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Exhibit 10.1

Portions of this Exhibit have been redacted because they are both (i) not
material and (ii) would be competitively harmful if publicly disclosed.
Information that was omitted has been noted in this document with a placeholder
identified by the mark “[***]”.
 
AMENDMENT NO. 1 TO CLINICAL TRIAL COLLABORATION
AND SUPPLY AGREEMENT
 
This Amendment No. 1 (“Amendment No. 1”) to the Agreement (as defined below),
made as of October 28, 2019 (“Amendment Effective Date”), is by and between MSD
International GmbH, having a place of business at Weystrasse 20, 6006 Luzern,
Switzerland (“Merck”) and PDS Biotechnology Corporation, having a place of
business at 303A College Road East, Princeton, NJ 08540 USA (“PDS”).  Merck and
PDS are each referred to herein individually as “Party” and collectively
“Parties”.
 
RECITALS
 
A.           WHEREAS, the Parties entered into that certain Clinical Trial
Collaboration and Supply Agreement dated as of May 19, 2017 (the “Agreement”);
 
B.           WHEREAS, the Parties desire to amend the Agreement to modify the
following:  (a) Protocol for the Study; (b) supply and delivery schedule of the
PDS Compound and the Merck Compound, and (c) Data Sharing and Sample Testing
Schedule to complete the Study as per the amended Protocol; all on the terms and
conditions set forth in this Amendment No. 1;
 
 NOW, THEREFORE, the Parties hereby agree as follows:
 
1.            Certain Definitions.  Capitalized terms used in this Amendment No.
1 and not defined herein shall have the meanings given to them in the Agreement.
 
2.            Amendment to the Agreement.  The Agreement is hereby amended as
follows:
 

2.1
Section 1.76 of the Agreement shall be deleted in its entirety and replaced with
the following:

 
““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 as
a first line treatment in subjects with recurrent and/or metastatic head and
neck cancer and high-risk human papillomavirus-16 (HPV16) infection.”
 

2.2
Section 3.7.1 of the Agreement shall be deleted in its entirety and replaced
with the following:

 
“The Joint Development Committee will agree as to which Party shall perform
Sample Testing.  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.”
 
1

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2.3
The first paragraph of Section 4.1 of the Agreement shall be deleted in its
entirety and replaced with the following:

 
“4.1 Protocol.  A Protocol has been agreed upon by the Parties as of the
Amendment 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) submit a draft statistical analysis
plan to Merck for Merck’s review, comment and approval; (c) consider in good
faith any further changes to the draft of the Protocol or statistical analysis
plan requested by Merck; (d) incorporate any changes requested by Merck with
respect to Merck Compound; and, (e) once a final version of the Protocol or
statistical analysis plan, incorporating all comments is ready, submit the
revised Protocol or statistical analysis plan to the JDC for final approval.  To
the extent the JDC cannot agree unanimously regarding the contents of the
Protocol or statistical analysis plan for final approval:  (i) PDS shall have
final decision-making authority with respect to matters in the Protocol or
statistical analysis plan related to the PDS Compound; (ii) Merck shall have
final decision-making authority with respect to matters in the Protocol or
statistical analysis plan 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 or statistical analysis plan on which the JDC cannot
agree shall be resolved in accordance with Section 3.10.3.  Once the final
Protocol or statistical analysis plan have been approved in accordance with this
Section 4.1, any material changes to such approved final Protocol or statistical
analysis plan (other than material changes relating solely to the PDS Compound)
and any changes to the final Protocol or statistical analysis plan (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.”
 

2.4
The contact information for PDS set forth in Article 22 of the Agreement shall
be deleted in its entirety and replaced by the following:

 
“If to PDS, to:
PDS Biotechnology Corporation
303A College Road East
Princeton, NJ 08540 USA
Attention:  Frank Bedu-Addo
Phone:  +1 (800) 208-3343
Facsimile:  +1 (908) 790-1212”

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2.5
Appendix A to the Agreement shall be deleted in its entirety and replaced with
the new Appendix A attached to this Amendment No. 1.

 

2.6
Appendix B to the Agreement shall be deleted in its entirety and replaced with
the new Appendix B attached to this Amendment No. 1.

 

2.7
Schedule I to the Agreement shall be deleted in its entirety and replaced with
the new Schedule I attached to this Amendment No. 1

 
3.           General.  Except as specifically modified or amended by this
Amendment No. 1, the terms and conditions of the Agreement remain unchanged and
in full force and effect.  All references in the Agreement to the “Agreement”
shall mean the Agreement as modified by this Amendment No. 1.  This Amendment
No. 1 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.  This Amendment No. 1 may be executed in two (2) or more
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.  For clarity, facsimile signatures and signatures
transmitted via PDF shall be treated as original signatures.
 
[Remainder of page intentionally left blank.]

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IN WITNESS WHEREOF, the Parties have caused this Amendment No. 1 to the
Agreement to be signed by their respective duly-authorized representatives as of
the Amendment Effective Date.
 
PDS BIOTECHNOLOGY CORPORATION

By:
/s/ Frank Bedu-Addo

Name:
Frank Bedu-Addo

Title:
President & CEO

MSD International GmbH

By:
/s/ Franz Escherich

Name:
Franz Escherich

Title:
Director

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Appendix A

PROTOCOL

[***]

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Appendix B

Supply of Compounds

[***]

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Schedule I

DATA SHARING AND SAMPLE TESTING SCHEDULE

[***]

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