that the value of the Merck Compound provided pursuant to this Section 4.4.2 changes, Merck shall notify PDS of such revised value and the effective date
          thereof.

      

      

      4.4.3     For purposes of this Section 4.4, “Transparency Report” means a transparency report in connection with
          reporting payments and other transfers of value made to health care professionals, including, without limitation, investigators, steering committee members, data monitoring committee members, and consultants in connection with the Study in
          accordance with reporting requirements under Applicable Law, including, without limitation, the Physician Payment Sunshine Act and state gift laws, and the European Federation of Pharmaceutical Industries and Associations Disclosure Code, or a
          Party’s applicable policies.

      

      

      

      

      

      

      

      

      

      

      

      

      

      

      

      

      

      

      
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      5.          Adverse

              Event Reporting.

      

      

      5.1       Pharmacovigilance Agreement.  PDS will be solely responsible for compliance with all Applicable Laws pertaining to safety reporting for the Study and related activities.  The Parties (or their
          respective Affiliates) will execute a Pharmacovigilance agreement (“Pharmacovigilance

            Agreement”) prior to the initiation of clinical activities under the Study, but in any event within *** days after the Effective Date, to ensure the exchange of relevant safety data within appropriate timeframes and in an appropriate
          format to enable the Parties to fulfill local and international regulatory reporting obligations and to facilitate appropriate safety reviews.  In the event of any inconsistency between the terms of this Agreement and the, Pharmacovigilance Agreement, the terms of this Agreement shall control.  The Pharmacovigilance Agreement

          will include safety data exchange procedures governing the coordination of collection, investigation, reporting, and exchange of information concerning any adverse experiences, pregnancy reports, and any other safety information arising from or
          related to the use of the Merck Compound and PDS Compound in the Study, consistent with Applicable Law.  Such guidelines and procedures shall be in accordance with, and enable the Parties and their Affiliates to fulfill, local and international
          regulatory reporting obligations to Government Authorities.

      

      

      5.2         Transmission of SAEs.  PDS will transmit to Merck all serious adverse events (“SAEs”) is follows:

      

      

      5.2.1      For drug-related fatal and life-threatening SAEs,
          PDS will send a processed case (on a CIOMS-1 form in English) within *** calendar days after receipt by PDS of such SAEs.

      

      

      5.2.2      For all other SAEs, including non-drug-related fatal
          and life-threatening SAEs, PDS will send a processed case (on a CIOMS-1 form in English) within *** calendar days after receipt by PDS of such SAEs.

      

      

      6.          Term
              and Termination.

      

      

      6.1         Term.  The term of this Agreement shall commence on the Effective Date and shall continue in full force and effect until the earlier of (i) delivery of the Final Study Report and (ii) Study
          Completion plus ***, or until terminated by either Party pursuant to this Article 6 (the “Term”).

      

      

      6.2         Merck Termination Right for Safety.  In the event that Merck in good faith believes that the Merck Compound is being used in the Study in an unsafe manner and notifies PDS in writing of the grounds
          for such belief, and PDS fails to promptly incorporate changes into the Protocol requested by Merck to address such issue or to otherwise address such issue reasonably and in good faith, Merck may terminate this Agreement and the supply of the
          Merck Compound immediately upon written notice to PDS.

      

      

      6.3        Material Breach.  Either Party may terminate this Agreement if the other Party commits a material breach of this Agreement, and such material breach continues for *** days after receipt of written
          notice thereof from the non-breaching Party; provided that if such material breach cannot reasonably be cured within *** days, the breaching Party shall
          be given a reasonable period of time to cure such breach; provided further, that if such material breach is incapable of cure, then the notifying Party may terminate this Agreement effective after the expiration of such *** day period.

      

      

      

      

      

      

      

      

      

      

      

      

      

      

      

      

      

      

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      6.4         Mutual Termination Right for Patient Safety.  If either Party determines in good faith, based on a review of the Clinical Data, Sample Testing Results or other Study-related Know-How or other
          information, that the Study may ***affect patient safety, such Party shall promptly notify the other Party of such determination.  The Party receiving such notice may propose modifications to the Study to address the safety issue identified by
          the other Party and, if the notifying Party agrees, shall act to implement immediately such modifications; provided, however, that if the notifying Party,
          in its sole discretion, believes that there is imminent danger to patients, such Party need not wait for the other Party to propose modifications and may instead terminate this Agreement immediately upon written notice to such other Party. 
          Furthermore, if the notifying Party, in its sole discretion, believes that any modifications proposed by the other Party will not resolve the patient safety issue, such Party may terminate this Agreement effective upon written notice to such
          other Party.

      

      

      6.5         Mutual Termination Right Due to Regulatory Action; Other Reasons.  Either Party may terminate this Agreement immediately upon written notice to the other Party in the event that any Regulatory
          Authority takes any action, or raises any objection, that prevents the terminating Party from supplying its Compound for purposes of the Study.  Additionally, either Party shall have the right to terminate this Agreement immediately upon written
          notice to the other Party in the event that it determines in its sole discretion to withdraw any applicable Regulatory Approval for its Compound or to discontinue development of its Compound, for medical, scientific or legal reasons.

      

      

      6.6         Return of Merck Compound.  In the event that this Agreement is terminated, or in the event PDS remains in possession (including through any Affiliate or Subcontractor) of Merck Compound at the time
          this Agreement expires, PDS shall, at Merck’s sole discretion, promptly either return or destroy all unused Merck Compound pursuant to Merck’s instructions.  If Merck requests that PDS destroy the unused Merck Compound, PDS shall provide written
          certification of such destruction.

      

      

      6.7         Anti-Corruption.  Either Party shall have the right to terminate this Agreement immediately upon written notice to the other Party, if such other Party fails to perform any of its obligations under
          Section 13.4 or breaches any representation or warranty contained in Section 13.4.  Except
          as set forth in Section 6.11, the non-terminating Party shall have no claim against the terminating Party for compensation for any loss of whatever nature by virtue of the termination of this Agreement in accordance with this Section 6.7.

      

      

      6.8         Survival.  The provisions of  *** through *** (inclusive), *** through *** (inclusive), *** through *** (inclusive), *** and ***, and *** through *** (inclusive), ***, and *** through ***
          (inclusive) shall survive the expiration or termination of this Agreement.

      

      

      

      

      

      

      

      

      

      

      

      

      

      

      

      

      

      

      

      

      
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      6.9         No Prejudice.  Termination of this Agreement shall be without prejudice to any claim or right of action of either Party against the other Party for any prior breach of this Agreement.

      

      

      6.10       Confidential Information.  Upon termination of this Agreement, each Party and its Affiliates shall promptly return to the Disclosing Party or destroy any Confidential Information of the Disclosing
          Party (other than Clinical Data, Sample Testing Results and Inventions) furnished to the Receiving Party by the Disclosing Party; provided, however that the Receiving Party may retain one copy of such Confidential Information in its confidential files, solely for purposes of exercising the
          Receiving Party’s rights hereunder, satisfying its obligations hereunder or complying with any legal proceeding or requirement with respect thereto, and provided
            further that the Receiving Party shall not be required to erase electronic files created in the ordinary course of business during automatic system back-up procedures pursuant to its electronic record retention and destruction practices
          that apply to its own general electronic files and information so long as such electronic files are (i) maintained only on centralized storage servers (and not on personal computers or devices), (ii) not accessible by any of its personnel (other
          than its information technology specialists), and (iii) are not otherwise accessed subsequently except with the written consent of the Disclosing Party or as required by law or legal process.  Such retained copies of Confidential Information
          shall remain subject to the confidentiality and non-use obligations herein.

      

      

      6.11     Manufacturing Costs.  In the event of termination by Merck pursuant to *** or *** above, Merck shall be entitled to reimbursement by PDS for the Direct Manufacturing Costs and Indirect Manufacturing
          Costs (as defined herein) incurred by Merck for its Compound Delivered for the Study.  “Direct Manufacturing Costs” shall be calculated consistent with
          Generally Accepted Accounting Principles (“GAAP”) and include manufacturing fees, raw materials, direct labor, freight and duty, and factory overhead costs
          that can be directly attributed to the Compound, including but not limited to equipment maintenance and repair, supplies, ongoing stability program costs, other plant services, indirect labor and depreciation on direct capital assets.  “Indirect Manufacturing Costs” shall be calculated consistent with GAAP and include allocations of indirect factory overhead and site support costs, including but
          not limited to utilities, quality, planning, engineering, maintenance, safety, site science and technology, and depreciation on indirect capital assets, procurement, warehousing, and corporate services.  Allocations shall be based on each
          Compound’s utilization relative to a Manufacturing Site’s total activity.

      

      

      7.           Costs

              of Study.

      

      

      The Parties agree that:  (a) Merck shall provide the Merck Compound for use in the Study, as described in Article 8 below; (b) each
          Party will be responsible for its own internal costs and expenses to support the Study and the costs of any Sample Testing conducted by such Party in connection with the Study; and (c) PDS shall bear all other costs associated with the conduct of
          the Study, including that PDS shall provide the PDS Compound for use in the Study, as described in Article 8 below.  For the avoidance of doubt, PDS will not be required to reimburse Merck for any costs or expenses incurred by Merck or its
          Affiliates in connection with the Study (except as provided in Section 6.11) and Merck will not be required to reimburse PDS for any costs or expenses incurred by PDS
          or its Affiliates in connection with the Study.

      

      

      

      

      

      

      

      

      

      

      

      

      

      

      

      

      

      

      

      

      
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      8.           Supply

              and Use of the Compounds.

      

      

      8.1        Supply of the Compounds.  Subject to the terms and conditions of this Agreement, each of PDS and Merck will use commercially reasonable efforts to supply, or cause to be supplied, the quantities of
          its respective Compound as are set forth in Appendix B, on the timelines set forth in Appendix B,
          in each case for use in the Study.  If the Protocol is changed in accordance with Section 4 in such a manner that may affect the quantities of Compound to be provided
          or the timing for providing such quantities, the Parties shall amend Appendix B to reflect any changes required to be consistent with the Protocol.  Each Party shall
          also provide to the other Party a contact person for the supply of its Compound under this Agreement.  Notwithstanding the foregoing, or anything to the contrary herein, in the event that either Party is not supplying its Compound in accordance
          with the terms of this Agreement, or is allocating under Section 8.10, then the other Party shall have no obligation to supply its Compound, or may allocate
          proportionally.

      

      

      8.2         Clinical Quality Agreement.  Within *** days from the Effective Date of this Agreement, the Parties (or their respective Affiliates) shall enter into a quality agreement that shall address and
          govern issues related to the quality of clinical drug supply to be supplied by the Parties for use in the Study (“Clinical Quality Agreement”).  In the event
          of any inconsistency between the terms of this Agreement and the Clinical Quality Agreement, ***.  The Clinical Quality Agreement shall, among other things:  (i) detail classification of any Compound found to have a Non-Conformance; (ii) include
          criteria for Manufacturer’s Release and related certificates and documentation; (iii) include criteria and timeframes for acceptance of Merck Compound; (iv) include procedures for the resolution of disputes regarding any Compounds found to have a
          Non-Conformance; and (v) include provisions governing the recall of Compounds.

      

      

      8.3        Minimum Shelf Life Requirements.  Each Party shall use commercially reasonable efforts to supply its Compound hereunder with an adequate remaining shelf life at the time of Delivery to meet the
          Study requirements.

      

      

      8.4          Provision of Compounds.

      

      

      8.4.1     Merck will deliver the Merck Compound *** to PDS’, or
          its designee’s, location as specified by PDS (“Delivery” with respect to such Merck Compound).  Title and risk of loss for the Merck Compound shall transfer
          from Merck to PDS at Delivery.  All costs associated with the subsequent transportation, warehousing and distribution of Merck Compound shall be borne by PDS.  PDS will, or will cause its designee to:  (i) take delivery of the Merck Compound
          supplied hereunder; (ii) perform the acceptance (including testing) procedures allocated to it under the Clinical Quality Agreement; (iii) subsequently label and pack the Merck Compound (in accordance with Section 8.5), and promptly ship the Merck Compound to the Study sites for use in the Study, in compliance with cGMP, GCP and other Applicable Law and the Clinical Quality Agreement; and (iv)
          provide, from time to time at the reasonable request of Merck, the following information:  any applicable chain of custody forms, in-transport temperature recorder(s), records and receipt verification documentation, such other transport or
          storage documentation as may be reasonably requested by Merck, and usage and inventory reconciliation documentation related to the Merck Compound.

      

      

      

      

      

      

      

      

      

      

      

      

      

      

      

      

      

      

      

      

      

      

      

      

      

      

      
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      8.4.2     PDS is solely responsible, at its own cost, for
          supplying (including all Manufacturing, acceptance and release testing) the PDS Compound for the Study, and the subsequent handling, storage, transportation, warehousing and distribution of the PDS Compound supplied hereunder.  PDS shall use
          diligent efforts to ensure that all such activities are conducted in compliance with cGMP, GCP and other Applicable Law and the Clinical Quality Agreement such diligent efforts for purposes of this Section 8.4.2 shall include but are not limited
          to site audits of Subcontractors utilized in the Manufacture, warehousing and transportation of PDS Compound.  For purposes of this Agreement, the “Delivery”
          of a given quantity of the PDS Compound shall be deemed to occur when such quantity is packaged for shipment to a Study site.

      

      

      8.5         Labeling and Packaging; Use, Handling and Storage.

      

      

      8.5.1     The Parties’ obligations with respect to the labeling
          and packaging of the Compounds are as set forth in the Clinical Quality Agreement.  Notwithstanding the foregoing or anything to the contrary contained herein, Merck shall provide the Merck Compound to PDS in the form of ***, and PDS shall be
          responsible for labeling, packaging and leafleting such Merck Compound in accordance with the terms and conditions of the Clinical Quality Agreement and otherwise in accordance with all Applicable Law, including cGMP, GCP, and health, safety and
          environmental protections.

      

      

      8.5.2      PDS shall:  (i) use the Merck Compound solely for
          purposes of performing the Study; (ii) not use the Merck Compound in any manner that is inconsistent with this Agreement or for any commercial purpose; and (iii) label, use, store, transport, handle and dispose of the Merck Compound in compliance
          with Applicable Law and the Clinical Quality Agreement, as well as all instructions of Merck.  PDS shall not reverse engineer, reverse compile, disassemble or otherwise attempt to derive the composition or underlying information, structure or
          ideas of the Merck Compound, and in particular shall not analyze the Merck Compound by physical, chemical or biochemical means except as necessary to perform its obligations under the Clinical Quality Agreement.

      

      

      8.6         Product Specifications.  A certificate of analysis shall accompany each shipment of the Merck Compound to PDS.  Upon request, PDS shall provide Merck with a certificate of analysis covering each
          shipment of PDS Compound used in the Study.

      

      

      8.7         Changes to Manufacturing.  Each Party may make changes from time to time to its Compound or the Manufacturing Site,

            provided that such changes shall be in accordance with the Clinical Quality Agreement.

      

      

      8.8         Product Testing; Noncompliance.

      

      

      8.8.1     After Manufacturer’s Release.  After Manufacturer’s Release of the Merck Compound and concurrently with Delivery of the Compound to PDS, Merck shall provide PDS with such certificates and documentation as are
          described in the Clinical Quality Agreement (“Disposition Package”).  PDS shall, within the time defined in the Clinical Quality Agreement, perform, with
          respect to the Merck Compound, the acceptance (including testing) procedures allocated to it under the Clinical Quality Agreement.  PDS shall be solely responsible for taking all steps necessary to determine that Merck Compound or PDS Compound,
          as applicable, is suitable for release before making such Merck Compound or PDS Compound, as applicable, available for human use, and Merck shall provide cooperation or assistance as reasonably requested by PDS in connection with such
          determination with respect to the Merck Compound.  PDS shall be responsible for storage and maintenance of the Merck Compound until it is tested and/or released, which storage and maintenance shall be in compliance with (a) the Specifications for
          the Merck Compound, the Clinical Quality Agreement and Applicable Law and (b) any specific storage and maintenance requirements as may be provided by Merck from time to time.  PDS shall be responsible for any failure of the Merck Compound to meet
          the Specifications to the extent caused by shipping, storage or handling conditions after Delivery to PDS hereunder.

      

      

      

      

      

      

      

      

      

      

      

      

      

      

      

      

      

      

      

      

      

      

      
        
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      8.8.2      Non-Conformance.

      

      

      (a)         In the event that either Party
          becomes aware that any Compound may have a Non-Conformance, despite testing and quality assurance activities (including any activities conducted by the Parties under Section 8.8.1),

          such Party shall immediately notify the other Party in accordance with the procedures of the Clinical Quality Agreement.  The Parties shall investigate any Non-Conformance in accordance with Section 8.9 (Investigations) and any discrepancy between them shall be resolved in accordance with Section 8.8.3.

      

      

      (b)         In the event that any proposed
          or actual shipment of the Merck Compound (or portion thereof) shall be agreed to have a Non-Conformance at the time of Delivery to PDS, then unless otherwise agreed to by the Parties, Merck shall replace such Merck Compound as is found to have a
          Non-Conformance (with respect to Merck Compound that has not yet been administered in the course of performing the Study).  Unless otherwise agreed to by the Parties in writing, the sole and exclusive remedies of PDS with respect to any Merck
          Compound that is found to have a Non-Conformance at the time of Delivery shall be (i) replacement of such Merck Compound as set forth in this Section 8.8.2(b) (ii)
          indemnification under Section 14.2.2 (to the extent applicable), and (iii) termination of this Agreement pursuant to Section 6.3 (to the extent applicable, but subject to the applicable cure periods set forth therein); provided that, for
          clarity, PDS shall not be deemed to be waiving any rights under Section 8.15.  In the event Merck Compound is lost or damaged by PDS after Delivery, Merck shall provide
          additional Merck Compound (if available for the Study) to PDS; provided that PDS shall reimburse Merck for the Direct Manufacturing Costs and Indirect
          Manufacturing Costs (as such terms are defined in Section 6.11) of such replaced Merck Compound; and provided further that Merck shall have no obligation to provide additional Merck Compound ***.  Except as set forth in the foregoing sentence, Merck shall have no obligation to provide replacement Merck Compound for
          any Merck Compound supplied hereunder other than such Merck Compound as has been agreed or determined to have a Non-Conformance at the time of Delivery to PDS.

      

      

      (c)        PDS shall be responsible for, and
          Merck shall have no obligation or liability with respect to, any PDS Compound supplied hereunder that is found to have a Non-Conformance.  PDS shall replace any PDS Compound as is found to have a Non-Conformance (with respect to PDS Compound that
          has not yet been administered in the course of performing the Study).  Unless otherwise agreed to by the Parties in writing, the sole and exclusive remedies of Merck with respect to any PDS Compound that is found to have a Non-Conformance at the
          time of Delivery shall be (i) replacement of such PDS Compound as set forth in this Section 8.8.2(b), (ii) indemnification under Section 14.2.1 (to the extent applicable), and (iii) termination of this Agreement pursuant to Section 6.3 (to the
          extent applicable, but subject to the applicable cure periods set forth therein); provided that, for clarity, Merck shall not be deemed to be waiving any
          rights under Section 8.15.

      

      

      

      

      

      

      

      

      

      

      

      

      

        

        

        

        

        
          
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      8.8.3      Resolution of Discrepancies.  Disagreements regarding any determination of Non-Conformance by PDS shall be resolved in accordance with the provisions of the Clinical Quality Agreement.

      

      

      8.9         Investigations.  The process for investigations of any Non-Conformance shall be handled in accordance with the Clinical Quality Agreement.

      

      

      8.10       Shortage; Allocation.  In the event that a Party’s Compound is in short supply such that a Party reasonably believes in good faith that it will not be able to fulfill its supply obligations
          hereunder with respect to its Compound, such Party will provide prompt written notice to the other Party thereof (including the shipments of Compound hereunder expected to, be impacted and the quantity of its Compound that such Party reasonably
          determines it will be able to supply) and the Parties will promptly discuss such situation (including how the quantity of Compound that such Party is able to supply hereunder will be allocated within the Study).  In such event, the Party
          experiencing such shortage shall (i) use its commercially reasonable efforts to remedy the situation giving rise to such shortage and to take action to minimize the impact of the shortage on the Study, and (ii) allocate to the other Party an
          amount of Compound at least proportionate to the total amount of the Compound shipments hereunder expected to be impacted by the shortage divided by the total demand for the Compound for the impacted time period.

      

      

      8.11       Records; Audit Rights.  PDS shall keep complete and accurate records pertaining to its use and disposition of Merck Compound (including its storage, shipping (cold chain) and chain of custody
          activities) and, upon request of Merck, shall make such records open to review by Merck for the purpose of conducting investigations for the determination of Merck Compound safety and/or efficacy and PDS’ compliance with this Agreement with
          respect to the Merck Compound.

      

      

      8.12        Quality.  Quality matters related to the Manufacture of the Compounds shall be governed by the terms of the Clinical Quality Agreement in addition to the relevant quality provisions of this
          Agreement.

      

      

      8.13      Quality Control.  Each Party shall implement and perform operating procedures and controls for sampling, stability and other testing of its Compound, and for validation, documentation and release of
          its Compound and such other quality assurance and quality control procedures as are required by the Specifications, cGM Ps and the Clinical Quality Agreement.

      

      

      8.14        Audits and Inspections.  The Parties’ audit and inspection rights related to this Agreement shall be governed by the terms of the Clinical Quality Agreement.

      

      

      8.15        Recalls.  Recalls of the Compounds shall be governed by the terms of the Clinical Quality Agreement.

      

      

      
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      8.16        VAT.

      

      

      (a)        It is understood and agreed
          between the Parties that any payments made and any other consideration given under this Agreement are each exclusive of any value added or similar tax (“VAT”),

          which shall be added thereon as applicable and at the relevant rate.  Subject to Section 8.16(b), where VAT is properly charged by the supplying Party and added to a
          payment made or other consideration provided (as applicable) under this Agreement, the Party making the payment or providing the other consideration (as applicable) will pay the amount of VAT properly chargeable only on receipt of a valid tax
          invoice from the supplying Party issued in accordance with the laws and regulations of the country in which the VAT is chargeable.  Each Party agrees that it shall provide to the other Party any information and copies of any documents within its
          Control to the extent reasonably requested by the other Party for the purposes of (i) determining the amount of VAT chargeable on any supply made under this Agreement, (ii) establishing the place of supply for VAT purposes, or (iii) complying
          with its VAT reporting or accounting obligations.

      

      

      (b)        Where one Party or its Affiliate
          (the “First Party”) is treated as making supply of goods or services
          in a particular jurisdiction (for VAT purposes) ***, and the other Party or its Affiliate (the “Second Party”) is treated as receiving such supply in the
          same jurisdiction, thus resulting in an amount of VAT being properly chargeable on such supply, the Second Party shall only be obliged to pay to the First Party the amount of VAT properly chargeable on such supply (and no other amount).  The
          Second Party shall pay such VAT to the First Party on receipt of a valid VAT invoice from the First Party (issued in accordance with the laws and regulations of the jurisdiction in which the VAT is properly chargeable).  Each Party agrees to (i)
          use its reasonable efforts to determine and agree the value of the supply that has been made and, as a result, the corresponding amount of VAT that is properly chargeable and (ii) provide to the other Party any information or copies of documents
          in its Control as are reasonably necessary to evidence that such supply will take, or has taken, place in the same jurisdiction (for VAT purposes).

      

      

      9.           Confidentiality.

      

      

      9.1        Confidential Information.  Subject to Section 13.4.8, PDS and Merck agree to hold in confidence any Confidential
          Information provided by or on behalf of the other Party, and neither Party shall use Confidential Information of the other Party except to fulfill such Party’s obligations under this Agreement or exercising its rights.  Without limiting the
          foregoing, the Receiving Party may not, without the prior written permission of the Disclosing Party, disclose any Confidential Information of the Disclosing Party to any Third Party except to the extent disclosure (i) is required by Applicable
          Law; (ii) is pursuant to the terms of this Agreement; or (iii) is necessary for the conduct of the Study, and in each case ((i) through (iii)) provided that

          the Receiving Party shall provide reasonable advance notice to the Disclosing Party before making such disclosure.  For the avoidance of doubt, PDS may, without Merck’s consent, disclose Confidential Information to clinical trial sites and
          clinical trial investigators performing the Study, the data safety monitoring and advisory board relating to the Study, and Regulatory Authorities working with PDS on the Study, in each case to the extent necessary for the performance of the
          Study and provided that such Persons (other than governmental entities) are bound by an obligation of confidentiality at least as stringent as the
          obligations contained herein.

      

      

      

      

      

      

      

      

      

      

      

      

      

      

      

      

      

      

      

      

      
        
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      9.2         Inventions.  Notwithstanding the foregoing:  (i) Inventions that constitute Confidential Information and are jointly owned by the Parties, shall constitute the Confidential Information of both
          Parties and each Party shall have the right to use and disclose such Confidential Information consistent with Articles 10, 11 and 12; and (ii) Inventions that constitute Confidential Information and are solely owned by one Party shall constitute
          the Confidential Information of that Party and each Party shall have the right to use and disclose such Confidential Information consistent with Articles 10, 11 and 12.

      

      

      9.3         Personal Identifiable Data.  All Confidential Information containing personal identifiable data shall be handled in accordance with all data protection and privacy laws, rules and regulations
          applicable to such data.

      

      

      10.         Intellectual

              Property.

      

      

      10.1        Joint Ownership and Prosecution.

      

      

      10.1.1   *** (each a “Jointly Owned Invention”) shall be owned jointly by PDS and Merck.  Merck hereby assigns to PDS an undivided one-half interest in, to and under the Jointly Owned Inventions that are
          invented or created solely by Merck or by Persons having an obligation to assign such rights to Merck.  PDS hereby assigns to Merck an undivided one-half interest in, to and under any Jointly Owned Inventions that are invented or created solely
          by PDS or by Persons having an obligation to assign such rights to PDS.  For those countries where a specific license is required for a joint owner of a Jointly Owned Invention to practice such Jointly Owned Invention in such countries:  (i)
          Merck hereby grants to PDS a perpetual, irrevocable, non-exclusive, world-wide, royalty-free, fully paid-up license, transferable and sublicensable, under Merck’s right, title and interest in and to all Jointly Owned Inventions to use such
          Inventions in accordance with the terms of this Agreement; and (ii) PDS hereby grants to Merck a perpetual, irrevocable, non-exclusive, worldwide, royalty-free, fully paid-up license, transferable and sublicensable, under PDS’ right, title and
          interest in and to all Jointly Owned Inventions to use such Inventions in accordance with the terms of this Agreement.  For clarity, the terms of this Agreement do not provide PDS or Merck with any rights, title or interest or any license to the
          other Party’s intellectual property except as necessary to conduct the Study and as expressly provided under this Agreement, including as set forth in Section 10.4.

      

      

      10.1.2   Each Party shall have the right to freely exploit each
          Jointly Owned Invention both within and outside the scope of the Study, without accounting to or any other obligation to the other Party; provided, however, that Merck may not use ***, and PDS may not use ***.

      

      

      

      

      

      

      

      

      

      

      

      

      

      

      

      

      

      

      

      

      

      

      
        
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      10.1.3   Promptly following the Effective Date, but in any
          event as soon as practicable after the discovery of a Jointly Owned Invention, patent representatives of each of the Parties shall meet (in person or by telephone) to discuss the patenting strategy for any Jointly Owned Inventions that may
          arise.  In particular, the Parties shall discuss which Party will file and prosecute a patent application (including any provisional, substitution, divisional, continuation, continuation in part, reissue, renewal, reexamination, extension,
          supplementary protection certificate and the like) in respect of any Jointly Owned Invention (each, a “Joint Patent Application”) and whether the Parties
          wish to appoint counsel that is mutually acceptable to the Parties.  In any event, the Parties shall consult and reasonably cooperate with one another in the preparation, filing, prosecution (including prosecution strategy) and maintenance of
          such patent application and shall equally share the expenses associated with the Joint Patent Applications and any corresponding Joint Patents.  In the event that one Party (the “Filing Party”) wishes to file a patent application for a Jointly Owned Invention and the other Party (the “Non-Filing Party”)
          does not want to file a patent application for such Jointly Owned Invention or does not want to file in a particular country, the Non-Filing Party shall execute in a timely manner and at the Filing Party’s reasonable expense an assignment of such
          Jointly Owned Invention to the Filing Party (in such country or all countries, as applicable) and any additional documents as may be reasonably necessary to allow the Filing Party to file and prosecute such patent application.  If a Party (the “Opting-out Party”) wishes to discontinue the prosecution and maintenance (or sharing in the costs with respect thereto) of a Joint Patent Application or Joint
          Patent (in one or more countries), the other Party, at its sole option (the “Continuing Party”), may continue such prosecution and maintenance.  In such
          event, the Opting-out Party shall execute in a timely manner and at the Continuing Party’s reasonable expense an assignment of such Joint Patent Application or Joint Patent to the Continuing Party (in such country or all countries, as applicable)
          and any additional documents as may be necessary to allow the Continuing Party to prosecute and maintain such Joint Patent Application or Joint Patent.  Any Jointly Owned Invention, Joint Patent Application or Joint Patent so assigned shall
          thereafter be owned solely by the Continuing Party or Filing Party (as applicable), shall no longer be considered jointly owned, and the Non-Filing Party or Opting-out Party (as applicable) shall have no right to practice under such Joint Patent
          Application or Joint Patent in the applicable country or countries.

      

      

      10.1.4   Except as expressly provided in Section 10.1.3 and in furtherance and not in limitation of Section 9.1, each Party agrees to
          make no patent application based on the other Party’s Confidential Information, and to give no assistance to any Third Party for such application, without the other Party’s prior written authorization.

      

      

      10.1.5    PDS shall have the first right to initiate legal
          action to enforce all Joint Patents against infringement and to protect all Jointly Owned Inventions from misappropriation by any Third Party, where such infringement or misappropriation results from the development or sale of a product that
          includes a PDS Class Compound but not a PD-1 Antagonist or to defend any declaratory judgment action relating thereto, at its sole expense.  In the event that PDS fails to initiate or defend such action within *** days after being first notified
          of such infringement, Merck shall have the right to do so at its sole expense.  Merck shall have the first right to initiate legal action to enforce all Joint Patents against infringement and to protect all Jointly Owned Inventions from
          misappropriation by any Third Party, where such infringement or misappropriation results from the development or sale of a product that includes a PD-1 Antagonist but not a PDS Class Compound or to defend any declaratory judgment action relating
          thereto, at its sole expense.  In the event that Merck fails to initiate or defend such action within *** days after being first notified of such infringement, PDS shall have the right to do so at its sole expense.  The Parties shall cooperate in
          good faith to coordinate legal action to enforce all Joint Patents against infringement, and to protect all Jointly Owned Inventions from misappropriation, by any Third Party where such infringement or misappropriation results from the
          development or sale of a product that includes both a PD-1 Antagonist and a PDS Class Compound or to defend any declaratory judgment action relating thereto, and shall share the costs and expenses of such litigation equally.

      

      

      

      

      

      

      

        

        

        

        

        

        

        

        

        

        

        
          
            
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      10.1.6    If one Party brings any prosecution or enforcement
          action or proceeding against a Third Party with respect to any Joint Patent, the second Party agrees to be joined as a party plaintiff where necessary and to give the first Party reasonable assistance and authority to file and prosecute the
          suit.  The costs and expenses of the Party bringing suit under this Section 10.1.6 shall be borne by such Party, and any damages or other monetary awards recovered
          shall be shared as follows:  (i) ***; and then (ii) ***.  A settlement or consent judgment or other voluntary final disposition of a suit under this Section 10.1.6 may
          not be entered into without the consent of the Party not bringing the suit.

      

      

      10.2       Inventions Owned by PDS.  Notwithstanding anything to the contrary contained in ***, the Parties agree that ***.  PDS shall be entitled to file and prosecute in its own name relevant patent
          applications and to own resultant patent rights for any PDS Invention.  For the avoidance of doubt, any Invention generically encompassing the PDS Compound or another PDS Class Compound (and not the Merck Compound) within its scope, even where
          the PDS Compound or PDS Class Compound is not disclosed per se, is a PDS Invention.  Merck hereby assigns its right, title and interest to any and all PDS Inventions to PDS.  For clarity, none of the inventions outlined in Appendix C shall be
          deemed Inventions as they are pre-existing inventions owned by PDS, including all intellectual property rights inherent thereto.

      

      

      10.3       Inventions Owned by Merck.  Notwithstanding anything to the contrary contained in ***, the Parties agree that ***.  Merck shall be entitled to file and prosecute in its own name relevant patent
          applications and to own resultant patent rights for any Merck Invention.  For the avoidance of doubt, any Invention generically encompassing the Merck Compound or another PD-1 Antagonist (and not the PDS Compound) within its scope, even where the
          Merck Compound or other PD-1 Antagonist is not disclosed per se, is a Merck Invention.  PDS hereby assigns its right, title and interest to any and all Merck Inventions to Merck.

      

      

      10.4       Mutual Freedom to Operate for Combination Inventions.

      

      

      10.4.1    PDS License In Merck.  PDS hereby grants to Merck a non-exclusive, worldwide, royalty-free.  fully paid-up license,
          transferable and sublicensable, to any patent Controlled by PDS that (a) has a priority claim that is earlier than the initiation of the Study (i.e., first dosing of the first patient in the Study) and (b) claims the Combination (the “PDS Background Patents”) ***; provided, however, that in no event shall Merck ***.

       

        

       

        

       

        

       

        

       

        

       

        

       

        

       

        

       

        

       

        

       

        

      

        
          
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      10.4.2   Merck License to PDS.  Merck hereby grants to PDS a non-exclusive, worldwide, royalty-free, fully paid-up license,
          transferable and sublicensable, to any patent Controlled by Merck that (a) has a priority claim that is earlier than the initiation of the Study (i.e., first dosing of the first patient in the Study) and (b) claims the Combination (the “Merck Background Patents”) ***; provided, however, that in no event shall PDS ***.

      

      

      10.4.3    No Other Rights.  For clarity, the terms of this Section

              10.4 do not provide Merck or PDS with any rights, title or interest or any license to the other Party’s intellectual property rights which do not have a priority claim that is earlier than the initiation of the Study or do not
          claim the Combination (i.e., intellectual property owned or licensed by either Party which does not constitute an Invention and does not claim or cover the Combination) except as necessary to conduct the Study.

      

      

      10.4.4    Termination.  Any and all licenses granted under this Section

              10.4 shall terminate upon the latest of (i) the termination of this Agreement and (ii) the completion of the Study or any Subsequent Study conducted pursuant to Section

              3.14.

      

      

      11.         Reprints;

              Rights of Cross-Reference.

      

      

      Consistent with applicable copyright, and other laws, each Party may use, refer to, and disseminate reprints of scientific, medical
          and other published articles and materials from journals, conferences and/or symposia relating to the Study that disclose the name of a Party, provided, however, that such use does not constitute an endorsement of any commercial product or service by the other Party.

      

      

      12.         Publications;

              Press Releases.

      

      

      12.1       Clinical Trial Registry.  PDS shall register the Study with the Clinical Trials Registry located at www.clinicaltrials.gov and is committed to timely publication of the results following Study
          Completion, after taking appropriate action to secure intellectual property rights (if any) arising from the Study.  The publication of the results of the Study will be in accordance with the Protocol.

      

      

      12.2       Publication.  Each Party shall use reasonable efforts to publish or present scientific papers dealing with the Study in accordance with accepted scientific practice.  The Parties agree that prior
          to submission of the results of the Study for publication or presentation or any other dissemination of such results including oral dissemination, the publishing Party shall invite the other to comment on the content of the material to be
          published, presented, or otherwise disseminated according to the following procedure:

      

      

      

      

      

      

      

      

      

      

      

      

      

      

      

      

      

      

      
        
          
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      12.2.1    At least *** days prior to submission for publication
          of any paper, letter or any other publication, or *** days prior to submission for presentation of any abstract, poster, talk or any other presentation, the publishing Party shall provide to the other Party the full details of the proposed
          publication, presentation, or dissemination in an electronic version (cd-rom or email attachment).  Upon written request from the other Party, the publishing Party agrees not to submit data for publication/presentation/dissemination for an
          additional *** days in order to allow for actions to be taken to preserve rights for patent protection.

      

      

      12.2.2    The publishing Party shall give reasonable
          consideration to any request by the other Party made within the periods mentioned in Section 12.2.1 to modify the publication and the Parties shall work in good faith
          and in a timely manner to resolve any issue regarding the content for publication.

      

      

      12.2.3    The publishing Party shall remove all Confidential
          Information of the other Party before finalizing the publication.

      

      

      12.3       Press Releases.  Unless otherwise required by Applicable Law, neither Party shall make any public announcement concerning this Agreement without the prior written consent of the other Party.  To
          the extent a Party desires to make such public announcement, such Party shall provide the other Party with a draft thereof at least *** Business Days prior to the date on which such Party would like to make the public announcement.

      

      

      13.          Representations

              and Warranties; Disclaimers.

      

      

      13.1       Due Authorization.  Each of PDS and Merck represents and warrants to the other that:  (i) it has the corporate power and authority and the legal right to enter into this Agreement and perform its
          obligations hereunder; (ii) it has taken all necessary corporate action on its part required to authorize the execution and delivery of this Agreement and the performance of its obligations hereunder; and (iii) this Agreement has been duly
          executed and delivered on behalf of such Party and constitutes a legal, valid and binding obligation of such Party that is enforceable against it in accordance with its terms.

      

      

      13.2        Compounds.

      

      

      13.2.1    PDS Compound.  PDS hereby represents and warrants to Merck that:  (i) PDS has the full right, power and authority to
          grant all of the licenses granted to Merck under this Agreement; and (ii) PDS Controls the PDS Compound.

      

      

      13.2.2    Merck Compound.  Merck hereby represents and warrants to PDS that:  (i) Merck has the full right, power and authority
          to grant all of the licenses granted to PDS under this Agreement; and (ii) Merck Controls the Merck Compound.

      

      

      13.3       Results.  PDS does not undertake that the Study shall lead to any particular result, nor is the success of the Study guaranteed.  Neither Party shall be liable for any use that the other Party may
          make of the Clinical Data nor for advice or information given in connection therewith.

      

      

      

      

      

      

      

      

      

      

      

      

      

      

      

      

      

      

      

      

      
        
          
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      13.4        Anti-Corruption.

      

      

      13.4.1   In performing their respective obligations hereunder,
          the Parties acknowledge that the corporate policies of PDS and Merck and their respective Affiliates require that each Party’s business be conducted within the letter and spirit of the law.  By signing this Agreement, each Party agrees to conduct
          the business contemplated herein in a manner that is consistent with all Applicable Law, including the Stark Act, Anti-Kickback Statute, Sunshine Act, and the U.S. Foreign Corrupt Practices Act, good business ethics, and its ethics and other
          corporate policies and agrees to abide by the spirit of the other Party’s guidelines, which may be provided by such other Party from time to time.

      

      

      13.4.2   Specifically, each Party represents and warrants that
          it has not, and covenants that it, its Affiliates, and its and its Affiliates’ directors, employees, officers, and anyone acting on its behalf, will not, in connection with the performance of this Agreement, directly or indirectly, make, promise,
          authorize, ratify or offer to make, or take any action in furtherance of, any payment or transfer of anything of value for the purpose of influencing, inducing or rewarding any act, omission or decision to secure an improper advantage; or
          improperly assisting it in obtaining or retaining business for it or the other Party, or in any way with the purpose or effect of public or commercial bribery.

      

      

      13.4.3    Neither Party shall contact, or otherwise knowingly
          meet with, any Government Official for the purpose of discussing activities arising out of or in connection with this Agreement, without the prior written approval of the other Party, except where such meeting is consistent with the purpose and
          terms of this Agreement and in compliance with Applicable Law.

      

      

      13.4.4    Each Party represents and warrants that it (i) is not
          excluded, debarred, suspended, proposed for suspension or debarment, in Violation or otherwise ineligible for government programs; and (ii) has not employed or subcontracted with any Person for the performance of the Study who is excluded,
          debarred, suspended, proposed for suspension or debarment, or is in Violation or otherwise ineligible for government programs.

      

      

      13.4.5    Each Party represents and warrants that, except as
          disclosed to the other in writing prior to the Effective Date, such Party:  (1) does not have any interest that directly or indirectly conflicts with its proper and ethical performance of this Agreement; (2) shall maintain arm’s length relations
          with all Third Parties with which it deals for or on behalf of the other in performance of this Agreement; and (3) has provided complete and accurate information and documentation to the other Party, the other Party’s Affiliates and its and their
          personnel in the course of any due diligence conducted by the other Party for this Agreement, including disclosure of any officers, employees, owners or Persons directly or indirectly retained by such Party in relation to the performance of this
          Agreement who are Government Officials or relatives of Government Officials.  Each Party shall make all further disclosures to the other Party as are necessary to ensure the information provided remains complete and accurate throughout the Term. 
          Subject to the foregoing, each Party agrees that it shall not hire or retain any Government Official to assist in its performance of this Agreement, with the sole exception of conduct of or participation in clinical trials under this Agreement, provided that such hiring or retention shall be subject to the completion by the hiring or retaining Party of a satisfactory anti-corruption and bribery (e.g.,
          FCPA) due, diligence review of such Government Official.  Each Party further covenants that any-future information and documentation submitted to the other Party as part of further due diligence or a certification shall be complete and accurate.

      

      

      
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      13.4.6   Each Party shall have the right during the Term, and
          for a period of *** years following termination of this Agreement, to conduct an investigation and audit of the other Party’s activities, books and records, to the extent they relate to that other Party’s performance under this Agreement, to
          verify compliance with the terms of this Section 13.4.  Such other Party shall cooperate fully with such investigation or audit, the scope, method, nature and duration
          of which shall be at the sole reasonable discretion of the Party requesting such audit.

      

      

      13.4.7   Each Party shall use commercially reasonable efforts
          to ensure that all transactions under the Agreement are properly and accurately recorded in all material respects on its books and records and that each document upon which entries in such books and records are based is complete and accurate in
          all material respects.  Each Party further represents, warrants and covenants that all books, records, invoices and other documents relating to payments and expenses under this Agreement are and shall be complete and accurate and reflect in
          reasonable detail the character and amount of transactions and expenditures.  Each Party shall maintain a system of internal accounting controls reasonably designed to ensure that no off the books or similar funds or accounts will be maintained
          or used in connection with this Agreement.

      

      

      13.4.8   Each Party agrees that in the event that the other
          Party believes in good faith that there has been a possible violation of any provision of Section 13.4, such other Party may make full disclosure of such belief and
          related information needed to support such belief at any time and for any reason to any competent government bodies and agencies, and to anyone else such Party determines in good faith has a legitimate need to know.

      

      

      13.4.9   Each Party shall comply with its own ethical business
          practices policy and any corporate integrity agreement (if applicable) to which it is subject, and shall conduct its Study-related activities in accordance with Applicable Law.  Each Party shall ensure that all of its employees involved in
          performing its obligations under this Agreement are made specifically aware of the compliance requirements under this Section 13.4.  In addition, each Party shall
          ensure that all such employees participate in and complete mandatory compliance training to be conducted by each Party, including specific training on anti-bribery and corruption, prior to his/her performance of any obligations or activities
          under this Agreement.  Each Party shall certify its continuing compliance with the requirements under this Section 13.4 on a periodic basis during the Term in such form
          as may be reasonably specified by the other Party.

      

      

      13.4.10 Each Party shall have the right to terminate this
          Agreement immediately upon violation of this Section 13.4 in accordance with Section 6.7.

      

      

      13.5      DISCLAIMER.  EXCEPT AS EXPRESSLY PROVIDED HEREIN, MERCK MAKES NO WARRANTIES, EXPRESS OR IMPLIED, INCLUDING ANY WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE, WITH RESPECT TO THE MERCK
          COMPOUND, AND COMPANY MAKES NO WARRANTIES, EXPRESS OR IMPLIED, INCLUDING ANY WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE, WITH RESPECT TO THE COMPANY COMPOUND.

      

      

      

      

      

      

      

      

      

      

      

      

      

      

      

      

      

      

      

      

      

      

      
        
          
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      14.          Insurance;

              Indemnification; Limitation of Liability.

      

      

      14.1       Insurance.  Each Party warrants that it maintains a policy or program of insurance or self-insurance at levels sufficient to support the indemnification obligations assumed herein.  Upon request, a
          Party shall provide evidence of such insurance.

      

      

      14.2        Indemnification.

      

      

      14.2.1    Indemnification by PDS.  PDS agrees to defend, indemnify and hold harmless Merck, its Affiliates, and its and their
          employees, directors, subcontractors and agents from and against any loss, damage, reasonable costs and expenses (including reasonable attorneys’ fees and expenses) incurred in connection with any claim, proceeding, or investigation by a Third
          Party arising out of this Agreement or the Study (a “Liability”), except to the extent that such Liability was caused by (i) negligence or willful misconduct
          on the part of Merck (or any of its Affiliates, or its and their employees, directors, subcontractors or agents); (ii) a breach on the part of Merck of any of its representations and warranties or any other covenants or obligations of Merck under
          this Agreement; or (iii) a breach of Applicable Law by Merck.

      

      

      14.2.2    Indemnification by Merck.  Merck agrees to defend, indemnify and hold harmless PDS, its Affiliates, and its and their
          employees, directors, Subcontractors and agents from and against any Liability to the extent such Liability was caused by (i) negligence or willful misconduct on the part of Merck (or any of its Affiliates, or its and their employees, directors,
          subcontractors or agents); (ii) a breach on the part of Merck of any of its representations and warranties or any other covenants or obligations of Merck under this Agreement; or (iii) a breach of Applicable Law by Merck.

      

      

      14.2.3    Procedure.  The obligations of Merck and PDS under this Section 14.2 are conditioned upon the delivery of written notice to Merck
          or PDS, as the case might be, of any potential Liability within a reasonable time after a Party becomes aware of such potential Liability.  The indemnifying Party will have the right to assume the defense of any suit or claim related to the
          Liability (using counsel reasonably satisfactory to the indemnified Party) if it has assumed responsibility for the suit or claim in writing; provided that
          the indemnified Party may assume the responsibility for such defense to the extent the indemnifying Party does not do so in a timely manner).  The indemnified Party may participate in (but not control) the defense thereof at its sole cost and
          expense.  The Party controlling such defense (the “Defending Party”) shall keep the other Party (the “Other
            Party”) advised of the status of such action, suit, proceeding or claim and the defense thereof and shall consider recommendations made by the Other Party with respect thereto.  The Defending Party shall not agree to any settlement of
          such action, suit, proceeding or claim without the prior written consent of the Other Party, which shall not be unreasonably withheld.  The Defending Party, but solely to the extent the Defending Party is also the indemnifying Party, shall not
          agree to any settlement of such action, suit, proceeding or claim or consent to any judgment in respect thereof that does not include a complete and unconditional release of the Other Party from all liability with respect thereto or that imposes
          any liability or obligation on the Other Party without the prior written consent of the Other Party.

      

      

      14.2.4   Study Subjects.  PDS shall not offer compensation on behalf of Merck to any Study subject or bind Merck to any indemnification obligations in favor of any Study subject.  Merck shall not offer compensation on
          behalf of PDS to any Study subject or bind PDS to any indemnification obligations in favor of any Study subject.

      

      

      
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      14.3       LIMITATION OF LIABILITY.  IN NO EVENT SHALL EITHER PARTY (OR ANY OF ITS AFFILIATES OR SUBCONTRACTORS) BE LIABLE TO THE, OTHER PARTY UNDER ANY THEORY FOR, NOR SHALL ANY INDEMNIFIED PARTY HAVE THE
          RIGHT TO RECOVER, ANY SPECIAL, INDIRECT, INCIDENTAL, CONSEQUENTIAL OR OTHER SIMILAR DAMAGES OR ANY PUNITIVE DAMAGES OR ANY LOST PROFIT, LOST SALE OR LOST OPPORTUNITY DAMAGES (WHETHER SUCH CLAIMED DAMAGES ARE DIRECT OR INDIRECT), WHETHER ARISING
          DIRECTLY OR INDIRECTLY OUT OF (X) THE MANUFACTURE OR USE OF ANY COMPOUND SUPPLIED HEREUNDER OR (Y) ANY BREACH OF OR FAILURE TO PERFORM ANY OF THE PROVISIONS OF THIS AGREEMENT OR ANY REPRESENTATION, WARRANTY OR COVENANT CONTAINED IN OR MADE
          PURSUANT TO THIS AGREEMENT, EXCEPT THAT SUCH LIMITATION SHALL NOT APPLY TO DAMAGES PAID OR PAYABLE TO A THIRD PARTY BY AN INDEMNIFIED PARTY FOR WHICH THE INDEMNIFIED PARTY IS ENTITLED TO INDEMNIFICATION HEREUNDER OR WITH RESPECT TO DAMAGES
          ARISING OUT OF OR RELATED TO A PARTY’S BREACH OF ITS OBLIGATIONS UNDER THIS AGREEMENT WITH RESPECT TO USE, DISCLOSURE, LICENSE, ASSIGNMENT OR OTHER TRANSFER OF CLINICAL DATA, CONFIDENTIAL INFORMATION, JOINTLY-OWNED INVENTIONS AND SAMPLE TESTING
          RESULTS.

      

      

      15.         Use
              of Name.

      

      

      Except as otherwise provided herein, neither Party shall have any right, express or implied, to use in any manner the name or other
          designation of the other Party or any other trade name, trademark or logo of the other Party for any purpose in connection with the performance of this Agreement without the other Party’s prior written consent.

      

      

      16.         Force

              Majeure.

      

      

      If, in the performance of this Agreement, one of the Parties is prevented, hindered or delayed by reason of any cause beyond such
          Party’s reasonable control (e.g., war, riots, fire, strike, acts of terror, governmental laws), such Party shall be excused from performance to the extent that it is necessarily prevented, hindered or delayed (“Force Majeure”).  The non-performing Party shall notify the other Party of such Force Majeure within *** days after such occurrence by giving written notice to the other Party stating
          the nature of the event, its anticipated duration, and any action being taken to avoid or minimize its effect.  The suspension of performance will be of no greater scope and no longer duration than is necessary and the non-performing Party shall
          use commercially reasonable efforts to remedy its inability to perform.

      

      

      17.         Entire

              Agreement; Amendment; Waiver.

      

      

      This Agreement, together with the Appendices and Schedules hereto and the Related Agreements, constitutes the sole, full and complete
          agreement by and between the Parties with respect to the subject matter of this Agreement, and all prior agreements, understandings, promises and representations, whether written or oral, with respect thereto are superseded by this Agreement.  In
          the event of a conflict between a Related Agreement and this Agreement, the terms of this Agreement shall control.  No amendments, changes, additions, deletions or modifications to or of this Agreement shall be valid unless reduced to writing and
          signed by the Parties hereto.  Any term or condition of this Agreement 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.  The waiver by either Party of any right hereunder or of the failure to perform or of a breach by the other Party shall not be deemed a waiver of any other right hereunder or of any other
          breach or failure by said other Party whether of a similar nature or otherwise.

      

      

      

      

      

      

      

      

      

      

      

      

      

      

      

      

      

      

      

      

      
        
          
            *** Portions of this page have been omitted pursuant to a request for Confidential Treatment filled separately with the Commission.  

          

        

      

      
        32

        
          

        
          	
                   

                	
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      18.         Assignment

              and Affiliates.

      

      

      Neither Party shall assign or transfer this Agreement without the prior written consent of the other Party; provided, however, that either Party may assign all or any part of this Agreement to
          one or more of its Affiliates without the other Party’s consent, and any and all rights and obligations of either Party may be exercised or performed by its Affiliates, provided that such Affiliates agree to be bound by this Agreement.

      

      

      19.         Invalid

              Provision.

      

      

      If any provision of this Agreement is held to be illegal, invalid or unenforceable, the remaining provisions shall remain in full
          force and effect and will not be affected by the illegal, invalid or unenforceable provision.  In lieu of the illegal, invalid or unenforceable provision, the Parties shall negotiate in good faith to agree upon a reasonable provision that is
          legal, valid and enforceable to carry out as nearly as practicable the original intention of the entire Agreement.

      

      

      20.         No
              Additional Obligations.

      

      

      PDS and Merck have no obligation to renew this Agreement or apply this Agreement to any clinical trial other than the Study.  Neither
          Party is under any obligation to enter into another type of agreement at this time or in the future.

      

      

      21.         Governing

              Law; Dispute Resolution.

      

      

      21.1       The Parties shall attempt in good faith to settle
          all disputes arising out of or in connection with this Agreement in an amicable manner.  Any claim, dispute or controversy arising out of or relating to this Agreement, including the breach, termination or validity hereof or thereof (each, a “Dispute”), shall be governed by and construed in accordance with the substantive laws of the State of New York, without giving effect to its choice of law
          principles.

      

      

      21.2       Nothing contained in this Agreement shall deny
          either Party the right to seek injunctive or other equitable relief from a court of competent jurisdiction in the context of a bona fide emergency irrespective irreparable harm, and such an action may be filed or maintained notwithstanding any
          ongoing discussions between the Parties.

      

      

      
        33

        
          

        
          	
                   

                	
                  Execution Version

                

        

      

      22.         Notices.

      

      

      All notices or other communications that are required or permitted hereunder shall be in writing and delivered personally, sent by
          facsimile (and promptly confirmed by personal delivery or overnight courier), or sent by internationally-recognized overnight courier addressed as follows:

      

      

      If to PDS, to:

      

      

      PDS Biotechnology Corporation

      675 US Highway One

      North Brunswick, NJ 08902

      Attention:  Frank Bedu-Addo

      Facsimile:  +1 732-745-7270

      

      

      If to Merck, to:

      

      

      MSD International GmbH

      Weystrasse 20

      6000 Luzern 6

      Switzerland

      Attention:  Director

      Facsimile:  +41 44 828 7208

      

      

      With copies (which shall not constitute notice) to:

      

      

      Merck Sharp & Dohme Corp.

      One Merck Drive

      PO Box 100

      Whitehouse Station, NJ 08889-0100

      Attention:  Office of Secretary

      

      

      Merck Sharp & Dohme Corp.

      351 North Sumneytown Pike

      Mailstop UG4CD-16

      North Wales, PA 19454-2505

      Attention:  Senior Vice President, Research Science

      

      

      Merck Sharp & Dohme Corp.

      2000 Galloping Hill Road

      Mailstop K-1-3045

      Kenilworth, NJ 07033-1310

      Attention:  Assistant General Counsel, Corporate Transactions

      

      

      23.         Relationship

              of the Parties.

      

      

      The relationship between the Parties is and shall be that of independent contractors, and does not and shall not constitute a
          partnership, joint venture, agency or fiduciary relationship.  Neither Party shall have the authority to make any statements, representations or commitments of any kind, or take any actions, that are binding on the other Party, except with the
          prior written consent of the other Party to do so.  All Persons employed by a Party will be the employees of such Party and not of the other Party and all costs and obligations incurred by reason of any such employment shall be for the account
          and expense of such Party.

      

      

      
        34

        
          

        
          	
                   

                	
                  Execution Version

                

        

      

      24.         Counterparts

              and Due Execution.

      

      

      This Agreement and any amendment may be executed in any number of counterparts (including by way of facsimile or electronic
          transmission), each of which shall be deemed an original, but all of which together shall constitute one and the same instrument, notwithstanding any electronic transmission, storage and printing of copies of this Agreement from computers or
          printers.  When executed by the Parties, this Agreement shall constitute an original instrument, notwithstanding any electronic transmission, storage and printing of copies of this Agreement from computers or printers.  For clarity, facsimile
          signatures and signatures transmitted via PDF shall be treated as original signatures.

      

      

      25.         Construction.

      

      

      Except where the context otherwise requires, wherever used, the singular will include the plural, the plural the singular, the use of
          any gender will be applicable to all genders, and the word “or” is used in the inclusive sense (and/or).  Whenever this Agreement refers to a number of days,
          unless otherwise specified, such number refers to calendar days.  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 term “including” as used herein shall be deemed to be followed by the phrase “without limitation” or like expression.  The term “will” as used herein means shall.  The terms
          “hereof”, “hereto”, “herein” and “hereunder” and

          words of similar import when used in this Agreement refer to this Agreement as a whole and no to any particular provision of this Agreement.  References to “Article,”

          “Section”, “Appendix” or “Schedule” are references to the numbered sections of this Agreement and the appendices attached to this Agreement, unless expressly stated otherwise.  Except where the context otherwise requires,
          references to this “Agreement” shall include the appendices attached to 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 will be applied against either Party hereto.

      

      

      [Remainder of page intentionally left blank.]

      

      

      
        35

        
          

        
          	
                   

                	
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      IN WITNESS WHEREOF, the respective representatives of the Parties have executed the Agreement as of the Effective Date.

       

        

      	
              PDS Biotechnology Corporation

            	 
	 	 

      	
              By:

            	/s/ Frank Bedu-Addo

            	 

      	 	 
	Frank Bedu-Addo	 
	
              Name

            	 
	 	 
	President	 
	
              Title

            	 
	 	 
	
              MSD International GmbH

            	 

      	
              By:

            	/s/ C. Kinsider 

            	 

      	 	 
	C. Kinsider 	 
	
              Name

            	 
	 	 
	Director	 
	
              Title

            	 

      

      

      
        36

        
          

        
          	
                   

                	
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      IN WITNESS WHEREOF, the respective representatives of the Parties have executed the Agreement as of the Effective Date.

       

        

      	
              PDS Biotechnology Corporation

            	 
	 	 

      	
              By:

            	 /s/ Frank Bedu-Addo	 

      	 	 
	 Frank Bedu-Addo	 
	
              Name

            	 
	 	 
	 President	 
	
              Title

            	 
	 	 
	
              MSD International GmbH

            	 

      	
              By:

            	 /s/ C. Kinsider 	 

      	

            	 
	 C. Kinsider 	 
	
              Name

            	 
	 	 
	 Director	 
	
              Title

            	 

      

      

      
        37

        
          

        
          	
                   

                	
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      Appendix A

      

      

      PROTOCOL SYNOPSIS

      

      

      
        A-1

        
          

        
          	
                   

                	
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       *** 

      

      

      ***

      

      

      Sponsor:

      PDS Biotechnology Corp.

      675 US Highway 1

      North Brunswick, NJ 08902

      

      

      

      

      

      

      

      

      

      

      

      

      

      

      

      

      

      

      

      

      

      

      

      

      
        
          
            
              *** Portions of this page have been omitted pursuant to a request for Confidential Treatment filled separately with the Commission.  

            

          

        

      

      
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      PROTOCOL SYNOPSIS

       

        

      	 	
              PROTOCOL TITLE

            	
               

            	
              ***

              

            
	 	
              SPONSOR

            	
               

            	***
	 	
              ESTIMATED NUMBER OF STUDY CENTERS AND COUNTRIES/REGIONS

            	
               

            	
              ***

            
	 	
              INVESTIGATIONAL PRODUCT

            	
               

            	
              ***

            
	 	
              PHASE OF DEVELOPMENT

            	
               

            	
              ***

              

            
	 	
              OBJECTIVES

            	
               

            	
              Primary:

               

              ·     ***

              ·     ***

              ·     ***

               

              Secondary:

               

              ·     ***

               

              Exploratory:

               

              ·     ***

              ·     ***

            
	 	
              RATIONALE FOR THE PDS0101-PEMBROLIZUMAB COMBINATION

            	
               

            	
              ***

              

                

              

              1.   ***

               

              2.   ***

            

       

      

       

      

       

      

       

      

       

      

       

      

       

      

       

      

       

      

       

      

      
        
          
            
              
                *** Portions of this page have been omitted pursuant to a request for Confidential Treatment filled separately with the Commission.  

              

            

          

        

      

      
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                            ***

              
                

                

                 ***

                

                 

                

                3.    ***

                 

                ***
                 

                ***
                 

                ***
                 

                ***
                 

                *** 

            
	 	
              RATIONALE FOR THE PHASE II CLINICAL STUDY IN HPV 16-SPECIFIC HEAD AND NECK CANCER

            	 	
              ***

                

            

       

      

       

      

       

      

       

      

       

      

       

      

       

      

       

      

       

      

       

      

      
        
          
            
              
                
                  *** Portions of this page have been omitted pursuant to a request for Confidential Treatment filled separately with the Commission.  

                

              

            

          

        

      

      
        A-4

        
          

        
          	
                   

                	
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              ***

              

            
	 	
              CLINICAL TRIAL DESIGN AND DESCRIPTION

            	 	
              ***

              

               

              ***

              

               

              ***

              

               

              ***

              

               

              ***

              

               

              ***

              

            

       

      

       

      

       

      

       

      

       

      

       

      

       

      

       

      

       

      

       

      

      
        
          
            
              
                
                  *** Portions of this page have been omitted pursuant to a request for Confidential Treatment filled separately with the Commission.  

                

              

            

          

        

      

      
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              Safety

               

              ***

               

              ***

               

              ***

               

              1. ***

               

              2. ***

               

              3. ***

               

              4. ***

               

              ·   ***

              ·   ***

              ·   ***

               

              5. ***

               

              ·   ***

              ·   ***

               

              6. ***

               

              ·   ***

               

              7. ***

               

              8. ***

               

              ***

               

              ·   ***

              ·   ***

              

              ·   ***

              

              ·   ***

              

              ·   ***

              

               

              ***

              

               

              ***

              

            

       

      

       

      

       

      

       

      

       

      

       

      

       

      

       

      

       

      

       

      

      
        
          
            
              
                
                  
                    *** Portions of this page have been omitted pursuant to a request for Confidential Treatment filled separately with the Commission.  

                  

                

              

            

          

        

      

      
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              Concomitant Medications/Vaccinations & Supportive Care

               

              ***

               

              ***

               

              ***

               

              HPV testing

               

              ***

               

              Immune Monitoring

               

              ***

            
	 	
              SAMPLE SIZE

            	 	
              ***

               

              ***

            
	 	
              DURATION OF STUDY

            	 	
              ***

            
	 	
              SUBJECT SELECTION CRITERIA

            	 	
              Inclusion:

               

              1.    ***

               

              2.    ***

               

              3.    ***

               

              4.    ***

            

       

      

      

      

      

      

      

      

      

      

      

      

      

      

      

      

      

      

      

      

      

      

      

      

      
        
          
            
              
                
                  
                    
                      *** Portions of this page have been omitted pursuant to a request for Confidential Treatment filled separately with the Commission.  

                    

                  

                

              

            

          

        

      

      
        A-7

        
          

        
          	
                   

                	
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              5.    ***

               

              6.    ***

               

              7.    ***

               

              8.     ***

               

              o     ***

               

              Note:  ***

               

              Note:  ***

               

              9.    ***

               

              10.  ***

               

              11.  ***

               

              12.   ***

               

              Note:  ***

               

              13.   ***

               

              Exclusion:

               

              ***

               

              1.  ***

            

       

      

       

      

       

      

       

      

       

      

       

      

       

      

       

      

       

      

      
        
          
            
              
                
                  
                    
                      
                        *** Portions of this page have been omitted pursuant to a request for Confidential Treatment filled separately with the Commission.  

                      

                    

                  

                

              

            

          

        

      

      
        A-8

        
          

        
          	
                   

                	
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              2.    ***

               

              3.    ***

               

              4.    ***

               

              5.    ***

               

              Note:  ***

               

              6.    ***

               

              7.    ***

               

              8.   ***

               

              Note:  ***

               

              ***

               

              9.    ***

               

              10.  ***

               

              11.  ***

               

              12.  ***

               

              13.  ***

            

       

      

       

      

       

      

       

      

       

      

       

      

       

      

       

      

       

      

      
        
          
            
              
                
                  
                    
                      
                        
                          *** Portions of this page have been omitted pursuant to a request for Confidential Treatment filled separately with the Commission.  

                        

                      

                    

                  

                

              

            

          

        

      

      
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              14.  *** 

               

              15.  *** 

               

              16.  *** 

               

              17.  *** 

               

              18.  *** 

               

              19.  *** 

               

              20.  *** 

               

              21.  *** 

            
	 	
              PRINCIPAL STATISTICAL METHODS

            	 	
              *** 

               

              *** 

               

              ·     *** 

              ·      *** 

               

              *** 

               

              ·      *** 

               

              *** 

               

              *** 

               

              *** 

            

       

      

       

      

       

      

       

      

       

      

       

      

       

      

       

      

       

      

       

      

      
        
          
            
              
                
                  
                    
                      
                        
                          
                            *** Portions of this page have been omitted pursuant to a request for Confidential Treatment filled separately with the Commission.  

                          

                        

                      

                    

                  

                

              

            

          

        

      

      
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              ***

               

              ***

               

              ***

            

      

      

      

      

      

      

      

      

      

      

      

      

      

      

      

      

      

      

      

      

      
        
          
            
              
                
                  
                    
                      
                        
                          
                            
                              *** Portions of this page have been omitted pursuant to a request for Confidential Treatment filled separately with the Commission.  

                            

                          

                        

                      

                    

                  

                

              

            

          

        

      

      
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      Schedule of Events

       

        

      	
              Period

            	
              Screening

            	
              Treatment & Observation Perioda

            
	
              Day and Visit Window

            	
              -28 to-II

            	
              leOd (Cycle 1)

            	
              22±3d (Cycle 2)

            	
              43e3t1

              (Cycle 3)

            	
              64+.3d (Cycle 4)

            	
              71+3

            	
              253&3d#

              (Cycle 12

            	
              EOT

            	
              Safety follow

              up

              30+7 dayss

            
	
              Initial Eligibility Procedures

            	 
	
              Informed consent

            	
              ***

            	 	 	 	 	 	 	 	 
	
              History of histologically-or cytologically-confirmed recurrent or metastatic disease and prior receipt of
                  platinum-based chemotherapyd

            	
              ***

            	 	 	 	 	 	 	 	 
	
              HPV test

            	
              ***

            	 	 	 	 	 	 	 	 
	
              HPV genotypingf

            	
              ***

            	 	 	 	 	 	 	 	 
	
              Procedure or Observation

            	 
	
              Inclusion/exclusion criteria

            	
              ***

            	 	 	 	 	 	 	 	 
	
              Blood sample for HIV testing

            	
              ***

            	 	 	 	 	 	 	 	 
	
              Medical history8

            	
              ***

            	 	 	 	 	 	 	 	 
	
              Complete physical examinationh

            	
              ***

            	
              ***

            	
              ***

            	
              ***

            	
              ***

            	 	
              ***

            	
              ***

            	 
	
              Vital signs

            	
              ***

            	
              ***

            	
              ***

            	
              ***

            	
              ***

            	 	
              ***

            	
              ***

            	 
	
              Prior & concomitant medications

            	
              ***

            	
              ***

            	
              ***

            	
              ***

            	
              ***

            	 	
              ***

            	 	 
	
              Clinical laboratory tests (hematology, chemistry, urinalysis)i

            	
              ***

            	
              ***

            	
              ***

            	
              ***

            	
              ***

            	 	
              ***

            	
              ***

            	 
	
              Serum/urine pregnancy testj

            	
              ***

            	
              ***

            	
              ***

            	
              ***

            	
              ***

            	 	
              ***

            	
              ***

            	 
	
              Blood sample for immuno-monitoringk

            	 	
              ***

            	 	 	 	
              ***

            	 	 	 
	
              Blood sample for HLA typing

            	 	
              ***

            	 	 	 	 	 	 	 
	
              Study vaccine injection

            	 	
              ***

            	
              ***

            	
              ***

            	
              ***

            	 	 	 	 
	
              Pembrolizumab administration#

            	 	
              ***

            	
              ***

            	
              ***

            	***	 	
              ***

            	 	 
	
              AE monitoringm

            	 	
              ***

            	
              ***

            	
              ***

            	
              ***

            	
              ***

            	
              ***

            	
              ***

            	 
	
              Dispense subject diariesn

            	 	
              ***

            	
              ***

            	
              ***

            	
              ***

            	
              ***

            	
              ***

            	 	 
	
              Collect subject diarieso

            	 	 	
              ***

            	
              ***

            	
              ***

            	
              ***

            	
              ***

            	
              ***

            	 
	
              Thyroid function testp

            	
              ***

            	 	 	
              ***

            	
              ***

            	 	 	
              ***

            	 
	
              Imaging assessmentq

            	
              ***

            	 	 	 	
              ***

            	 	 	***	 
	
              Biomarker — PD-LIr

            	
              ***

            	 	 	 	 	 	 	 	 
	
              Biomarker — RNA profiling

            	
              ***

            	 	 	 	 	 	 	
              ***

            	 

      

      

      

      

      

      

      

      

      

      

      

      

      

      

      

      

      

      

      

      

      
        
          
            
              
                
                  
                    
                      
                        
                          
                            
                              
                                *** Portions of this page have been omitted pursuant to a request for Confidential Treatment filled separately with the Commission.  

                              

                            

                          

                        

                      

                    

                  

                

              

            

          

        

      

      
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      ***

      

      

      
        
          	

                	a.	
                  ***

                

        

      

      

      

      
        
          	

                	b.	
                  ***

                

        

      

      

      

      
        
          	

                	c.	
                  ***

                

        

      

      

      

      
        
          	

                	d.	
                  ***

                

        

      

      

      

      
        
          	

                	e.	
                  ***

                

        

      

      

      

      
        
          	

                	f.	
                  ***

                

        

      

      

      

      
        
          	

                	g.	
                  ***

                

        

      

      

      

      
        
          	

                	h.	
                  ***

                

        

      

      

      

      
        
          	

                	i.	
                  ***

                

        

      

      

      

      
        
          	

                	j.	
                  ***

                

        

      

      

      

      
        
          	

                	k.	
                  ***

                

        

      

      

      

      
        
          	

                	l.	
                  ***

                

        

      

      

      

      ***

      

      

      

      

      

      

      

      

        

        

        

        

        

        

        

        

        

        

        
          
            
              
                
                  
                    *** Portions of this page have been omitted pursuant to a request for Confidential Treatment filled separately with the Commission.  

                  

                

              

            

          

        

        

      

      
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                	m.	
                  ***

                

        

      

      

      

      
        
          	

                	n.	
                  ***

                

        

      

      

      

      
        
          	

                	o.	
                  ***

                

        

      

      

      

      
        
          	

                	p.	
                  ***

                

        

      

      

      

      
        
          	

                	q.	
                  ***

                

        

      

      

      

      
        
          	

                	r.	
                  ***

                

        

      

      

      

      
        
          	

                	s.	
                  ***

                

        

      

      

      

      

      

      

      

      

      

      

      

      

      

      

      

      

      

      

      

      

      

      

      

      
        
          
            
              
                
                  
                    
                      
                        
                          
                            
                              
                                
                                  *** Portions of this page have been omitted pursuant to a request for Confidential Treatment filled separately with the Commission.  

                                

                              

                            

                          

                        

                      

                    

                  

                

              

            

          

        

      

      

      

      
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      Appendix B

      SUPPLY OF COMPOUND

      

      

      Schedule of Deliveries for PDS0101

       

            

      	
              Delivery Date

            	
              Quantity of Vials

            
	
              ***

            
	
              ***

            	
              ***

            
	
              ***

            
	
              ***

            	
              ***

            

      

      

      Schedule of Deliveries for KEYTRUDA®

       

            

      	
              Delivery Date

            	
              Quantity of Vials 

              

              (Liquid - 10mL, 100mg vial)

            
	
              ***

            	
              ***

            
	
              ***

            	
              ***

            
	 	
              ***

            

      

      

      

      

      

      

      

      

      

      

      

      

      

      

      

      

      

      

      

      

      
        
          
            
              
                
                  
                    
                      
                        
                          
                            
                              
                                
                                  
                                    *** Portions of this page have been omitted pursuant to a request for Confidential Treatment filled separately with the Commission.  

                                  

                                

                              

                            

                          

                        

                      

                    

                  

                

              

            

          

        

      

      
        B-1

        
          

        
          	
                   

                	
                  Execution Version

                

        

      

      
      Appendix C

      

      

      PDS INVENTIONS

      

      

      *** 

      

      

      

      

      

      

      

      

      

      

      

      

      

      

      

      

      

      

      

      

      

      

      
        
          
            
              
                
                  
                    
                      
                        
                          
                            
                              
                                
                                  
                                    
                                      *** Portions of this page have been omitted pursuant to a request for Confidential Treatment filled separately with the Commission.  

                                    

                                  

                                

                              

                            

                          

                        

                      

                    

                  

                

              

            

          

        

      

      
        C-1

        
          

        
          	
                   

                	
                  Execution Version

                

        

      

      
      Schedule I

      

      

      DATA SHARING AND SAMPLE TESTING SCHEDULE

       

        

      	 	
              Study Procedures

            	
              Shared

              between the

              Two Parties

            	
              Not

              Shared

            	
              Timing to provide item 

              

              (data/sample, etc.)

            	
              Party to

              Analyze Data/Sample

            
	 	
              *** 

               

              *** 

            	
              *** 

            	 	*** 	
              *** 

            
	 	
              *** 

               

              *** 

            	
              *** 

            	 	*** 	
              *** 

            
	 	
              *** 

               

              *** 	
              *** 

            	 	*** 	
              *** 

            
	 	
              *** 

            	
              *** 

            	 	*** 	
              *** 

            
	 	
              *** 

            	*** 	 	*** 	
              *** 

            
	 	
              *** 

            	
              *** 

            	 	*** 	
              *** 

            
	 	
              *** 

            	 	
              *** 

            	
              *** 

            	
              *** 

            
	 	
              *** 

            	
              *** 

            	 	*** 	
              *** 

            

      

      

      

      

      

      

      

        

        

        

        

        

        

        

        

        

        

        

        

        

        

        
          
            
              
                
                  
                    
                      
                        
                          
                            
                              
                                
                                  
                                    
                                      
                                        
                                          *** Portions of this page have been omitted pursuant to a request for Confidential Treatment filled separately with the Commission.  

                                        

                                      

                                    

                                  

                                

                              

                            

                          

                        

                      

                    

                  

                

              

            

          

        

        

      

      
        SCH-1

Source: [{"source": "alea-institute/alea-institute/kl3m-data-edgar-agreements/train-00291-of-00352.parquet"}, [{"source": "alea-institute/alea-institute/kl3m-data-edgar-agreements/train-00291-of-00352.parquet"}]]