Con?dential Disclosure Agreement

In order to protect con?dential information misting to research, development, business plans, and other
technology, which may be disclosed between them, the Vaccine Research Center, National Institute of
Allergy and Infectious Diseases, National Institutes of Health and the ?Collaborator? identi?ed
below (individually, a ?Party?; collectively the ?Parties"), intending to be legally bound as of the date of
the last signature hereto (?Effective Date?), agree that:

l. A Party (?Disclosing Party") may disclose information to the other (?Receiving Party?) for the
purpose of assessing their interest in research collaboration (the ?Purpose?). The Disclosing Parties are:
Moderna Therapeutics, Inc. and its lnfO  (the ?Collaborator?).

 

 

2. The Parties? representatives for disclosing or receiving information (if known):

For NIAID: Barney Graham and other employees and contractors of NIAID as needed to
ful?ll the Purpose.

For Collaborator: Giuseppe Ciaramella,
Stephane Bancel,
Lee Cooper, and other employees of the Collaborator as needed to ?llfiil the
Purpose

3. The information disclosed under this Agreement (?Con?dential Information") includes any and all
technical, business and financial information, including third party relating to the Disclosing
Party, including but not limited to: non-public pateat applications; and other
proprietary information, ideas, gene sequences, samples, chemical compoun s, to ogical materials,
techniques, works of authorship, non-public inventions, know-how and processes related to the current,
future, and proposed products andfor services of the Disclosing Party or its partners, and including without
limitation, information concerning research, experimental work, development, design details and
speci?cations, engineering, ?nancial information, procurement requirements, purchasing, manufacturing,
customer lists, investors, employees, business and contractual relationships, business forecasts, analyst
reports, marketing plans and any additional non-public information that the Disclosing Party provides.

 

The Con?dential information disclosed under this Agreement is described as:

For NIAID: NIAID's proprietary information and data relating to the development of vaccines for
HIV, in?uenza, Ebola and MERS and development of broadly neutralizing monoclonal antibodies for
preventative and therapeutic use.

For Collaborator: Moderna?s proprietary and con?dential information related to design and
manufacture of a messenger RNA platform and messenger RNA constructs for treatment and
preventi0n of disease.

4. The Receiving Party will not disclose the Con?dential Information of the Disclosing Party to any
person except its employees, consultants, contractors, directors, or professional advisers or authorized
representatives to whom it is necessary to disclose the Con?dential Information for the Purpose described
above, and any such disclosures shall be under terms at least as restrictive as those speci?ed herein. Any
of the persons mentioned above who are given access to the Con?dential Information shall be informed of
this Agreement. The Receiving Party shall protect the Con?dential Information by using the same degree

{00016216.1} Con?dential Disclosure Agreement Modems Therapeutics, 
NIAID Ref. No. 2015-33448 Page 1 of4

of care, but no less than a reasonable degree of care, as the Receiving Party uses to protect its own
con?dential information.

5. The Disclosing Party shall use reasonable efforts to mark Con?dential Information in any
written document, memorandum, report, correspondence, drawing, or other tangible material, or computer
software or program, developed or prepared by the Disclosing Party or any of its representatives as
?Con?dential? and reduce oral disclosures to writing (this may be by summary email or other electronic
communication) marked ?Con?dential? within thirty (30) days after disclosure. Notwithstanding the
above, failure to mark information as ?Con?dential? will not disqualify that infonnation from constituting
"Con?dential Information? under this Agreement if a reasonable person would consider such information
to be con?dential based on the nature of such information and the circumstances of disclosure.

6. Notwithstanding any other provision of this Agreement, Con?dential Information shall not include I
any item of information, data, patent or idea that: is within the public domain prior to the time of the
disclosure by the Disclosing Party to the Receiving Party or thereafter becomes within the public domain
other than as a result of disclosure by the Receiving Party or any of its representatives in violation of this
Agreement; Was, on or before the date of disclosure in the possession of the Receiving Party as shown
by contemporaneous written record; is acquired by the Receiving Party from a third party not under an
obligation of con?dentiality; is hereafter independently developed by the Receiving Party, without
reference to the information received from the Disclosing Party; or the Disclosing Party expressly
authorizes in writing the Receiving Party to disclose.

7. At the request of the Disclosing Party, the Receiving Party agrees to return or certify the
destruction of all Con?dential lnforrnation received from the Disclosing Party except that the Receiving
Party may retain in its con?dential ?les one (I) copy of written Con?dential Information for record
purposes only.

3. If the Receiving Party, or anyone to whom it discloses the Con?dential Information in accordance
with Paragraph 4, becomes legally required to disclose any of the Con?dential Information, the Receiving
Party shall provide the Disclosing Party with timely notice and, to the extent practicable, consult with the
Disclosing Party prior to any disclosure.

9- This Agreement constitutes the entire understanding between the Parties with respect to the subject
matter hereof and merges any and all prior agreements, understandings and representations. The
Agreement may not be superseded, amended or modi?ed except by written agreement between the Parties.
Any dispute under this Agreement shall be brought in the federal court located in the District of Columbia,
and the Parties hereby consent to the personal jurisdiction and exclusive venue of that court. This
Agreement is to be made under and shall be construed in accordance with New York and U.S. federal law
as applied in the federal court of the District of Columbia In case of con?ict of laws, U.S. federal law as
applied in the federal court of the District of Columbia shall prevail. Each Party acknowledges that its
breach of this Agreement may cause irreparable damage and hereby agrees that the other Party may be
entitled to seek injunctive relief under this Agreement for any actual or threatened breach, as well as such
further relief as may be granted by a court of competentjurisdiction. if any provision of this Agreement is
found by a proper authority to be unenforceable or invalid, such unenforceability or invalidity will not
render this Agreement unenforceable or invalid as a whole, and such provision will be changed and
interpreted so as to best accomplish the objectives of such unenforceable or invalid provision within the
limits of applicable law or applicable court decisions.

10. This Agreement will control the disclosure of Confidential Information for a disclosure period
beginning on the Effective Date and expiring twelve (12) months thereafter, and will otherwise remain in

{000162161} Con?dential Disclosure Agreement Modems Therapeutics, 
MAID Ref. No. 2015-33448 Page 2 of 4

effect for three (3) years ?'orn the Effective Date. Either Party may terminate this Agreement upon thirty
{30) days written notice to the other Party, however, each Parties? obligation of maintaining con?dentiality
will survive termination for three (3) years after the Effective Date.

11. This Agreement may he executed in counterparts, each of which shall be deemed an original, and
all of which, taken together, shall constitute one and the same instrument. A facsimile, scanned electronic
signature or certi?ed electronic signature shall be as effective as an original signature.

SIGNATURES BEGIN ON NEXT PAGE

{900162161} Con?dential Disclosure Agreement Moderna Therapeutics, 
NIAID Ref. No. 2015-33448 Page 3 of4

Moderna Therapeutics, Inc.
320 Bent Street
Cambridge, MA 02141

Authorized Signature:

4&9.

Name:  Eamon
Corporate Counsel
Title:

 

Date: 11 lo tzois?

{00016216.1} Con?dential Disclosure Agreement

NIAID Ref. No. 2015-33443

Vaccine Research Center, NIAID, NIH

do Technology Transfer 8: Intellectual Property Office
Suite MSC 9804

5601 Fishers Lane

Rockville, MD 20852

Authorized Signature:


Carol A. Salata -S :m?1mm-wm

Carol Salem1 ?1.13.
Senior Technology Transfer Adviser
Technology Transfer Intellectual Property O?lce, NIAID

Date:
Acknowledged by VRC Representa?v?s)

Disclosin 1, ivng um?? Infoma?om
..  I. . I I 
 Date:  (Jill K)

Beg lyeoceiwhe/ 

 

     

Modema Therapeutics, 
Page 4 of 4



Amendment to the Confidential Disclosure A 

 

AMENDMENT TO THE CONFIDENTIAL DISCLOSURE AGREEMENT
(this ?Amendmenf'l, is entered into as of October 23, 20K) (the ?Amendment Effective Date?),
by and between ModernaTX, Inc. known as Moderna Therapeutics, Inc.) (?Modema?),
and the Vaccine Center, National Institute of Allergy and Infectious Diseases, National Institutes
Health Each of Modema and NIAID may he referred to herein as a or
together as the ?Parties?.

WHEREAS, Moderna and are parties to a Confidential Disclosure Agreement
dated November 9, 20 I 5 {the ?Ag rcement");

WHEREAS, the Agreement expires on November 9, 2016; and

WHEREAS, Modems and NIAID desire to continue the Agreement in accordance with
and subject to the terms and conditions therein, as more fully described herein.

NOW THEREFORE, her good and valuable consideration, the receipt and suf?ciency of
which is hereby mutually acknowledged, NIAID and Moderna hereby agree as follows:

1. De?nitions. All terms used in this Amendment and not otherwise de?ned herein
shall have the same meanings ascribed to them in the Agreement.

2. Amendments.

(13) Section 3. The Con?dential Infonnation to be disclosed under
the A grcem eat is hereby amended to include the Bike virus and related vaccines and assays.

Section 10. Section ID of the Agreement is deleted in its entirety and is
replaced with the following:

10. This Agreement will control the disclosure Con?dential Information for a
disclosure period beginning on the [Effective Date and expiring twenty-four (24) months
thereafter (Le. November 9, 2017), and will otherwise remain in effect for four years
?om the Effective Date. Either Party may terminate this Agreement upon thirty (3 0) days
Written notice to the other Party, however, each Parties? obligations of maintaining
confidentiality will survive termination for a period of four (4) years after the Effective
Date.

3. Generai Terms. Except with respect to the amendments as set forth in Section 2
above, the terms and conditions of the Agreement shall remain unchanged. This Amendment shall
be construed in in accordance with and governed by the same laws that govern the Agreement.

[Remainder intentional! ie tbinnk]

IN WITNESS WHEREOF. NIAID and Medea-I121 each has caused this
Amendment in be executed by its duly authorized representative.

INC.
By: A  0L
(Signaturel/

Name: Ben?amin Emerson
Corporate Counsel

 

Title:

 

VACCINE CENTER, INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES,
NATIONAL INSTITUTES OF HEALTH

By: 6?7 

(Signature)

Name: 
Title: Senior MUI?s?r/??g frechr?lUIij Wm?j?ri IUJHID

 

 

AMENDMENT NO. 2
TO
CONFIDENTIAL DISCLOSURE AGREEMENT

This Amendment No. 2 to Nondisclosure Agreement (NIAID Ref. No. 201?33448) is made
as of the 18th day of November, 2016 by and between ModernaTX, Inc. (?Moderna?) and the
Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes
of Health Each of Moderna and NIAID may be referred to herein as a ?Party? or
together as ?Parties.?

WHEREAS, Moderna and NIAID entered into a Con?dential Disclosure Agreement, dated
November 9, 2015 (the ?Agreement?) and amended once effective on October 28, 2016; and

WHEREAS, the parties desire to amend the Agreement as set forth herein;

NOW, THEREFORE, for good and valuable consideration, the receipt of which is hereby
acknowledged, and intending to be legally bound, the parties hereto agree as follows:

1. De?nitions. All terms used in this Amendment and not otherwise de?ned herein shall have
the same meanings ascribed to them in the Agreement.

2. Amendments. -
Section 3. The Con?dential Information of NIAID to be disclosed under the
Agreement is hereby amended to include information relating to The human parain?uenza
virus and related vaccines and assays.

3. All other terms and conditions of the Agreement shall remain unchanged.

SIGNATURES BEGIN ON NEXT PAGE

1 NIAID Ref. No. 2015-33443-2

IN WITNESS WHEREOF, each party has caused this Amendment No. 1 to Nondisclosure
Agreement to be executed by its authorized representative.

Authorized Signatures:

ModernaTX, Inc.

 

 ?gs/2M

 

 

Name: Bc?iamjn Enersnn
Co

Title: mom?: comma

Date: 11) W,on

 

Vaccine Research Center, National Institute of
Allergy and Infectious Diseases, National
Institutes of Health

 

By:

Name: Carol Salata, 

 

Title: Lead TTPS, TT 1P0, NIAID, NIH

 

Date:

 

2 NIAID Ref. No. 2015-3344342

AMENDMENT NO. 3
TO
CONFIDENTIAL DISCLOSURE AGREEMENT

This Amendment N0. 3 to Norldisolosure Agreement (NIAID Ref. No. 2015-33448) is
made as of the 17?? day of August, 2017 by and between ModemaTX, Inc. (?Modems?) and the
Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National InStitutes
of Health Each of Modems and NIAID may be referred to herein as a ?Party? or
together as ?Parties.?

WHEREAS, Modems and NIAID entered into a Con?dential Disclosure Agreement, dated
November 9, 2015 (the ?Agreement") and amended twice effective on October 28, 2016 and
November 18, 2016; and

WHEREAS, the Agreement expires on November 9, 2017; and

WHEREAS, the parties desire to amend the Agreement as set forth herein;

NOW, THEREFORE, for good and valuable consideration, the receipt of which is hereby
acknowledged, and intending to be legally bound, the parties hereto agree as follows:

1. Defmitions. All terms used in this Amendment and not otherwise de?ned herein shall have
the same meanings ascribed to them in the Agreement.

2. Amendments.
Section 3. The Con?dential Information of NIAID to be disclosed under the
Agreement is hereby amended to include information relating to the Nipah virus and
related vaccines and assays.
Section 10. Section 10 of the Agreement is deleted in its entirety and is replaced with
the following:

10. This Agreement will control the disclosure Con?dential Information for a disclosure
period beginning on the Effective Date and expiring thirty-six (36) months from the
E?ec?ve Date (Le. November 9, 2018). Either Party may terminate this Agreement upon
thirty (30) days written notice to the other Party, however, each Parties? obligations of
maintaining confidentiality will survive the expiration or earlier termination of this
Agreement for a period of ?ve (5) years from the Effective Date.

3. All other terms and conditions of the Agreement shall remain unchanged.

SIGNATURES BEGIN ON NEXT PAGE

{000260743} 1 NIAID Ref. No. 2015-3344qu

IN WITNESS WHEREOF, each party has caused this Amendment No. 3 to 
Agreement to be executed by its authorized representative.

Authorized Signatures:

McdernaTX, Inc.

By:  we.? 

Name: Daphne M. Van de 

 

Title: Counsel, Transactions

 

Date: _Aug. 31. 2017

{000260743}

Vaccine Research Center, National Institute of
Allergy and Infectious Diseases, National
Institutes of Health

By: 66 i?


Name: Carol Salata, 

 

Title: Lead TTPS, TTIPO, NIAID, NIH

 

Date:  I: 

 

2 mam Ref. No. 2015-33443?3

AMENDMENT NO. 4
TO
CONFIDENTIAL DISCLOSURE AGREEMENT

This Amendment No. 4 to Confidential Disclosure Agreement (NIAID Ref. No. 2015?33448)
(?Amendment No. is made as of the date of the last authorized signature below (?Amendment No. 4
Effective Date"), by and between ModernaTX, Inc. ("Moderna") and the Vaccine Research Center,
National Institute of Allergy and Infectious Diseases, National Institutes of Health Each of
Moderna and NIAID may be referred to herein as a "Party" or together as "Parties."

WHEREAS, Moderna and NIAID entered into a Confidential Disclosure Agreement, dated
November 9, 2015 (the "Agreement?) and amended thrice effective on October 28, 2016, November 18,
2016, and August 17, 2017; and

WHEREAS, the Agreement expires on November 9, 2018; and
WHEREAS, the parties desire to amend the Agreement as set forth herein.

NOW, THEREFORE, for good and valuable consideration, the receipt of which is hereby
acknowledged, and intending to be legally bound, the parties hereto agree as follows:

1. De?nitions. All terms used in this Amendment No. 4 and not otherwise de?ned herein shall have
the same meanings ascribed to them in the Agreement.

2. Amendments:
Section 10. Section 10 of the Agreement is deleted in its entirety and is replaced with the following:

?10. This Agreement will control the disclosure Con?dential Information for a disclosure period
beginning on the Effective Date and expiring sixty (60) months from the Effective Date 
November 9, 2020). Either Party may terminate this Agreement upon thirty (30) days written notice
to the other Party, however, each Parties' obligations of maintaining con?dentiality will survive the
expiration or earlier termination of this Agreement for a period of S'Dp?em' years from the Effective
Date.?

 

 

 

 

3. All other terms and conditions of the Agreement shall remain unchanged.

SIGNATURES BEGIN ON NEXT PAGE

{00032038.1} 1

NIAID Ref. No. 2015-33448-4

IN WITNESS WHEREOF, each party has caused this Amendment No. 4 to Con?dential

Disclosure Agreement to be executed by its authorized representative.
ACCEPTED AND AGREED TO:

FOR NIAID:

Digitally signed by Amy F. Fetn?k 

Amy F. Petrik 5



 

Amy Petrik, I
Senior TTPS, TTIPO, NIAID, NIH

Mailing Address for Notices:

ATTN: CDA NIAID REF. No. 21315?334434

TECHNOLOGY TRANSFER AND INTELLECTUAL PROPERTY OFFICE, NIAID
Suite 61), MSC 9804, 5601 Fishers Lane

Reckville, MD 20852

Tel: 301-496-2644fFax:240-627-311?

FOR ModernaTX, Inc.  .  

 

NAME OF AUTHORIZED SIGNATORY

Mailing Address for Notices: Counsel Transacti
OHS

Moderna?l?x, lnc.

Attn: General Counsel
200 Technology Square
Cambridge, MA 02139

{000320331} 2

NIAID Ref. No. 2015-3334484

Daphne Van de 

Date

334/101. 2018

Date

AMENDMENT NO. 5
TO
CONFIDENTIAL DISCLOSURE AGREEMENT

This Amendment No. 5 to Con?dential Disclosure Agreement (NIAID Ref. No. 2015-33448)
(?Amendment No. is made as of the date of the last authorized signature below (?Amendment No. 5
Effective Date?), by and between ModernaTX, Inc. ("Modema") and the Vaccine Research Center,
National Institute of Allergy and Infectious Diseases, National Institutes of Health Each of
Modema and NIAID may be referred to herein as a "Party" or together as "Parties."

WHEREAS, Modema and NIAID entered into a Con?dential Disclosure Agreement, dated
November 9, 2015 (the "Agreement") and amended four times, effective on October 28, 2016, November
18, 2016, August 17, 201?, and December 19, 2018; and

WHEREAS, the Agreement expires on November 9, 2020; and
WHEREAS, the parties desire to amend the Agreement as set forth herein.

NOW, THEREFORE, for good and valuable consideration, the receipt of which is hereby
acknowledged, and intending to be legally bound, the parties hereto agree as follows:

1. De?nitions. All terms used in this Amendment No. 4 and not otherwise de?ned herein shall have
the same meanings ascribed to them in the Agreement.

2. Amendments:
Section 3. Section 3 of the Agreement is deleted in its entirety and is replaced with the following:

The information disclosed under this Agreement (?Con?dential Information?) includes any and
all technical, business and ?nancial information, including third party information, relating to the
Disclosing Party, including but not limited to: nonpublic patent applications; and
other proprietary information, ideas, gene sequences, samples, chemical compounds, biological
materials, techniques, works of authorship, non-public inventions, know-how and processes related to
the current, future, and proposed products andfor services of the Disclosing Party or its partners, and
including without limitation, information concerning research, experimental work, development,
design details and speci?cations, engineering, ?nancial information, procurement requirements,
purchasing manufacturing, customer lists, investors, employees, business and contractual
relationships, business forecasts, analyst reports, marketing plans and any additional non-public
information that the Disclosing Party provides.

The Con?dential Information disclosed under this Agreement is described as:

{00033096.1} 1

NIAID Ref. No. 2015-33448-5

For NIAID: proprietary information and data relating to the development of vaccines for
HIV, in?uenza, Ebola, MERS, Nipah, measles, and mumps and development of
broadly neutralizing monoclonal antibodies for prevention and therapeutic use.

For Collaborator: Moderna?s proprietary and con?dential information related to design and
manufacture of a messenger RNA platform and messenger RNA constructs for treatment and
prevention of disease."

3. All other terms and conditions of the Agreement shall remain unchanged.

SIGNATURES BEGIN ON NEXT PAGE

{00033096.1} 2

NIAID Ref. No. 2015-33448-5

IN WITNESS WHEREOF, each party has caused this Amendment No. 4 to Con?dential

Disclosure Agreement to be executed by its authorized representative.
ACCEPTED AND AGREED TO:

FOR NIAID:

 

Amy Petrik, 
Senior TTPS, TTIPO, NIAID, NIH

Mailing Address for Notices:

ATTN: CDA NIAID REE, No. 2015-33448-4

TECHNOLOGY TRANSFER AND INTELLECTUAL PROPERTY OFFICE, NIAID
Suite 6D, MSC 9804, 5601 Fishers Lane

Roekville, MD 20352

Tel: 301-496?2644 Fax: 240-627-3117

FOR ModernaTX, Inc.

  HEW DLL c/Li/

NAME or AUTHORIZED SIGNATORY
Mailing Address for Notices:

ModemaTX, Inc.

Attn: General Counsel

200 Technology Square
Cambridge, MA 02139

{00033096.1} 3

NIAID Ref. No. 2015?3341486

Date

AM :26. 20101

Date

 Envelope ID: 

AMENDMENT NO. 6
TO
CONFIDENTIAL DISCLOSURE AGREEMENT

This Amendment No. 6 to Con?dential Disclosure Agreement Ref. No. 2015-33448)
(?Amendment No. is made as of the date of the last authorized signature below (?Amendment No. 6
Effective Date?), by and between ModernaTX, Inc. ("Modema") and the Vaccine Research Center,
National Institute of Allergy and Infectious Diseases, National Institutes of Health Each of
Moderna and NIAID may be referred to herein as a "Party" or together as "Parties."

WHEREAS, Moderna and NIAID entered into a Con?dential Disclosure Agreement, dated
November 9, 2015 (the and amended ?ve times, effective on October 28, 2016, November
18, 2016, August 17, 201?, December 19, 2018 and April 29, 2019; and

WHEREAS, the Agreement expires on November 9, 2020; and
WHEREAS, the parties desire to amend the Agreement as set forth herein.

NOW, THEREFORE, for good and valuable consideration, the receipt and suf?ciency of which is
hereby acknowledged, and intending to be legally bound, the parties hereto agree as follows:

1. De?nitions. All terms used in this Amendment No. 6 and not otherwise defined herein shall have
the same meanings ascribed to them in the Agreement.

2. Amendments:
Section 3. Section 3 of the Agreement is deleted in its entirety and is replaced with the following:

The information disclosed under this Agreement (?Con?dential Information?) includes any and
all technical, business and ?nancial information, including third party information, relating to the
Disclosing Party, including but not limited to: nonpublic patent applications; and other
proprietary information, ideas, gene sequences, samples, chemical compounds, biological materials,
techniques, works of authorship, non-public inventions, know-how and processes related to the
current, future, and proposed products andfor services of the Disclosing Party or its partners, and
including without limitation, information concerning research, experimental work, development,
design details and speci?cations, engineering, ?nancial information, procurement requirements,
purchasing manufacturing, customer lists, investors, employees, business and contractual
relationships, business forecasts, analyst reports, marketing plans and any additional non-public
information that the Disclosing Party provides.

The Con?dential Information disclosed under this Agreement is described as:

{00032038.1} 1

NIAID Ref. No. 2015-33448-5

DocuSlgn Envelope ID: 

For NIAID: proprietary information and data relating to the development of vaccines for
HIV, in?uenza, Ebola, MERS, Nipah, measles, mumps and pieornoviruscs and
development of broadly neutralizing monoclonal antibodies for prevention and therapeutic use.

For Collaborator: Moderna?s proprietary and con?dential information related to design and
manufacture of a messenger RNA platform and messenger RNA constructs for treatment and
prevention of disease, including without limitation, the design and manufacture ofa messenger RNA
platform and messenger RNA constructs related to the diseases referenced in this Section.?

3. All other terms and conditions ofthe Agreement shall remain unchanged.

SIGNATURES BEGIN ON NEXT PAGE

{00032038.1} 2

NIAID Ref. No. 2015-33448-6

DocuSign Envelope ID: 

IN WITNESS WHEREOF, each party has caused this Amendment No. 4 to Con?dential
Disclosure Agreement to be executed by its authorized representative.

ACCEPTED AND AGREED TO:

FOR NIAID: Digitally signed by Amy F. Petrik

Amy F. Petrik -s 

Amy Petrik, Date
Senior TTPS, TTIPO, NIAID, NIH

 

Mailing Address for Notices:

ATTN: CDA NIAID REF. NO. 2015-33448-4

TECHNOLOGY TRANSFER AND INTELLECTUAL PROPERTY OFFICE, NIAID
Suite 6D, MSC 9804, 5601 Fishers Lane

Roekville, MD 20852

Tel: 301-496-2644 Fax: 240-62131 17

 

OR ModernaTX, Inc. Docusmned by:
 Mimi.? Corporate Counse'l 2/4/9020
NAME OF AUTHORIZED SIGNATORY  Date

Mailing Address for Notices:

ModernaTX, Inc.

Attn: General Counsel
200 Technology Square
Cambridge, MA 02139

{00032038.1} 3

NIAID Ref. No. 2015-33448-5

PUBLIC HEALTH SERVICE

COOPERATIVE RESEARCH AND DEVELOPMENT AGREEMENT

This Agreement is based on the model Cooperative Research and Development Agreement
adopted by the US. Public Health Service Technology Transfer Policy
Board for use by components of the National Institutes of Health the Centers for Disease
Control and Prevention and the Food and Drug Administration which are
agencies of the PHS within the Department of Health and Human Services 

This Cover Page identifies the Parties to this CRADA:
The US. Department of Health and Human Services, as represented by
National Institute of Allergy and Infectious Diseases 
an Institute or Center (hereinafter referred to as the of the
NIH
and
Moderna Therapeutics, Inc.
hereinafter referred to as the ?Collaborator?,

having of?ces at 320 Bent Street. Cambridge. MA 0214],
created and operating under the laws of the State of Delaware.

PHS CRADA Agreement Ref. No. 2016?0005 MODEL ADOPTED June 18, 2009
Page 1 of 25 Cnn?dential Revised August I. 2012

COOPERATIVE RESEARCH AND DEVELOPMENT AGREEMENT
Article 1. Introduction

This CRADA between 1C and Collaborator will be effective when signed by the Parties, which
are identified on both the Cover Page and the Signature Page. The official contacts for the
Parties are identified on the Contacts Information Page. Publicly available information regarding
this CRADA appears on the Summary Page. The research and development activities that will
be undertaken by IC and Collaborator in the course of this CRADA are detailed in the Research
Plan, attached as Appendix A. The staffing, funding, and materials contributions of the Parties
are set forth in Appendix B. Any changes to the model CRADA are set forth in Appendix C.

Article 2. De?nitions

The terms listed in this Article will carry the meanings indicated throughout the CRADA. To the
extent a definition of a term as provided in this Article is inconsistent with a corresponding
definition in the applicable sections of either the United States Code (U.S.C.) or the Code of
Federal Regulations the de?nition in the U.S.C. or C.F.R. will control.

2.1 ?Affiliate? means any corporation or other business entity controlled by, controlling, or
under common control with Collaborator at any time during the term of the CRADA. For
this purpose, ?control? means direct or indirect beneficial ownership of at least ?fty
percent of the voting stock or at least fifty percent interest in the income of
the corporation or other business entity.

2.2 ?Background Invention" means an Invention conceived and first actually reduced to

practice before the Effective Date or Perrietarr Info
Proprietary Info i

 

2.3 ?Collaborator Materials? means all tangible materials not first produced in the
performance of the Research Plan that are owned or controlled by Collaborator and used
in the performance of the Research Pian.

2.4 ?Confidential Information? means confidential scienti?c, business, or financial
information disclosed or made available by or on behalf of a Party or its Affiliates to the
other Party or its Affiliates provided that the information does not include:

(3) information that is publicly known or that is available from public sources
through no fault of the receiving Party;

information that has been made publicly available by its owner;

to] information that receiving Party can establish is already known by the receiving
Party, or information that is independently created or compiled by the receiving
Party without reference to or use of the provided information; or

information that relates to potential hazards or cautionary warnings associated
with the production, handling, or use of the subject matter of the Research Plan.

PHS CRADA Agreement Ref. No. MODEL ADOPTED June 18, 2009
Page 2 of 25 Con?dential Revised August 1, 2012

 

 

 

 

 

2.5 ?Cooperative Research and Development Agreement? or means this
Agreement, entered into pursuant to the Federal Technology Transfer Act of 1986, as
amendedUS U.S.C. 3710a et seq), and Executive Order 12591 of April 10, 1987.

2.6 Data? means all recorded information first produced in the performance of the
Research Plan. PmpnetaW 

Propn'elary Info

2.7 Materials? means all new tangible materials first produced in the performance
of the Research Plan other than CRADA Data.

2.8 Subject Invention? means any Invention of either or both Parties, conceived
or ?rst actually reduced to practice in the performance of the Research Plan.

2.9 ?Effective Date? means the date of the last signature of the Parties executing this
Agreement.

2.10 ?Government? means the Government of the United States of America.

2.11 Materials? means all tangible materials not first produced in the performance of this
CRADA that are owned or controlled by 1C and used in the performance of the Research
Plan.

2.12 ?Invention? means any invention or discovery that is or may be patentable or otherwise
protected under Title 35 of the United States Code, or any novel variety of plant which is
or may be protectablc under the Plant Variety Protection Act. 7 U.S.C. 2321 at seq.

2.13 ?Patent Application? means an application for patent protection for a CRADA Subject
Invention with the United States Patent and Trademark Of?ce or the
corresponding patent-issuing authority of another nation.

2.14 ?Patent? means any issued United States patent. any international counterpart(s), and any
corresponding grantts) by a non?US. government in place of a patent.

2.15 ?Principal lnvestigator(s)? or means the person(s} designated by the Parties
who will be responsible for the scientific and technical conduct of the Research Plan.

2. '16 ?Research Plan" means the statement in Appendix A of the respective research and
development commitments of the Parties.

Article 3. Cooperative Research and Development

PHS CRADA Agreement Ref. No. 2016?0005 MODEL ADOPTED June 18, 2009

Page 3 of 25

Confidential Revised August 1. 2012

 

3.1

3.2

3.4

3.5

Performance of Research and Development. The research and development activities
to be carried out under this CRADA will be performed solely by and Collaborator
(including Valera LLC or another Affiliate of the Collaborator) unless specifically stated
elsewhere in this Agreement. The will be reSponsible for the scienti?c and technical
conduct of this project on behalf of their employers. Any Collaborator employees who
will work at IC facilities will be required to sign an agreement appropriately modi?ed in
view of the terms of this CRADA.

Research Plan. The Parties recognize that the Research Plan describes the collaborative
research and development activities they will undertake and that interim research goals
set forth in the Research Plan are good faith guidelines. Should events occur that require
modification of these goals, then by mutual agreement the Parties can modify them
through an amendment. according to Paragraph 13.6.

Use and Disposition of Collaborator Materials and Materials. The Parties agree to
use Collaborator Materials and Materials only in accordance with the Research Plan,
not to transfer these materials to.IPmp?9?aW '?lo lhird
parties except in accordance with the Research Plan or as approved by the owning or
providing Party, and, upon expiration or termination of the CRADA, to dispose of these
materials as directed by the owning or providing Party.

 

 

Third-Party Rights in Collaborator?s CRADA Subject Inventions. If Collaborator
has received (or will receive) support of any kind from a third party in exchange for
rights in any of Collaborator?s CRADA Subject Inventions. Collaborator agrees to ensure
that its obligations to the third party are both consistent with Articles 6 through 8 and
subordinate to Article 7 ofthis CRADA.

Disclosures to IC. Prior to execution of this CRADA, Collaboralor agrees to disclose to
IC all instances in which outstanding royalties are due under a PHS license agreement,
and in which Collaborator had a PBS license terminated in accordance with 37 C.F.R. 
404.10. These disclosures will be treated as Confidential Information upon request by
Collaborator in accordance with Paragraphs 2.4, 8.3, and 8.4.

Article 4. Reports

4.1

4.2

PHS CRADA
Page 4 of 25

Interim Research and Development Reports. The PIs should exchange information
regularly, in writing. This exchange may be accomplished through meeting minutes,
annual reports, detailed correspondence, and circulation of draft manuscripts.

Final Research and Development Reports. The Parties will exchange final reports of
their results within four (4) months after the expiration or termination of this CRADA.
These reports will set forth the technical progress made; any publications arising from the
research: and the existence of invention disclosures of potential CRADA Subject
Inventions andr'or any corresponding Patent Applications.

Agreement Ref. No. 2016-0005
Cari?ldential

MODEL ADOPTED June 18. 2009
Revised August 1. 2012

4.3

Fiscal Reports. If Collaborator has agreed to provide funding to IC under this CRADA
and upon the request of Collaborator, then concurrent with the exchange of final research
and development reports according to Paragraph 4.2, will submit to Collaborator a
statement of all costs incurred by K: for the CRADA. If the CRADA has been
terminated. IC will specify any costs incurred before the date of termination for which IC
has not received funds from Collaborator, as well as for all reasonable termination costs
including the cost of returning Collaborator property or removal of abandoned
Collaborator property, for which Collaborator will be responsible.

Article 5. Staf?ng, Financial, and Materials Obligations

5.1

5.2

5.3

5.4

PHS CRADA
Page 5 of 25

IC and Collaborator Contributions. The contributions of any staff, funds, materials,
and equipment by the Parties are set forth in Appendix B. The Federal Technology
Transfer Act of 1986, 15 U.S.C. prohibits from providing funds to
Collaborator for any research and development activities under this CRADA.

IC Staf?ng. No 1C employees will devote 100% of their effort or time to the research
and development activities under this CRADA. 1C will not use funds provided by
Collaborator under this CRADA for IC personnel to pay the salary of any permanent IC
employee. Although personnel hired by IC using CRADA funds will focus principally
on CRADA research and development activities, Collaborator acknowledges that these
personnel may nonetheless make contributions to other research and development
activities, and the activities will be outside the scope of this CRADA.

Collaborator Funding. Collaborator acknowledges that Government funds received by
Collaborator from an agency of the Department of Health and Human Services may not
be used to fund IC under this CRADA. If Collaborator has agreed to provide funds to 
then the payment schedule appears in Appendix and Collaborator will make payments
according to that. schedule. If Collaborator fails to make any scheduled payment, 1C will
not be obligated to perform any of the research and development activities Specified
herein or to take any other action required by this CRADA until the funds are received.
will use these funds exclusively for the purposes of this CRADA. Each Party will
maintain separate and distinct current accounts, records, and other evidence supporting its
financial obligations under this CRADA and, upon written request, will provide the other
Party a Fiscal Report according to Paragraph 4.3, which delineates all payments made
and all obligated expenses, along with the Final Research Report described in Paragraph
4.2.

Capital Equipment. Collaborator?s commitment, if any, to provide IC with capital
equipment to enable the research and development activities under the Research Plan
appears in Appendix B. If Collaborator transfers to IC the capital equipment or provides
funds for IC to purchase it, then lC will own the equipment. if Collaborator loans capital
equipment to IC for use during the CRADA, Collabomtor will be responsible for paying
all costs and fees associated with the transport, installation, maintenance, repair, removal,
or disposal of the eQUipment, and 1C will not be liable for any damage to the equipment.

Agreement Ref. No. 2016-0005
Con?dential

MODEL ADOPTED June 18. 2009
Revised August 1, 2012

Article 6. Intellectual Property

6.1 Ownership of CRADA Subject Inventions, CRADA Data, and CRADA Materials.
Subject to the Government license described in Paragraph 7.5, the sharing requirements
of Paragraph 8.1, and the regulatory filing requirements of Paragraph 8.2, the producing
Party will retain sole ownership of and title to all copies of CRADA Data; and all
CRADA Materials produced solely by its employeets}. The Parties will own jointly all
copies of CRADA Data and all CRADA Materials developed jointly. Ownership of all
CRADA Subject Inventions will follow inventorship, which will be determined in
accordance with US. patent law. CRADA Subject Inventions made solely by IC
employee(s) or by employee(s) of Collaborator shall be owned by the Government or
Collaborator, respectively. CRADA Subject Inventions made jointly by 1C employee(s)
and employeets) of Collaborator shall be jointly-owned by the Government and
Collaborator. 

 

 

Proprietary Info

 

 

 

6.2 Reporting. The Parties will report to each other in writing, generally within 60
days, each CRADA Subject Invention reported by their respective personnel, and any
Patent Applications filed thereon, resulting from the performance of the Research Plan.
Each Party will report all CRADA Subject Inventions to the other Party in sufficient
detail to determine inventorship, which will be determined in accordance with U.S. patent
law. These reports will be treated as Confidential Information in accordance with Article
8. Formal reports will be made by and to the Parenting and Licensing Of?ces identified
on the Contacts Information Page herein.

6.3 Filing of Patent Applications. Each Party will make timely decisions regarding the
filing of Patent Applicationsgon the CRADA Subject Inventions made solely by its
employee(s), and will notify the other Party in advance of filing. Collaborator will have
the first opportunity to file a Patent Application on joint CRADA Subject Inventions and
will notify PHS of its decision within sixty (60) days of an Invention being reported or at
least thirty (30) days before any patent filing deadline. whichever occurs sooner. If
Collaborator fails to notify PHS of its decision within that time period or notifies PHS of
its decision not to file a Patent Application, then PHS has the right to file a Patent
Application on thejoint CRADA Subject Invention. Neither Party will be obligated to
file a Patent Application. Collaborator will place the following statement in any Patent
Application it files on a CRADA Subject Invention: ?This invention was created in the
performance of a Cooperative Research and Development Agreement with the National
Institutes of Health, an Agency of the Department of Health and Human Services. The
Government of the United States has certain rights in this invention." If either Party files
a Patent Application on a joint CRADA Subject Invention, then the filing Party will
include a statement within the Patent Application that clearly identi?es the Parties and
states that the joint CRADA Subject Invention was made under this CRADA.

6.4 Patent Expenses. Unless agreed otherwise, the Party filing a Patent Application will be
responsible for all expenses and fees in connection with the preparation, filing,

PHS CRADA Agreement Ref, No. 20160005 MODEL ADOPTED June 18, 2009
Page f) of 25 Corr?a?enriel Revised August I, 2012

prosecution, and maintenance of any Patent applications and Patents. If a license to any
CRADA Subject Invention is granted to Collaborator, then Collaborator will be
responsible for all expenses and fees. past and future, in connection with the preparation,
filing, prosecution, and maintenance of any Patent Applications and Patents claiming
exclusively-licensed CRADA Subject Inventions and will be responsible for a pro-rated
share. divided equally among all licensees, of those expenses and fees for non-
exclusiver licensed CRADA Subject Inventions. Collaborator may waive its exclusive
option rights at any time, and incur no subsequent financial obligation for those Patent
Application(s) or Patent(sl

6.5 Prosecution of Patent Applications. The Party filing a Patent Application will provide
the non?filing Party with a copy of any official communication relating to prosecution of
the Patent Application within thirty {30) days of transmission of the communication.
Each Party will also provide the other Party with the power to inspect and make copies of
all documents retained in the applicable Patent Application or Patent file. The Parties
agree to consult with each other regarding the prosecution of Patent Applications directed
to joint CRADA Subject Inventions. I

 

 

 

Propn'elary Into

 

 

 

 

 Pmp'19?3r? 1f Collaborator elects to file and prosecute Patent
Applications on joint CRADA Su eject Inventions, then Collaborator agrees to use the
U.S.P.T.O. Customer Number Practice and/or grant PHS a power(s) of attorney (or
equivalent) necessary to assure PHS access to its intellectual property rights in these
Patent Applications. PHS and Collaborator will cooperate with each other to obtain

necessary signatures on Patent Applications, assignments. or other I
Propn'etary Into

 

 

 

 

 

 

Article 7. Licensing

7.1 Background Inventirms. Other than as specifically stated in this Article 7, nothing in
this CRADA will be construed to grant any rights in one Party?s Background lnventionl?s)
to the other Party, except to the extent necessary for the Parties to conduct the research
and development activities described in the Research Plan.

7.2 Collaborator?s License Option to CRADA Subject Inventions. With respect to
Government rights to any CRADA Subject Invention made solely by an IC
employee(s) for which a Patent ApplicatiOn was filed, PHS hereby grants to Collaborator
an exclusive option to elect an exclusive or nonexclusive development and
commercialization license and (ii) jointly by an IC employeets) and an employee(s) of
Collaborator for which a Patent Application was filed, PHS hereby grants to Collaborator
an exclusive option to elect an exclusive development and commercialization license
under the Government?s rights to such jointly made Invention. The license will be
substantially in the form of the appropriate model PHS license agreement and will fairly
reflect the nature of the CRADA Subject Invention, the relative contributions of the

PHS CRADA Agreement Ref. No. 2016?0005 MODEL ADOPTED June 18. 2009
Page 7 of 25 Confidential Revised August 1, 2012

Parties to the CRADA Subject Invention and the CRADA. a plan for the development
and marketing of the CRADA Subject Invention, the risks incurred by Collaborator. and
the costs of subsequent research and development needed to bring the CRADA Subject
Invention to the marketplace. The field of use of the license will not exceed the scope of
the Research Plan.

7.3 Exercise of Collaborator?s License Option. To exercise the option of Paragraph 7.2
Collaborator must submit a written notice to the PHS Patenting and Licensing Contact
identified on the Contacts information Page {and provide a copy to the IC Contact for
CRADA Notices) within three (3) months after either Collaborator receives written
notice from PHS that the Patent Application has been filed or (ii) the date on which
Collaborator files the Patent Application. The written notice exercising this option will
include a completed ?Application for License to Public Health Service Inventions? and
will initiate a negotiation period that expires Prom-Eta? '"fo lifter the exercise of the
option. If PHS has not responded in writing to the last proposal by Collaborator within
this Ipmp??atan? Iperiod, the negotiation period will be extended to expire two (2)
months after PHS so responds. during which period the Parties will work diligently and
in good faith to finalize the agreement. In the absence of Collaborator?s exercise of the
option. or upon election of a nonexclusive license, PHS will be free to license the
CRADA Subject Invention to others. These time periods may be extended at the sole
discretion of PHS upon good cause shown in writing by Collaborator.

 

 

 

7.4 Government License in IC Sole CRADA Subject Inventions and Joint CRADA
Subject Inventions. Pursuant to [5 U.S.C. 3710a(b)(l for CRADA Subject
Inventions owned solely by or jointly by IC and Collaborator, and licensed pursuant to
the option of Paragraph 7.2, Collaborator grants to the Government a nonexclusive,
nontransferable. irrevocable. paid-up license to practice the CRADA Subject Invention or
have the CRADA Subject Invention practiced throughout the world by or on behalf of the
Government. In the exercise of this license. the Government will not publicly disclose
trade secrets or commercial or financial information that is privileged or confidential
within the meaning of 5 U.S.C. 552(b)(4) or which would be considered privileged or
con?dential if it had been obtained from a non-federal party.

7.5 Government License in Collaborator Sole CRADA Subject Inventions. Pursuant to
15 U.S.C. for CRADA Subject Inventions made solely by an employee of
Collaborator, Collaborator grants to the Government a nonexclusive. nontransferablc.
irrevocable. paid-up license to practice the CRADA Subject Invention or

ave the CRADA Subject Invention practiced throughout the world by or on
a the Government for research or other Government purposes.

7.6 Third Party License. Pursuant to 15 U.S.C. if PHS grants to
Collaborator and its Af?liates an exclusive license to a CRADA Subject Invention made
solely by an IC employee or jointly with a Collaborator employee. the Government will
retain the right to require Collaborator to grant to a responsible applicant a nonexclusive.
partially exclusive, or exclusive sublicense to use the CRADA Subject Invention in
Collaborator's licensed ?eld of use on terms that are reasonable under the circumstances;

PHS CRADA Agreement Ref. No. 2016?0005 MODEL ADOPTED June 18. 2009
Page 8 of 25 Confidential Revised August I. 2012

7.7

7.8

7.9

or, if Collaborator fails to grant a license, to grant the license itself. The exercise of these
rights by the Government will only be in exceptional circumstances and only if the
Government determines the action is necessary to meet health or safety needs that. are
not reasonably satisfied by Collaborator, (ii) the action is necessary to meet requirements
for public use specified by federal regulations, and such requirements are not reasonably
satisfied by Collaborator; or Collaborator has failed to comply with an agreement
containing provisions described in 15 U.S.C. 3710a(c)(4)(B). The determination made
by the Government under this Paragraph is subject to administrative appeal and judicial
review under 35 U.S.C. 203(b).

Third-Party Rights in IC Sole CRADA Subject Inventions. For a CRADA Subject
Invention conceived prior to the Effective Date solely by an employee that is first
actually reduced to practice after the Effective Date in the performance of the Research
Plan, the option offered to Collaborator in Paragraph 7.2 may be restricted if, before the
Effective Date, PHS had ?led a Patent Application and has either offered or granted a
license or has executed a license in the CRADA Subject Invention to a third party.
Collaborator nonetheless retains the right to apply for a license to any such CRADA
Subject Invention in accordance with the terms and procedures of 35 U.S.C. 209 and 37
C.F.R. Part 404.

 

 

Proplielary Into

 

Article 8. Rights of Access and Publication

8.1

8.2

PHS CRADA
Page 9 of 25

Right of Access to CRADA Data and CRADA Materials. and Collaborator agree
to exchange all CRADA Data and to share all CRADA Materials.

Use of CRADA Data and CRADA Materials. The Parties will be free to utilize
CRADA Data and CRADA Materials internally for their own purposes, consistent with
their obligations under this CRADA. The Parties may share CRADA Data or CRADA
Materials with their Affiliates, agents, contractors, provided the obligations of this Article
8.2 are simultaneousl conveyed. For clarity, no rights under any Patents are granted by
one Party to the other Party by operation of this Section 8.2.

CRADA Data.

 

 

Proprietary Info

 

 

 

Agreement Ref. No. 2016-0005
Con?dential

MODEL ADOPTED une 18, 2009
Revised August 1. 2012

8.3

PHS CRADA
Page ID of 25

the extent permitted by law. each Party will have the right to use any and all CRADA
Data in and for any regulatory filing by or on behalf of the Party. Imp"Etary W0

 

Propn'elary Into

 

 

CRADA Materials.

 

Proprietary Info

 

 

 

 

Proplietary info Without limiting the foregoing. Collaborator acknowledges
that the basic research mission of PHS includes sharing with third parties for further
research those research resources made in whole or in part with NIH funding.
Consistent with this mission and the tenets articulated in ?Sharing of Biomedical
Research Resources: Principles and Guidelines for Recipients of NIH Research
Grants and Contracts?. December 1999. available at
tool.aspx, following publication either Party
may make available to third parties for further research those CRADA Materials
made jointly by both PHS and Collaborator. Notwithstanding the above. if those joint
CRADA Materials are the subject of a pending Patent Application or a Patent. the
Parties may agree to restrict distribution or freely distribute them. Either Party may
distribute those CRADA Materials made solely by the other Party only upon written
consent from that other Party or that other Party?s designee. Imp?Etary 

 

 

Proprietary info

 

 

Con?dential Information. Each Party agrees to limit its disclosure of Confidential
Information to the amount. necessary to carry out. the Research Plan, and will place a
confidentiality notice on all such information. A Party orally disclosing Confidential
Information to the other Party will summarize the disclosure in writing and provide it to
the other Party within fifteen (15) days of the disclosure. Notwithstanding the above.
failure to mark information as ?confidential? will not disqualify that information from
constituting ?Confidential In formation? under this Agreement if a reasonable person
would consider such information to be confidential based on the nature of such
information and the circumstances of disclosure. Each Party receiving Confidential
Information agrees to use it. only for the purposes described in the Research Plan. Either

MODEL ADOPTED June 18. 2009
Revised August I. 201?.

Agreement Ref. No. 2016?0005
Con?dential

 

 

8.4

8.5

8.6



PHS CRADA
Page 11 of 25

Party may object to the designation of information as Confidential Information by the
other Party.

Protection of Confidential Information. Confidential Information will not be
disclosed, copied, reproduced or otherwise made available to any other person or entity
without the consent of the owning or providing Party except as required by a court or
administrative body of competent jurisdiction. or federal law or regulation; provided,
however, that Collaborator may disclose Con?dential Information to its Affiliates,
employees, agents, who have signed confidentiality agreements or are otherwise bound
by confidentiality obligations at least as restrictive as those contained herein. Each Party
agrees to use reasonable efforts to maintain the confidentiality of Confidential
Information, which will in no instance be less effort than the Party uses to protect its own
Confidential Information. Each Party agrees that a Party receiving Confidential
Information will not be liable for the disclosure of that portion of the Confidential
Information which, after notice to and conSultation with the disclosing Party, the
receiving Party determines may not be lawfully withheld, provided the disclosing Party
has been given a reasonable opportunity to seek a court order to enjoin disclosure.

Protection of Human Subjects? Information. The research and development activities
to be conducted under this are not intended to involve human subjects or human
tissues within the meaning of 45 C.F.R. Part 46 and 21 CPR. Part 50. Should it become
necessary to utilise human subjects or human tissues, or to provide a Party with access to
information about identifiable human subjects. the Parties agree to amend this CRADA in
accordance with Paragraph 13.6 to ensure that the research and development activities
conducted hereunder will conform to the appropriate federal laws and regulations,
including but not Iimited to all applicable FDA regulations and HHS regulations relating
to the protection of human subjects.

Duration of Confidentiality Obligation. The obligation to maintain the confidentiality
of Confidential Information will expire at the earlier of the date when the information is
no longer Confidential Information as defined in Paragraph 2.4 or three (3) years after the
expiration or termination date of this CRADA. Collaborator may request an extension to
this term when necessary to protect Confidential Information relating to products not yet
commercialized.

 

Publication. Fromm? Info  the Parties are
encouraged to make publicly available the results of their research and development
activities hereunder. Before either Party submits a paper or abstract for publication or
otherwise intends to publicly disclose information about a CRADA Subject Invention.
CRADA Data or CRADA Materials, the other Party will have thirty (30) days to review
the proposed publication or disclosure to assure that Confidential Information is
perCted.  Propnetary Into

 

 

Propn'elary Into

 

MODEL ADOPTED June 18. 2009
Revised August I. 20l2

Agreement Ref. No. 2016?0005
Confidential

 

request in writing that the proposed publication or other disclosure be delayed for up to
thirty (30) additional days as necessary to file a Patent Application.

Article 9. Representations and Warranties

9.1

9.2

Representations of IC. 1C hereby represents to Collaborator that:

has the requisite power and authority to enter into this CRADA and to perform
according to its terms, and that lC?s official signing this CRADA has authority to do
so.

To the best of its knowledge and belief, neither lC nor any of its personnel involved
in this CRADA is presently subject to debarment or suspension by any agency of the
Government which would directly affect its performance of the CRADA. Should 
or any of its personnel involved in this CRADA be debarred or suspended during the
term of this CRADA. will notify Collaborator within thirty (30) days of receipt of
final notice.

 

Proprietary Info

 

 

 

Representations and Warranties of Collaborator. Collaborator hereby represents and
warrants to IC that:

Collaborator has the requisite power and authority to enter into this CRADA and to
perform according to its term 3, and that Collaborator?s official signing this CRADA
has authority to do so.

Neither Collaborator nor any of its personnel involved in this CRADA. including
Affiliates. agents, and contractors are presently subject to debarment or suspension by
any agency of the Government. Should Collaborator or any of its personnel involved
in this CRADA be dcbarred or Suspended during the term of this CRADA,
Collaborator will notify 1C within thirty {30} days of receipt of final notice.

Subject to Paragraph 12.3. and if and to the extent Collaborator has agreed to provide
funding under Appendix B, Collaborator is financially able to satisfy these
obligations in a timely manner.

Article 10. Expiration and Termination

10.1

PHS CRADA
Page l2 of 25

Expiration. This CRADA will expire on the last date of the term set forth on the
Summary Page. In no case will the term of this CRADA extend beyond the term
indicated on the Summary Page unless it is extended in writing in accordance with
Paragraph 13.6.

Agreement Ref. No. 2016?0005
Con?dential

MODEL ADOPTED June 18. 2009
Revised August 1, 2012

10.4

Article 



Termination by Mutual Consent. IC and Collaborator may terminate this CRADA at
any time by mutual written consent.

Unilateral Termination. Either or Collaborator may unilaterally terminate this
CRADA at any time by providing written notice at least sixty (60) days before the
desired termination date. lC may, at its option, retain funds transferred to before
unilateral termination by Collaborator.

Funding for IC Personnel. If Collaborator has agreed to provide funding for IC
personnel and this CRADA is mutually or unilaterally terminated by Collaborator before
its expiration, then Collaborator agrees that funds for that purpose will be available to 
or a period of six (6) months after the termination date or until the expiration date of the
CRADA. whichever occurs sooner. If there are insufficient funds to cover this expense.
Collaborator agrees to pay the difference.

New Commitments. Neither Party will incur new expenses related to this CRADA after
expiration, mutual termination. or a notice of a unilateral termination and will, to the
extent feasible, cancel all outstanding commitments and contracts by the termination
date. Collaborator acknowledges that IC will have the authority to retain and expend any
funds for up to one year subsequent to the expiration or termination date to cover any
unpaid costs obligated during the term of the CRADA in undertaking the research and
development activities set forth in the Research Plan.

Disputes

Settlement. Any dispute arising under this CRADA which is not disposed of by
agreement of the Principal Investigators will be submitted jointly to the signatories of this
CRADA. If the signatories, or their designees. are unable to jointly resolve the dispute
within thirty days after notification thereof, the Assistant Secretary for Health (or
hisr'her designee or successor) will propose a resolution. Nothing in this Paragraph will
prevent any Party from pursuing any additional administrative remedies that may be
available and, after exhaustion of such administrative remedies. pursuing all available

judicial remedies.

Continuation of Work. Pending the resolution of any dispute or claim pursuant to this
Article I l. the Parties agree that performance of all obligations will be pursued diligently.

Article 12. Liability

12.l

PHS CRADA
Page l3 01'25

NO WARRANTIES. EXCEPT AS SPECIFICALLY STATED IN ARTICLE 9, THE
PARTIES MAKE NO EXPRESS OR IMPLIED WARRANTY AS TO ANY MATTER
WHATSOEVER. INCLUDING THE CONDITIONS OF THE RESEARCH OR ANY
INVENTION OR MATERIAL, WHETHER TANGIBLE OR INTANGIBLE, MADE
OR DEVELOPED UNDER OR OUTSIDE THE SCOPE OF THIS CRADA, OR THE
OWNERSHIP, MERCHANTABILITY, OR FITNESS FOR A PARTICULAR
PURPOSE OF THE RESEARCH OR ANY INVENTION OR MATERIAL. OR THAT

Agreement Ref. No. 2016-0005
Confidential

MODEL ADOPTED June 13. 2009
Revised August I. 2012

12.2

A TECHNOLOGY UTILIZED BY A PARTY IN THE PERFORMANCE OF THE
RESEARCH PLAN DOES NOT INFRINGE ANY THIRD-PARTY PATENT RIGHTS.

Indemni?cation and Liability. Collaborator agrees to hold the Government harmless
and to indemnify the Government for all liabilities, demands, damages, expenses and
losses arising out of the use by Collaborator for any purpose of the CRADA Data,
CRADA Materials or CRADA Subject Inventions produced in whole or part by 1C
employees under this CRADA, unless due to the negligence or willful misconduct of IC,
its employees, or agents. The Government has no statutory authority to indemnify
Collaborator. Each Party otherwise will be liable for any claims or damages it incurs in
connection with this CRADA, except that IC. as an agency of the Government, assumes
liability only to the extent provided under the Federal Tort Claims Act. 28 U.S.C. Chapter
171.

Force Majeure. Neither Party will be liable for any unforeseeable event beyond its
reasonable control and not caused by its own fault or negligence, which causes the Party
to be unable to perform its obligations under this CRADA, and which it has been unable
to overcome by the exercise of due diligence. If a force majeure event occurs, the Party
unable to perform will notify the other Party. It will use its best efforts to
resume performance as quickly as possible and will suspend performance only for such
period of time as is necessary as a result of thcforce majeure event.

Article 13. Miscellaneous

13.]

13.2

13.3

PHS CRADA
Page 14 of 25

Governing Law. The construction, validity, performance and effect of this CRADA will
be governed by US. federal law, as applied by the federal courts in the District of
Columbia. If any provision in this CRADA con?icts with or is inconsistent with any
US. federal law or regulation, then the U.S. federal law or regulation will preempt that
provision.

Compliance with Law. IC and Collaborator agree that they will comply with, and
advise their contractors and agents to comply with, all applicable statutes, Executive
Orders. HHS regulations. and all FDA, CDC, and NIH policies relating to research on
human subjects (45 GER. Part 46. 21 CPR. Parts 50 and 56) and relating to the
appropriate care and use of laboratory animals (7 U.S.C. 2131 at seq; 9 C.F.R. Part 
Subchapter A). Additional information on these subjects is available from the HHS
Of?ce for Human Research Protections or from the NIH Office of Laboratory Animal
Welfare. Collaborator agrees to ensure that employees, contractors, and agents of
Collaborator who might have access to a ?select agent or toxin? (as that term is defined in
42 C.F.R. 73.4-73.5) transferred from is properly licensed to receive the ?select
agent or toxin?.

Waivers. None of the provisions of this CRADA will be considered waived by any Party
unless a waiver is given in writing to the other Party. The failure of a Party to insist upon
strict performance of any of the terms and conditions hereof, or failure or delay to

Agreement Ref. No. 2016-0005
Con?dential

MODEL ADOPTED June 2009
Revised August I. 2012

13.4

13.5

13.6

13.7

13.8

13.9

13.10

PHS CRADA
Page 15 of 25

exercise any rights provided herein or by law, will not be deemed a waiver of any rights
of any Party.

Headings. Titles and headings of the articles and paragraphs of this CRADA are for
convenient reference only. do not form a part of this CRADA, and will in no way affect
its interpretation.

Severability. The illegality or invalidity of any provisions of this CRADA will not impair,
affect. or invalidate the other provisions of this CRADA.

Amendments. Minor modifications to the Research Plan may be made by the mutual
written consent of the Principal Investigators. Substantial changes to the CRADA.
extensions of the term. or any changes to Appendix (I will become effective only upon a
written amendment signed by the signatories to this CRADA or by their representatives
duly authorized to execute an amendment. A change will be considered substantial if it
directly expands the range of the potential CRADA Subject Inventions. alters the scope
or field of any license option governed by Article 7. or requires a significant increase in
the contribution of resources by either Party.

Assignment. Neither this CRADA nor any rights or obligations of any Party hereunder
shall be assigned or otherwise transferred by either Party without the prior written
consent of the other 

 

 

 

Proprietary Info

 

Parties agree that the identity of the Collaborator is matenal to the performance of this
CRADA and that the duties under this CRADA are nondelegable. except as otherwise
provided in Article 3.1.

Notices. All notices pertaining to or required by this CRADA will be in writing, signed
by an authorized representative of the notifying Party. and delivered by first class.
registered. or certified mail. or by an express/overnight commercial delivery service.
prepaid and properly addressed to the other Party at the address designated on the
Contacts Information Page. or to any other address designated in writing by the other
Party. Notices will be considered timely if received on or before the established deadline
date or sent on or before the deadline date as verifiable by U.S. Postal Service postmark
or dated receipt from a commercial carrier. Notices regarding the exercise of license
options will be made pursuant to Paragraph 7.3. Either Party may change its address by
notice given to the other Party in the manner set forth above.

Independent Contractors. The relationship of the Parties to this CRADA is that of
independent contractors and not agents of each other or joint venturers or partners. Each
Party will maintain sole and exclusive control over its personnel and operations.

Use of Name; Press Releases. By entering into this CRADA, the Government does not

directly or indirectly endorse any product or service that is or will be provided. whether

ADOPTED June 18.
Revised August l.

2009
2012

Agreement Ref. No. 20160005
Con?dential

 

directly or indirectly related to either this CRADA or to any patent or other intellectual-
property license or agreement that implements this CRADA by Collaborator, its
successors, assignees, or licensees. Collaborator will not in any way state or imply that
the Government or any of its organizational units or employees endorses any product or
service. Each Party agrees to provide proposed press releases that reference or rely upon
the work under this CRADA to the other Party for review and comment at least seven (7)
days prior to publication. Either Party may disclose the Summary Page to the public
without the approval of the other Party.

13.11 Reasonable Consent. Whenever a Party? 5 consent or permission is required under this
CRADA. its consent or permission will not be unreasonably withheld.

13.12 Export Controls. Collaborator agrees to comply with US. export law and regulations.
If Collaborator has a need to transfer any CRADA Materials made in whole or in part by
1C. or Materials, or lC?s Con?dential Information, to a person located in a country
other than the United States, to an Af?liate organized under the laws of a country other
than the United States. or to an employee of Collaborator in the United States who is not
a citizen or permanent resident of the United States. Collaborator will acquire any and all
necessary export licenses and other appropriate authorizations.

13.13 Entire Agreement. This CRADA constitutes the entire agreement between the Parties
concerning the subject matter of this CRADA and supersedes any prior understanding or
written or oral agreement. Specifically. the Con?dential Disclosure Agreement (CDA),
executed between the Parties on 9 November 2015 (NIAID Ref. No. 2015-33448) is
hereby superseded and succeeded by the terms of this CRADA. The confidential
information exchanged between the Parties under the CDA shall be governed by the
terms of the CRADA as it relates to con?dentiality effective as of the date of execution of
the CDA.

13.14 Survivability. The provisions of Paragraphs 3.3. 3.4, 4.2. 4.3. 5.3. 5.4. 6.1?9.2, 10.3-

10.5. 11.1. 12.1-12.3. 13.1-13.3. 13.10 and 13.14 will survive the expiration or early
termination of this CRADA.

SIGNATURES BEGLN ON THE NEXT PAGE

PHS CRADA Agreement Ref. No. 2016-0005 MODEL ADOPTED June 18. 2009
Page 16 of 25 Con?dential Revised August 1.2012

PUBLIC HEALTH SERVICE
COOPERATIVE RESEARCH AND DEVELOPMENT AGREEMENT

SIGNATURE PAGE

ACCEPTED AND AGREED
BY EXECUTING THIS AGREEMENT. EACH PARTY REPRESENTS THAT ALL STATEMENTS MADE HEREIN
ARE TRUE, COMPLETE, AND ACCURATE TO THE BEST OF ITS KNOWLEDGE. COLLABORATOR
THAT IT MAY BE SUBJECT TO CRIMINAL, CIVIL, CR ADMINISTRATIVE PENALTIES FOR
KNOWINCLV MAKING A FALSE, FICTITIDUS, OR FRAUDULENT STATEMENT (JR CLAIM.


5%ij 

Hu?h Auchineloss, In, li/ID. Date

Principal Deputy Director
National Institute of Allergy and Infectious Diseases

F0 IC:

 

 

 

FOR COLLABORATOR:
gk [201 5
Stephen Hoge, MD. Date 1

President, Modema Therapeutics, Inc.

PI-IS CRADA Agreement Ref. No. 2016-0005 MODEL ADOPTED June 18, 21309
Page of 25 Con?dential Revised August 1. 2012

PUBLIC HEALTH SERVICE
COOPERATIVE RESEARCH AND DEVELOPMENT AGREEMENT

CONTACTS INFORMATION PAGE

 

CRADA Notices

For 10 For Collaborator:
Michael R. MOWatt. ATTN: Modems Legal Department
Director, Technology Transfer and Moderna Therapeutics. Inc.

Intellectual Property Of?ce 320 Bent Street
National Institute of Allergy and Cambridge, MA 0214]

Infectious Diseases
Suite 6D, MSC 9804 With a copy to:
5601 Fishers Lane Giuseppe (Pine) Ciaramella
Rockville. MD 20852 Chief Scienti?c Officer. Valera LLC
Tel: 301-496-2644 500 Technology Square. 7&1 Floor
Fax: 240?627-311 17 Cambridge. MA 02l39

Patenting and Licensing

For lC: For Collaborator (if separate from above):
Division Director. Division of Technology Same as above

Development and Transfer
NIH Of?ce of Technology Transfer
60]} Executive Boulevard. Suite 325
Rockville. Maryland 20852?3804
Tel: 301?496-7057
Fax: 301-402-0220

Delivery of Materials Identi?ed in Appendix (if any)

For 1C: For Collaborator:

Barney Graham. MD. Giuseppe (Pino) Ciaramella. 

Building 40 Room 2502 Chief Scientific Of?cer. Valera LLC

40 Convent Drive 500 Technology Square. Floor

Bethesda. MD 20814 Cambridge. MA 02139

Tel: 301-594-8436 Tel: 209-5818

PHS CRADA Agreement Ref. No. MODEL ADOPTED June IS. 2009

Page 18 of 25 Con?dean Revised August 1. 2012

PUBLIC HEALTH 
COOPERATIVE RESEARCH AND DEVELOPMENT AGREEMENT

SUMMARY PAGE

PARTY MAY, WITHOUT FURTHER CONSULTATION OR PERMISSION,
REIEASE THIS SUMMARY PAGE TO THE PUBLIC.

TITLE OF CRADA: The use of Moderna Therapeutic, Inc.?s Proprietary messenger RNA
technology for the development of HIV-1 vaccine candidates

PHS 1C Component: NIAID
IC Principal Investigator: Barney Graham, MD, John Mascola, Richard
Koup, MD: Peter D. Kwong. 

Collaborator: Modema Therapeutics, Inc.
Collaborator Principal Investigator: Giuseppe Ciaramella, 

TERM OF CRADA: Three (3) years from the Effective Date.

ABSTRACT OF THE RESEARCH PLAN:
Under a Cooperative Research and Development Agreement, Moderna Therapeutics, Inc. and the
National Institute of Allergy and Infectious Diseases will collaborate to develop vaccine
candidates for Human Immunodeficiency Virus type 1 (HIV-1) based on antigens developed by
the National Institute of Allergy and Infectious Diseases and using Moderna Therapeutics, Inc?s
propriety vaccine technology.

PHS CRADA Agreement Ref. No. 2016-0005 MODEL ADOPTED June IS, 2009
Page 19 of 25 Con?dential Revised August 1, 2012

APPENDIX A
RESEARCH PLAN

Title of the CRADA
The use of Moderna Therapeutics, Inc?s Proprietary messenger RNA for the development
of HIV-1 vaccine candidates

NIAID, NIH Principal Investigator
Barney S. Graham. MD, 
Richard Koup, MD
Peter D. Kwong, 
John R. Mascola, MD
Vaccine Research Center. NIAID

Collaborator Principal Investigator
Giuseppe Ciaramclla, 
Moderna Therapeutics. Inc.

Term of CRADA
3 years from the Effective Date

GOAL or THIS CRADA

The rinei al oal of this CRADA is to identify and optimize the next generation of 
vaccine antigens by enabling the accelerated expression and characterization of

cad molecules through Moderna?s technology. The gene constructs will be based on the
ongoing research on g?p?eanti gens by the VRC. described in several publications. The scope of
this CRADA, including any in vitro and in viva testing conducted by Drs. John Mascola, Rick
Koup, Peter Kwon and Barney Graham, members oftheir laboratories, and other VRC, 
investigators is strictly limited to the development and testing of Hlel antigen seqoences.
provided by NIATD. that utilize Moderna?s proprietary constructs.

 

 

 

 

INTRODUCTION

Vaccine development to induce broadly neutralizing antibodies (bNAbs) against HIV-1 is a
global health priority. Although potent bNAbs against the Pmpnetarr Info

ave been isolated from HIV-infected individuals, vaccination
strategies developed to date have failed to generate similar bNAbs.

 

 

 

 

 

 

Several major faet0rs contribute to the poor antigenicity of Env immunogens, including
conformational evasion, immunodorninance of non?neutralizing surfaces, glycan shielding of key
neutralizing epitopes, and high genetic variation. Generating stabilized, pre-fusion trimer
proteins may allow a solution fer conformational evasion and immunodominanee, and rapid
evaluation of iterative designs using technology may allow the glycosylation and genetic

PHS CRADA Agreement Ref. No. 2016?0262 MODEL ADOPTED June 18, 2009
Page 20 of 25 Con?dential Revised August 1. 2012

variation issues to be addressed to achieve the goal of inducing bNAbs.

The aim of this collaboration is to discover antigens that can induce broadly neutralizing
antibodies, or stimulate bNAb lineages that can be detected by sequencing of cell transcripts,
following vaccination with Moderna?s technology. Modema?s technology will
be used to accelerate the design~to~test cycle for the discovery of these novel HIV antigens,
as well as to test the preclinical efficacy of an vaccine encoding for these proteins.

plan:

EXPERTISE OF THE PARTIES

VRC investigators have extensive experience in leading research efforts related to the structural
basis of antibody-based virus neutralization and to vaccine development more broadly.
Additionally, they have been involved in the design, planning, and execution of numerous
clinical trials in virology and immunology, and have been involved with the clinical evaluation
of candidate HIV vaccines for over 25 years. NIAID has identified several approaches to
stabilizing the trimeric HIV envelope in conformations known to expose neutralization-sensitive
epitopes.

Moderna Therapeutics, Inc. (?Moderna?), along with its affiliate focused on infectious disease,
Valera LLC (?Valera?), has assembled a highly experienced team of senior level executives and
scientists who have extensive experience and a proven track record in the development of
vaccines. Moderna?s functional expertise includes areas of pro-clinical and clinical research and
development, regulatory, manufacturing, and product quality control and assurance.
Scientifically, Modema?s team, led by Dr. Giuseppe Ciaramella as Chief Scienti?c Officer of
Valera, has been involved with the development of vaccines across several global leaders in the
field, including Pfizer, Merck, Boehringer Ingelheim. Novartis, and AstraZeneca. In addition, the
Moderna team has specific experience in selecting, formulating, and validating antigens for
encoding in vaccines. Moderna?s vaccine development efforts have spanned various
infectious diseases. and include world-class expertise in construct production
optimization, up to and including drug product manufacturing in order to bring clinical
candidates forward through regulatory processes in the US and EU. Moderna?s expertise in
vaccines will facilitate and accelerate the development of vaccines against HIV-
1.

EXPERIMENTAL PLAN

The experimental details that follow are approximate and may be changed upon mutual
agreement of NIAID and Moderna. Any substantive change to the Research Plan will be by
mutual agreement and written Amendment to this CRADA.

Several steps, listed below, are planned for the identification, production, and functional
characterization of antigens that can induce broadly neutralizing antibodies against HIV-1.
Broadly, the work is broken out into two phases, with Phase 1 acting as a gating mechanism
before initiating Phase 2.

Phase 1: Proof of Concept

PI-IS CRADA Agreement Ref. No. 2016?0262 MODEL ADOPTED June 18. 2009
Page 21 of 25 Con?dentiat Revised August I. 20l2

The goal of this phase of research is to test the underlying premises of this collaboration, namely:
ability of IAID to design genetic constructs that recapitulate the immunogenicity of soluble
trimers, (ii) ability of Moderna to produce vaccine product based on NIAID antigen polypeptide
sequences: and preliminary readout of HIV vaccine immunogenieity in. viva.
Proprietary Info

 

 

 

 

Phase 2: Proiect Expansion Lead Discoverv

Execution of Phase 2 is dependent upon mutual agreement that Phase 1 proof ?of?concept was
Successfully met. The goal of Phase 2 is the iterative production and in. viva testing of 
antigens, utilizing vaccine?formulated Moderna 111RNA constructs.

 

Proprietary Info

 

 

 

PHS (TRADA Agreement Ref. No. 2016?0263 MODEL ADOPTED June IS. 2009
Page 22 01?25 Confidential Revised August 1. 2012

DESCRIPTION OF THE CONTRIBUTION AND RESPONSIBILITIES OF THE
PARTIES

Vaccine Research Center, NIAID

Polypeptide sequences for antigens

Animal models for in vivo inoculation

Immune response characterization

protein structural and antieenic analvsis
. . . Proprietary Info

Protein unmunogens tor

 

 

 

regimen studies

 

Moderna Therapeutics, Inc.

0 Optimization and production
- vaccine formulation for in vitro and injection into animals

Vaccine Research Center, NIAID AND Moderna Therapeutics, Inc.

0 Evaluate the results from Phase 1 in order to determine which antigen constructs, if
any, will proceed to Phase 2

IAID AND COLLABORATOR AGREEMENTS
The Confidential Disclosure Agreement executed by the Parties on 9 November 2015
(NIAID Ref. No. 2015?33448) is hereby superseded and succeeded by the terms of this CRADA.
The confidential information exchanged between the Parties under the CDA shall be governed
by the terms of the CRADA as it relates to confidentiality effective as of the date of execution of
the CDA.
RELATED INTELLECTUAL PROPERTY OF THE PARTIES

Collaborator Patents and Patent Applications:

The technology Collaborator intends to contribute for the work under the CRADA arises out of a
combination of numerous patents and patent families. and notjust one (or a few) patents.

NIAID Patent Applications

PCTIUS20 $048729 filed 4 September 2015. titled. ?Recombinant Envelope Proteins
and their Use"

PHS CRADA Agreement Ref. No. 2016?0262 MODEL ADOPTED June IS, 2009
Page 23 of 25 Revised August I. 2012

APPENDIX 

STAFFING, FUNDING, AND MATERIALSIEQUIPMENT CONTRIBUTIONS
OF THE PARTIES

Sto?ing Contributions:
will provide scienti?c staff and other support necessary to conduct the research and other

activities described in the Research Plan. [C?s scienti?c staff will include Principal
Investigator and technical staff.

 

. . . .
IC estimates {halal-:5? person?years of effort per year Will be required to complete the CRADA

research. 

 

 

 

Collaborator will provide scientific staff and other support necessary to conduct the research and
other activities described in the Research Plan. Collaborator?s scientific staff will include
Collaborator?s Principal Investigator and technical staff.

 

. Proan I 
Collaborator estimates that {are rerson-years of effort per year be requrred to complete the
Infn
CRADA research.

and in Contributions:

 

 

 

Collaborator agrees to provide funds in the amount of Jet year of the CRADA for to use to
acquire technical, statistical, and administrative support for the research activities. as well as to
pay for supplies and travel expenses. Collaborator will provide funds in equal annual
installments. The first installment will be due within thirty days of the Effective Date. Each
subsequent installment will be due within thirty {30) days of each anniversary of the Effective
Date. Collaborator agrees that 1C can allocate the funding between the various categories in

support of the CRADA research as 1C sees fit.

 

CRADA PAYMENTS:
Collaborator will make checks payable to the NIAID, will reference the CRADA number and
title on each check. and will send them via trackable mail or courier to:

NIAID CRADA CoordinatOr. TTIPO. NIAID
5601 Fishers Lane. Suite 6D
Rockville, MD 20852-9804

CRADA Travel Payments:

Travel arrangements for all Government staff will be made in accordance with the Federal Travel
Rules and Regulations, whether arranged by IC and funded using either appropriated funds or
CRADA funds. or arranged and funded directly by Collaborator.

Materials/Equipment Contributions:

PHS CRADA Agreement Ref. No. 2016-0262 MODEL ADOPTED June 18. 2009
Page 24 of 25 Cornidentrm Revised August 1. 2012

lC will provide to Collaborator the following lC Materials for use under this CRADA:

Polypeptide sequences for HlV?ltary

Protein 

 

Proprie

 

tarv

 

 

 

Proan

 

 

antigens

 

mmunogens, as needed for prime-boost regimens

Collaborator will provide to K: the following Collaborator Materials andfor capital equipment for
use under this CRADA:

Collaborator Materials:

including encoding for 

 

Propn'el

 

 

mti gens

1traecine formulation for in vitro transl?ection studies and in vivo animal studies

Capital Equipment:

None.

If either Party decides to provide additional Materials for use under this CRADA, those
Materials will be transferred under a cover letter that identifies them and states that they are
being prowided under the terms of the CRADA.

PHS CRADA
Page 25 of 25

Agreement Ref. No. 20lt?r0262
Con?dential

MODEL ADOPTED June 18? 2009
Revised August I. 2012

 

NIAID RECIPIENT MTA NUMBER. 2MB 1223

 

 

PUBLIC IlEAL'l?l?l SliRVlli?lii
MATERIAL TRANSFER AGREEMENT

This Material 'l?ransl'er Agreement (?MTJ?thl has been adopted For use by the National Institutes ol'llealtlt. the Food
and Drug Administration and the Centers tor Disease and Prevention. collectively referred to herein as the
Public lealth Service in all transfers ol? research material [Research Material] whether Pl IS is identi?ed
below as its Provider or Recipient.

Provider: Mariermr?t. Inc.

Recipient: Nitrirmnt fin-imme- tJAHergv and Infectious D?renses. Nitrirmui Institutes of


Provider agrees to transler to Recipient?s Investigator the following ?Research Material":

Sera from are mice that have been vaccinated with Provider?s investigational zika virus vaccine PTEDPEEW

placebo samples and 5 active samples).



THIS RESEARCH MATERIAL MAY NOT BE USED lN The
Research Material will only be used for research purposes by Recipient?s investigator in hisfher lahrnatoryr. 
the Research Project deseribed below. under suitable containment conditions. This Research Material will not
be used For commercial purposes such as screening. production or sale. For which a commercialization license
may be required. Recipient agrees to comply with all Federal rules and regulations applicable to the Research
Project and the handling ol'the Research Material.

Are the Research Materials ol'huntan origin?.?
_s__No
b. it" Yes in 2a. were Research Materials collected according to 45 CPR Part 46. "Protection

ot" ltnnan Subjects??

Yes Plenso provide Assurance Number:
No

3. This Research Material will be used by Recipient?s Investigator solely in connection with the following
research project (?Research Project?) described with speci?city as l?ollows {use an attachment page if
necessary}:

The sera will be tested in a reporter virus particle (RVP) assay to understand the con'elatioa with other commonly
used assays for neutralizing titer in which the sera have already been tested. The RVP assay is more sensitive
than plaque or Focus reduction assays.

4. In addition to and not in lieu ol'any other con?dentiality agreements between the Parties. either Party and its
Af?liates (?Disclosing Party?) may disclose Confidential Information {as de?ned below] to the other Party
("Receiving Party?) during the term of this Agreement. For purposes ol?this Agreement, ?Af?liate? means any
corporation or other business entity controlled by, controlling or under common control with a Party at my time
during the term ot'this Agreement; ?control? means direct or indirect bene?cial ownership of at least ?fty
percent ot? the voting stock ol'at least ?lly percent interest in the income oi" the corporation of

{0002339Ll} PHS MT A. Model

95 214 Page 1 of4
MAID Recipient

otlter business entity. Con?dential disclosed pursuant to this Agreement shall be governed only by
this Agreement and without regard for arty other con?dentiality agreements between the Parties. Neither Party,
when acting as the Receiving Party. will, either during or for a period oI Proprietary Info

I?Ihis Agreement, disclose to any third party the Disclosing Party?s Con?dential Information.
or use any Confidential litibrtturtion ofthc Disclosing Party for any purpose other than the perfonnance of
the Research Project. without the prior written authorization of the Disclosing Party. For purposes of this
paragraph 4, ?Con?dential Information" ot'Providcr includes. without limitation, information concerning the
Research Material and non-public technical. business and financial information relating to Provider and its
Atl'iliates. Each Disclosing Party will use reasonable efforts to mark or designate Con?dential 
provided in written or other tangible [brat as [or with a similar designation convey ing
con?dentiality}. Each Disolosin Party will use reasonable efforts to identify Con tidential Information which is
orally disclosed as at the time ofdisclosure. or in a writing marked as
provided by the Disclosing Party within thirty (30) days ofsuch disclosure.
Notwithstanding the above. to mark, identi f} or summarize information as ?Con?dential? shall not
disqualify such information li'om constituting ?Con?dential lnfornurtiorf1 herein where such information would
be reasonably expected to be treated in a con?dential manner under the circumstances ofdisclos are. Receiving
?arty"s obligations shall not extend to any part ofthe Confidential ot'a Disclosing Party: that
can be demonstrated to have been in the public domain or publicly known at the time ofdisclosurc; that can
be demonstrated to have been in the Receiving Party's possession (as evidenced by written record} or that can
be demonstrated to have been readily available to the Receiving Party from another source prior to the
disclosure; that becomes part of the public domain or publicly known by publication or otherwise, not due to
any unauthorized act by the Receiving Party: that can be demonstrated as independently developed or
acquired by Receiving Party without reference to or reliance upon such Con?dential in fonuation; or {at that is
required to be disclosed by law.

 

 

5. This Research Material represents a signi?cant investment on the part ot'l?rovidcr and is considered proprietary
to Provider. Recipient?s Investigator therefore agrees to retain control over this Research Material and further
agrees not to transfer the Research Material to other people not under her or his direct supervision without
advance written approval of Provider. All data, in [intention and results generated by Recipient from the
Research Project {the ?Results") shall be treated as Con?dential Information until published pursuant: to Section
7; provided that the Parties may use the Results for any internal purpose and Provider may disclose the Results
and Reports (de?ned below) in connection with regulatoryr or patent ?ling, or in contidcncu to Provider?s actual
or potential investors who are not pharmaceutical, biotech. or other companies primarily engaged in the
business of discovering. developing, ntanu?lcturing or the marketing ol'phannaceutical reduces, or to
Provider?s bona ?de third art - collaborators rvi Prorieta Info
Proprietary Info
be approved in advance by the Recipient. Upon completion ofthe Research Projch or upon
Provider?s request, Recipient shall furnish a report (?Report?) to Provider regarding the use of the Research
Material. Results and the status of tlte Research Project. Provider reserves the right to distribute the Research
Material to others and to use it for its own purposes. When the Research Project is completed or three (3) years
have elapsed. whichever occurs ?rst, the Research Material will be disposed ol'as directed by Provider.

      

  
  

   
         

 

h. This Research Material is provided as a servico to the research community. ?1 IS lililN Ci SUPPLIED TU
RECIPIENT WI'l'l-l NO WARRANTIESs OR ANY
WARRANTY OF OR FITNESS FOR A PARTICULAR
PURPOSE. Provider makes no representations that the use ofthe Research Material will not infringe any
patent or proprietary rights parties. No license is granted under this Agreement by either ptuty to the
other, either expressly or by implication. eseept tor Recipient's right to use the Research Material solely tor
purposes of the Research Project.

Provider agrees that Recipient may publish the Results irt peer-reviewed scienti?c journals or present these
Results at academic symposia or similar professional meetings in accordance with the tbtlowing provisions.
Such public disclosure may be made only alter Provider has had thirty (3U) days to review the proposed
disclosure to determine if it includes any Con?dential information or patentahlc invention, as de?ned under
United States patent law. Recipient will comply with Provider?s requests to remove its Con?dential
information from any proposed disclosure and Provider will trial-re a good faith cllorl to provide substitute
noncon?deutial int?bnnation. il?availablc. in the case that such is necessary for a publication to

Model
Page 2 old

Kill!) Recipleut

 

Ian-mum: Proprietary Info I

Proprietary Info

 

 

 

 

info In all oral presentations or written publications concerning the
Research Project, Recipient will achno?ledge Provider?s contribution ot?this Research Material 
1 

 

 

Proprietary Info

 

 

 

Provider and Recipient recognize that inventorship 1drill be determined udder U.S. patent law. info I

 

Proprietary Info

 

 

 

The undersigned Provider and Recipient expressly certify and at??nn that the contents of any statements made
herein are truthful and acourate.

't'his MTA shall he construed in accordance with Federal law as applied by the Federal courts in the District of
Columbia.

. This Agreement shall expire six (6) months from the date oflast signature. Either party shall have the right to
terminate this Agreement upon 30-day advance written notice to the other party. Notwithstanding. such
termination. the provisions of this Agreement shall survive termination other than with respect to Recipient?s
rights to continue the Research Project.

SIGNATURES BEGIN ON NEXT PAGE

M'l'fL Model
Page 3 ot'il

{00132339 I. 
915ch1
NIAID Recipient

MATERIAL TRANSFER AGREEMENT
SIGNATURE PAGE

FOR RECIPIENT:
Rec-rpm?: 

Barney Cir-alum], MD. 
Deputy Director. VRC

Dale:

Mailing Address For Materials:

Tel:   ..  .. . FM:

FOR PRDVIDER:

Pruvfdc?l' iv 

gl?nalure
Sac-7??  

i'ir'inted Name and $166 

Date:   

Mailing; Address;

 


 bti?aakm? . 03.11%  

W: 13317333! Fax: 

10002335? . a 
9512 14
lepicnt

 

July A mhm'rsz

can aims; 

Senior Advisor Technology 
NIAID

Dale:  
Mailing Address [in Notices:
Technology Trans fur and Intellectual Pmpurly Of?ce
National lnstiluti: and In fuctious Disuasus
5501 Fishers Lane, Suite 6D

Marylimd 20392-9804
Courier: Rockvillc, Maryland 20852?9304

Duly .r'l Hmurr'ard n1

@w5?rg c1: A.le Main?A

Tim?mu 'un'd' Trill.-
 i I  1.

Mailing Address 1hr Nolicm:

  l-?rm.

l?l IS MIA. Mudcl
l?agu :1 UN

RESEARCH COLLABORATION AGREEMENT

This Research Collaboration Agreement (?Agreement?) is between the National Institute of Allergy and
infectious Diseases which is a component of the National institutes of Health an
agency of the US. Department of Health and Human Services, having offices located at 5601 Fishers Lane,
Rockville, MD 20852, and ModernaTX, Inc. (??Modema? or ?Collaborator?), having a principal place of
business at 320 Bent Street, Cambridge, MA. 0214! and incorporated in the State of Delaware (collectively,
the ?Parties?]. This Agreement is neither a funding agreement as de?ned in 35 U.S.C. 2010)) nor a
cooperative research and development agreement authorized under the Federal Technology Transfer Act of
I986. as amended. 15 U.S.C. areas. and Executive Order [259] oprril It}, 1987. MAR) enters
into this Agreement pursuant to the authority of the Public Health Services Act of 1944, as amended (42
U.S.C. 241).

BACKGROUND
NIAID and Col Iaborator want to collaborate on a research project; and

2. MAID and Collaborator want to transfer between the laboratories of their investigators, during the
term of this Agreement, proprietary research materials required to conduct the research project.

TERMS AND CONDITIONS

Article 1 DEFINITIONS

l.l ?Affiliate? means any corporation or other business entity controlled by, controlling, or under
common control with Coilaborator at any time during the term of this Agreement For this purpose,
?control? means direct or indirect beneficial ownership of at least titty percent of the voting
stock Or at least fiin percent interest in the income of the corporation or other business entity.

1.2 ?Con?dential Information" includes scienti?c, business, or ?nancial information pertaining to
the Research Project (de?ned below) that is disclosed by Provider (de?ned below). Con?dential
Information does not include information that: is in the public domain other than as a result of a
disclosure by Recipient (de?ned below) or any of Recipient?s representatives in violation of this
Agreement; (ii) was in the possession of Recipient before disclosure by the Provider; is
acquired by Recipient train a third party having no obligation of con?dentiality to Provider; (iv) is
hereafter independently developed by Recipient, without reference to Con?dential Information
received them Provider; or Provider expressly authorizes Recipient to disclose.

1.3 ?Invention? means any invention or discovery that is or may be patentable or protectabie under
applicable laws.

1.4 ?Investigator? means the principal researcher designated by a Party to direct the Research Project.

LS ?Material? means Original Material, Progeny, and any material created by Recipient that
constitutes an unmodi?ed functional subunit of or product expressed by Original Material including
but not limited to subclon'of unmodi?ed cell lines, puri?ed or fractionated subsets, proteins
expressed by or monoclonal antibodies secreted by a hybridoma cell line.

1.6 ?Original Material" means a material provided by one of the Parties to be used in the Research
Project. 

1.7 ?Progeny? means unmodi?ed descendant from Material, such as virus Rom virus, cell from cell,
or organism from organism.

Research Collaboration Agreement Page I of ID
NIAID tModema 04.13.20?
MAID Ref. No. 2016-1424



1.8 ?Provider? means the Party that provides Original Material or discloses Con?dential information
to the other Party under this Agreement. "Provider" includes, with respect to Collaborator,
Affiliates of Collaborator.

l.9 ?Recipient? means the Party that receives Original Material or Con?dential lnfonnation from the
other Party under this Agreement. "Recipient" includes, with respect to Collaborator, Af?liates of
Collaborator.

0 ?Research Project" means the collaborative research described in Appendix A.

Article 2 COLLABORATIVE RESEARCH

NLAID and Collaborator agree to collaborate on the Research Project. The Investigators for NIAID
will be Barney Graham, MD, John Mascola, MD, Ted Pierson, and the Investigator for
Collaborator will be Scott Butler, 

2.2 Nothing in this Agreement will be construed to limit the freedom of either Party from engaging in
similar research with other parties, providing the research does not create a con?ict with the Parties?
obligations under this Agreement, especially with regard to Article 3.

2.3 The Parties recognize that the Research Project describes the collaborative research to be conducted
under this Agreement and that the goals set forth in Appendix A are good ?rith guidelines. if events
occur that require substantial modi?cation of the Research Project, the Parties may amend
Appendix A according to Paragraph 6.9 of this Agreement.

Article 3 PUBLICATIONS

3.1 Con?dential Information

Research Collaboration Agreement
NIAID minder-rm
olalPiersonr'Burler

3.1.1
3.1.2

Either Party may disclose or receive Con?dential Information under this Agreement

The Disclosing Party shall use reasonable efforts to mark Con?dential information in
any written document, memorandum, report, drawing, or other tangible
material as ?Con?dential Information? or ?Con?dential? and reduce oral disclosures of
Con?dential Information, or disclosures through observation of Con?dential information,
to a writing marked ?Con?dential lnforrnation? or ?Confidential? within 30 days after
disclosure to be considered Con?dential Information. Notwithstanding the above, failure
to mark information as ?Con?dential? will not disqualify that information from
constituting ?Confidential Inform ation" under this Agreement if a reasonable person would
consider such information to be con?dential based on the nature of such information and
the circumstances of disclosure.

3.1.3 Recipient will maintain Con?dential Information in confidence for a period of ?ve (5)
years from the Effective Date and will protect Con?dential Information with the same
degree of care as Recipient uses to protect its own Con?dential information but in no event

less than a reasonable standard of care.

Recipient may disclose Con?dential information to its and its employees.
consultants, or contractors to whom it is necessary to disclose this information for the
purpose of the Research Project; Recipient may make these only under terms
at least as restrictive as those specified in this Agreement. Recipient agrees that disclosure
of Con?dential Information may not be made to any party not listed herein unless Provider
grants prior written approval to Recipient.

3.1.4

3.1.5 Recipient may disclose Provider?s Con?dential lnfonnation if required to do so by law,

regulation, or court order. If Recipient, or anyone to whom it discloses Confidential

Page 2 of 10
04.13.2015
NIAID Ref. No. 2016-1424

3.1.6

3.2


3.2.2

Article 4
4.1
4. I . I

4.1.2

Research Collaboration Agreement
NWD lModema


Information in accordance with Article 3, becomes legally required to disclose any
Con?dential information, Recipient will provide timely notice to Provider and, to the
extent practicable, consult with Provider prior to any disclosure.

Either Party may disclose the Abstract of the Research Project (in Appendix A) to the
public.

 

 

Proprietary Info

 

Publications; Press Releases

Publications

3.2.l.l In addition to the speci?c goals of the Research Proicct, the Parties view
dissemination of research ?ndings, both by publication and oral presentation, as
an essential objective of the Research Project. Authorship will be decided

according to commonly accepted conventions for scienti?c publications.

3 .2. .2 The Parties are encouraged to make publicly available the Results of the Research

Project.  Proprietary Info

 

 

Proprietary Info

 

 

 

Proprietary Info Before either
Party submits a paper or abstract for publication or otherwise intends to publicly
disclose infonnation about the Results or any Invention made in the course ot'the
Research Project, the other Party will have ?30 days to review proposed
manuscripts and 7 days to review proposed abstracts to ensure that Con?dential
Information andfor Inventions are protected. Either Party will have the right to
remove any Con?dential Information of that Party and its Af?liates from any
such proposed publication or other public disclosure and will make a good faith
effort to provide substitute information, if available, in the case that such
information is necessary for the proposed publication to proceed; Proprietary W0

 

 

Proprietary Info

 

 

 

addition, either Party may request in writing that the proposed publication or
other disclosure be delayed for up to 30 additional days as necessary to ?le a
patent application.

Press Releases
. Press releases that reference or rely upon the research under this Agreement will be made
available to the other Party for review and comment at least 7 days prior to publication.

DATA

Inventions

The Parties acknowledge the possibility that Inventions may be made in the 
of the Research Project. Ownership of such. inventions will follow inventorship, which
will be determined in accordance with applicable US. laws and regulations.

Inventions made in the perfonnanee of the Research Project will be owned by the Party
emotoying the inventor or inventors. Inventions made in the performance of the Research

Page 3 of 10
5
NIAID Ref: No. 2016- I424

Project that are invented jointly by employees of both Parties will be owned jointly. For
clarity, references to ?employeem? of a Party in this Section 4. shall include employees
and agents of such Party and its Af?liatcs that are conducting or performing activities as a
part of the Research Project.

4. I .3 Each Party will report to the other Party, in writing, all inventions made in the performance
of the Research Project no later than three months from the time the invention is
disclosed to a Party by its Investigator. The reports will be written in suf?cient detail to
determine inventorship and will be treated as Con?dential Information in accordance with
Article 3. The Parties will confer with each other regarding a patent ?ling strategy for
jointly made Inventions. If either Party ?les a patent application on a jointly made
Invention, then the ?ling Party will include a statement in the patent application that clearly
identi?es the Parties and states that the Invention was madejointly under this Agreement.

 

4. I _4 Proprietary lnio

 

 

 

4.2 Data

Upon the request of the other Party, each Party will disclose to the other Party a summary of all
data, information and results generated ??orn the use of the Material(s) in the performance of the
Research Project under this Agreement (?Results?). The Parties may use the Results for their own
intemai purposes, but shall otherwise maintain the Results in con?dence until published in
accordance with Article 3.2; provided that the Parties shall have the right to disclose the Results
prior to publication in connection with any regulatory or patent ?ling. urther, Collaborator shall
have the right to disclose the Results prior to publication to Col laborator?s actual or potential
investors who are not pharmaceutical, biotech, or other companies primarily engaged in the
business of discovering, developing, manufacturing or the marketing of pharmaceutical product,
Collaborator's bona ?de third party collaborators as of the Effective Date, Proprietary I
 Proprietary Info 

W0  and with prior written conSent of NIAID, bona ?de collaborators of
Collaborator arising after the Effective Date, provided that in each case such actual or
potential investors and third party collaborators are bound by written agreement to treat the Results
as con?dential and such written agreements contain con?dentiality obligations at least as restrictive
as those herein.

 

Article 5 THE TRANSFER AND USE OF MATERIAL
5.1 Mechanics of Transfer

Either Party may provide or receive Original Material under this Agreement. Provider will send
Original Material to Recipient with a cover letter as described in Appendix B. The letter will refer
to this Agreement and identify Original Material. if either Party transfers to the other Party a
material not listed in Appendix A, the Parties will amend this Agreement to include the additional
material.

5.2 Conditions of Use

5.2.1 RECIPIENT WILL NOT USE MATERIAL IN RESEARCH HUMAN
SUBJECTS.

Research Collaboration Agreement Page 4 of lo
NIAID rivloderna 64.] 3.11015
NIAID Ref. No. 2016-1424

5.2.2

5.2.3

5.2.4

5.2.5
5.2.6

5.2.7

5.2.8

Article 6
Effective Date
This Agreement will be effective on the date of the last authorized signature below.



6.2

6.3

Research Collaboration Agreement
NIAID Modems
GrahameascolafPiersonfButler

Recipient?s Investigator will use Material solely in connection with the Research Project
in the lnvestigator's laboratory. ll" Recipient wants to use Material for commercial
putposes, Recipient agrees to ?rst obtain the appropriate commercial use or
commercialization license from Provider.

Recipient agrees that Recipient?s Investigator will retain control over Material and further
agrees that Recipient?s Investigator will not transfer Material to people not under the
investigator's direct supervision without advance written annmwit mF pmuirlm-

Propnetary Info

 

 

Recipient will use Material in compliance with all applicable laws, regulations and policies.

Nothing in this Agreement shall restrict Provider from using or distributing its Original
Materials.

Upon lamination of this Agreement, Recipient agrees that Recipient?s Investigator will
return any and all remaining Original Material unless Provider gives Recipient?s
Investigator directions for disposing of Original Material by another means.

Nothing in this Agreement will be construed as conferring on Recipient any implied license
to Material, or option to license Material, any technology, or any patent or patent
application owned by Provider and will not create any obligation, by implication or
otherwise, of either Party to enter into any further agreement with the other Party.

TERMINATION AND GOVERNANCE

Term and Termination

6.2. I.

6.2.2

6.2.3

The Parties agree that this Agreement will be effective for one (I) year from the date of the
last authorized signature below and may be extended as mutually agreed by the Patties in
a written amendment to this Agreement.

This Agreement will terminate immediately upon the mutual agreement of the Parties in
Writing.

This Agreement will terminate in 30 days after either Party receives written notice of the
other Party?s desire to terminate this Agreement.

Representations, Warranties, and Liability



6.3.2

Material is understood to be experimental in nature and may have hazardous properties.
ORIGINAL MATERIAL IS BEING SUPPLIED T0 RECIPIENT WITH NO
WARRANTIES, EXPRESS OR IMPLIED, INCLUDING ANY WARRANTY OF
MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE.
Provider makes no representations that the use of Material will not in?-inge any patent or
other proprietary rights of third parties.

No indemni?cation for any loss, claim, damage, or liability is intended or provided by
either Party under this Agreement. Each Party will be liable for any loss, claim, damage.
or liability that the Party incurs as a result of its activities under this Agreement, except

Page 5 of IO
04.13.2015
NIAID Ref. No. 2016-1424

 

6.4

6.5

6.6



6.3

6.9

6.10

Research Collboration Agreement
NIAID iModema
Graham?Mascola?Piersonl'Butler

that NIAID, as an agency of the U.S. Government, assumes liability only to the extent
provided under the Federal Tort Claims Act, 28 267] etseq.

Assignment
Neither this Agreement nor any rights or obligations ofeither Party hereunder may be assigned or

 

 

otherwise trans?en-ed by either Party without the prior written consent of the other Party, Propn'et

 

Proprietary Info

 

 

Propn'elarr Info  This Agreement will be binding upon the Parties and their respective

 

successors and permitted assigns.
Non-endorsement

By entering into this Agreement, NIAID does not directly or indirectly endorse any product or
service that is or will be provided, whether directly or indirectly related to this Agreement, by
Collaborator, its successors, permitted assigns, or licensees. Collaborator will not in any way state
or imply that this Agreement is an endorsement of any such product or service by the US.
Government or any of its organizational units or employees.

Survivability

Articles 3, 4, 5.2, 6.3, 6.5, 6.6 and 6.3 will survive expiration or earlier lamination of this
Agreement.

Severahility

The illegality or invalidity of any provisions oflhis Agreement will not impair, affect, or invalidate
the other provisions of this Agreement.

Governing Law

The construction, validity, performance, and effect of this Agreement will be governed by federal
law as applied by the federal courts in the District of Columbia. Federal law and regulations will
preempt any con?icting or inconsistent provisions in this Agreement.

Entire Agreement

This Agreement, together with all appendices, constitutes the entire agreement between the Parties
and supersedes any prior or contemporaneous oral or Written agreements or communications
between them with respect to the subject matter hereof. This Agreement may be amended only by
written instrument signed by authorized representatives of and Collaborator.

Notices

All notices pertaining to or required by this Agreement shall be in writing, shall be signed by an
authorized representative and shall be delivered to the addresses indicated on the signature page for
each Party.

SIGNATURES BEGIN ON THE NEXT PAGE

Page 6 of lo
04.13.2015
Ref. No. acre-1424

 

FOR NIMD:
Mu; a a 
Vince JD 

Branch Chief, NIAID

Mailing Address for Notices:

ATTN: COLLABORATION AGREEMENT

TECHNOLOGY TIMNSFER AND PROPERTY OFFICE, 
Suite 60, MSC 9804, 5601 Fishers Lane

Roekville, MD 20352

Tel: 30 I 496-2644 Fax: 240-62T-3 1 l7

 

Acknowledgmentlg, live my


Barney Graham, 
Deputy Director, VRC, MW

John Mascola, MD 
Director, VRC, NIAID

 

Ted Pierson, MD
Chief, Viral Pathogenesis Section
Laboratory of Viral Diseases, NMID

FOR ModemaTX:

Pri?hd name 5 05??t? 
Title curt? suapruc-a. ?ancee? wan-6h; 

Mailing Address for Notices:
ModemaTX, Inc.

320 Bent Street

Cambridge, MA 0214]

Tel Fax:

945?le-

Date

525 2-02?

Date

02! FER ole! 7
Date

 

Date

ZZILIZZOW

Date

 

Aelmowledgme by/Modym? Investigator:

Scott 
Director of Virology and Project Leader
Valera LLC, an Af?liate of ModemaTX, Inc.

Research Collaboration Agreement
NIAID {Madonna


Z?q (2317

Date

Page of'H}
04.13.2015
N]le Ref: NO. 2016-1424

APPENDIX A

Research Proieet
Evaluation ol'an vaccine for Zika virus

I. Abstract of the Research Project for Public Release
MAY, WITHOUT FURTHER CONSULTATION on PERMISSION,
RELEASE nus ABSTRACT To THE PUBLIC.

NIAID and Modems will collaborate to evaluate immunogcnicity of an vaccine for Zika virus in
animal models.

Goal[s} of Project

The goals of this project are m:

 

0 Evaluate the immunogcnicity of a Zika virus [11 RNA info
I Determine ef?cacy of the vaccine Proprietary info I

 

 

Background

Zika virus (ZIKV) is a major public health threat for which there are currently no licensed vaccines or anti-
viral treatments. Infection with ZIKV, an enveloped, positive-stranded RNA virus from the Flaviviridae
family, can cause a infection characterized by fever, rash, arthralgia, headache, malaise,
muscle pain and periorbital pain. Importantlv, contraction onlKV during, has been associated
with birth defects, most notany microcephaly. The ZIKV outbreak in Brazil in 20i5 and subsequent
association with congenital discase led to a declaration ofa global health emergency. Therefore, accelerated
vaccine development is a high priority and rapidly acquiring information on immunogenicity and ef?cacy
of vaccine candidates is desirable. to this collaborative pr?ject, we will evaluate immunogenicity and
efficacy of a vaccine against info

 

 

The Vaccine Research Center, NIAID has extensive experience with the development of
vaccines against infectious diseaSes. In particular, has previoust developed avaccine against
West Nile virus, a ?avi virus related to Zika Virus and has evaluated two DNA vaccine candid ates for ZIKV.
Additionally, NIAID has also developed diagnostic assays to evaluate immunogenicity of vaccine
candidates and antibody neutralization.

Moderna has prior experience using as a vaccine platform, including for development of two
vaccines that are currently being evaluated in Phase I clinical trials, and they have deveIOped a proprietary
vaccine for ZiKlv'.

The purpose of these studies is to evaluate immunogenicity and ef?cacy of a vaccine for ZIKV

 

 

Propnetarv Info

 

 

Research Collaboration Agreement Page ii of in
MAID Modem 04.13.2015
Ref. No. 2016-1424

IV.

ii.

V.

RC, ?ml:

Original Materials Contributed by the Parties

VRC. MAID Original Material:
II Zikn virus challenge stock
0 Reagents for serol ogicai assays

Collaborator Original Material:
Control vaccine
I- Modema's proprietary Zika Virus vaccine

Respective Contributions of the Parties

Proprietary Info

 

 

will:

VI.

The Parties will work together to plan these experiments and discuss the results.

 

 

Proprietary Inio

 

 

Experimental Plan

 

Proprietary Info

 

 

Research Collaboration Agreement
NIAID 
Gmhan?MaseolafPiersnm?Buller

Page 9 of It}
04.13.20l5
MAID Rel?. No. ZONE-I424

 

 

APPENDIX 

Sample Material Transfer Cover Letter

A sample tellerfoli'ows.

 

RE: TRANSFER OF Mareamus) UNDER COLLABORATION AGREEMENT BETWEEN NIAID ann

{mien  DATED {mm

Dena on. [Ham 

The Marlena ?f?w  Dim noses) or Colinhm] is pleased to
provide you with the following materiallslifm The mate'ialls) dwelt)de by than!
me], are being shipped tOyou by 

The material(s) may only be used for research conducted between NIAID and 
under the CollaboratiOn Agreement referenced above. In addition, you understand that any remaining
material(s) will be returned to or disposed of according to the written instructions
of .. when the Collabomtion Agreement expires, unless 
obtains permission from  to continue using the materials.

Please acknowledge receipt of die material{s) by signing below. At your earliest convenience,
please fax a copy of this letter to your technology transfer of?ce at -- -

 
 

 

 

   
   

I 

Sincerely,

Miami): 
Title
on:

Acknowledged by NIAIBIColiabm-ator Fl Recipient}

 

 

Signature Date

 

Printed Name and Title

Research Collaboration Agreement Page 10 of lo
NIAID Modems 04.l3.2015
Graham/MaseolslPiersonlBuiler Ref. No. ZONE-1424

Con?dential Disclosure Agreement

In order to protect con?dential information relating to research, development, business plans, and other
technology, which may be disclosed between them, the National Institute of Allergy and Infectious
Diseases, a component ofthe National Institutes of Health, an agency ofthe U.S. Department ofIIealth and
Human Services and Moderna TX, Inc. and the following Af?liates of ModernaTX, Inc.
(??Af?liate? means any corporation or other business entity controlled by, controlling, or under common
control with Collaborator at any time during the term of this Agreement. For this purpose, ?control? means
direct or indirect bene?cial ownership of at least ?fty percent of the votingr stock or at least ?fty
percent interest in the income of the corporation or other business Inf?

 

 

Ipmpnetaw Info kcollectively, the ?Collaborator?) (collectively the ?Parties? and
individually a ?Party?), intending to be legally bound as of the date of the last authorized Signature harem
(?Effective Date?), agree that: 

l. A Party (?Disclosing Party?) may disclose information to the other (?Receiving Party?) for the
purpose of assessing their interest in a research collaboration (the ?Purpose?). The Disclosing Parties are:
NIAID, NIH and Collaborator. The Receiving Parties are: NIAID, NIH and Collaborator.

2. The Parties? representatives for disclosing or receiving information (if known):
For NIAID, NIH: Dr. Jeffrey Cohen
For Collaborator: Giuseppe Ciaramella,
Leslie Johnson,

Shinu John, and other employees of the Collaborator as needed to ful?ll the Purpose.

The information disclosed under this Agreement (?Con?dential Information?) is described as:

NIAID, NIH may disclose results of in vitro and animal model studies of NLAID, 
candidate vaccines against Epstein Barr Virus and Herpes Simplex Virus

Ll)

Collaborator may disclose non-public technical, business and ?nancial information,
including third party information for which Collaborator has an obligation to maintain as
con?dential, relating to the research, design, manufacture, development, and
commercialization of messenger RNA and the use of for the treatment
and prevention of disease.

4. The Receiving Party shall use Con?dential Information of the Disclosing Party only for the
Purpose, and for no other purpose. The Receiving Party will not disclose the Con?dential Information of
the Disclosing Party to any person except its employees, consultants and contractors, to whom it is
necessary to disclose the Con?dential Information for the Purpose described above, and any such
disclosures shall be under terms at least as restrictive as those speci?ed herein. Any of the persons
mentioned above who are given access to the Con?dential Information shall be informed of this Agreement.
The Receiving Party shall protect the Con?dential Information by using the same degree of care, but no
less than a reasonable degree ofcare, as the Receiving Party uses to protect its own con?dential information.

5. The Receiving Party?s duties under this Agreement shall apply only to Con?dential Information in
any written document, memorandum, report, correspondence, drawing, or other tangible material, or
computer software or program, developed or prepared by the Disclosing Party or any of its representatives
that has been clearly marked ?Con?dential? by the Disclosing Party. Oral disclosures must be reduced to

Con?dential Disclosure
Agreement Page 1 of 3
NIAID No. 2017?0492 modi?ed June 16, 2014

writing (this may be by summary email or other electronic communication) and marked ?Con?dential?
within thirty (3 0) days after disclosure to be considered Con?dential Information.

6. Notwithstanding any other provision of this Agreement, Con?dential Information shall not include
any item of information, data, patent or idea that: is within the public domain prior to the time of the
disclosure by the Disclosing Party to the Receiving Party or thereafter becomes within the public domain
other than as a result of disclosure by the Receiving Party or any of its representatives in violation of this
Agreement; was, on or before the date of disclosure in the possession of the Receiving Party; is
acquired by the Receiving Party from a third party not under an obligation of con?dentiality; is hereafter
independently developed by the Receiving Party, without use of or reference to the Confidential
Information received from the Disclosing Party; or the Disclosing Party expressly authorizes in writing
the Receiving Party to disclose.

7. At the request of the Disclosing Party, the Receiving Party agrees to return or destroy all
Con?dential Information received from the Disclosing Party except that the Receiving Party may retain in
its con?dential files one (I) copy of written Confidential Information for record purposes only.

8. If the Receiving Party, or anyone to whom it discloses the Confidential Information in accordance
with Paragraph 4, becomes legally required to disclose any of the Con?dential Information, the Receiving
Party shall, to the extent practicable, provide the Disclosing Party with timely notice and, to the extent
practicable, consult with the Disclosing Party prior to any disclosure.

9. This Agreement is to be made under and shall be construed in accordance with Federal laws as
applied by the Federal Courts in the District of Columbia, and constitutes the entire understanding between
the Parties with respect to the subject matter hereof and merges any and all prior agreements, understandings
and representations. The Agreement may not be superseded, amended or modified except by written
agreement between the Parties. This Agreement will control the disclosure of Confidential Information for
a disclosure period beginning on the Effective Date and expiring one (1) year thereafter, and the remaining
terms and conditions of this Agreement will expire four (4) years from the Effective Date. Either party
may terminate this Agreement upon thirty (3 0) days written notice to the other Party.

10. This Agreement may be executed in counterparts, each of which shall be deemed an original, and
all of which, taken together, shall constitute one and the same instrument. A facsimile, scanned electronic
signature or certified electronic signature shall be as effective as an original signature.

ModernaTX, Inc. National Institute of Allergy and Infectious
320 Bent Street Diseases
Cambridge, MA 0214] Technology Transfer and Intellectual
Property Of?ce
Suite 6D, MSC 9804
5601 Fishers Lane
Rockville, MD 20852
Authorized Signature: Authorized Signature:

I, the undersigned, hereby warrant that I have
the authority to legally bind ModernaTX Inc.
and its Af?liates, Valera LLC, Elpidera LLC,
Onkaitio LL/gr'and Caperaa LLC, under this Maryann T. Puglielli, J.D.,
Con?dential?Discl Agreement. Lead TDS, TTIPO, NIAID, NIH

 

Date: May 30,2017
 313me 1 Con?dential Disclosure

Agreement Sandor 03 Page 2 of 3
NIAID No. 2017-0 92 9 3 modi?ed June 16, 2014

 

 

Name:
Title: Acknowledged by NIAID Representative(s)
Con?dential Information:

 

Date:

 

 

Jeffrey 1. Cohen, M.D.,

Chief, Laboratory of Infectious Diseases, NIAID,
NIH

Date:

 

Con?dential Disclosure
Agreement Page 3 of3
No. 7?0492 modified June 16, 2014

 

 

 

NIAID PROVIDER TD FUR-PROFIT TRACKING NUMBER: 201' ?-0993

 

 

 

MATERIAL TRANSFER AGREEMENT

This Materiai Transfer Agreement has been adopted for use by the National Institute of Allergy and
Infectious Diseases an institute at the National Institutes of Health. which is part of the Department of
Health and Human Services, an agency ofthe United States Government (?Provider?) in transfers ofresearch material
to for-profit institutions for internal research.

Recipient: ModernaTX, lnc., having offices at 500 Technology Square Cambridge, MA D2i39, created and
operating under the laws of Delaware.

l. Provider agrees to transfer to Recipient?s Investigator the following Inateriallfs), including known functional
components or subunits and unmodified descendants thereoft?Research Material?}:

 

 

 

 

 

 

 

i NamefDescription Reference
RVP a EDNA Dowd et at, Cell Rep. 201-5 Aug 9; 16(6): 1485?--
expression construct expressing [491. (PMID: 2T48l466)
structural genes of ZIKV strain 
iti?i?tt??: DNA Ansarah-Sobrinho et al., Virology. 2003 Nov
expression construct expressing C-prl?vl-E ll]; 381(1 18801552)
structural genes of DENV strain Western
Pacific
a DNA Ansarah-Sobrinho et al., Virology. 2003 Nov
expression construct expressing C?prl?vI?E ll]; 38 $801552)
structural genes of DENV strain  668l
pFurin; a DNA expression construct expressing Davis ct al., Virol. 2006 Feb; 
human furin protease (PMID: [-54 5006)
Regimens]: a WNV Pierson et at, Virology. 2006 Mar 
lineage replicon expressing GFP and zeocin 65. 16325883)
resistance
Repiicon?: pWN?v?lI-Rep-Ren-IB; a WNV Pierson er oi. Virology. 2006 Mar 
lineage replicon expressing Renilla luciferase 65. (PMID: 16325333)
and blasticidin resistance

 

 

 

 

2. THIS RESEARCH MATERIAL MAY NOT BE USED IN HUMAN The
Research Material will only be used for commercial research purposes by Recipient?s Investigator in hisr'her
laboratory, for the research project described below, under suitable containment conditions. The Resea reh Material
will not be used in any product offered for sale or processes for the manufacture thereof, including quality
controi procedures, or in commercial services for which a commercialization license from the National
Institutes of Health is required. The Research Material and methods of using the Research Material
are the subject of and foreign patent applications. Please contact the TTIPO, NIAID, if information is
desired concerning the present status of this invention or how to license the Research Material andror patents
covering the Research Material. The HHS Reference number to these inventions is E-lBl-Z?lof?.

Recipient agrees to comply with all laws, rules and regulations applicable to the Research Project and the handling
of the Research Material.

a. ls the Research Material of human origin?

MAID FP-MTA {modified} NIAID 'l'raclting Number 20 l7?D?393
Page i ofd

 

 

 

 



NIAID {modified}

Ell/es 

b. it" Yes in 2a, was Research .?v?iaterial collected according to 45 C.F.R. Part 46, ?Protection oF Human
Subjects??r

DYes
Dixie

This Research Material will be used by Recipient?s Investigator solely in connection with the following research
project (?Research Project?) described with specificity as follows:

The Recipient will use the Research Material to perform neutralizing titer assays Info
4 an immuno enicit readout for several in vivo studies the Recipient will run in support of its
vaccine programs lnfo

In all oral presentations or written publications concerning the Research Project, Recipient will acknowledge
Provider?s contribution of this Research Material unless requested otherwise. To the extent permitted by law,
Recipient agrees to treat in confidence, for a period of three (3) years from the date of its disclosure, any of
Provider?s written infonnation about this Research Material that is stamped except for
information that was previously known to Recipient or that is or becomes publ iciy available or which is disclosed
to Recipient without a con?dentiality obligation. Any oral disclosures from Provider to Recipient shall be
identified as being CONFIDENTIAL by notice delivered to Recipient within ten {10} days after the date ofthe
oral disclosure. Recipient may publish or otherwise publicly disclose the results cfthe Research Project, but if
Provider has given CONFIDENTIAL information to Recipient such public disclosure may be made only after
Provider has had thirty (30) days to review the proposed disclosure to determine if it includes any
CONFIDENTIAL information, except when a shortened time period under court order or the Freedom of
information Act pertains.

Please provide Assurance Number:

This Research Material represents a signi?cant investment on the part oi" Provider and is considered proprietary
to Provider. Recipient therefore agrees that Recipient?s Investigator will retain control over this Research
Material and further agrees that Recipient?s investigator will not transfer the Research Material to other people
not under her or his supervision without advance written approval of Provider. Provider reserves the right to
distribute the Research Material to others and to use it for its own purposes. When the Research Project is
completed, or this RITA is terminated, or nine (9) months have elapsed, whichever occurs ?rst, the
Research Material will be returned to the Provider or disposed of as directed by Provider. Ifthe Recipient
depletes its supply of Research Material or destroys the Research Material pursuant to this Paragraph 4
Recipient will so notify Provider in writing.

This Research Material is provided as a service to the research community. IT is BEING SUPPLIED T0
RECIPIENT WITH NO WARRANTIES, EXPRESS OR IMPLIED, INCLUDING ANY
WTARRANTY 0F OR FITNESS FOR A PARTICULAR PURPOSE.

Provider makes no representations that the use oftlte Research Material will not in fringe any patent or proprietary
rights ofthird parties.

Recipient shall retain title to any patent or other intellectual property rights in inventions made by its employees
in the course of the Research Project. Recipient agrees not to claim, infer, or imply governmental endorsement
of the Research Project, the institution or personnel conducting the Research Project or any resulting product(s].
Each Party shall be responsible for its own negligence under this M'i?rk. Unless prohibited by law from doing so,
recipient agrees to hold the United States Government harmless and to indemnify the Government for all
liabilities, demands, damages, expenses and losses arising out of any third party claim or suit in connection with
the Recipient?s use for any purpose ofthe Research Material, except to the extent that any such liability, demand.
damage, expense or loss is attributable to Provider?s negligence.

The undersigned Provider and Recipient expressly certify and affirm that the contents of any statements made
herein are truthful and aCcurate.

'l'raclring Number 2t'il "3-0993
Page 2 oral

 

 

 

 

 

 

it}.

ll.

12.

13.

This MTA shall be construed in accordance with Federal law as applied by the Federal courts in the District of
Columbia.

In the event that Recipient wishes to use the Research Material for commercial purposes other than the
commercial research described in Paragraph 3 above, Recipient agrees to first obtain from NIH the appropriate
commercial use or commercialization license.

Either Provider or Recipient n1 ay unilaterally terminate this MTA at any time by giving written notice to the other
Party at least thirty (30) days prior to the desired termination date.

The provisions of Paragraphs 4, 5, 7, 9, and [2 ofthis MTA will survive expiration or termination.
This MTA may be executed in counterparts. each of which shall be deemed an original. and all of which. taken

together, shall constitute one and the same instrument. A t?acsimile? scanned electronic signature or certified
electronic signature shall be as ettective as an original signature.

. The Research Material will be used for the Research Project described in Article 3 only. The Research Material

will not be used in research projects:

involving collaboration with another for-pro?t organization;
sponsored or Funded by another l'or-prolit organization;
in which Recipient or Recipientis Investigator is obligated to assign inventions

containing the Research Material or offer an exclusive license to inventions containing
the Research Material to an organization other than Recipient or a contractor of" Recipient
that manages Recipient?s inventions on behait'of Recipient; or

(ti) in which Recipient or Recipient?s investigator is obligated to receive permission from an
organization other than Recipient before publicly disclosing results of research involving
the Research Material.

NOTE: lfRecipient wishes to use the Research Material in a research project that is forbidden above, Recipient
should contact the Technology Transfer and Intellectual Property Office 1National Institute rat?s-?allergy and
Infectious Diseases (MAID), to discuss whether permission to use the Research Material in such project can be
obtained.

NIAID {modified}

SIGNATURES BEGIN ON NEXT PAGE

NIAID Traci-ting Number Ell-ll ii-ti?ilgil
Page 3 oid

 

 

 

 

MATERIAL TRANSFER AGREEMENT
SIGNATURE PAGE

FOR RECIPIENT:

Recreate Ht ?3 we?

 

Signature

 
 

 

Scott Butler, 
Director of Virology 62 Project Leader

Date: 

 

Mailing Address for Materials:
Moderna
50G Technology Square

Cambridge. MA 02139
Attn: Brooke Bellman

 

Tel: (781)434-8246
Email: Scott.butler@valeratxtcom

FOR PROVIDER:

Provider '3 Investigator

 

Theodore Pierson, 

Chief, Viral Pathogenesis Section
Laboratory of Viral Diseases
NIAID

Date 

 

Mailing Address:
33 RM 2E19A2
33 North Drive
Bethesda= MD 20892

Tel: Fax: 

NIAID {modi?ed}

 

Dal rrt?orized
2H [yrs PM top/Q7

Sigh?ture 
Lift of, apt/311 EN.
. . I
Printed Name and Title

Date:  (is if) I 

Mailing Address for Notices:

Winder? 

?00 Technaleav Set var-L,
Combtra'rJq-L: Ma 
Tel: Gt?rtmunfrgif Fax:

 

 

 

Duly Authorized

Christopher M. Kornak -S 
Chris Kornak, M's.

Lead TTPS, Technology Transfer and Intellectual

Property Of?ce


(rr?ll 
arr-Cease
"il?dMCQ Iluol-r 5-

 
 
 
 

 

09?06?20 1 7
Date:

 

Mailing Address for Notices:

TECHNOLOGY 'I?aANsrsa AND INTEI .LFCTUAI.
PROPERTY OFFICE

NIH

Suite (SD, MSC 9304

5601 Fishers Lane

Reelwille1 MD 20352

301?496?2644 (Of?ce)

Tel: Fax: 3GIr'r4-02e7 23

Tracking Number 20 1 10993
Page 4 of?-

 

 

AMENDMENT NUMBER ONE TO
MATERIAL TRANSFER AGREEMENT

This Amendment Number One (the "First Amendment?} to the Material Transfer Agreement
Reference Number 20110993), having an effective date of September 18, 2017 is entered
into as of the date of last authorized signature hereto (the "First Amendment Effective Date?) and made
by and between National Institute of Allergy and Infectious Diseases, National Institutes of Health, with its
principal place of business at 5601 Fishers Lane, Suite 6D, MSC 9804, Rockville, MD 20352 (?Provider?) and
ModernaTX, lnc., having offices at 200 Technology Square Cambridge, MA 02139, created and operating
under the laws of Delaware (?Recipient?). Each of Provider and Recipient may be referred to herein
individually as a ?Party? and collectively as the "Parties."

WHEREAS, Provider and Recipient desire that the MTA be amended a first time as set forth below
in order to modify the scope of the MTA Research ProjectIPmPriElafY ?if?

Empnetary Info

 

 

Proprietary Info and

 

WHEREAS, the Parties have been operating under the MTA and desire to extend the term of MTA-
FP 2017-0993 by one month to July 18, 2013 while Company and NIAID conclude
negotiations/finelization of License Agreement A-261-2013 and corresponding MTA-FP 2018-
0664;3nd

WHEREAS, the Parties desire to amend the MTA as set forth in this First Amendment.

NOW, THEREFORE, the Parties hereby agree as follows:

1.

Unless otherwise defined herein, capitalized terms used in this First Amendment have the
meanings assigned thereto in the MTA.

This First Amendment may be signed by each Party separately on different signature
pages, and each document when fully signed by a Party and delivered shall constitute an
original instrument, and all such multiple signed documents shall constitute one and the
same instrument. This First Amendment shall be effective as of the date of the final
authorized signature hereto, the First Amendment Effective Date. Execution by the
Parties shall be by original signature, electronic signature, or copy of signature received
via portable document format and an electronic signature or a PDF signature shall
be deemed to be and shall be as effective as an original signature.

The description of the Research Project in paragraph 3 of the MTA is hereby deleted and
replaced by the following:

The Recipient?s use of the Research Material will be con?ned solely to the scope of "Zika
virus vaccine development? as limited to and de?ned by the BARBA-

funded Zika virus vaccine development award.

Paragraph 5 of the MTA is hereby deleted and replaced with the following:

Amendment Number One Page I
NIAID Reference 2016-09934

This Research Material represents a significant investment on the part of Provider and is
considered proprietary to Provider. Recipient therefore agrees that Recipient's
investigator will retain control over this Research Material and further agrees that
Recipient?s investigator will not transfer the Research Material to other people not under
her or his supervision 'without advance written approval of Provider. Provider reserves
the right to distribute the Research Material to others and to use it for its own purposes.
When the Research Project is completed, or this MT A is terminated, or on July 18, 2018.
whichever occurs first, the Research Material will be destroyed by the Recipient. If the
Recipient depletes its supply of Research Material or destroys the Research Material
pursuant to this Paragraph 5 Recipient will so notify Provider in writing.

5. Except as amended herein, all other terms and conditions of the MTA remain in full force
and effect.

The Parties hereby accept and agree to the terms and conditions of this First Amendment.

SIGNATURES BEGIN ON NEXT PAGE

Amendment Number One Page 2
NIAID Reference 2016-09934

IN WITNESS WHEREOF, the authorized Parties hereto have caused this First Amendment to be
duly executed and to be effective as of the First Amendment Effective Date.

National Institute of Allergy and Infectious Diseases, National Institutes of Health (?Provider?):

Benjamin E. Hurley Signed by Benjamin 5.
Hill-2r -5

Dm:2ou.us.15 Date: 15 JUNE 2018

 

 

Benjamin Hurley
NIAID, NIH

ModemeTX, Inc. (?Recipient?):

 \f0?  Date:  
Nan'ie Daflw? We 
Title Gum

 

 

Read 8: Understood by Recipient Investigator

 

 

  Date: Juan, 1% 1 3.0%
Kapii Bahl, -
Senior Scientist, ModernaTx, Inc.

Amendment Nomber One Page 3
NIAID Reference 2016?09934

AMENDMENT NUMBER TWO TO
MATERIAL TRANSFER AGREEMENT

This Amendment Number Two {the ?Second Amendment?} to the Material Transfer Agreement
Reference Number 2017-0993}, having an effective date of September 18, 2017' is entered
into as of the date of last authorized signature hereto [the "Second Amendment Effective Date?) and
made by and between National Institute ofAllergy and Infectious Diseases, National Institutes of Health, with
its principal place of business at 5501 Fishers Lane, Suite 60, MSC 9804, Rockville, MD 20852 ("Provider") and
ModernaTX, lnc., having offices at 200 Technology Square Cambridge, MA 02139, created and operating
under the laws of Delaware ["Recipient"). Each of Provider and Recipient may be referred to herein
individually as a "Party" and collectiver as the "Parties."

WHEREAS, Provider and Recipient desire that the MTA be amended a second time as set forth

 

 

below in order to modify the scope of the MTA Research Project Proprietary Info 
Proprietary Info I

 

lPropneIary Into I and

 

WHEREAS, the Parties have been operating under the MTA and desire to extend the term of MTA-
FP ZOE-0993 by two (2) months to August 18, 2018 while Company and NIAID conclude
negotiationsffinalization of License Agreement and corresponding MTA-FP 2018-
0664;and

WHEREAS, the Parties desire to amend the MTA as set forth in this Second Amendment.
NOW, THEREFORE, the Parties hereby agree as follows:

1. Unless otherwise defined herein, capitalized terms used in this Second Amendment have
the meanings assigned thereto in the MTA.

2. This Second Amendment may be signed by each Party separately on different signature
pages, and each document when fully signed by a Party and delivered shall constitute an
original instrument, and all such multiple signed documents shall constitute one and the
same instrument. This Second Amendment shall be effective as of the date of the final
authorized signature hereto, the Second Amendment Effective Date. Execution by the
Parties shall be by original signature, electronic signature, or copy of signature received
via portable document format (PDF) and an electronic signature or a PDF signature shall
be deemed to be and shall be as effective as an original signature.

3. The description of the Research Project in paragraph 3 ofthe MTA is hereby deleted and
replaced by the following:

The Recipient?s use of the Research Material will be con?ned solely to the scope of ?Zika
virus vaccine development? as limited to and de?ned by the HH50100201600029C BARDA-
funded Zika virus vaccine development award.

4. Paragraph 5 of the MTA is hereby deleted and replaced with the following:

Amendment Number Two Page I
NIAID Reference 2016-0993-2

This Research Material represents a significant investment on the part of Provider and is
considered proprietary to Provider. Recipient therefore agrees that Recipient?s
Investigator will retain control over this Research Material and further agrees that
Recipient?s Investigator will not transfer the Research Material to other people not under
her or his supervision without advance written approval of Provider. Provider reserves
the right to distribute the Research Material to others and to use it for its own purposes.
When the Research Project is completed, or this MTA is terminated, or on August 18,
2013, whichever occurs first, the Research Material will be destroyed by the Recipient.
If the Recipient depletes its supply of Research Material or destroys the Research
Material pursuant to this Paragraph 5 Recipient will so notify Provider in writing.

5. Except as amended herein, all other terms and conditions of the MTA remain in full force
and effect.

The Parties hereby accept and agree to the terms and conditions of this Second Amendment.

SIGNATURES BEGIN ON NEXT PAGE

Amendment Number Two Page 2
NIAID Reference 2016-0993-2

IN WITNESS WHEREOF, the autherited Parties hereto have caused this Second Amendment to be
duiy executed and to be effective as ofthe Second Amendment Effective Date.

National Institute of AIIergy and Infectious Diseases, Natienal Institutes of Health (?Previder?]:

maxim-um Mam-1E-

Benjamin E.
day-5
-

Hurley -5

 

Benjamin Hurleyr
TIPS, MAID, NEH

I ModernaTX, Inc. 

mam-xi..ch

mame' Daphne Van de 
Title Gourmet, Transactions

 

Read Understood by Recipient Investigator

 f) Date:

Kapil Bahl, 
SenierScientist, Moderna?, Inc.

Amendment Number Two
NIAJD Reference 2016-1210-2

Date:

July 16, 2013

 

Date:

1111)? 18, 2018



*1 in; in:

Page 3

IN WITNESS WHEREOF, the authorized Parties hereto have caused this Second Amendment to be
duly exeCUted and to be effective as ofthe Second Amendment Effective Date.

National Institute of Allergy and Infectious Diseases, National Institutes of Health (?Provider?):

Benjamln E- Hurley - 
- Date: July 16, 2013

 

 

Benjamin Hurley?r
TTPS, MIAID, NIH

ModernaTI, Inc. (?Recipient?):

  Date:     20 

Name

Title Daphne Van de 
Counsel, Transactions 

 

 

Read 84 Understood by Recipient Investigator

We} with?)

Kapil Bahl, Pho'.
Senior Scientist, ModernaTX, Inc.

Amendment Number Two - . Page 3
MAID Reference 2016-0993-2

RESEARCH COLLABORATION AGREEIWEN 

This Research Collaboration Agreement (?Agreement?) is between the National Institute of Allergy and
Infectious Diseases which is a component of the National Institutes of Health an
agency of the 13.5. Department of Health and Human Services, having of?ces located at 5601 Fishers Lane,
Rockville, MD 20852, and ModernaTX, Inc. (?Moderna? or ?Collaborator?), having a principal place of
business at 200 Technology Square, Cambridge, MA 02139 and incorporated in the State of Delaware
(collectively, the This Agreement is neither a funding agreement as de?ned in 35 U.S.C. 
201(b) nor a cooperative research and development agreement authorized under the Federal Technology
Transfer Act of 1936, as amended, 15 U.S.C. 3710a et seq., and Executive Order 12591 of April 10,
1987. NIAJD enters into this Agreement pursuant to the authority of the Public Health Services Act of
1944, as amended (42 U.S.C. 241). .

BACKGROUND
1. NIAID and Collaborator want to collaborate on a research project; and

2. NIAID and Collaborator want to transfer between the laboratories of their investigators, during the
term of this Agreement, proprietary research materials required to conduct the research project.

TERMS AND CONDITIONS

Article 1 DEFINITIONS

1.1 ?Af?liate? means any corporation or other business entity controlled by, controlling, or under
common control With Collaborator at any time during the term of this Agreement. For this purpose,
?control? means direct or indirect bene?cial ownership of at least ?fty percent of the voting
stock or at least fifty percent interest in the income of the corporation or other business entity.

1.2 ?Con?dential Information" includes scientific, business, or ?nancial information pertaining to
the Research Project (de?ned below) that is disclosed by Provider {de?ned below). Con?dential
Informntion does not include information that: is in the public domain other than as a result ofa
disclosure by Recipient (de?ned below) or any of Recipient?s representatives in violation of this
Agreement; (ii) was in the possession of Recipient before disclosure by the Provider; is
acquired by Recipient item a third party having no obligation of con?dentiality to Provider; (iv) is
hereafter independently developed by Recipient, without reference to Con?dential Information
received from Provider; or Provider expressly authorizes Recipient to disclose.

1.3 "Invention" means any invention or discovery that is or may be patentable or protectable under
applicable laws.

1.4 ?Investigator? means the principal researcher designated by a Party to direct the Research Project.

1.5 ?Material? means Original Material, Progeny, and any material created by Recipient that
constitutes an unmodified functional subunit of or product expressed by Original Material including
but not limited to subclones of unmodi?ed cell lines, puri?ed or fractionated subsets, proteins
expressed by DNAIRNA, or monoclonal antibodies secreted by a hybridoma cell line.

1.6 ?Original Material? means a material provided by one of the Parties to be used in the Research
Project.

?Progeny? means unmodi?ed descendent from Material, such as virus ??om virus, cell from cell,
er organism from organism.

Research Collaboration Agreement Page 1 of 
NIAID Modema 04. I 3.201 5
GrahamfI-Iimansu NIAID Ref. No. 2017-1179

1.8 ?Provider? means the Party that provides Original Material or discloses Con?dential Information
to the other Party under this Agreement. "Provider" includes, with respect to Collaborator,
Affiliates of Collaborator.

1.9 ?Recipient? means the Party that receives Original Material or Con?dential Information from the
other Party under this Agreement. ?Recipient? includes, with respect to Collaborator, Af?liates of
Collaborator.

1.10 ?Research Project" means the collaborative research described in Appendix A.

Article 2 COLLABORATIVE RESEARCH

2.1 NIAID and Collaboratcr agree to collaborate on the Research Project. The Investigator for NIAID
will be Barneyr Graham, MD, and the Investigator for Collaborator will be Sunny Himansu.

2.2 Nothing in this Agreement will be construed to limit the freedom of either Party from engaging in
similar research with other parties, providing the research does not create a conflict with the Parties?
obligations under this Agreement. especially with regard to Article 3.

2.3 The Parties recognize that the Research Project describes the collaborative research to be conducted
under this Agreement and that the goals set forth in Appendix A are good faith guidelines. If events
occur that require substantial modi?cation of the Research Project, the Parties may amend
Appendix A according to Paragraph 6.9 of this Agreement.

Article 3 PUBLICATIONS
3.1 Con?dential Information
3.1.1 Either Party may disclose or receive Con?dential Information under this Agreement.

3.1.2 The Disclosing Party shall use reasonable efforts to mark Con?dential Information in
any written document, memorandum, report, correspondence, drawing, or other tangible
material as ?Con?dential Information? or "Con?dential" and reduce cral disclosures of
Con?dential Information, or disclosures through observation of Con?dential Information,
to a writing marked ?Con?dential Information? or "Confidential" within 30 days after
disclosure to be considered Con?dential Information. Notwithstanding the above, failure
to mark information as ?Con?dential? will not disqualify that information from
constituting ?Con?dential Information? under this Agreement if a reamnable person would
consider such information to be con?dential based on the nature of such information and
the circumstances of disclosure.

3.1.3 Recipient will maintain Con?dential Information in con?dence for a period of ?ve (5)
years firm: the Effective Date and will protect Con?dential Information with the same
degree of care as Recipient uses to protect its own Con?dential Information but in no event
less than a reasonable standard of care.

3.1.4 Recipient may disclose Con?dential Information to its and its Af?liates' employees,
consultants, or connectors to whom it is necessary to disclose this information for the
purpose of the Research Project; Recipient may make these disclosures only under terms
at least as restrictive as those speci?ed in this Agreement. Recipient agrees that disclosure
of Con?dential Information may not be made to any party not listed herein unless Provider
grants prior written approval to Recipient.

3.1.5 Recipient may disclose Provider's Con?dential Information if required to do so by law,
regulation, or court order. If Recipient, or anyone to whom it discloses Con?dential
Information in accordance with Article 3, becomes legally required to disclose any

Research Collaboration Agreement Page 2 of I

NIAID Modems 04.13.2015
Gmhamfl'limensu NIAID Ref. No. 11'9

3.1.6

3.1.?r

3.2
3.2.1

3.2.2

Research Collaboration Agreement

MAID Modems

Graham?Himansu

Con?dential Information, Recipient will provide timer notice to Provider and, to the
extent practicable, consult with Provider prior to any disclosure.

Either Part3r may disclose the existence of the Agreement to the public but any further
information regarding the Research Project conducted under the Agreement will be limited
to the following language: and Mode-mo will collaborate to evaluate
immtmogenicinz of MRNA vaccines for Middle East Respiratory coronovr?ms
and Nina}: virus in animal models.?  Proplietarr Info

Proprietaryr lnlo

 l IUPI I

Proprietary lnlo

 

 

 

Publications; Press Releases

Publications

3.2.1.1 In addition to the speci?c goals of the Research Project, the Parties view
dissemination of research ?ndings, both by publication and oral presentation, as
an essential objective of the Research Project. Authorship will be decided

according to commonly accepted conventions for scienti?c publications.

The Parties are encouraged to make publiclv available the Results 0ftl15 
Project. lProprielary Info 
Proprietary Into

3.2.1.2

 

 

Pmp?emw IBefore either
Party submits a paper or abstract for publication or otherwise intends to publicly
disclose information about the Results or any Invention made in the course of the
Research Project, the other Party will have 30 days to review proposed
manuscripts and 7 days to review proposed abstracts to ensure that Confidential
Information andfor Inventions are protected. Either Party will have the right to
remove any Con?dential Information of that Party and its Af?liates from an)r
such proposed publication or other public disclosure and will make a good faith
effort to provide substitute information, if available, in the case that such
information is necessary for the proposed publication to proceed;

Proprietary lnlo

 

 

 

 

 

addition, either Party may request in writing that the proposed publication or
other disclosure be delayed for up to 30 additional days as necessary to ?le a
patent application. 

Press Releases

Press releases that reference or rely upon the research under this Agreement will be made
available to the other Party for review and comment at least days prior to publication.

Page 3 of I I
M.l3.20l5
NIAID Ref. No. 2017-??9

 

Article 4 DATA
4.1 Inventions

4.1.1 The Parties acknowledge the possibility that Inventions may be made in the performance
of the Research Project. Ownership of such Inventions will follow inventorship, which
will be determined in accordance with applicable U.S. laws and regulations.

4.1.2 Inventions made in the performance of the Research Project will be owned by the Party
employing the inventor or inventors. Inventions made in the performance of the Research
Project that are invented jointly by employees of both Parties will be owned jointly. For
clarity, references to ?employee(s)? of a Party in this Section 4.1.2 shall include employees
and agents of such Party and its Affiliates that are conducting or performing activities as a
part of the Research Project.

4.1.3 Each Party will report to the other Party, in writing, all Inventions made in the performance
of the Research Project no later than three (3) months from the time the invention is
disclosed to a Party by its Investigator. The reports will be written in suf?cient detail to
determine inventorship and will be treated as Con?dential Information in accordance with
Article 3. The Parties will confer with each other regarding a patent strategy for
jointly made Inventions. If either Party ?les a patent application on a jointly made
Invention, then the ?ling Party will include a statement in the patent application that clearly
identi?es the Parties and states that the Invention was made jointly under this Agreement.

 

4 4 

 

 

 

4.2 Data

Upon the request of the other Party, each Party will disclose to the other Party a summary of all
data, information and results generated from the use of the Material(s) in the performance of the
Research Project under this Agreement (?Results?). The Parties may use the Results for their own
internal purposes, but shall otherwise treat the Results as ?Con?dential Information? of the other
Party until published in accordance with Article 3.2; provided that the Parties shall have the right
to disclose the Results prior to publication in connection with any regulatory or patent ?ling.
Further, Collaborator shalt how the right to disclose the Results prior to publication to 
Collaborator?s actual or potential investors who are not pharmaceutical, biotech, or other
companies primarily engaged in the business of discovering, developing, manufacturing or the
marketing of pharmaceutical product, Collaborator?s bona tide third party collaborators as of
the Effective Date,  Pr0prietarr nf0

 

 

leP?ElaW had with the prior written consent of NIAID, bona ?de collaborators of
Uollaborator ansmg after the Effective Date, provided that in each case such actual or
potential investors and third party collaborators are bound by written agreement to treat the Results
as con?dential and such written agreements contain con?dentiality obligations at least as restrictive
as those herein.

 

Article 5 THE TRANSFER AND USE OF MATERIAL

5.1 Mechanics of Transfer
Either Party may provide or receive Original Material under this Agreement. Provider will send
Original Material to Recipient with a cover letter as described in Appendix B. The letter will refer

Research Collaboration Agreement Page 4 of 

NIAID Modems {14.13.2015
GrahamI?I-Iimansu NIAID Ref. No. 2017-1179

to this Agreement and identity Original Material. If either Party transfers to the other Party a
material not listed in Appendix A, the Parties will amend this Agreement to include the additional
material.

5.2 Conditions of Use

5.2.1 RECIPIENT WILL NOT USE MATERIAL IN RESEARCH INVOLVING HUMAN
SUBJECTS.

5.2.2 Recipient?s Investigator will use Material solely in connection with the Research Project
in the Investigator?s laboratory. If Recipient wants to use Material for commercial
purposes, Recipient agrees to ?rst obtain the appropriate commercial use or
commercialization license from Provider.

5.2.3 Recipient agrees that Recipient?s Investigator will retain control over Material and further
agrees that Recipient?s Investigator will not transfer Material to people not under the
lnvestigator?s direct supervision without advance written approval of Provider.

 

5 2 4 Proplielary Info

 

 

 

5.2.5 Recipient will use Material in compliance with all applicable laws, regulations and policies.
5.2.6 Nothing in this Agreement shall restrict Provider from using or distributing its Original
Materials.

Upon termination of this Agreement, Recipient agrees that Recipient?s Investigator will
return any and all remaining Original Material unless Provider gives Recipient?s
Investigator directions for disposing of Original Material by another means.

5.2.8 Nothing in this Agreement will be construed as conferring on Recipient any implied license
to Material, or option to license Material, any technology, or any patent or patent
application owned by Provider and will not create any obligation, by implication or
otherwise, of either Party to enter into any further agreement with the other Party.

Article 6 TERMINATION AND GOVERNANCE
6.1 E?'ective Date
This Agreement will be effective on the date of the last authorized signature below.

6.2 Term and Termination

6.2.1. The Parties agree that this Agreement will be effective for three (3) years from the date of
the last authorized signature below and may be extended as mutually agreed by the Parties
in a written amendment to this Agreement.

6.2.2 This Agreement will terminate immediately upon the mutual agreement of the Parties in
writing.

6.2.3 This Agreement will terminate in 30 days after either Party receives written notice of the
other Party?s desire to terminate this Agreement.

6.3 Representations. Warranties, and Liability

6.3.1 Material is understood to be esperimental in nature and may have hazardous properties.
ORIGINAL MATERIAL IS BEING SUPPLIED T0 RECIPIENT WITH NO

Research Collaboration Agreement Page 5 of 

NIAID Mariana 04.13.20?
Graham?l-limansu Ref. No. 2017-1??

 EXPRESS OR MLIED, INCLUDING ANY WARRANTY OF
MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE.
Provider makes no representations that the use of Material will not infringe any patent or
other proprietary rights of third parties.

6.3.2 No indemni?cation for any loss, claim, damage, or liability is intended or provided by
either Party under this Agreement. Each Party will be liable for any loss, claim, damage,
or liability that the Party incurs as a result of its activities under this Agreement, except
that NIAJI), as an agency of the US. Government, assumes liability only to the extant
provided under the Federal Tort Claims Act, 28 U.S.C. 2671 et seq.

6.4 Assignment

Neither this Agreement nor any rights or obligations of either Party hereunder may be assigned or
otherwise transferred by either Party without the prior written consent of the other Partv. Propn'etarl
Proprietary Info

 

 

 

 

Proprietarr Info  This Agreement will be binding upon the Parties and their respective
successors and penmtted assigns.

 

6.5 Non-endorsement

By entering into this Agreement, NIAID does not directly or indirectly endorse any product or
service that is or will be provided, whether directly or indirectly related to this Agreement, by
Collaborator, its successors, permitted assigns, or licensees. Collaborator will not in any way state
or imply that this Agreement is an endorsement of any such product or service by the US.
Govermnent or any of its organizational units or employees.

6.6 Survivability

Articles 3, 4, 5.2, 6.3, 6.5, 6.6 and 6.3 will survive expiration or earlier termination of this
Agreement.

6.7 Severability

The illegality or invalidity of any provisions of this Agreement will not impair, affect, or invalidate
the other provisions of this Agreement.

6.8 Governing Law

The construction, validity, performance, and effect of this Agreement will be governed by federal
law as applied by the federal courts in the District of Columbia. Federal law and regulations will
preempt any con?icting or inconsistent provisions in this Agreement.

6.9 Entire Agreement

This Agreement, together with all appendices, constitutes the entire agreement between the Parties
and supersedes any prior or contemporaneous oral or written agreements or communications
between them with respect to the subject matter hereof. This Agreement may be amended only by
written instrument signed by authorized representatives of NIAID and Collaborator.

6.10 Notices

All notices pertaining to or required by this Agreement shall be in writing, shall be signed by an
authorized representative and shall be delivered to the addresses indicated on the signature page for

each Party.
Research Collaboration Agreement Page 6 of 11
NIAID Modems 04.l3.2015

NIAID Ref. No. 2011-1179

 

SIGNATURES BEGIN ON THE NEXT PAGE

Research Collaboration Agreement Page '1 of 
NIAID Modems (14.13.2015

Gmhm?-Iimansn NIAID Ref. No. 2011-1179

FOR NIAID: I
Wee/31? .  Fl- j?j? 7
Date

Vincent JD -
Branch Chief, NIAID

Mailing Address for Notic:

ATTN: COLLABORATION AGREEMENT

TECHNOLOGY TRANSFER AND INTELLECTUAL PROPERTY OFFICE, NIAID
Suite 6B, MSC 9804, 5601 Fishers Lane

Rookville, MD 20852

Tel: 301?496-2644 1' Fax: 240-627-241 17

 
 
 

Aeknowledrators:
Barney G?fal?m, Mil?W Date
Deputy Director, vac, NIAID

 

FOR Modeme Inca

(J?ggcw ?jffl?a?i gr CK [Lariat]

Printed name Date
Title

 

Mailing Address for Notices:
Modema'l'X, Inc.

200 Technology Square
Cambridge, MA 02139

Te11+l?l7 679.5645 Far-H 6l7 553 [996?

Acknowledgment by Moderna?s Investigator:

.w We

Sunny Himansu Date
Sr. Manager, hfeetious Disease Research

F.de Collaboration Agreement Page 8 of! 

Modema 0413.20?
Gr?nn?iimansu NIAID Ref. No. 2011-] 179

APPENDIX A

Research Proiect
Evaluation of an vaccine for Zika virus

I. Abstract of the Research Project - for Public Release
PARTY MAY, WITHOUT FURTHER CONSULTATION OR PERMISSION,
RELEASE THIS ABSTRACT To THE. PUBLIC.

NIAID and Madame will collaborate to evaluate immunogenicity of vaccines for Middle East
Respiratory coronavirus and Nipah virus in animal models.

Goal(s) of Project

he goals ofthis project are to:

 

Propn'elarv Info
0

 

 

 

Ill. Background

and Nipab virus are potential epidemic threats and have been recognized on the World
Health Organization?s list of top emerging diseases liker to cause major epidemics and Coalition for
Epidemic Preparedness Innovations priority pathogens list. No vaccines to prevent or Nipah
virus infection are currently available. Thus, there is a need to rapidly develop vaccine candidates that
could be used to prevent and Nipah virus infection in case of an outbreak. Nucleic acid?
based vaccine platforms allow for rapid generation of vaccine candidates using reverse genetics. In this
collaborative project, we will evaluate immunogenicity of vaccines for and Nipah
vints in animal models.

The Vaccine Research Center, NIAID has extensive experience with the development of
vaccines against infectious diseases and structure-based design of vaccine candidates. In particular,
has developed stabilized profusion l'VIliJitS-Covr spike protein, which is more immunogenic
than wild-type or subunit proteins. This stabilized profusion protein is currently being evaluated in
preclinical studies. Based on the prior experience stabilizing the fusion (F) protein in its prefusion
conformation with the related respiratory virus and parain?uenza virus 3 (PIVS), the VRC has
designed stabilized Nipah proteins which are currently being evaluated in preclinical studies.

Modems has developed a proprietary vaccine platform, and has used this for development of

vaccines that are currently bein evaluated in Phase clinical trials. in addition, Moderna is evaluating a
RNA vaccine in animal models. Modems has also developed a

"It? 3 - I . . linical development which targets two viruses including PIV3 which is in
the same paramyxovirdiae family as Nipah virus.

The put-peso of these studies is to evaluate immunogenicity of vaccines for and
Nipah virus in animal models.

Research Collaboration Agreement Page 9 of it
NIAID Modems 5
Graham?-Iimansu NIAID Ref. No. l79

IV. Original Materials Contributed by the Parties

i. VRC, NIAID Original Material:
Including but not limited to:

 

Proprietary info

 

 

 

if. Collaborator Original Material:

 

Proprietary Info

 

 

 

V. Respective Contributions of the Parties

VRC, NIAID will:

 

Proprietary Info

 

 

Collaborator will:

 

Proprietary Info

 

 

Both Parties will:
0 Share data and materials
- Discuss results and plan next steps

 

 

 

 

VI. Experimental Plan
1 Proprietary Info
2
3.
4. Both parties will share and discuss the results.

Research Collaboration Agreement
NIAID Modems
Gmhanu'l-limanm

Page 

Ref. No. 

 

 

APPENDIX 
Sample Material Transfer Cover Letter

A sample letter follows.
Date

Provider Organization Name
Provider Organization Address
Tel:

Fax:

Recipient PI
Recipient Organization
Recipient Organization Address

RE: TRANSFER or Museums) UNDER Commentators AGREEMENT BETWEEN MAID AND
or DATED {monument}

DEAR DR. or NIAID PI on COLLABORATOR 

The [National Institute of Allergy and Infectious Diseases or Collaborator] is pleased to
provide you with the following material(s): [Describe The material(s) developed by [insert
name], are being shipped to you by [lillAIDfCollaborstor].

The materiai(s) may only be used for research conducted between NIAID and [Collaborator]
under the Collaboration Agreement referenced above. In addition, you understand that any remaining
material(s) will be returned to [NMIDlCoilaborator] or disposed of according to the Mitten instructions
of [NIAID/Collabomtor] when the Collaboration Agreement expires, unless [NiAlDlColIaborator]
obtains permission ?'om [NMIDfCoIlaborator] to continue using the materials.

Please acknowledge receipt of the materialfs) by signing below. At your earliest convenience,
please fax a copy of this letter to your technology transfer office at [NIAlDl?Collaborator].

Sincerely,
NIAID/Coliaborator [Provider]

Title
cc:

Acknowledged by NLAIDICollaborator PI [Recipient]

 

 

Signature Date

Printed Name and Title

Research Collaboration Agreement Page I I of 1 I
Modems 04. IJJBIS

Grehanu?l'limansu NIAID Ref. No. 20l1-l179

Research Collaboration Agreement 2017-1179

Amendment Number One (1)
The purpose of this Amendment is to change certain terms of the Research Collaboration Agreement (RCA) executed
May 14, 2019 between the National Institute of Allergy and Infectious Diseases (NIAID) and ModernaTX, Inc.
(?Modems?). These changes are re?ected below, and except for these changes, all other provisions of the original RCA
shall remain in full force and effect. This Agreement may be executed in one or more counterparts, each of which together
shall be deemed original but all of which together shall constitute one and the same document. A facsimile or Portable
Document Format (PDF) of the original signature of the representative of a party shall have the same validity as an
original signature for the purpose of this Agreement. For purposes of identi?cation, the NIAID reference number of the
original RCA is 2017-1179.

The above-referenced RCA is amended as follows:

1. Upon final signature, Appendix A will read as follows (all additions are shown in underline and all deletions are
shown in seikeeut?:

APPENDIX A

I. Evaluation of an vaccine for Nipah virus and Middle East Respiratory coronavirus
1. Abstract of the Research Project for Public Release

EITHER PARTY MAY, WITHOUT FURTHER CONSULTATION on PERMISSION,
RELEASE THIS ABSTRACT To THE PUBLIC.

NLAID and Modems will collaborate to evaluate immunogenicity of vaccines for Middle East Respiratory
coronavirus and Nipah virus in animal models.

Goal{s} of Project

The goals ofrl'r is project are to:

 

Proprietary Info


 

 

 

Background

and Nipah virus are potential epidemic threats and have been recognized on the World Health Organization?s
list of top emerging diseases liker to cause major epidemics and Coalition for Epidemic Preparedness Innovations
priority pathogens list. No vaccines to prevent or Nipah virus infection are currently available. Thus, there
is a need to rapidly develop vaccine candidates that could he used to prevent and Nipah virus infection in
case of an outbreak. Nucleic acid-based vaccine platforms allow for rapid generation of vaccine candidates using reverse

genetics. In this collabOrative project, we will evaluate immunogenicity of vaccines for MERS-COV and Nipah
virus in animal models.

The Vaccine Research Center, NIALD has extensive experience with the development of vaccines
against infectious diseases and structure-based design of vaccine candidates. In particular, VRCINIAID has developed
stabilized profusion spike protein, which is more immune-genie than wild-type or subunit proteins. This
stabilized profusion protein is currently being evaluated in preclinical studies. Based on the prior experience
stabilizing the fusion (F) protein in its pre?rsion conformation with the related respiratory virus and
parainfluenza virus 3 (PIVS), the VRC has designed stabilized Nipah proteins which are currently being evaluated in
preclinical studies:

Modems has developed a proprietary vaccine platform, and has used this for development of vaccines that are

currently being evaluated in Phase I clinical trials. In addition, Moderna is evaluating rotein
vaccine in animal models. Modems has also developed a vaccine at is clinical development
which targets two viruses including PIV3 which is in the same paramyxovirdiae family as Nipah virus.

   

The purpose of these studies is to evaluate immunogenicity of vaccines for and Nipah virus in animal
models.

IV. Original Materials Contributed by the Parti

i. VRC, NIAID Original Material:
Including but not limited to:

 

Proprietary Into

 

 

 

ii. Collaborator Original Material:
Proprietary Info

 

 

 

 

V. Respective Contributions of the Parties

VRC, NIAH) will:

 

Proprietary Into

 

 

 

Collaborator will:

 

Proprietary Into

 

 

 

 

Proprietary Info

 

 

Both Parties will:
0 Share data and materials
It Discuss results and plan next steps

 

 

 

VI. Experimental Plan

I Proprietary Info

2.

3.

4. Both parties will share and discuss the results.

ACCEPTED AND AGREED TO:
FOR NIAID:

\imhi cm 
Vincent ?hD, JD
Branch Chief, NIAID

FDR MODERNA:

?rm 0i;
Andreabm?, 
Head, Infectious Disease Researe Modems

1'3 203-0

Dar

il?

Date

 

 

 

 

mam Paovioea To FOR-PROFIT NIAID TRACKING NUMBER: 201121210

 

 

 

MATERIAL TRANSFER AGREEMENT

This Material Transfer Agreement has been adopted for use by the National Institute of Allergy and
Infectious Diseases an institute at the National Institutes of Health, which is part of the Department of
Health and Human Services, an agency ofthe United States Government (?Provider?) in transfers of research material
to for?pro?t institutions for internal research.

Recipient: ModernaTX, Inc., having offices at 501] Technology Square Cambridge, Ma [12139, created and
operating under the laws ofDelawarc.

1. Provider agrees to transfer to Recipient?s investigator the following materialls}, including known functional
components or subunits and unmodified descendants Material?):

 

 

 

 

 

 

 

 

 

NamefDescription Reference
(realms til: PMID: 16415006 and 181105691
Ceiliine PMID: 16415006 and 1300569]
2. THIS RESEARCH MAY NOT BE USED IN HUMAN SUBJECT S. The

Research Material will only be used for commercial research purposes by Recipient?s Investigator in hisr'her
laboratory, the research project described below, under suitable containment conditions. The Research Material
will not be used in any,r product offered for sale or processes for the manufacture thereof, including quality
control procedures.J or in commercial services for which a commercialization license from the National
Institutes of Health is required. The Research Material and methods of using the Research Material
are the subject of 1.1.5. and foreign patent applications. Please contact the if information is
desired concerning the present status of this invention or how to license the Research Material andfer patents
covering the Research Material.

Recipient agrees to comply with all laws, rules and regulations applicable to the Research Project and the handling
of the Research Material.

a. Is the Research Material ofhurnan origin??
1:1Yes Elie

b. 11ch in 2a, was Research Material collected according to 45 Part 46, ?Protection of Human
Subjects"?

Elites Please provide Assurance Number:  

DNO

3. This Research Material will be used by Recipient?s investigator solely in connection with the following research
project (?Research Project"} described with speci?city as follows:
The Recipient will use the Research Material to perform neutralizing titer assays Propr'emw mm
an immunoenicit readout for several in vivo studies the Recipient will run in support of its
vaccine programs PIUDTIEIBW ?110
FP-MTA (modified) NI.?th Tracking Number 20171-12161

Page 1 of4

 

 

 

 

NIAID FP-MTA {modified}

In all oral presentations or written publications concerning the Research Project, Recipient will acknowledge
Provider?s contribution ofthis Research Material unless requested otherwise. To the extent permitted by law,
Recipient agrees to treat in con?dence1 for a period of three (3) years from the date of its disclosure, any of
Provider?s written information about this Research Material that is stamped except for
information that was previously known to Recipient or that is or becontes publicly available or which is disclosed
to Recipient without a confidentiality obligation. Any oral disclosures from Provider to Recipient shall be
identi?ed as being CONFIDENTIAL by notice delivered to Recipient within ten (1 0) days after the date of the
oral disclosure. Recipient may publish or otherwise publicly disclose the results ofthe Research Project, but it"
Provider has given CONFIDENTIAL information to Recipient such public disclosure may be made only after
Provider has had thirty (30) days to review the proposed disclosure to determine if it includes any
CONFIDENTIAL information, except when a shortened time period under court order or the Freedom of
Information Act pertains.

This Research Material represents a signi?cant investment on the part of Provider and is considered proprietary
to Provider. Recipient therefore agrees that Recipient?s Investigator will retain control over this Research
Material and further agrees that Recipient?s investigator will not transfer the Research Material to other people
not under her or his supervision without advance written approval of Provider. Provider reserves the right to
distribute the Research Material to others and to use it for its own purposes. When the Research Project is
completed, or this is terminated, or on 13 June 2018, whichever occurs ?rst, the Research Material
will be returned to the Provider or disposed of as directed by Provider. If the Recipient depletes its supply
of Research Material or destroys the Research Material pursuant to this Paragraph 4 Recipient will so
notify Provider in writing.

This Research Material is provided as a service to the research community. IT IS BEING SUPPIJED TO
RECIPIENT WITH NO WARRANTIES, EXPRESS OR IMPLIED, ANY
WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE.

Provider maltes no representations that the use ct?the Research Material will not infringe any patent or proprietary
rights ofthird parties.

Recipient shall retain title to any patent or other intellectual property rights in inventions made by its employees
in the course ofthe Research Project. Recipient agrees not to claim, infer, or imply governmental endorsement
ofthe Research Project, the institution or personnel conducting the Research Project or any resulting productts).
Each Party shall be responsible for its own negligence under this MTA. Unless prohibited by law from doing so,
recipient agrees to hold the United States Government harmless and to indemnify the Government for all
liabilities, demands. damages, expenses and losses arising out of any third party claim or suit in connection with
the Recipienfs use for any purpose ofthe Research Material, except to the extent that any such liability, demand,
damage, expense or loss is attributable to Provider"s negligence.

The undersigned Provider and Recipient expressly certify and af?rm that the contents of any statements made
herein are truthful and accurate.

This MTA shall be construed in accordance with Federal law as applied by the Federal courts in the District of
Columbia.

. [n the event that Recipient wishes to use the Research Material for commercial purposes other than the

commercial research described in Paragraph 3 above, Recipient agrees to ?rst obtain from NIH the appropriate
commercial use or commercialization license.

. Either Provider or Recipient may unilaterally terminate this PvlTa at any time by giving written notice to the other

Party at least thirty [30) days prior to the desired termination date.

. The provisions of Paragraphs ofthis MTA will survive expiration or termination.

NIAED Tracking Number 20 T- 2 
Page 2 oi'4

 

 

 

 

13. This MTA may be executed in counterparts, each of which shall be deemed an original, and all of which. taken
together, shall constitute one and the same instrument. A facsimile, scanned electronic signature or certified
electronic signature shall be as effective as an original signature.

The Research Material will be used for the Research Project described in Article 3 only. The Research Material
wiII not be used in resoarch projects:
involving collaboration with another for-profit organization;
sponsored or funded by another for-profit organization;
in which Recipient or Recipient?s Investigator is obligated to assign inventions
containing the Research Material or offer an exclusive license to inventions containing
the Research Material to an organization other titan Recipient or a contractor of Recipient
that manages Recipient?s inventions on behalfof Recipient; or
in which Recipient or Recipient?s Investigator is obligated to receive permission from an
organization other titan Recipient before publicly disclosing results of research involving
the Research Material.
NOTE: If Recipient wishes to use the Research Material in a research project that is forbidden ahove, Recipient
should contact the Technology Transfer and intellectual Property Of?ce (TTIPD), National Institute ofAllergy and
Infectious Diseases (MAID), to discuss whether permission to use the Research Material in such project can he
obtained.
SIGNATURES BEGIN ON NEXT PAGE
Niall) FP-MTA (modi?ed) MAID Number 20 T- 2 1 
Page 3 of-il

 

 

 

 

 

 

MATERIAL TRANSFER AGREEMENT
SIGNATURE PAGE

FOR RECIPIENT:

 

Signature

 

Scott Butler, 
Director of?v?irology 8: Project Leader

Date: lo/Lfleal"?

Mailing Address for Materials:
Modema

500 Technology Sguare
Cambridge. MA 02139
Atm: Brooke Bellman

Tel: (781}434?3246
Email: Scott.butler@vaieratx.corn

FOR PROVIDER:

Provider '3 Investigator

 

Theodore Pierson, 

Chief, 1iv?iral Pathogenesis Section
Laboratory of Viral Diseasos
NIAID

Date:

 

Mailing Address:
33 RM 2E19A2
33 North Drive
Bethesda, MD 20392

Tel: 30H451-79TT Fax: BUEMS 4978

FP-MTA {modified}

.01 'x atomized

Signaure

Giuseipf?e. Ciarmlelk
Printed Name and Title

Date: 101'?

 

 

Mailing Address for Notices:
5?00 Tl-chnoloa?y SQuhf?L

. Mil 

 

Tel: Fax:

Daily A atomized
Digitally signed by Christopher M.

Christopher M. Kornak -S Kernels-S

Date: 1m [1.25 {l4'00'

 

Chris Kornak, 

Lead TTPS. Technology Transfer and intellectual
Property Office

NIAID

1 0-25-201 7
Date:

 

Mailing Address for Notices:

TECHNOI .oo?r TRANSFER AND INTELLECTUAL
PROPERTY OFFICE

MAID, NIH

Suite 6D, MSC 9804

560i Fishers Lane

Roekvilie, MD 20352

301-496-2644 (Office)

Fax: 

Tracking Number 201 E2 ll]
Page i oil-1

 

 

 

AMENDMENT NUMBER ONE TO
MATERIAL TRANSFER AGREEMENT

This Amendment Number One [the "First Amendment"} to the Material Transfer Agreement
Reference Number 2017-1210), having an effective date of October 25, 2017 is entered
into as of the date of last authorized signature hereto (the "First Amendment Effective Date?) and made
by and between National institute of Allergy and Infectious Diseases, National Institutes of Health, with its
principal place of business at 5601 Fishers Lane, Suite 6D, MSC 9804, Rockville, MD 20852 ("Provider") and
Moderna'?t, Inc, having offices at 200 Technology Square Cambridge, MA 02139, created and operating
under the laws of Delaware ("Recipient"). Each of Provider and Recipient may be referred to herein
individually as a ?Party? and collectively as the "Parties."

WHEREAS, Provider and Racipient desire that the MTA be amended a first time as set forth below
in order to modify the scope of the MTA Research 

 

lPropnetary Info

 

lPropn'eiary Info and

 

WHEREAS, the Parties have been operating under the MTA and desire to extend the term of MTA-
FP 2017-1210 by one month to July 18, 2018 while Company and NIAID conclude
negotiationslfinalization of License Agreement A-261-2018 and corresponding MTA-FP 2018-
0664; and

WHEREAS, the Parties desire to amend the MTA as set forth in this First Amendment.

NOW, THEREFORE, the Parties hereby agree as follows:

1.

Unless otherwise defined herein, capitalized terms used in this First Amendment have the
meanings assigned thereto in the MTA.

This First Amendment may be signed by each Party separately on different signature
pages, and each document when fully signed by a Party and delivered shall constitute an
original instrument, and all such multiple signed documents shall constitute one and the
same instrument. This First Amendment shall be effective as of the date of the final
authorized signature hereto, the First Amendment Effective Date. Execution by the
Parties shall be by original signature, electronic signature, or copy of signature received
via portable document format and an electronic signature or a PDF signature shall
be deemed to be and shall be as effective as an original signature.

The description of the Research Project in paragraph 3 of the MTA is hereby deleted and
replaced by the following:

The Recipient?s use of the Research Material will be con?ned soier to the scope of "like
virus vaccine development" as limited to and de?ned by the HHSOIOOZOIGDODZBC BARBA-

funded Zika virus vaccine development award.

Paragraph 5 of the MTA is hereby deleted and replaced with the following:

Amendment Number One Page I
Reference 

This Research Material represents a significant investment on the part of Provider and is
considered proprietaryr to Provider. Recipient therefore agrees that Recipient's
investigator will retain control over this Research Material and further agrees that
Recipient's Investigator will not transfer the Research Material to other people not under
her or his supervision without advance written approval of Provider. Provider reserves
the right to distribute the Research Material to others and to use it for its own purposes.
When the Research Project is completed, or this MTA is terminated, or on 18 July 2018,
whichever occurs first, the Research Material will be destroyed by the Recipient. If the
Recipient depletes its supply of Research Material or destroys the Research Material
pursuant to this Paragraph 5 Recipient will so notify Provider in writing.

5. as amended herein, all other terms and conditions of the MTA remain in full force
and effect.

The Parties hereby accept and agree to the terms and ccmditions of this First Amendment.

BEGIN ON NEXT PAGE

Amendment Number One Page 2
NIAID Reference 20l6-12l0-i

IN WITNESS WHEREOF, the authorized Parties hereto have caused this First Amendment to be
duly executed and to be effective as of the First Amendment Effective Date.

National Institute of Allergy and Infectious Diseases, National Institutes of Health ("Provider"):

1 Dtg?aly signed by Ien?rnln 
Benjamin E. Hurley ?5 Hurley -5
Date.- IDIIDGJS ?3:26.11 4141}?

 

Benjamin Hurley
TTIPO, NIAID, NIH

ModernaTx, Inc. ("Recipient"):

WM 

Marne barker. H. dc  
?tie (banal, an, a

 

Read Understood by Recipient Investigator

We} 

Kapil Bahl, 
Senior Scientist, ModernaTX, Inc.

Amendment Number One
MAID Reference 201642104

Date: 15 June 2013

 

Date: 30:8

Date: ?x 1 g'o?

 

Page 3

AMENDMENT NUMBER TWO TO
MATERIAL TRANSFER AGREEMENT

This Amendment Number Two {the ?Second Amendment?} to the Material Transfer Agreement
Reference Number 2017-1210), having an effective date of  October 25, 2017 is entered
into as of the date of last authorized signature hereto [the "Second Amendment Effective Date?) and
made by and between National Institute ofAIIergy and Infectious Diseases, National Institutes of Health, with
its principal place of business at 5501 Fishers Lane, Suite ED, MSC 9804, Rockville, MD 20852 ("Provider") and
ModernaTX, lnc., having offices at 200 Technology Square Cambridge, MA 02139, created and operating
under the laws of Delaware ["Recipient"). Each of Provider and Recipient may be referred to herein
individually as a "Party" and collectively as the "Parties."

WHEREAS, Provider and Recipient desire that the MTA be amended a second time as set forth

below in order to modify the scope of the MTA Research Projectlf?mprietaw 
Proprietary Info

 

 

 

lPropneIary Into

land

 

WHEREAS, the Parties have been operating under the MTA and desire to extend the term of MTA-
FP 2012-1210 by two (2) months to August 18, 2018 while Company and NIAID conclude
negotiationsffinalization of License Agreement and corresponding MTA-FP 2018-
0664;and

WHEREAS, the Parties desire to amend the MTA as set forth in this Second Amendment.

NOW, THEREFORE, the Parties hereby agree as follows:

1.

Amendment Number Two

Unless otherwise defined herein, capitalized terms used in this Second Amendment have
the meanings assigned thereto in the MTA.

This Second Amendment may be signed by each Party separately on different signature
pages, and each document when fully signed by a Party and delivered shall constitute an
original instrument, and all such multiple signed documents shall constitute one and the
same instrument. This Second Amendment shall be effective as of the date of the final
authorized signature hereto, the Second Amendment Effective Date. Execution by the
Parties shall be by original signature, electronic signature, or copy of signature received
via portable document format (PDF) and an electronic signature or a PDF signature shall
be deemed to be and shall be as effective as an original signature.

The description of the Research Project in paragraph 3 ofthe MTA is hereby deleted and
replaced by the following:

The Recipient?s use of the Research Material will be con?ned solely to the scope of "Zika
virus vaccine development? as limited to and de?ned by the HH50100201600029C BARDA-
funded Zika virus vaccine development award.

Paragraph 5 of the MTA is hereby deleted and replaced with the following:

Page I

NIAID Reference 2016-1210-2

This Research Material represents a significant investment on the part of Provider and is
considered proprietary to Provider. Recipient therefore agrees that Recipient?s
Investigator will retain control over this Research Material and further agrees that
Recipient?s Investigator will not transfer the Research Material to other people not under
her or his supervision without advance written approval of Provider. Provider reserves
the right to distribute the Research Material to others and to use it for its own purposes.
When the Research Project is completed, or this MTA is terminated, or on 18 August
2013, whichever occurs first, the Research Material will be destroyed by the Recipient.
If the Recipient depletes its supply of Research Material or destroys the Research
Material pursuant to this Paragraph 5 Recipient will so notify Provider in writing.

5. Except as amended herein, all other terms and conditions of the MTA remain in full force
and effect.

The Parties hereby accept and agree to the terms and conditions of this Second Amendment.

SIGNATURES BEGIN ON NEXT PAGE

Amendment Number Two Page 2
NIAID Reference 2016-1210-2

IN WITNESS WHEREOF, the autherited Parties hereto have caused this Second Amendment to be
duiy executed and to be effective as ofthe Second Amendment Effective Date.

National Institute of AIIergy and Infectious Diseases, Natienal Institutes of Health (?Previder?]:

maxim-um Mam-1E-

Benjamin E.
day-5
-

Hurley -5

 

Benjamin Hurleyr
TIPS, MAID, NEH

I ModernaTX, Inc. 

mam-xi..ch

mame' Daphne Van de 
Title Gourmet, Transactions

 

Read Understood by Recipient Investigator

 f) Date:

Kapil Bahl, 
SenierScientist, Moderna?, Inc.

Amendment Number Two
NIAJD Reference 2016-1210-2

Date:

July 16, 2013

 

Date:

1111)? 18, 2018



*1 in; in:

Page 3

IN WITNESS WHEREOF, the authorized Parties hereto have caused this Second Amendment to be
duly exeCUted and to be effective as ofthe Second Amendment Effective Date.

National Institute of Allergy and Infectious Diseases, National Institutes of Health (?Provider?):

Benjamln E- Hurley - 
- Date: July 16, 2013

 

 

Benjamin Hurley?r
TTPS, MIAID, NIH

ModernaTI, Inc. (?Recipient?):

  Date:     20 

Name

Title Daphne Van de 
Counsel, Transactions 

 

 

Read 84 Understood by Recipient Investigator

We} with?)

Kapil Bahl, Pho'.
Senior Scientist, ModernaTX, Inc.

Amendment Number Two - . Page 3
MAID Reference 2016-0993-2

Con?dential Disclosure Agreement

In order to protect con?dential information relating to research, development, business plans, and other
technology, which may be disclosed between them, the National Institute of Allergy and Infectious
Diseases (N LAID), a component of the National Institutes of Health (Nil-I), an agency of the U.S.
Department of Health and Human Services, as represented by the Division of Microbiology and
Infectious Diseases and Moderna TX, Inc. and the following Af?liates of Moderna TX, inc.
(?Affiliate? means any corporation or other business entity controlled by, controlling, or under common
control with Moderna TX, Inc at any time during the term of this Agreement. For this purpose, ?control?
means direct or indirect bene?cial ownership of more than fifty percent of the votin stock or more
than fifty percent interest in the income of the corporation or other business entity):
Proprietary '?fo [collectively, the ?Collaborator?) identi?ed below

(collectively the ?Parties? and individualiy a ?Party?}, intending to be legally bound as of the date of the
last authorized signature hereto (?Effective Date?), agree that:

 

 

l. A Party (?Disclosing Party") may disclose information to the other (?Receiving Party?) for the
purpose of assessing their interest in a research collaboration (the ?Purpose?). The Disclosing Party is 
Collaborator

2. The Parties? representatives for disclosing or receiving information (if known):

For DMID: Carolyn Deal, Thomas I-liltke

For Collaborator:Nadia Cohen, and other employees of the Collaborator as needed to ful?ll the Purpose

3. The information disclosed under this Agreement (?Con?dential Information?) is described as:

 

Collaborator may disclose results '?iU of Collaborator?s
candidate vaccines '?lO non-public technical, business and ?nancial
information, including third party information for which Collaborator has an obligation to
maintain as con?dential, relating to the research, design, manufacture, development, and
commercialization of messenger RNA and the use of for the treatment
and prevention of disease.

 

4. The Receiving Party shall use Confidential Information of the Disclosing Party only for the Purpose,
and for no other purpose. The Receiving Party will not disclose the Con?dential Information of the
Disclosing Party to any person except its employees, consultants, and contractors, to whom it is necessary
to disclose the Con?dential Information for the Purpose described above, and any such disclosures will be
under terms at least as restrictive as those specified herein. Any of the persons mentioned above who are
given access to the Con?dential Information will be informed of this Agreement. The Receiving Party
will protect the Con?dential Information by using the same degree of care, but no less than a reasonable
degree of care, as the Receiving Party uses to protect its own confidential information.

5. The Receiving Party?s duties under this Agreement will apply only to Confidential Information in any
written document, memorandum, report, correspondence, drawing, or other tangible material, or computer
software or program, developed or prepared by the Disclosing Party or any of its representatives that has
been clearly marked ?Con?dential? by the Disclosing Party. Oral disclosures must be reduced to writing
Proprietary Info and marked ?Con?dential? by the
Disclosing Party within thirty (30) days after disclosure to be considered Con?dential Information.

 

 

{000270295} 13 Feb 2015 DMID CDA Template 1iv?ersion 2.0
Moderno TX, Inc.~ DMID CDA

Page 1 of 3

6. Notwithstanding any other provision ofthis Agreement, Con?dential Information will not include
any item of information, data, patent or idea that: is within the public domain prior to the time ofthe
disclosure by the Disclosing Party to the Receiving Party or thereafter becomes within the public domain
other than as a result of disclosure by the Receiving Party or any ofits representatives in violation ofthis
Agreement; was, on or before the date of disclosure in the possession of the Receiving Party; is
acquired by the Receiving Party from a third party not under an obligation of con?dentiality; is
hereafter independently developed by the Receiving Party, without use of or reference to the Con?dential
Information received from the Disclosing Party; or the Disclosing Party expressly authorizes in
writing the Receiving Party to disclose.

T. At the request ofthe Disclosing Party, the Receiving Party agrees to return or destroy all Con?dential
information received from the Disclosing Party except that the Receiving Party may retain in its
con?dential ?les one copy of written Con?dential Information for record purposes only.

8. Ifthe Receiving Party, or anyone to whom it discloses the Confidential Information in accordance
with Paragraph 4, becomes legally required to disclose any of the Con?dential Information, the Receiving
Party will, to the extent practicable, provide the Disclosing Party with timely notice and, to the extent
practicable, consult with the Disclosing Party prior to any disclosure.

9. It is acknowledged that nothing herein will deem to constitute, by implication or otherwise, the grant
to either Party by the other of any license or other rights under any patent, patent application or other
intellectual property right or interest.

10. It is acknowledged and agreed by both Parties that each represents to the other Party that each Of?cial
signing this Agreement has authority to so do.

1 l. The illegality or invalidity of any provision ofthis Agreement will not impair, affect or invalidate the
other provisions ofthis Agreement.

12. This Agreement is to be made under and will be construed in accordance with Federal laws as applied
by the Federal Courts in the District of Columbia, and constitutes the entire understanding between the
Parties with respect to the subject matter hereof and merges any and all prior agreements, understandings
and representations with respect to the subject matter hereof. The Agreement may not be superseded,
amended or modi?ed except by written agreement between the Parties.

13. This Agreement will control Con?dential Information disclosed only between the Effective Date
and one year thereafter and the remaining terms and conditions of this Agreement will expire four (4)
years from the Effective Date. Either party may terminate this Agreement upon thirty (30} days written
notice to the other Party.

14. This Agreement may be executed in counterparts, each of which shall be deemed an original, and all
of which, taken together, shall constitute one and the same instrument. A facsimile, scanned electronic
signature shall be as effective as an original signature.

SIGNATURES BEGIN ON THE NEXT PAGE

{000270295} 13 Feb 2015 DMID CDA Template Version 2.0
Madame TX, Ine? DMID CDA

Page 2 of3

ModerneTX, Inc.

Authorized Signature:

union now/u, -

National Institute of Allergy and Infectious
Diseases

Division of Microbiology and Infectious
Diseases

5601 Fishers Lane

Room 

Bethesda MD 20892

MSC 9826

Authorized Signature:
EmilyJ- 
Erbelding -

 

 

Narnia: Dag?ne Van de 
Title: Counsel. itansac?ous?w

Date:  3 20H:

{000270295}

Page 3 of3

 

Date: 201112.08

Emily Ethel-ding, MD, MPH
Director, Division of Microbiology and
Infectious Diseases
National institute of Ailergy and Infectious
Diseases

Date:

 

Mailing Address for Notices:

5601 Fishers Lane
Room 7F29
Bethesda, MD 20392
MSC 9826

Ph. 240~292-092?

13 Feb 2015 CDA Template Version 2.0
Madame TX, Ine- DMID CDA

Acknowledged by DMH) Cnn?dumiah?l?mpriumry an'nrmmiun:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

{Branchf??iceh DMID
Dan:
I I Ef?e,  {Jam . 
his?!" 5' 1r-
Dale
and -:  f3. 
Ir
Dan;
DORA, DMID
Dan:
im? Dam:
ORA. DMID
Dam:

Data
lOIher)
Dam;
Madame TX, Inc- Pagc 4 0H

nmdil'luzi anmhur .13. l?ll

 

 

 

NIAID. PROVIDER TD FDR-PROFIT TRACKING NUMBER: 2013-0664

 

 

 

MATERIAL TRANSFER AGREEMENT

This Material Transfer Agreement has been adopted for use by the National Institute of Allergy and
Infectious Diseases an institute at the National Institutes of Health, which is part of the Department of
Health and Human Services, an agency of the United States Government (?Provider?) in transfers of research material
to for-pro?t institutions for internal research.

Recipient: ModernaTX. Inc, having offices at 500 Technology.F Square Cambridge, MA 032i 39, created and
operating under the laws of Delaware

1. Provider has previously transferred to Recipient?s Investigator the following materiahs), including known
functional components or subunits and modi?ed or unmodi?ed descendants thereof (?Research Material"):

 

 

 

 

 

 

 

 

 

Namer?Description Reference

Lifelines 16415006 and PMID: 18005691
i6415006 and 18005691

pFurin; a DNA expression construct expressing Davis et Virol. 2006 Feb; 
human furin protease 16415006)

Regimens-i: a WNV Pierson at at, Virology. 2006 Mar 
lineage ll. replic'on expressing GFP and acocin 65. (PMFD: 16325883}

resistance 

Heglt'corti?': a Pierson or at. Virology. 2006 Mar 
lineage ll rcpiicon expressing Renilla luciferase 65. (PMID: l6325333}

and blasticidin resistance

 

2. THIS RESEARCH MATERIAL MAY NOT BE USED IN HUMAN SUBJECTS. The
Research Material will onl},F be used for commercial research purposes by Recipient?s Investigator in hisr?hcr
laboratory, for the research project described below, under suitable containment conditions. The Research Material
will not be used in any product offered for sale or processes for the manufacture thereof, including quality
control procedures, or in commercial services. .

Recipient agrees to comply with all laws, rules and regulations applicable to the Research Project and the handling
of the Research Material.

a. Is the Research Material of human origin?
Elites ENG

b. If Yes in 2a. was Research Material collected according to 45 C.F.R. Part 46, ?Protection of Human
Subjects??

Please provide Assurance Number:

also

{000302032} FP-MTA {modi?ed}
Tracking Number 20E $0664
Page i of

 

 

 

 

 



12.

{000302932 ,1

This Research Material will be used by Recipient?s Investigator solely in connection with the following research
project (?Research Project?) described with speci?city as follows:

The Recipient?s use of the Research Material will be limited to the scope of BARDA Contract No.
as it pertains to neutralization assays for further development of Licensee?s
proprietary vaccine{s] speci?cally directed against Zika viruses. lPlOPllemW W0
Proprietary Info

 

 

 

 

In all oral presentations or written publications concerning the Research Project, Recipient will acknowledge
Provider?s contribution of this Research Material unless requested otherwise.

This Research Material represents a signi?cant investment on the part of Provider and is considered proprietary
to Provider. Recipient therefore agrees that Recipient?s Investigator will retain control over this Research
Material and further agrees that Recipient's Investigator will not transfer the Research Material to other people
not under her or his supervision without advance written approval of Provider. Provider reserves the right to
distribute the Research Material to others and to use it for its own purposes. If the Recipient depletes its supply
of Research Material or destroys the Research Material pursuant to Paragraph 11, Recipient will so notify
Provider in writing.

This Research Material is provided as a service to the research community. IT iS BEING SUPPLIED TU
RECIPIENT WITH NO WARRANTIES, EXPRESS OR IMPLIED, ANY

WARRANTY OF OR FITNESS FOR A PARTICULAR PURPOSE.
Provider makes no representations that the use of the Research Material will not infringe any patent or proprietary
rights of third parties.

Recipient shall retain title to any patent or other intellectual property rights in inventions made by its employees
in the course of the Research Project. Recipient agrees not to claim, infer, or imply governmental endorsement
of the Research Project, the institution or personnel conducting the Research Project or any resulting productl's].
Each Party shall be responsible for its own negligence under this MTA. Unless prohibited by law from doing so,
Recipient agrees to hold the United States Government harmless and to indemnify the Government for all
liabilities, demands, damages, expenses and losses arising out of any third party claim or suit in connection
Recipient?s use for any purpose of the Research Material, except to the extent that any such liability, demand,
damage, expense or loss is attributable to Provider?s negligence.

The undersigned Provider and Recipient expressly certify and af?rm that the contents of any statements made
herein are truthful and accurate.

This MTA shall be construed in accordance with Federal law as applied by the Federal courts in the District of
Columbia.

. In the event that Recipient wishes to use the Research Material for commercial purposes other than the

commercial research described in Paragraph 3 above, Recipient agrees to first obtain from NIH the appropriate
commercial use or commercialization authorization.

The provisions of Paragraphs 4, 5, 7, 9, Ill. 1 and IE ofthis MTA will survive expiration or termination.

This MTA may be executed in counterparts, each of which shall be deemed an original, and all of which, taken
together, shall constitute one and the same instrument. This will be effective when executed by the duly
authorized signatories below. Provider has previously provided materials to Recipient under separate materials
transfer agreements {MW-ls 2617-12! 0, 2121111 Elli?l, 2017?0993, BOW-09934 and 
Upon execution, these prior MTAs will be automatically terminated [if not already expired) and this MTA 2013-
6664 will govern the use ofthe Research Material. When the commercial license associated with the license
application having NIH reference number A-Z?l-Z?ls expires, is cancelled or is terminated, this MTA will
he automatically terminated. The Research Material including known functional components or subunits

terror} FP-MTA {modified}
Tracking Number 20 10664
Page 2 of 4

 

 

 

 

and modi?cdfunmodi?cd descendants, will be destroyed by the Recipient within thirty (3d) days of
termination or cancellation of this Mlle. A Facsimile, scanned electronic signature or certi?ed electronic
signature shail be as effective as an original signature.

13. The Research Material will be used terms Research Project described in Article 3 only. The Research Material
will not be used in research projects:



(6)

(ti)

NOTE:

involving collaboration with another for-profit organization;

sponsored or funded by another for-pro?t organization;

in which Recipient or Recipientis Investigator is obligated to assign inventions
containing the Research Material or offer an exclusive license to inventions containing
the Research Material to an organization other than Recipient or a contractor of Recipient
that manages Recipient?s inventions on behalf'ot" Recipient; or

in which Recipient or Recipient?s Investigator is obligated to receive permission from an
organization other than Recipient before publicly disclosing results ofresearch invoiving
the Research Material.

if Recipient wishes to use the Research Material in a research project that is forbidden above, Recipient

should contact the Technology Transfer and intellectual Property Office National Institute of Allergy and
Infectious Diseases (NIAID), to discuss whether permission to use the Research Material in such project can be

obtained.

{000302032}

SIGNATURES BEGIN ON NEXT PAGE

FP-MTA {modified}
NIAID Tracking Number 20] 13664
Page 3 ot?a

 

 

 

 

MATERIAL TRANSFER AGREEMENT

 

 

 

 

 

SIGNATURE PAGE
FOR RECIPIENT:
Recipient ?5 Investigator Duly Authorized
$11, ?aL? (Dew/14w  V?s-e almme
Signature Signatilre I
. Daphne. H. the rip (banal
Eapn Baht, Printed Name and Title 1
Senior Scientist, Infectious Disease 
r.  Date: Slaill??
Date:  5'1" lib

 

Mailing Address for Materials:
ema

500 Sguag
Cambridge, M3 02'39

Attn: Brooke Bellman
Tel: 209-5355
Email: kapil.bah1@medematx.com

FOR PROVIDER:

{000302012}

flin Address 1
0 U'naf 1 {Juli in

?lm 'Stixewer Gm 
rengtpeiquS-EFW Sesr Hall?

 

All?! ?wmeilm?eix
Emmft rm 62431

Duly Aulhurized
Benja E. H'u ?ay - ?ux-wanna?;
5 Wrmanmln Human-m

 

Benjamin Hurley 
TTPS, Technology Transfer and Intellectual Property
Of?ce NIAID

Date: August 10, 2013

 

Mailing Address for Notices:

TECHNOLOGY TRANSFER AND INTELLECTUAL
PROPERTY OFFICE

NIAID, NIH

Suite 6B, MSC 9364

5601 Fishers Lane

Rockville, MD 28852

301-496-2644 (Of?ce)

Tel: 301l'496-2644 Fax: 301i402-7123

MAID FP-MTA [modified]
NIAID Tracking Number 20 lT-0664
Page 4 0H

 

 

PUBLIC HEALTH SERVICE
MATERIAL TRANSFER AGREEMENT

This Material Transfer Agreement has been adopted for use by the National Institutes of Health, the Food
and Drug Administration and the Centers for Disease Control and Prevention, collectively referred to herein as the

Public Health Service in all transfers of research material (Research Material) whether PHS is identi?ed
below as its Provider or Recipient.

Providers: National Institute ofAliergy and Infectious Diseases, Nationotlrmitares of
Health 

ModemaTX, (?Modema?)
Recipient: The University of North Carolina at Chapel Hill
1. Provider agrees to transfer to Recipient's Investigator the following Research Material:
RNA cronavir vaccine can and tl ed MA and ema.

2. THIS RESEARCH MATERIAL MAY NOT BE USED IN HUMAN SUBJECTS. The

Research Material will only be used for research purposes by Recipient?s Investigator in hist'her laboratory, for
the research project described below, under suitable containment conditions. This Research Material will not
he used for commercial purposes such as screening, production or sale, for which a commercialization
license may be required. Recipient agrees to comply with all Federal rules and regulations applicable to the
Research Project and the handling of the 

a. Are the Research Materials of human origin2a, were Research Materials collected according to 45 CFR Part 46, ?Protection
of Human Subj cots??

#Yes Please provide Assurance Number:
_No

3. This Research Material will be used by Recipient's Investigator solely in connection with the following
research project (?Research Project?) described with speci?city as follows (use an attachment page if
necessary}:

 

4. Upon a Provider?s reasonable request, Recipient will furnish a status report to such Provider regarding the use
of the Research Materials and any data or results generated therefore. In all oral presentations or written
publications concerning the Research Project, Rmipicnt will acknowledge Providers? contribution of this
Research Material unless requested otherwise. To the extent permitted by law, Recipient agrees to treat in
con?dence, and not to disclose to third parties or use for any purpose other than the performance of the
Research Project, for a period of three (3) years from the date of its disclosure, any of Providers? written
information about this ReSearch Material that is stamped except for infortnation that was
previously known to Recipient or that is or becomes publicly available or which is disclosed to Recipient
without a confidentiality obligation. Any oral disclosures from Providers to Recipient shall be identi?ed as
being CONFIDENTIAL by notice delivered to Recipient within ten (10) days after the date of the oral
disclosure. Notwithstanding the foregoing, all information discloSed by Providers relating 

lPropnetary Info Pfthe Research Material will be treated as CONFIDENTIAL infomatton as set orlh
above, whether or not marked or otherwise identi?ed as ?con?dentia Recipient may publish orotherwise

 

{00034264.1} PHS MTA, Model 951214

Page 1 of 5
Provider

MAID Ref. No. 2019-1177

publicly disclose the results of the Research Project, but if Providers have given CONFIDENTIAL information
to Recipient such public disclosure may be made only after Providers have had thirty (30) days to review the
proposed disclosure to determine if it includes any CONFIDENTIAL information, except when a shortened
time period under court order, law {including the North Carolina Public Records Act), or the Freedom of
Information Act pertains. Recipient will comply with all requests to delete CONFIDENTIAL information ?-om
any proposed publication or presentation; provided. that Providers agree to allow use of sufficient information
regarding the identity and properties of the Research Material to reasonably enable publication of the results of
the Research Project.

5. This Research Material represents a signi?cant investment on the part of Providers and is considered
proprietary to Providers. Recipient?s Investigator therefore agrees to retain control over this Research Material
and further agrees not to transfer the Research Material to other people not under her or his direct supervision
without advance written approval of Provider. Providers reserve the right to distribute the Research Material to
others and to use it for their own purposes. When the Research Project is completed or three (3) years have
elapsed, whichever occurs ?rst, the Research Material will be disposed of as directed by Providers.

6. This Research Material is provided as a. service to the research community. IT IS BEING SUPPLIED T0
RECIPIENT WITH NO WARRANTIES, EXPRESS OR IMPLIED, INCLUDING ANY
WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR
PURPOSE. Provider makes no representations that the use of the Research Material will not infringe any
patent or proprietary rights of third parties.

7. Inventorship of any inventions or discoveries arising from the use of the Research Material hereunder
(?Inventions?), shall be determined according to 1.1.3. patent law. Ownershi shall t'llow invent 
I l- . I Illil'llil .lII'il' I'lil

  
 
     

.l I
Proprietary Into

 

 

 

Proprietary Info Unless prohibited by law from doing so, including the North Carolina Tort Claims Act,
Reelptent agrees to hold the United States Government harmless and to indemnify the Government for all
liabilities, demands, damages, expenses and losses arising out of Recipient's use for any purpose of the
Research Material-

8. The undersigned Providers and Recipient expressly certify and af?rm that the contents of any statements made
herein are truthful and accurate.

9. This MTA shall be construed in accordance with Federal law as applied by the Federal courts in the District of

Columbia.
SIGNATURES BEGIN ON NEXT PAGE
{00034264.1} PHS MTA, Model 951214
Page 2 of 5
NIAID Provider

MAID Ref. No. 2019-1177

MATERIAL TRANSFER AGREEMENT
SIGNATURE PAGE

FOR RECIPIENT:

Recipient ?s 

 

Ralph Eerie. 
Professor

Date: 131222019

Mailing Address for Materials:

 

Attention: Dr. Rachel Graham, Department of

 

Epidemiology, University of North Carolina at

 

Chapel Hill, 135 Dauer Drive, 2101 McGavran-
Greenherg Hall, CB #7435, Chapel Hill, NC 27599-
7435

Tcl:9 9-966-3395 Fax:
FOR PROVIDERS:

MAID 
.  


Date:

  

 

{00034264.1}

Provider
NIAID Ref. No. 2019-117?

Duly A uthorized

JacqueliniQuay 5
Director, Licensing 3.: Innovati Support, OTC

Date:   

Mailing Address for Notices:

The University of North Carolina at Chapel Hill
Of?ce of Technology Commercialization

109 Church Street, Chapel Hill, NC 22516

Tel: 919-966-3929 on: 919-962-0646

Dub! Authorized m" I h. m.
Amy F. all-uni?" 

Date: 
Amy Petrik, Pet-Hie 
Technologyr Transfer Specialist, TTIPD, MAID

Date:

 

Mailing Address for Notices:

Technology Transfer and Intellectual Property Of?ce
National Institute of Allergy and Infectious Diseases
Department of Health and Human Services

Suite 6D, MSC 9804

5601 Fishers Lane

Rockville, MD 20352

Tel: 30114964644 Fax: 240-627-131 i?

PHS MTA, Model 951214
Page 3 of 5

Modema ?s Investigator

44*

Sunny Himansu, 

Dam 

 

{00034254.1}

NIAID Provider
NIAID Ref. No. 2019-117?

Duly Authorized

3m IQIM

Shaun Ryg'l
Deputy General Counsel

Date: 1 2H 71' 1 9

Mailing Address for Notices:

ModemaTX, Inc.

200 Technology Square
Cambridge, MA 20139
Ann: General Counsel

PHS MTA. Model 951214

Fagc4of5

Exhibit A
Research Program

 

 

Proprietary Info

 

PHS MTA, Model 951214

Page 5 of 5
NIAID Provider

NIAED Ref. No. 2019-1 17"?

 

PUBLIC HEALTH SERVICE

NON-EXCLUSIVE PATENT LICENSE AGREEMENT
FOR INTERNAL. RESEARCH USE
and

BIOLOGICAL MATERIALS LICENSE AGREEM ENT - Internet Use

This Agreement is based on the model Non-Exclusive Patent Internal Use Agreement adopted by the U.S. Public
Health Service Technology Transfer Policy Board for use by components of the National Institutes of
Health the Centers for Disease Control and Prevention and the Food and Drug Administration
which are agencies of the PHS within the Department of Health and Human Services 

This Cover Page identifies the Parties to this Agreement:

The US. Department of Health and Human Services. as represented by
National Institute of Allergy and Infectious Diseases
an Institute or Center (hereinafter referred to as the ofthe
NIH

and

ModernaTX, lne.,
hereinafter referred to as the ?Licensee?,
haying of?ces at 320 Bent Street 3rd Floor, Cambridge. MA 0214],
created and operating under the laws of Delaware.

Tax ID 

A-DGJ-ZO 8

CONFIDENTML
NIH Patent License Agreement lnlerna] Use Only Nonexelusiye
Mode] til-205 Page ch9 [Final] [ModernaTX, Inc] [January list 2013]

For internal use only:

License Number: LON-2011110

License Application Number: A-003-2018

Serial Numberis) of Licensed Patentts] or Patent Application(s):

1.

11.



IV.

V1.

V11.



X1.

X11.

IS

CONFIIJENTIAL

U.S. Provisional Application 621096.744 ?led 121243014 entitled ?Recombinant
Metapneumovirus Proteins and Their Use" Ref: No. 1]

PCT Patent Application 51059991 ?led 1212412015 entitled ?Recombinant
Metapneurnovirus Proteins and Their Use? Ref. No. 

U.S. Patent Application l5f539,640 ?led 061'231'2017 entitled ?Recombinant Metapneumovirus 
Proteins and Their Use" Ref. No. 5-260-20 

U.S. Provisional Application 621412.699 ?led 100.5!2016 entitled ?Recombinant Parainfluenza
Virus Proteins and Their Use" Ref. No. 

U.S. Provisional Application 6lf730.910 ?led 0311312013 entitled ?Prefusion RSV Proteins and
Their Use? Ref. No. 

U.S. Provisional Application 611193.339 ?led 0311519013 entitled ?Prefusion RSV Proteins and
Their Use? Ref. No. 31' 

U.S. Provisional Application 6 "351,613 filed 0112312013 entitled ?Prefusion RSV Proteins and
Their Use" Ref. No. 

U.S. Provisional Application 611363.909 ?led 0810910013 entitled ?Prefusion RSV Proteins and
Their Use" Ref. No. 

PCT Patent Application PCTIU820141026714 ?led 0331312014 entitled ?Prefusion RSV 
Proteins and Their Use? Ref. No. 

U.S. Patent Application 1412073 '12 issued 03122120 1 i' entitled ?Prefosion RSV Proteins and
Their Use? Ref. No. 

5. Patent Application l4f7'l6.651 ?led 14:20 15 entitled ?Profusion RSV Proteins and Their
Use? Ref. No. 8-081-20l3f4-US-l2]

S. Patent Application 15531518 ?led DdedeDl? entitled ?Pret'usion RSV Proteins and Their
Use" Ref. No. 13-08 

NIH Patent License Agreement?? Internal Ute Only 

Model 111-1015

Pagezoflil [Final] [ramming] [January 16.20Itl]

Cooperative Research and Development Agreement (CRADA) Number (ifs subject invention): NM

Additional Remarks:

 

I Proprietary Info
Public Bene?tis):

 

 

 

This Patent License Agreement, hereinafter referred to as the ?Agreement?, consists of this Cover Page, an attached
Agreement, 3 Signature Page, Appendix A (List of Patentts) or Patent Application{s)), Appendix (Licensed
Materials, Processes, Territory, Field of Use and Term}, Appendix {Royalties}, Appendix (Shipping
lnfonnatiOn) and Appendix (Royalty Payment Options).

I ll

CONFIDENTIAL
NIH Patent License Agreement Internal Use Duhr Nonexelusive
Model Page 3 of I9 [Final] [ModemaTX, [January 

The NIAID and the Licensee agree as follows:

1. BACKGROUND



1.3

L4

1.5

In the course ofconducting biomedical and behavioral research, the NIAID investigators made
inventions and develolsed tangible materials that may have commercial applicability.

By assignment of rights from the NIAID employees and other inventors, HHS, on behalfofthe
Government, owns intellectual property rights claimed in any United States or foreign patent
applications or patents corresponding to the assigned inventions. HHS also owns any tangible
embodiments of these inventions actually reduced to practice by the NIAID, regardless of whether
patents or patent applications claiming the tangible materials exist.

The Secretary of HHS has delegated to the MAID the authority to enter into this Agreement for
the licensing ofrights to these inventions under 35 U.S.C. 56200-212, the Federal Technolggy
Transfer Act of 1936. IS U.S.C. Billie. and the regulations governing the licensing of
Government-owned inventions, 37 CPR. Part 404.

The NIAID desires to transfer these inventions and tangible materials to the private sector through
commercial research licenses to facilitate the commercial development of products and processes
for public use and bene?t.

The Licensee desires to acquire the rights to use certain ofthese inventions and tangible materials
in order to develop processes, methods, or marketable products for public use and bene?t.

2. DEFINITIONS



2.2

2.3

2.4

8

CONFIDENTIAL

?Af?liate?j? means a corporation or other business entity, which directly or indirectly is
controlled by or controls, or is under common control with the Licensee. For this purpose, the
term "control" shall mean ownership of more than ?fty percent of the voting stock or other
ownership interest of the corporation or other business entity, or the power to elect or appoint
more than filly percent of the members ofthe governing body ofthe corporation or other
business entity.

?Govern ment? means the government of the United States of America.

?Licensed Additional Documentation" means information relating to the materials, owned or
controlled by the NIAID inventors? laboratory, including but not limited to, protocols, analytical
procedures, processes, formulas, clinical and non-clinical data, puri?cation methods, scale up
experience, alternate cell growth platforms, media development, alternate formulations, know-
hoW, Proprietary Info
lnfo land which during the term ofthis
Agreement are in the possession or control and (ii) are necessary or useful to
Licensee in the Licensed Fields of Use, including without limitation, in connection with the
research, development, manufacture, or use of Licensed Products in the Licensed Territory.

 

 

 

?Licensed Patent Rights? shall mean:

NIH Patent License Agreement Internal Use Only 

Model 10-20 l5

Page 4 of I9 [Final] [ModernaTX, Inc.] [January 16. I?lli]

 U.S. patent applications and patents listed in Appendix A, all divisions
and continuations ofthese applications, all patents issuing from such
applications. divisions, and continuations, and any reissues,
reexaminations, and extensions ofall such patents:

to the extent that the following contain one or more claims directed to
the invention or inventions claimed in 

continuations?in-part 
(ii) all divisions and continuations of these continuations-in-part;
all patents issuing from these continuations-in-part, divisions,

and continuations; and
(iv) any reissues, reexaminations, and extensions of these patents:

to the extent that the following contain one or more claims directed to
the invention or inventions claimed in all counterpart fereign
applications and patents to 2.4{al and including those listed in
Appendix and

Licensed Patent Rights shall not include 2.40)) or 2.4(c) to the extent
that they contain one or more claims directed to new matter which is
not the subject matter ofa claim in 2.4ia).

2.5 ?Licensed Products?

means tangible materials, identi?ed in Appendix B, including progeny,
subclones, unmodi?ed derivatives, fractions, or components isolated
therefrom, whether or not within the scope ofthe claims ofthe
Licensed Pa tent Rights;

other tangible materials which, in the course of manufacture. use, sale,
or importation would be within the scope ofone or more claims ofthe
Licensed Patent Rights that have not been held unpatentable, invalid
or unenforceable by an unap pealed or unappealablejudgment of a court
of competent jurisdiction;

modi?cations created by Licensee that contain or incorporate any ofthe
tangible materials identi?ed in Paragraph 2.4{a} and 2.4(b) above.

2.6 ?Licensed Processes? means processes which, in the course of being practiced, would be within
the scope of'one or more claims ofthe Licensed Patent Rights that have not been held
unpatentable, invalid or unenforceable by an unappealed or unappealable judgment ofa court of
competent jurisdiction.

?Licensed Territory" means the geographical area identi?ed in Appendix B.

2.8 ?Licensed Fields of Use? means the ?eld ofuse identi?ed in Appendix B.

NUDE-EDI 

CONFIDENTIAL
NIH Patent License Agreement Internal Use Only Nonexclusivc
Model Pages oi?  9 [Final] [ModemaTX, [January 16,20l?]

3. GRANT OF RIGHTS

3.1 The NIAID hereby grants and the Licensee accepts, subject to the terms and conditions of this
Agreement, a nonexclusive license under the Licensed Patent Rights, under the Licensed
Products and under certain Licensed Additional Documentation in the Licensed Territory to
make and to use. but not to sell Licensed Products and Licensed Processes in the Licensed
Fields of Use. Proprietary Info

Proprietary Info

 

 

 

 

3.2 The Licensee has no right to sublicense.

3.3 This Agreement confers no license or rights by implication, estoppcl, or otherwise under any
patent applications or patents of the NIAID other than the Licensed Patent Rights regardless of
whether such patents are dominant or subordinate to the Licensed Patent Rights.

3.4 The NIAID acknowledges that information relating to the Licensed Patent Rights or Licensed
Products may be of assistance to the Licensee in its research efforts. Accordingly, the NIAID
shall consider reasonable requests by the Licensee for access to the inventors of the Licensed
Patent Rights and Licensed Products. For clarity, the NIAID hereby agrees to share with the
Licensee the sequences, as available, to the tangible materials identi?ed in Section I, of
Appendix B, which sequences constitute Licensed Additional Documentation.

4. ROYALTIES

The Licensee agrees to pay the NIAID a non-creditable, nonrefundable license issue royalty as set
forth in Appendix C.

4.2 The Licensee agrees to pay the NIAID a nonrefundable annual royalty as set forth in Appendix C.

4.3 All royalties due under this Agreement shall be paid in U.S. dollars, net ofall non?U3. taxes, and
payment options are listed in Appendix E. For conversion of foreign currency to US. dollars. the
conversion rate shall be the New York foreign exchange rate quoted in The Wait Street Journal on
the day that the payment is due.

4.4 Additional royalties may be assessed by the NIAID on any payment that is more than ninety 
days overdue at the rate of one percent per month. This one percent per month rate
may be applied retroactively from the original due date until the date ofreceipt by the NIAID of
the overdue payment and additional royalties. The payment of any additional royalties shall not
prevent the NIAID from exercising any other rights it may have as a consequence ofthe lateness
of any payment.

A-DUS-ZU 

CONFIDENTIAL
NIH Patent License Agreement Internal Use Only 
Model 10-2015 Page 6 of 19 [Final] [ModernaTX. Inc] [January I6, l?lil]

5.

5.1

5.2

5.3

5.4
aces?2013
CONFIDENTIAL

PERFORMANCE

Upon receipt and veri?cation of the royalties due under Paragraphs 4.1 and 4.2, the NIAID agrees,
if available to the MAID, to provide the Licensee, at the Licensee?s expense, with samples ofthe
tangible materials identi?ed in Appendix to the individual and address listed in Appendix 
and, at reasonable cost to the Licensee, to replace them in the event oftheir unintentional
destruction. The NIAID also agrees to make reasonable efforts to provide the Licensee with the
Licensed Additional Documentation set forth in Paragraph 3.4 hereof. The Licensee agrees to

retain control over the Licensed Products and Licensed Additional Documentation 2 I I 
not distribute or release them to others without the prior written consent ofthe MAID

 

lF?roprietaryr Info I

 

The Licensee shall expend reasonable efforts and resources to carry out the research development
plan submitted with the Licensee's application for a license.

The Licensee agrees in its use ofany Licensed Products provided by the NIAID to comply with
all applicable statutes, regulations, and guidelines, including NIH and HHS regulations and
guidelines. The Licensee agrees not to use the Licensed Products for research involving human
subjects or clinical trials in the United States without complying with 2] C.F.R. Part 50 and 
C.F.R. Part 46. The Licensee agrees not to use the Licensed Products for research involving
human subjects or clinical trials outside ofthe United States without notifying the NIAID, in
writing, ofthis research or trials and complying with the applicable regulations ofthe appropriate
national control authorities. Written noti?cation to the NIAID of research involving human
subjects or clinical trials outside ofthe United States shall be given no later than sixty (60} days
prior to commencement of this research or trials.

All plans and reports required by this Agreement shall be treated by the NIAID as commercial
and financial information obtained from a person and as privileged and con?dential and. to the
extent permitted by law, not subject to disclosure under the Freedom of Information Act, 5 1.1.5.9

?552.

NIH Patent License Internal Use Only Nonexclusivc

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6. NEOATION OF WARRANTIES AND INDEMNIFICATION
6.I The NIAID offers no warranties other than those expressly speci?ed in Article I.

6.2 The NIAID does not warrant the validity ofthe Licensed Patent Rights and makes no
representations whatsoever with regard to the scope of the Licensed Patent Rights, or that the
Licensed Patent Rights may be exploited without infringing other patents or other intellectual
property rights of third parties.

6.3 THE NIAID MAKES NO WARRANTIES, EXPRESSED OR IMPLIED, OF
MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE OF ANY SUBJECT
MATTER DEFINED BY THE CLAIMS OF THE LICENSED PATENT RIGHTS OR
LICENSED ADDITIONAL DOCUMENTATION OR OF ANY LICENSED PRODUCTS
PROVIDED TO THE LICENSEE UNDER PARAGRAPH SJ.

6.4 The NIAID does not represent that it shall commence legal actions against third parties infringing
the Licensed Patent Rights.

6.5 The Licensee shall indemnify and hold the NIAID, its employees, students, fellows. agents, and
consultants harmless front and against all liability, demands, damages, expenses, and losses,
including but not limited to death, personal injury, illness, or property damage in connection with
Or arising out of:

the use by the Licensee, its directors, employees, or third parties of any
Licensed Patent Rights or Licensed Additional Documentation; or

the design, manufacture, distribution, or use of any Licensed Products
or materials provided under Paragraph 5. I, or other products or
processes developed in connection with or arising out of the Licensed

 

Patent Rights.
6.6 The Licensee agrees to maintain a liability insurance program consistent with sound business
practice.
TERM, TERMINATION AND MODIFICATION OF RIGHTS
This Agreement is effective when signed by all parties, unless the provisions of Paragraph 3.8 are

not ful?lled, and shall expire at the time speci?ed in Appendix B, unless previously terminated
under the terms ofthis Article 

1.2 In the event that the Licensee is in default in the performance of any material obligations under
this Agreement, including but not limited to the obligations listed in Paragraph 7.3 and ifthc
default has not been remedied within ninety {90) days after the date of notice in writing ofthe
default, the NIAID may terminate this Agreement by written notice and pursue outstanding
royalties owed through procedures provided by the Federal Debt Collection Act.

The NIAID shall speci?cally have the right to terminate this Agreement by written notice ifthe
Licensee:

a-cos 40 I 8

CONFIDENTIAL
NIH Patent License Agreement Internal Use Only Nonexclusive
Model Pagc?of l9 [Final] [ModcmaTX. Inc] [January 

14

7.5

7.6



18



CONFIDENTIAL

has not demonstrated that it is executing the research plan submitted
with its application for a license or that it has not taken or cannot be
expected to take, within a reasonable time, effective steps to achieve
the practical application of the Licensed Patent Rights or Licensed
Products as contemplated by this Agreement; or

has willfully made a false statement ofor willfully omitted a material
fact in its application for a license or in any report required by this
Agreement.

The NIAID reserves the right according to 35 U.S.C. ?209td?31 to terminate this Agreement ifit
is determined that this action is necessary to meet the requirements for public use speci?ed by
Federal regulations issued after the date of the license and these requirements are not reasonably
satis?ed by the Licensee.

The Licensee shall have a unilateral right to terminate this Agreement by giving the NIAID sixty
(60} days written notice to that effect.

Within thirty (30) days of receipt of written notice of the unilateral decision to modify or
terminate this Agreement, the Licensee may, consistent with the provisions of3? C.F.R. l,
appeal the decision by written submission to the designated NIAID official. The decision ofthe
designated NIAID of?cial shall be the ?nal agency decision. The Licensee may thereafter
exercise any and all administrative orjudicial remedies that may be accessible.

If either party desires a modi?cation to this Agreement, the parties shall, upon reasonable notice
of the proposed modi?cation by the party desiring the change, confer in good faith to determine
the desirability ofthe modi?cation. No modi?cation shall be effective until a written amendment
is signed by the signatories to this Agreement or their designees.

Within ninety (90} days ofexpiration, termination or term extension ofthis Agreement under this
Article 7, a ?nal report shall be submitted by the Licensee. The Licensee shall send the report to
the NIAID at the Mailing Address for Agreement notices indicated on the Signature Page.

The report shall include, but not be limited t0, progress on the research
and development involving the Licensed Patent Rights, the Licensed
Products or the Licensed Processes.

Any royalty payments, including those incurred but not yet paid {such
as the full minimum annual royalty) due to the NIAID shall become
immediately due and payable upon termination or expiration. Unless
otherwise speci?cally provided for under this Agreement, upon
termination or expiration of this Agreement, the Licensee shall return
all Licensed Products or other materials included within the Licensed
Patent Rights to the NIAID or provide the NIAID with written
certi?cation of the destruction thereof.

lfthe term ofthe Agreement is extended at the Licensee's request,
then the NIAID and the Licensee will negotiate in good faith regarding
the schedule for reports regarding the information required in 18(3);

NIH Patent License Agreement Internal Use Only 

Model l?~2?l5

Page 9 of l9 [Final] [ModernTX, lnc.] [January 16,1018]

T3

Ifthe term ofthis Agreement is longer than ten (10) years. then the
NIAID may request a status update report after the ?fth year of
the Agreement; and

The Licensee may not be granted additional NIAID licenses ifthis
reporting requirement is not ful?lled.

Paragraphs 4.3, 4.4, 5.4, 6.1-6.5, 7.6, 7.8 and 7.9 ofthis Agreement shall survive termination of
this Agreement.

3. GENERAL PROVISIONS



8.2

3.3

3.4

8.5

3.6



I 

CONFIDENTIAL

This Agreement constitutes the entire agreement between the parties relating to the subject matter
of the Licensed Patent Rights and Licensed Products, and the Licensed Additional
Documentation, and all prior negotiations, representations, agreements, and understandings are
merged into, extinguished by. and completely expressed by this Agreement.

The provisions ofthis Agreement are severablc, and in the event that any provision ofthis
Agreement shall be determined to be invalid or unenforceable under any controlling body of law,
such determination shall not in any way affect the validity or enforceability of the remaining
provisions ofthis Agreement.

The construction, validity, performance, and effect of this Agreement shall be governed by
Federal law as applied by the Federal courts in the District of Columbia.

All Agreement notices required or permitted by this Agreement shall be given by prepaid, ?rst
class, registered or certi?ed mail properly addressed to the other party at the address designated on
the following Signature Page. or to another address as may be designated in writing by such other
party, and shall be effective as ofthe date ofthe postmark of such notice.

This Agreement shall not be assigned or otherwise transferred {including any transfer by legal
process or by operation of law, and any transfer in bankruptcy or insolvency, or in any other
compulsory procedure or order of court} except to the Licensee?s Af?liate{s} without the prior
written consent of the NIAID. The parties agree that the identity of the parties is material to the
formation ofthis Agreement and that the obligations under this Agreement are nondelegable.

The Licensee acknowledges that it is subject to and agrees to abide by the United States laws and
regulations (including the Administration Act of I979 and Arms Export Control Act)
controlling the export of technical data, computer software, laboratory prototypes, biological
materials and other commodities. The transfer ofthese items may require a license from the
appropriate agency of the Government or written assurances by the Licensee that it shall not
export these items to certain foreign countries without prior approval of the agency. The NIAID
neither represents that a license is or is not required or that, ifrequired, it shall be issued.

The parties agree to attempt to settle amicably any controversy or claim arising under this
Agreement or a breach ofthis Agreement, except for appeals ofmodi?cation or termination
decisions provided for in Article T. The Licensee agrees ?rst to appeal any such unsettled claims
or controversies to the designated MAID of?cial, or designee, whose decision shall be considered
the ?nal agency decision. Thereafter, the Licensee may exercise any administrative orjudicial
remedies that may be available.

NIH Patent License Agreement Internal Use lOnly Nonexclusive

Model 10-20 I 5

Page 10 of [9 [Final] [ModernaTX. lnc,] [January 16, 

3.8

A-OOS-ZDIS
CONFIDENTIAL

The terms and conditions ofthis Agreement shall, at the sole option, be considered by
the NIAID to be withdrawn from the Licensee?s consideration and the terms and conditions of
this Agreement. and the Agreement itselfto be null and void, unless this Agreement is executed
by the Licensee and a fully executed original is received by the NIAID within sixty (60} days
from the date of the NIAID signature found at the Signature Page.

SIGNATURES BEGIN ON NEXT PAGE

NIH Patent License Agreement Internal Use Only Nonexciusive

Model 5

Page II of 9 [Final] [ModemeTX, Incl] [Januaryr 

NIH NON-EXCLUSIVE PATENT LICENSE AGREEMENT
FOR INTERNAL RESEARCH USE

 

 

FOR NIAID:


by; Meat/? 2.2 2018
Michael R. Mowatt, Date
Director

Technology Transfer and Intellectual Property Of?ce
National Institute of Allergy and Infectious Diseases

Mailing Address or E-mail Address for Agreement notices and reports:

License Compliance and Administration
Monitoring d: Enforcement

Office ofTechnology Transfer

National Institutes of Health

6011 Executive Boulevard, Suite 325
Rockville, Maryland 20352-3804 USA.

E-mail: 

For the Licensee {Upon information and belief, the undersigned expressly certi?es or af?rms that the contents of
an}.r statements of the Licensee made or referred to in this document are truth?Jl and accurate):

 

Licensee
by: 5;
GiuseppWiaramella Date

Graif??e? 

Printed Name

Chief Scienti?c Of?cer. Infectious Disease
Title

1. Of?cial and Mailing Address for Agreement notices:

Shaun Ryan
Name

Deputy General Counsel
Title

Mailing Address

A4103 JO 1 3

CONFIDENTIAL
NIH Patent License Agreement lnternal Use Only 
Model Page 12 of19 [Final] [ModemaTX, Ine.] [January 

320 Bent Street Floor
Cambridge, MA {ill-?ll

 

 

EmailAddress: shaun.ryan@modematx.com

 

Phone: 6 171-209-5832

 

Fax: 617-22 8-7911]

 

Ii. Of?cial and Mailing Address for Financial notices (Licensee?s contact person for royalty payments)

Richard Wansta_ l
Name

 

Head of Audit Finance Operations
Title

Mailing Address:

320 Bent ?treet 3?1 Floor

Cambridge, MA 02l4l

 

 

 

EmailAddress: rick.wanstall@modernatx.com

Phone: 617-209-5360

 

Fax: 6  

 

Any false or misleading statements made, presented, or submitted to the Government, including any relevant
omissions. under this Agreement and during the course ofnegotiation ofthis Agreement are subject to all
applicable civil and criminal Statutes including Federal statutes 3] U.S.C. 658801-3812 {civil liability} and 
1.1.313. ?1ng1 (criminal liability including ?ne(s} or imprisonment).

3

CONFIDENTIAL
NIH Patent License Agreement Internal Use Duly Nonexclusive
Model Page l3 ol' [9 [Final] [Moderna'l'X, Inc] [January 

APPENDIX A 0R PATENT 

Patent(s) or Patent Application(s]:

1.

VI.

VII.



IX.

XI.

XII.

101-003'20'3

CONFIDENTIAL

U.S. Provisional Application 621096.144 ?led 1212412014 entitled ?Recombinant
Metapneumovirus Proteins and Their Use" Ref. No. E-260-201410-Usa?l]

PCT Patent Application PCT11320151059991 ?led 1212412015 entitled ?Recombinant
Metapneumovirus Proteins and Their Use" Ref. No. 

US. Patent Application 151539.640 ?led 0612312017 entitled ?Recombinant Metapneumovirus 
Proteins and Their Use" Ref. No. 

US. Provisional Application 621412.699 ?led 1012512016 entitled ?Recombinant Parainfluenza
Virus Proteins and Their Use? Ref. No. 

US. Provisional Application ?1780.910 ?led 0311312013 entitled ?Prefusion RSV Proteins and
Their Use" Ref. No. 

U.S. Provisional Application 6 11798.389 ?led 0311512013 entitled ?Pre?lsion RSV Proteins and
Their Use? Ref. No. 

U.S. Provisional Application 611857.613 ?led 0712312013 entitled ?Prefusion RSV Proteins and
Their Use" Ref. No. 

US. Provisional Application 611863.909 ?led 0810912013 entitled ?Prefusion RSV Proteins and
Their Use? Ref. No. 

PCT Patent Application PCT1US20 111102611 14 ?led 0311312014 entitled ?Prefusion 
Proteins and Their Use? Ref. No. 

U.S. Patent Application 141207.372 issued 081221201? entitled ?Prefusion RSV Proteins and
Their Use" Ref. No. 

S. Patent Application 141776.651 ?led 0911412015 entitled ?Prefusion RSV Proteins and Their
Use" Ref. No. 

S. Patent Application 151633.578 filed 0612612017 entitled ?Prefusion RSV Proteins and Their
Use? Ref. No- 

NIH Patent License Agreement Internal Use Only Nonexelusive

Model 10-2015

Page14of19 [Final] [ModemaT'X.lnc.] [January-16.1013]

APPENDIX - LICENSED PRODUCTS, PROCESSES, TERRITORY, FIELD OF USE AND
TERMINATION
l. Tangible Materials:
Five hundred micrograms of pre fusion HMPV monomer
Five hundred micrograms of pre fusion RSV trimer
Five hundred micrograms ofpre fusion HMPV trimer
Five hundred micrograms ofpost fusion HMPV trimer
to) Five hundred micrograms of pre fusion trimer
Five hundred micrograms (Eating) ofpost fusion PIVE trimer
Licensed Territory:
Research facilities of Licensee and of its third party contractors in the United States of America
ill. Licensed Fields of Use (Tangible Materials 

The use of the Licensed Products, Licensed Processes, Licensed Additional Documentation, and
Licensed Patent Rights as reagentsIPIODrletaW I

IV. Licensed Fields of Use (Tangible Materials 

The use ofthe Licensed Products, Licensed Processes, Licensed Additionai Documentation, and
Licensed Patent Info I
lProprietary Info I

 

V. Licensed Fields of Use (sequences to Tangible Materials 

The use of the Licensed Products, Licensed Processes, Licensed Additonal Documentation and
Licensed Patent Rights to Proprietary lniU

 

Proprietary Info

 

 

 

VI. Term:

This Agreement shall expire nine (9) years from the effective date as de?ned in Paragraph 7.1 unless
previously terminated under Article 7.



CONFIDENTIAL
NIH Patent License Agreement Internal Use Only 
Model ill-2015 Page I5 of I9 [Final] [Moderna'I'X, Inc_] [January 

APPENDIX ROYALTIES

 

 

 

 

Royalties:

I. The Licensee a recs to pay to the NIAID a noncreditable. nonrefundable license issue royalty in
the amount Proprietary Info Iwithin sixty (60} days from the effective date of
this Agreement.

il. The Licensee agrees to pay to the NIAID a nonrefundable annual royalty in the amount of

lProprielary Info I35 fonows:
The first annual royalty is due within sixty (60] days ofthe effective date ofthis
Agreement and may be prorated according to the fraction of the calendar year remaining
between the effective date ofthis Agreement and the next subsequent January and
[11) Subsequent annual royalty payments are due and payable on January 1 of each calendar
year.
A-DUS-IUIB
CONFIDENTIAL
NIH Patent License Agreement Internal Use Only Nonexclusive
Model 10'2015 Page 16 oil? [Final] Ine] [January 

APPENDIX - SHIPPING INFORMATION

The Licensee?s Shipping Contact: information or questions regarding shipping should be directed to the
Licensee?s Shipping Contact at:

 

 

_Research Associate
Shipping Contact?s Name Title
Phone: SDI-2492 Fax: 583-1993 E-mail:

 

 



 

Shipping Address: Name Address to which Materials should be shipped (please be specific):
Modems Therapeutics, Infectious Disease

Companyr Name 3; Department

Address:

500 Teehnoloesr Square

Mont-Modern; Shibninsr Room

Cambridge. MA D2l39

 

The Licensee's shipping carrier and account number to be used for shipping purposes:

i


 

 

8

CONFIDENTIAL
NIH Potent License Agreement Internal Use Only Honor-(elusive
Model Iii-2015 Page i? of IQ [Final] [Mode-mam. lnc.] [January 16.2043]

APPENDIX ROYALTY PAYMENT OPTIONS

The License Number MUST appear on payments, reports and correspondence.
Credit and Debit Ca rd Payments

Credit and debit card payments can be submitted for amounts up to $29,999. Submit your payment through
the U.S. Treasury web site located at: 

Automated Clearing House (ACH) for payments through U.S. banks only

The IC encourages its licensees to submit electronic funds transfer payments through the Automated Clearing House
(ACH). Submit your ACH payment through the U.S. Treasury web site located at:
Please note that the IC ?only? accepts ACH payments through
this U.S. Treasury web site.

Electronic Funds Wire Transfers

 

The following account information is provided for wire payments. In order to process payment via I
Electronic Funds Wire Transfer sender MUST supply the following information within the transmission:

Drawn on a U.S. bank account via FEDWIRE should be sent directly to the following account:

Bene?ciary Account: Federal Reserve Bank of New York or TREAS NYC
Bank: Federal Reserve Bank of New York

02 I 030004

Account Number: 

Bank Address: 33 Liberty Street, New York, NY 10045

Payment Details: License Number 

Name of the Licensee

Drawn on a foreign bank account should be sent directly to the following account. Payment must be sent
in U.S. Dollars using the following 

Bene?ciary Account: Federal Reserve Bank of New YorlleS or 
Bank: Citibank NA. (New York)

SWIFT Code: CETIUS33

Account Number: 36833368

Bank Address: 388 Greenwich Street. New York, NY l0013

Payment Details (Line 70): NIH 75030031

License Number 
Name of the Licensee
Detail ofCharges {line Charge Our

Checks

All checks should be made payable to Patent Licensing?



CONFIDENTIAL
NIH Patent License Agreement Internal Use Only Noneitclusive
Model 10-20? Page IE of [9 [Final] [ModemaTX. lne.] [January I6. 

Checks drawn on a US. bank account and sent by US Postal Service should be sent directly to the
following address:

National Institutes of Health
PD. Box 979071
St. Louis, MO 63197-9000

 Checks drawn on a U.S. bank account and sent by Overnight or courier should be sent to the following
address:

US Bank

Government Lockbox SL-MO-CZGL
IUDS Convention Plaza

St. Louis. MO 63101

Phone: 314-418-4087

Checks drawn on a foreign bank account should he sent directly,r to the following address:

National Institutes of Health

Of?ce of Technology Transfer

License Compliance and Administration
Royalty Administration

6011 Executive Boulevard

Suite 325, MSC ??660

Rockville, Maryland 20852

3

CONFIDENTIAL.
NIH Patent License Agreement Internal Duly.l Nonexclusive
Model Page 19 of I9 {Final} [Modema'I'X, [no] [Ianunry to, 2013]

PUBLIC HEALTH SERVICE

Amendment

This Agreernent is based on the model Amendment Agreement adopted by the US. Public Health Service 

Technology Transfer Policy Beard for use by components of the National Institutes of Health the Centers

for Disease Control and Prevention and the Food and Drug Administration which are agencies
of the PHS within the Department of Health and Human Services 

This Cover Page identi?es the Parties to this Agreement:

The US. Department of Health and Human Services, as represented by
National Institute of'AlIergy and infectious Diseases
an Institute or Center (hereinafter referred to as the of the
NIH

and

ModemaTX, Inc..
hereinafter referred to as the ?Licen see",
having offices at 200 Technology Square, Cambridge, MA 02139,
created and operating under the laws of Delaware.

Tax ID 



CONFIDENTIAL -NIH

First Amendment of SID Final ModcmaTX October 22, 20! 9
Model Ill-Ellis Page oi'E

FIRST AMENDMENT TO 

This is the First amendment (?First Amend merit") of the agreement-by and between the IC and Licensee having an
effective date of 23 January 2018 and having IC Reference Number L-tl44-2018lil (?Agreement?). This First
Amendment, having IC Reference Number L-?44-2i118fl includes, in addition to the amendments made below, 1)
a Signature Page, 2] Attachment 1 (Shipping Information) and 3) Attachment 2 {Royalty Payment Information).

WHEREAS, the IC and the Licensee desire that the Agreement be amended a ?rst time as set forth below in order
to include additional tangible materials.

NOW, THEREFORE, in consideration of the mutual covenants and promises contained herein, the 1C and the
Licensee, intending to be bound, hereby mutually agree to the following:

i) Amend section I of Appendix to include an additional one milligram (ling) of profusion RSV trimer protein

2) Upon receipt by of the license amendment royalty and veri?cation of this royalty, NIAID agrees to
provide the above-named tangible materials, as available, and to replace these tangible materials, as available, at
reasonable cost, to the Licensee in the event of their unintentional destruction. 

3) Within sixty (60) days ofthe execution ofthis First Amendmen the Licensee shall pay the an amendment
issue royalty in the sum Info I, and payment options may be found in

Attachment 2.

 

4) In the event any provision(s) of the Agreementdsiare inconsistent with Attachment I andr'or 2, such
provision(s) isfare hereby amended to the extent required to avoid such inconsistency and to give effect to the
shipping and payment information in such Attachment 1 andfor 2.

5) All terms and conditions ofthe Agreement not herein amended remain binding and in effect.

6} The terms and conditions ofthis First Amendment shall, at the [Us sole option, be considered by the to be
withdrawn from the Licensee?s consideration and the terms and conditions ofthis First Amendment, and the
First Amendment itself, to be null and void, unless this First Amendment is executed by the Licensee and a
fully executed original is received by the IC within sixty {60) days from the date of the signature found at
the Signature Page. -

T) This First Amendment is effective upon execution by all parties.

SIGNATURES BEGIN ON NEXT PAGE



CONFIDENTIAL 
First Amendment of Final Modema'I'X October 21, 20 9

Model Ill-2015 Page '2 of 8

FIRST AMENDMENT TO 

SIGNATURE PAGE

in Witness Whereof, the parties have executed this First Amendment on the dates set forth below. Any
communication or notice to be given shall be forwarded to the respective addresses listed below.

 

For the IE: I

29 i=7" 43:: 
Michael R. Mowart, Date 
Director

Technology Transfer and Intellectual Property Office
National institutes of Health

Mailing Address or E-mail Address for Agreement notices and reports:

License Compliance and Administration
Monitoring 3; Enforcement

Of?ce of Technology Transfer

National Institutes of Health

6'3] Executive Boulevard, Suite 325
Rockyille. Maryland 20352-3304 USA.

E-mail: 

For the Licensee (Upon information and belief, the undersigned expressly certi?es or affirms that the contents of
any statements of the Licensee made or referred to in this document are truthful and accurate):

 WM 50 Oak/atom

Signaturs of Authorized Of?cial  Date
Name: Saehin Mani
Title: Director, Biomarkers Assays, Infectious Disease Research

l. Of?cial and Mailing Address for Agreement notices:

Shaun Ryan
Name

Deputy General Counsel
Title

Mailing Address:



CONFIDENTIAL -NIH
First Amendment of IBr'ti Final ModemaTX October 22, 2019

Model Page 3 of ii

200 Technology Square

Cambridge. MA 02139

 

 

Email Address: shann.ryan@moriematx.com

 

Phone: 6 I 1714-6500

 

Fax: 61?-583-1993

II. Of?cial and Mailing Address for Financial notices (the Licensee's contact person for royalty payments):

Jennifer Lee
Name

Chief Accounting Officer
Title

Mailing Address:
200 Technology: Square

Cambridge. MA 02139

 

 

Email Address: Jennifer.lee@modernaoc.com

 

Phone: 61 4-6500

Fax: GIT-5834998

Any false or misleading statements made, presented, or submitted to the Government, including any relevant 
omissions, under this Agreement and during the course of negotiation of this Agreement are subject to all
applicable civil and criminal statutes including Federal statutes 31 U.S.C.. ??3801-38 12 (civil liability) and La
U.S.C. ?i?tll (criminal liability including ?ne(s) or imprisonment).

A-OIUQUZD

CONFIDENTIAL 
First Amendment of Final ModemaT'X October 22, 2019
Model 10-2015 Page 4 of 

ATTACHMENT 1 SHIPPING INFORMATION

The Licensee?s Shipping Contact: information or questiuns regarding shipping should be directed to the
Licensee?s Shipping Contact at:

 

Sachin Mani Director, Biomarkers ?2 Assays, Infectious Disease Research_
Shipping Contact's Name Title
Phone: 852-4565 Fax: {61115834293 Email; Sachin.mani@modemetx.com_

 

Shipping Address: Name 3: Address to which Materials should be shipped (please be speci?c):

ModemaTX. loo. infectious Disease Research
Company Name :95 Department

Address:

500 Technoloev Drive

Basement Modems Shipping Room
Cambridge, MA 02139

 

The Licensee's shipping carrier and account number to he used for shipping purposes:

FedEx: 12'3394610

 



CONFIDENTIAL 
First Amendment of L-?44-2018f? Final ModemeT'X October 22, 2D19

Model Page 5 of 

ATTACHMENT 2 ROYALTY PAYMENT INFORMATION
New Payment Options Effective March 2018

The License Number MUST appear on payments, reports and correspondence.

Credit and Debit Card Payments: Credit and debit card payments can be submitted for amounts up to $24,999.
Submit your payment through the U.S. Treasury web site located at:

paygovipubliciformista r028680443.

Automated Clearing House for payments through US. banks only

The encourages its licensees to submit electronic funds transfer payments through the Automated Clearing House
(ACH). Submit your ACH payment through the US. Treasury web site located at:
Please note that the 1C "only" accepts ACH payments through this
US. Treasury web site.

Electronic Funds Wire Transfers: The following account information is provided for wire payments.
in order to process payment via Electronic Funds Wire Transfer sender MUST supply the following
- information within the transmission: 

Dram on a US. bank account via FEDWIRE:

Please provide the following instructions to your Financial institution for the remittance of Fedwire payments to the
NIH ROYALTY FUND. .

 

Fetlwire

 

     

 

 

 

 

 

 

 

 

Field Tag edwire Field Name Required Information
{1510} TypeiSubtype 1000
{2000} Amount (enter payment amount)
{3400} Receiver ABA routing number? 021030004
{3400} Receiver ABA short name TREAS NY 
{3600} Business Function Code CTR (or CTP)
{4200} Beneficiary Identi?er (account number} (enter i 2 digit gatewmr account it)
- 375080031006
{4200} Bene?ciary Name 1" enter agency name associated with tire
Bene?ciary Identifier)
DHHS i NIH (75030030
{5000} Originator (enter the name oftite originator oftne
payment)

COMPANY NAME
{6000} Originator to Bene?ciary Information Line 1 (enter information to identity the purpose oftire

payment)
ROYALTY

{6000} Originator to Beneficiary Information Line 2 {enter information to identi?- the purpose oftite

payment)
LICENSE NUMBER

{6000} Originator to Bene?ciary information Line 3 {enter information to identh the purpose ofthe

romeo
nv voice NUMBER

[6000} Originator to Bene?ciary Information Line 4 (enter information to identi?r the purpose oftire
remand

 

 

 

 

 

 

 

 

 

ill-0202020

CONFIDENTIAL 
First Amendment of L?044-20l8i0 Final ModernaTX October 22, 2019

Model Iii-2015 Page 6 of' 3

 

Fedwire
Field Tag

 

Fodwire Field Name

Required Information

 

Notes:

*The ?nancial institution address for Treasury?s roo?ng number is 33 Liberty Street New York. NY 10045.

 

 

Agency Contacts: Of?ce of Technology Transfer (OTT) {301) 496-705? 

Dream on a foreign bank account via FEOWIRE:

The following instructions pertain to the Fedwire Network. Deposits made in US Dollars 

Should your remitter utilize a correspondent US domestic bank in transferring electronic funds, the following
Fedwirc instructions are applicable.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

edwire Field Name Required Information
{1510} TypeiSubtype 1000
{2000} Amount (enter payment amount)
{3100} Sender Bank ABA routing number (enter the US correspondent bank '3 ABA
ranting number)
{3400} Receiver ABA routing number'Ir 021030004
{3 400} Receiver ABA short name TREAS NYC
{3600} Business Function Code CTR {or CTP)
{4200} Beneficiary Identifier (account number)? (enter i2 digit gateway account it)
BT5030031006
{4200} Beneficiaryl Name (enter agency name associated with tire
Bene?ciary identi?er)
DHHS NIH (75080031)
[5000} Originator (enter the name oftne originator oftne

NAME
[6000} Originator to Bene?ciary Information Line 1 (enter information to identn?J the purpose oftne
payment)
ROYALTY
{6000] Originator to Bene?ciary Information Line 2 {enter information to identi?) the purpose oftne
payment)
LICENSE NUMBER
{6000} Originator to Beneficiary Information ?Line 3 (enter information to identi?: the purpose oftne
payment)
INVOICE NUMBER
{6000} Originator to Bene?ciary Information Line 4 (enter information to identi?! tire purpose oftne
retreat)
Notes:
I?The ?nancial institution address for Treasury?s routing number is 33 LibertyI Street. New York. NY 10045.
?Anything other than the 12 digit gateway account it will cause the Fedwire to be returned SWIFT CODE:
FRNYUSES

 

Agency Contacts:

Office of Technology Transfer (OTT)

A-020-2020

CONFIDENTIAL -NIH

First Amendment ofL-044-20 Ei0 Final ModernaTX
Model 10-20! 5 Page of?

{301) 496-705?

alties maii.nih. or

October 22, 20]?

 

 

Checks
All checks should be made payable to Patent Licensing"

Checks drawn on a U.S. bank account and sent by US Postal Service should be sent directly to the following
address:

National Institutes of Health
P.O. Box 979011
St. Louis, MO 63 

Checks draw: on a US. bank account and sent by overnight or courier should be sent to the following address:

US Bank

Government Lockbox 
1005 Convention Plaza

St. Louis, MO 63101

Phone: 314-413-403?

Checks drawn on a foreign bank account should be sent directly to the following address:

National Institutes of Health

Of?ce of Technology Transfer

License Compliance and Administration
Royalty Administration

6011 Executive Boulevard

Suite 325, MSC 

Rockville, Maryland 2ll352



CONFIDENTIAL .
First Arnendment of Final ModemaTX October 12, 20 9
Model Ill-2015 Page 3 ot'B

PUBLIC HEALTH SERVICE

NON-EXCLUSIVE PATENT LICENSE AGREEMENT
FOR INTERNAL RESEARCH USE
and
BIOLOGICAL MATERIALS LICENSE AGREEMENT - Internet Use

This Agreement is based on the model Non-Exclusive Patent IntemaI Use Agreement adopted by the U.S. Public
Health Service Technology Transfer Policy Board for use by components of the National Institutes of
Health the Centers for Disease Control and Prevention and the Food and Drug Administration
which are agencies ofthe PHS within the Department of Health and Human Services 

This Cover Page identi?es the Parties to this Agreement:

The US. Department of Health and Human Services, as represented by
National Institute of Allergy and Infectious Diseases
an Institute or Center (hereinafter referred to as the of the
NIH

and

ModemaTX, lnc.,
hereinafter referred to as the ?Licensee?,
having of?ces at 200 Technology Square, Floor, Cambridge, MA 02] 39,
created and operating under the laws of Delaware.

Tax ID NIL: 2T-0226313

{000296216} A-26l 

CONFIDENTIAL
NIH Patent License Agreement Internal Use Only Nonexclusive
Model Page I of [Final] [ModemaTX. Inc.] August 6, Z?la

For intemal use only:
License Number:
License Application Number: A-261-2018

Serial Numberis) of Licensed Patent(s) or Patent Application(s}:

I. U.S. Provisional Application ?led 09f19f20l? entitled ?Zika Virus Vaccines" 
Ref. No. E-lBi-Z?lofD-US-?l]

ll. PCT Patent Application PCTIU3201W044468 ?led entitled ?Zika Virus Vaccines?
Ref. No. E-l 

Cooperative Research and Development Agreement Number (ifa subject invention): NKA

Additional Remarks:

 

Proprietary Info

Public for use in

development of Zara 

 

 

 

This Patent License Agreement, hereinafter referred to as the "Agreement", consists of this Cover Page, an attached
Agreement, a Signature Page, Appendix A (List of'Patent{s) or Patent Application(s)), Appendix (tangible
materials, Licensed Territory, Licensed Field of Use and Term), Appendix (Royalties) and Appendix (Royalty
Payment Options}.

{000296216} 40] 

CONFIDENTIA 
NIH Patent License Agreement Internal Use Gull)r Nonexclusive
Model Page 2 ofl? [Final] [ModernaTX, Inc] August 6, 204.3

The NIAID and the Licensee agree as follows:

I. BA KGROUND

l.l



In the course ofconducting biomedical and behavioral research, the NIMD investigators made
inventions and developed tangible materials that may have commercial applicability.

By assignment of rights from the NIAID employees and other inventors, HHS, on behalfofthe
Government, owns intellectual property rights claimed in any United States or foreign patent
applications or patents corresponding to the assigned inventions. HHS also owns any tangible
embodiments ofthese inventions actually reduced to practice by the NIAID, regardless ofwhether
patents or patent applications claiming the tangible materials exist.

The Secretary of HHS has delegated to the NIAID the authority to enter into this Agreement for
the licensing ofrights to these inventions under 35 H.542, l2, the Federal Technology

Transfer Act gf l936, 15 U.S.C. ?3710a, and the regulations governing the licensing of
Govemment-owned inventions, 31' CPR. Pan 404.

The NIAID desires to transfer these inventions and tangible materials to the private sector through
commercial research licenses to facilitate the commercial development of products and processes
for public use and bene?t.

The Licensee desires to acquire the rights to use certain ofthese inventions and tangible materials
in order to develop processes. methods. or marketable products for public use and bene?t.

2. DEFINITIONS

2.1

2.2

2.3

[0002962163


means a corporation or other business entity. which directly or indirectly is
controlled by or controls, or is under common control with the Licensee. For this purpose, the
term "control" shall mean ownership of more than ?fty percent of the voting stock or other
ownership interest ofthe corporation or other business entity. or the power to elect or appoint
more than ?fty percent ofthe members of the governing body of the corporation or other
business entity.

"Government" means the government ofthe United States ofAmerica.
?Licensed Patent Rights" shall mean:

U.S. patent applications and patents listed in Appendix A, all divisions
and continuations ofthese applications, all patents issuing from such

applications. divisions, and continuations, and any reissues,
reexaminations, and extensions ofall such patents;



to the extent that the following contain one or more claims directed to
the invention or inventions claimed in 

(bl

continuations-impart of 

all divisions and continuations ofthese continuations-in?part;

{ii}



NIH Patent License Agreement Internal Use Only Nonexclusive

Model "34015

PageJot?lT [Final] Augustozma

2.4

2.5

2.6



2.3

all patents i5$uing from these continuations-in?part, divisions,
and continuations; and

(iv) any reissues. reexaminations, and extensions of these patents;

to the extent that the following contain one or more claims directed to
the invention or inventions claimed in 13(3): all counterpart foreign
applications and patents to 2.3{a} and including those listed in
Appendix and

Licensed Patent Rights shall not include 2.3{b} or 2.3(c) to the extent
that they contain one or more claims directed to new matter which is
not the subject matter ofa claim in 

?Licensed Products?

means tangible materials. identi?ed in Appendix B. including progeny,
subclones, unmodi?ed derivatives, fractions, or components isolated
therefrom. whether or not within the scope of the claims of the
Licensed Patent Rights;

other tangible materials which, in the course ofrnanufacture. use, sale,
or importation would be within the scope ofone or more claims ofthe
Licensed Patent Rights that have not been held unpatentable, invalid
or unenforceable by an unappealed or unappealable judgment of a ooun
ofcompetent jurisdiction;

modi?cations created by Licensee that contain or incorporate any of
the tangible materials identi?ed in Paragraph 2.4(a) and 2.4{b} above.

?Licensed Processes" means processes which, in the course of being practiced, would be within
the scope ofone or more claims oftl?te Licensed Patent Rights that have not been held
unpatentable, invalid or unenforceable by an unappealed or unappealablejudgment ofa court of
competentjurisdiction.

?Licensed Territory? means the geographical area identi?ed in Appendix B.

?Licensed Field of Use" means the ?eld of use identi?ed in Appendix B.

means Biomedical Advanced Research and Development Authority, part of the HHS
Of?ce of the Assistant Secretary for Preparedness and ReSponse.

3. GRANT OF RIGHTS

3.1

3.2

{000196216}

CONFIDENTIAL

The NIAID hereby grants and the Licensee accepts. subject to the terms and conditions of this
Agreement. a nonexclusive license under the Licensed Patent Rights and under the Licensed
Products in the Licensed Territory to make and to use. but not to sell Licensed Products and
Licensed Processes in the Licensed Field of Use.

The Licensee has no right to sublicense.

401 

NIH Potent License Agreement Internal Use I3anr 

Model 5

Pagedofl'r' {Final} August?j?ls

3.3

4.1

4.2

4.3

4.4

This Agreement confers no license or rights by implication, estoppel, or otherwise under any
patent applications or patents ofthe NIAID other than the Licensed Patent Rights regardless of
whether such patents are dominant or subordinate to the Licensed Patent Rights.

ROYALTIES

The Licensee agrees to pay the NIAID a non?creditable, nonrefundable license issue royalty as set
forth in Appendix C.

The Licensee agrees to pay the NIAID a nonrefundable annual royalty as set forth in Appendix C.

All royalties due under this Agreement shall be paid in U.S. dollars, net ofall non-US. taxes, and
payment options are listed in Appendix D. No royalties shall be paid with funds stemming from
any federal contract, grant, or cooperative agreement. For conversion of foreign Currency to
U.S. dollars, the conversion rate shall be the New York foreign exchange rate quoted in The Wolf
Street Journal on the day that the payment is due.

- Additional royalties may be assessed by the MAID on any payment that is more than ninety (90)

days overdue at the rate ofone percent I per month. This one percent per month rate
may be applied retroactively from the original due date until the date of receipt by the MAID of
the overdue payment and additional royalties. The payment of any additional royalties shall not
prevent the MIME) from exercising any other rights it may have as a consequence ofthe lateness
ofany payment.

5. PERF RMANCE



5.2

5.3

{000296216}

CONFIDENTIAL

NIAID has previously provided materials to Licensee under separate materials transfer
agreements (MAID Material Transfer Agreements 20] T4210, and
20l7-0993-l}. Upon execution, this Agreement will govern the use of' Licensed Products. The
Licensee agrees to retain control over the Licensed Products and shall not distribute or release
them to others without the prior written consent of the NIAI D.

The Licensee shall expend reasonable efforts and resources to can'y out the research develoPment
plan submitted with the Licensee's application for a license and shall begin research within six (6)
months of the effective date of this Agreement.

The Licensee agrees in its use ofany Licensed Products provided by the NIAID to comply with
all applicable statutes, regulations, and guidelines, including NIH and HHS regulations and
guidelines. The Licensee agrees not to use the Licensed Products for research involving human
subjects or clinical trials in the United States without complying with 2  C.F.R. Part 50 and 
C.F.R. Part 46. The Licensee agrees not to use the Licensed Products for research involving
human subjects or clinical trials outside ofthe United States without notifying the MAID, in
writing, ofthis research or trials and complying with the applicable regulations ofthe appropriate
national control authorities. Written notification to the ofresearch involving human
subjects or clinical trials outside ofthe United States shall be given no later than sixty (60) days
prior to commencement ofthis research or trials.

A-BGI JDI 3

NIH Patent License Agreement Internal Use ?nly 

Model 

Page?ol'l'l' [Final] August-5.20m

5.4

5.5

All plans and reports required by this Agreement shall be treated by the NIAID as commercial
and ?nancial information obtained from a person and as privileged and con?dential and, to the
extent permitted by law, not subject to disclosure under the Freedom of Information Act, 

M-

The Licensee is encouraged to publish the results of its research projects using the Licensed
Patent Rights, the Licensed Products andfor the Licensed Processes. In all oral presentations or
written publications concerning the Licensed Patent Rights, the Licensed Products andfor the
Licensed Processes, the Licensee shall acknowledge the contribution of Dr. Theodore Pierson,
the NIAID Laboraton of?v?iral Diseases and NIAID as the HHS agency supplying the Licensed
Patent Rights, the Licensed Products anon the Licensed Processes, unless requested otherwise
by the NIAID or Dr. Theodore Pierson.

6. NEGATI OF WARRANTIES AND INDEMNIFICATION



6.2

6.3

6.4

6.5

6.6



CONFIDENTIAL

The NIAID offers no warranties other than those expresst speci?ed in Article I.

The NIAID does not warrant the validity ofthe Licensed Patent Rights and makes no
representations whatsoever with regard to the scope ofthe Licensed Patent Rights, or that the
Licensed Patent Rights may be exploited without infringing other patents or other intellectual
property rights ofthird patties.

THE NIAID MAKES NO WARRANTIES, EXPRESSED OR IMPLIED, OF
MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE OF ANY SUBJECT
MATTER DEFINED BY THE CLAIMS OF THE LICENSED PATENT RIGHTS DR OF
ANY LICENSED PRODUCTS PROVIDED TO THE LICENSEE UNDER PARAGRAPH 5.I.

The NIAID does not represent that it shall commence legal actions against third parties infringing
the Licensed Patent Rights.

The Licensee shall indemnify and hold the NIAID, its employees, students, fellows, agents, and
consultants hann less from and against all liability, demands, damages, expenses, and losses,
including but not limited to death, personal injury, illness, or property damage in connection with
or arising out of:

ta} the use by the Licensee, its directors, employees, or third parties ofany
Licensed Patent Rights, or

the design, manufacture, distribution, or use ofany Licensed Products
or materials provided under Paragraph or other products or
processes developed in connection with or arising out ofthe Licensed
Patent Rights.

The Licensee agrees to maintain a liability insurance program consistent with sound business
practice.

it'll-26] -20  3

NIH Patent Liconso Agreement Internal Use Duly Nonexclusive

Model 5

Pagoda?? [Final] [ModernaTX,lnc.] August?,2?l8

7. TERM TERMINATION AND MODIFICATION OF RIGHTS

 



7.2

7.3

7.4

7.5

16

7.7

7.3

{000296216}

CON FIDENTIAL

This Agreement is effective when signed by all parties, unless the provisions of Paragraph 8.8 are
not ful?lled, and shall expire at the time Speci?ed in Appendix B, unless previously terminated
under the terms of this Article 7.

In the event that the Licensee is in default in the performance of any material obligations under
this Agreement, including but not limited to the obligations listed in Paragraph 7.3 and if the
default has not been remedied within ninety (90) days after the date of notice in writing of the
default, the NIAID may terminate this Agreement by written notice and pursue outstanding
royalties owed through procedures provided by the Federal 'Debt Collection Act.

The NIAID shall Specifically have the unilateral right to terminate this Agreement by written
notice if the Licensee: 

has not demonstrated that it is executing the research plan submitted
with its application for a license or that it has not taken or cannot be
expected to take. within a reasonable time, effective steps to achieve
the practical application ofthe Licensed Patent Rights or Licensed
Products as contemplated by this Agreement; or

has willfully made a false statement of or willfully omitted a material
fact in its application for a license, in its representations made to
NIAID in the course of establishing this Agreement, or in any report
required by this Agreement.

The NIAID reserves the right according to 35 U.S.C. ?2091d?31 to terminate this Agreement ifit
is determined that this action is necessary to meet the requirements for public use speci?ed by
Federal regulations issued after the date of the license and these requirements are not reasonably
satis?ed by the Licensee.

The Licensee shall have a unilateral right to terminate this Agreement by giving the NIAID sixty
(60) days written notice to that effect.

Within thirty (30) days of receipt of written notice of the unilateral decision to modify or
terminate this Agreement, the Licensee may, consistent with the provisions of 3? (LEE. ?404.l l,
appeal the decision by written submission to the designated NIAID official. The decision ofthe
designated NIAID of?cial shall be the ?nal agency decision. The Licensee may thereafter
exercise any and all administrative orjudicial remedies that may be accessible.

If either party desires a modi?cation to this Agreement, the parties shall, upon reasonable notice
of the proposed modification by the party desiring the change, confer in good faith to determine
the desirability of the modi?cation. No modi?cation shall be effective until a written amendment
is signed by the signatories to this Agreement or their designees.

The NIAID Material Transfer Agreement identi?ed as 2013-0664 shall be terminated immediately
and automatically upon expiration or termination of this Agreement.



NIH Patent License Agreement Internal Use Only Nonexclusive

Model 10-20 I 5

Fage'i?ofl'i? [Final] [ModernaTX,lnc.] August?j?l?

19

Ill]



'r'.l2

This Agreement and MAID Material Transfer Agreement identi?ed as 2013-0664 shall be
terminated immediately and automatically upon cancellation, revocation or termination of
BARDA Contract No. HHSOIOOZOIGUOOZQC. The Licensee shall alert the NIAID to the
cancellation, revocation or lamination or termination of BARDA Contract No.
within ?ve days ofsuch occurance.

Within ninety (90) days of expiration, termination or term extension ofthis Agreement under this
Article a ?nal report shall be submitted by the Licensee. The Licensee shall send the report to
the NIAID at the Mailing Address for Agreement notices indicated on the Signature Page.

The report shall include, but not be limited to, progress on the research
and development involving the Licensed Patent Rights, the Licensed
Products or the Licensed Processes.

Any royalty payments, including those incurred but not yet paid (such
as the full minimum annual royalty) due to the NIAID shall become
immediately due and payable upon termination or expiration

[f the term of the Agreement is extended at the Licensee?s request.
then the NIAID and the Licensee will negotiate in good faith regarding
the schedule for reports regarding the information required in 

Ifthe term ofthis Agreement is longer than ten years, then the
NIAID may request a status update report after the ?fth year of
the Agreement; and

The Licensee may not be granted additional NIAID licenses ifthis
reporting requirement is not ful?lled.

Within thirty (30) days oftennination or expiration ofthis Agreement, the Licensee shall destroy
all materials associated with the NIAID Material Transfer Agreement identi?ed as 20 I 3&664, all
Licensed Products and all other materials included within the Licensed Patent Rights, and
provide the NIAID with written certi?cation ofthe destruction thereof. The Licensee may not be
granted additional NIAID licenses ifthis reporting requirement is not ful?lled.

Paragraphs 4.14.4, 5.4, 5.5, 6. l-6.5, 7.6, 18, 19, "Al and 7J2 ofthis Agreement shall
survive termination ofthis Agreement.

8. GENERAL PROVESIONS

3.1

3.2

{accesses}

CONFIDENTIAL

This Agreement censtitutes the entire agreement between the parties relating to the subject matter
of the Licensed Patent Rights and Licensed Products, and all prior negotiations, representations,
agreements, and understandings are merged into, extinguished by, and completely expressed by
this Agreement.

The provisions ofthis Agreement are severable, and in the event that any provision ofthis
Agreement shall be determined to be invalid or unenforceable under any controlling body of law,
such determination shall not in any way affect the validity or enforceability ofthe remaining
provisions ofthis Agreement.

ill-215 40 I 3

NIH Patent License Agreement Internal Use Only Noneer usive

Model Ill?201 5

PageSol'l? [Final] [ModemaTX.lnc.] Augustd,20l3

3.3

3.4

3.5

3.6

3.7

3.8

{000290215}

CONFIDENTIAL

The construction. validity, performance, and effect ofthis Agreement shall be governed by
Federal law as applied by the Federal courts in the District ofColumbia.

All Agreement notices required or permitted by this Agreement shall be given by prepaid. ?rst
class, registered or certi?ed mail properly addressed to the other party at the address designated on
the following Signature Page1 or to another address as may be designated in writing by such other
party, and shall be effective as ofthe date ofthe postmark ofsueh notice.

This Agreement shall not be assigned or otherwise transferred (including any transfer by legal
process or by operation of law, and any transfer in bankruptcy or insolvency, or in any other
compulsory procedure or order ofcourt} except to the Licensee?s Af?liatets) without the prior
written consent ofthe NIAID. The parties agree that the identity ofthe parties is material to the
formation of this Agreement and that the obligations under this Agreement are nondelegable.

The Licensee acknowledges that it is subject to and agrees to abide by the United States laws and
regulations (including the Exmrt Administration Act of I979 and Arms Export Con_trol Act)
controlling the export of technical data, computer software, laboratory prototypes. biological
materials and other commodities. The transfer items may require a license from the
appropriate agency of the Government or written assurances by the Licensee that it shall not
export these items to certain foreign countries without prior approval of the agency. The NIAI 
neither represents that a license is or is not required or that. ifrequired, it shall be issued.

The patties agree to attempt to settle amicably any controversy or claim arising under this
Agreement or a breach ofthis Agreement. except for appeals of modi?cation or termination
decisions provided for in Article 7. The Licensee agrees ?rst to appeal any such unsettled claims
or controversies to the designated NIAID of?cial, or designee, whose decision shall be considered
the ?nal agency decision. Thereafter, the Licensee may exercise any administrative or judicial
remedies that may be available.

The terms and conditions ofthis Agreement shall. at the sole option, be considered by
the NIAID to be withdrawn from the Licensee?s consideration and the terms and conditions of
this Agreement. and the Agreement itselro be null and void, unless this Agreement is exeCuted
by the Licensee and a fully executed original is received by the NIAID within sixty {60) days
from the date ofthe NIAID signature found at the Signature Page.

SIGNATURES BEGIN ON NEXT PAGE

3

NIH Patent License Agreemean Internal Use 

Model 

Page 9 of [Finall I [ModernaTX. in: August 6. 2018

NON EXCLUSIVE PATENT LICENSE. AGREEMENT
FOR INTERNAL RESEARCH USE
and
BIOLOGICAL MATERIALS LICENSE AGREEMENT Internal Use

 

FDR NIAID:

by;  Exitin- 20/8
Michael R. Mowett, PILD. Date

Director

Technology Transfer and Intellectual Property Of?ce
National Institute ofAlIergy and infectious Diseases
National lnstitues of Health

Mailing Address or Email Address for Agreement notices and reports:

License Compliance and Administration
Monitoring 3: Enforcement

Of?ce of Technology Transfer

National Institutes ofHeaith

GUI 1 Executive Boulevard, Suite 325
Reckville, Maryland 20852-3804 USA.

E-nmi]: 

For the Licensee {Upon infon?nation and belief. the undErsigned expresst certi?es or ellirnis that the contents of
any statements ofthe Licensee made or referred to in this document are truthful and accurate}:

Licensee

by:   Vie A4, Cirrung  .31'20l3?

Signature'ofAuthorizcd Of?cial Date

Daphne M. Van de 
Printed Name

Counsel
Title

{00029-5216} 

CONFIDENTIAL
l?ulent License Agreement Internal Use Only 
h-ledel ID-EDIS Page ID of]? [Fund] [Modernn'l'X Inc.  Auguste. IBIS

1. Of?cial and Mailing Address for Agreement notices:

Lori Henderson

Name

 

General Counsel
Title

Mailing Address

mm floor
Cambridge. MA 02141

Email Address: legal@modematx.com

 

Phone: 6 17-? l4-6100

Fax: 617-533-1998

II. Of?cial and Mailing Address for Financial notices {Licensee?s contact person for royalty payments)

Ill. The NIAID will invoice the Licensee for all amounts due hereunder and will send all invoices to the
attention of"r\ocounts Payable" at the following email address: moderna invoioe?ooncursolutions.com.

Ew?

Name

 

1' in erations
Title

Mailing Address:

200 Technology SguareI floor

Cambridge. MA 02139

Email Address: rick.wanstall@modernatx.com
Phone: 6 7-209-5360

Fax: 6 I 1225-7910

Any false or misleading statements made, presentedI or submitted to the Government, including any relevant
omissions, under this Agreement and during the course of negotiation of this Agreement are subject to all
applicable civil and criminal statutes including Federal statutes 3i ??330l-33l2 (civil liability] and 
95.9, ?10tll_ (criminal liability including ?ne(s) or imprisonment).

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NEH Patent License Agreement Internal Use Only Nonexclusive
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APPENDIX A - PATENTQSI ORLPATENT APPLICATIONS)

Paten?s) or Patent Applieation(s):

l. U.S. Provisional Application 6239.5,613 ?led 09fl9f20 6 entitled ?Zika Virus Vaccines" 
Ref. No. 

ll. PCT Patent Application PCTIUSZUIWD44468 filed 07f23l'2017 entitled ?Zika Virus Vaccines"
Ref. No. 

{00029623,6l sum 40] 

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NIH Patent License Agreement Internal Use Only Nonexclusive
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APPENDIX LICENSED TERRITORY, LICENSED FIELD OF USE AND
TERM.
l. Tangible Materials:

a DNA expression construct expressing structural genes onlKV
strain HIPFZU I 3

l-WestFac-CprME; DNA expression construct expressing structural genes of 
strain Western Paci?c

1668 l-CprME; a DNA expression construct expressing structural genes of DENV
strain 1668]

ll. Licensed Territory:
Research facilities of Licensee located in the United States of America

Licensed Field of Use:
The use of the Licensed Products, Licensed Processes, and Licensed Patent Rihts limited to the scape
of canon Contract No. as it pertains to or further
development of Licensee?s proprietary vaccineis) speci?cally directed against Zika viruses. For
the sake of clarity, the Licensed Field of Use speci?cally excludes the use of Licensed Products,

Licensed Processes, and Licensed Patent Rights inIPfUDfiElaW Inon-Zika virus
vaccines. as well as DNA-based Zika vaccines expressing virus-like particle antigens.

 

 

IV. Tenn:

This Agreement shall expire August 27, 2020. the end of the period of performance for BARDA
Contract No. HH50100201600029C. unless previously terminated under Article 7.

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NIH Ptent License Agreement internal Use Only 
Model 10-20IS Page Hot [Final] [ModemaTX. Inc.] August 6. 20l8

APPENDIX - ROYALTI ES

Royalties:

I. The Licensee agrees that the Licensed Products, Licensed Processes, and Licensed Patent
Rights represent a signi?cant investment on the part ofthe MAID, and that the Licensed
Products, Licensed Processes, and Licensed Patent Rights are ofsubstentiel value.
Non-withstanding the foregoing, the NIAID hereby grants to the Licensee a royalty-free, non-
exclusive license, subject to the terms and conditions ofthis Agreement, due to the research
support of BARDA Contract No. HH $010020] ISUOOZQC.

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APPENDIX D- ROYALTY PAYMENT OPTIONS
New Payment Options Effective March 2018

The License Number MUST appear on payments, reports and correspondence.

Credit and Debit Card Payments: Credit and debit card payments can be submitted for amounts up to $24,999.
Submit your payment through the U.S. Treasury web site located at:

rti28680443.
Automated Clearing House for payments through US. banks only

The IC encourages its licensees to submit electronic funds transfer payments through the Automated Clearing House
(ACH). Submit your ACH payment through the LLB. Treasury web site located at:
Please note that the "only" accepts ACH payments through
this U.S. Tleasury web site

Electronic Funds Wire Transfers: The following account information is provided for wire payments.
In order to process payment via Electronic Funds Wire Transfer sender MUST supply the following
information within the transmission:

Drawn on a U.S. bank account via FEDWIRE:

Please provide the following instructions to your Financial Institution for the remittance of Fedwire payments to the

NIH I FUND.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Fedwire Field Name Required Information

l510} Typet'Subtype I000

{2000} Amount (enter payment amount,I

{3400} Receiver ABA routing number? 021030004

{3400} Receiver ABA short name TREAS NYC

{3600] Business Function Code (or TP)

{4200} Bene?ciary Identi?er {account number) (enter i2 digit gateway account ti)

8?5080031006

{4200} Bene?ciary Name (enter agency name associated with the
Bene?ciary identifier)
DIIHS i NIH 05080031)

{5000} Originator (enter the name of the originator of the
payment)
COM PANY NAM 

{6000} Originator to Bene?ciary Information Line I (enter information to identity the purpose of the
payment)
ROYALTY

{6000} Originator to Bene?ciary Information Line 2 (enter information to identi?' the purpose ofthe
payment)
LICENSE NUMBER

[6000} Originator to Beneficiary Information Line 3 (enter information to ia'entii}l the purpose of the
payment)
JNVOICE NUMBER

[00029623.6} tat-26 I ~20] 

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NIH Patent License Agreement Internal Use Only Nonexclusive
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Fedwire Field Name Required lnfonnation
[6000} Originator to Bene?ciary Information Line 4 (enter information to identi?; the purpose oftne
payment)
Notes:

*The ?nancial institution address for Treasury?s routing number is .33 Libem StreetI New York! NY 10045.

Agency: Contacts: Of?ce ofTechnology Transfer(OTT) 

Drawn on a foreign bank account via FEDWIRE:

The following in5tructions pertain to the Fedwire Network. Deposits made in US Dollars 1 

Should your remitter utilize a correspondent US domestic bank in transferring electronic funds, the following
cdwire instructions are applicable.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

5:13}; Fedwire Field Name Required [nfon'nation

{1510} Typet'Subtype 1000

{2000} Amount (enter payment amount)

{3100] Sender Bani-t ABA routing number (enter the US correspondent bani: ?s ABA
routing number)

{3400} Receiver ABA routing number"I 021030004

{3400} Receiver ABA short name TREAS NYC

{3600} Business Function Code CTR [or 

{4200} Bene?ciary Identi?er (account number)? (enter t2 digit gateway account it)
3250800311106

{4200] Bene?ciary Name (enter agency name associated with the
Bene?ciary identifier)
NIH (75030031)

{5000] Originator (enter the name oftne originator ofthe
payment)
NAME

{6000} Originator to Beneficiary Infon-nation - Line I (enter information to identity the purpose ofthe
payment)
ROYALTY

{6000} Originator to Bene?ciary Information Line 2 (enter information to identnj/ the purpose of the
payment)
LICENSE NUMBER

{6000] Originator to Bene?ciary Information Line 3 (enter information to identify the purpose oftne
payment)
NUMBER

{6000} Originator to Bene?ciary Information Line 4 (enter information to identify the purpose oftne
payment!

Notes:

"Tltc financial institution address For Treasury?s routing nUmber is 33 Libett'r Street. New York. NY 10045.
?Anything other than the 12 digit gateway account it will cause the Fedwire to be returned SWIFT CODE:
FRNYUS33

immense: east acts
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NIH Patent License Agreement Internal Use Only

Model 10-2015

Nonexclusivc
Page loofi?i [Final] 

[ModernaTX, Inc] August a, 2018

 

 

Agency Contacts:

Office ofTecl'tnology Transfer (OTT) {30] 496-7057 OTT-Rogaltiesmgmail.nih.gov

Checks
All checks should be made payable to Patent Licensing?

Checks drawn on a U3. bank account and sent by US Postal Service should be sent directly to the following
address:

National Institutes ofHealth
PD. Box 9?90?l
St. Louis, MO 631973000

Checks drawn on a US. bank account and sent by overnight or courier should he sent to the following address:

US Bank

Government Lockbox SL-MO-CZGL
I005 Convention Plaza

St. Louis, MO 6310]

Phone: 314-4 

Checks drawn on a foreign bank account should be sent directly to the following address:

National Institutes of Health

Of?ce of Technology Transfer

License Compliance and Administration
Royalty Administration

60] 1 Executive Boulevard

Suite 325, MSC 7660

Rockville, Maryland 20352

{000296216} midi-2013

CONFIDENTIAL
NIH Patent License Agreement Internal Use Uni)r Hones-elusive
Model l0-2015 Page lilol' [Final] [ModemaTX. Incl August?leB