I . CONTRACT ID CODEAMENDMENT OF SOLICITATIONAVIODIFICATION OF CONTRACT

PAGE OF PAGES

1
2. AMENDMENT/MODIFICATION NO.

3. EFFECTIVE DATE

P00081

4. REQUISMON/PURCHASE REQ. NO.

col*

89

SEE SCHEDULE

05-Aug-2020

6. ISSUED BY

I

5. PROJECT NO.(Ifapplicable)

7. ADMINISTERED BY Mother than item6)
DCMA ATLANTA
2300 LAKE PARK DRIVE SUITE 300
SMYRNA GA 30080-4091

W150KN

US ARMY CONTRACTING COMMAND
PHIPPS ROAD
PICATINNY NJ 07806-5000

S1 103ACODE

9A. AMENDMENT OF SOLICITATION NO.

8. NAME AND ADDRESS OF CONTRACTOR (No., Street, County, State and Zip Code)ADVANCED TECHNOLOGY INTERNATIONALON BEHALF OF THE NCBDC
315 SIGMA DR
SUMMERVILLE SC 23486-7790

9B. DATED (SEE ITEM 1 1)
10A. MOD. OF CONTRACT/ORDER NO.
W15QKN-16-9-1002
10B. DATED (SEE ITEM 13)

CODE

08-Apr-2016
1 1 . THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS

1G3V8

X

FACILITY CODElIIJThe above numbered solicitation is anended as set forth in Item14. The hour and date specified for receipt ofOffer

is extended.

is not extended.

Offer insist acknowledge receipt ofthis amendment prior to the hour and date specified in the solicitation or as amended by one ofthe following methods:(a) By completing Items 8 and 15, and returning
copies ofthe amendment: (b) By acknowledging receipt ofthis amendrrent on each copy ofthe olEr submitted:or (c) By separate letter or telegram which includes a reErence to the solicitation and amendment numbers. FAILURE OF YOUR ACKNOWLEDGMENT TO BE
RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATE SPECIFIED MAY RESULTINREJECTION OF YOUR OFFER. Ifby virtue ofthis amendment you desire to change an offer already submitted. such change nay be made by telegram or letter,
provided each telegramor letter makes reference to the solicitation and this amendment, and is received prior to the opening hour and date specified.
12. ACCOUNTING AND APPROPRIATION DATA (If required)

See Schedule
13. THIS ITEM APPLIES ONLY TO MODIFICATIONS OF CONTRACTS/ORDERS.
IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14.
A. THIS CHANGE ORDER IS ISSUED PURSUANT TO: (Specify authority) THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE
CONTRACT ORDER NO. IN ITEM 10A.
B. THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES (such as changes in paying
office, appropriation date, etc.) SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(B).
C. THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF:
x D. OTHER (Specify type of modification and authority)
1AW the terms and conditions of the OTA.

E. IMPORTANT: Contractor

is not,X

is required to sign this document and return1

copies to the issuing office.

14. DESCRIPTION OF AMENDMENT/MODIFICATION (Organized by UCF section headings, including solicitation/contract subject matter
where feasible.)
Modification Control Number: martins201688
See "SUNTAARY OF CHANGES" for Atdification Description.

Except as provided herein, all terns and conditions ofthe document rekrenced in Item9A or 10A as heretofore changed remains unchanged and in fill force and effect.

15A. NAME AND TITLE OF SIGNER (Type or print)

16A. NAME AND TITLE OF CONTRACTING OFFICER (Type or print)/CONTRACTING OFFICER
TEL:

15B CONTRACTOR/OFFEROR‘)

wan. mica.

15C DATE SIGNEDSr Vice President, Contracts and Procurement'tu g 42020
2020(Signature of person authorized to sign)
EXCEPTION TO SF 30
APPROVED BY OIRM 11-84

EMAIL

16B. UNITED STATES OF AMERICA

16C. DATE SIGNED

BY

05-Aug-2020(Signature of Contracting Officer)

30-105-04

STANDARD FORM 30 (Rev. 10-83)
Prescribed by GSA
FAR (48 CFR) 53.243

W15QKN-16-9-1002
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SECTION SF 30 BLOCK 14 CONTINUATION PAGE
SUMMARY OF CHANGESSECTION A - SOLICITATION/CONTRACT FORM

The following have been added by full text:
MOD DESCRIPTION - P00081

The purpose of this modification is to:1) Award RPP 20-11, MCDC2011-004 (Janssen Pharmaceuticals, Inc.) via incorporation of
the Terms and Conditions below:
2) Add incremental funding to the following project:
RPP 20-11, PRE-20-11 (Janssen): $1,001,650,000.00 via CLIN 0058.
3) Incorporate an updated MCDC Award Tracker, listing the cost/fee and ceiling breakouts
for each awarded project via MCDC Award Tracker P00081.

The information, redlines, exchanges, comments provided herein are part of ongoing negotiations that the Parties consider
to be Government deliberative process and Janssen trade secrets, commercial or financial information. The Parties aresharing this information, redlines, exchanges, comments under the assurance that each Party shall maintain theconfidentiality of the information under the Trade Secrets Act, Procurement Integrity Act, other applicable statutes,
regulations, rules, case law, contractual provisions, protective orders or otherwise, and as such, the information, redlines,
exchanges, comments provided herein are exempt from disclosure under Exemptions 4 and 5 of the Freedom of Information
Act ("FOIA").

P00081 Modification to MCDC OTA No. W150KN-16-9-1002
BETWEENJANSSEN PHARMACEUTICALS, INC.
1125 TRENTON-HARBOURTON ROAD
TITUSVILLE, NJ 08560, USAAND
THE U.S. ARMY CONTRACTING COMMAND — NEW JERSEYPHIPPS ROAD, BUILDING 9PICATINNY ARSENAL, NJ 07806-5000
AND

WI SQKN-16-9-1002
P00081Page 3 of 89

THE MEDICAL DEFENSE CBRN DEFENSE CONSORTIUM
C/O ADVANCED TECHNOLOGY INTERNATIONAL
315 SIGMA DRIVE
SUMMERVILLE, SC 29486
CONCERNING
COVID-19 PANDEMIC-VACCINE RAPID ADVANCED RESEARCH &DEVELOPMENT ("ARD") TO LARGE-SCALE MANUFACTURING

WI 5QKN- 16-9-1002
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Modification to MCDC OTA No. W15QKN-16-9-1002: P00081
Project Identifier: MCDC2011-004
Requiring Activity: Joint Program Executive Office for Chemical, Biological,
Radiological, and Nuclear Defense (JPEO-CBRND)
Total Amount of the Agreement: $1,001,650,000
Funds Obligated: $1,001,650,000
Effective Date of Agreement:
Period of Performance: Contract Award—January 31, 2022 (estimated)
Authority: 10 U.S.C. 2371b, and 10 U.S.C. 2371b(f)WI 5QKN-16-9-1002(martins201688)
Page 5 of 89

This Agreement is entered into between the United States of America, represented by the
Department of Defense ("DoD"), Army Contracting Command-New Jersey; Advanced
Technology International ("ATI") as the Consortium Management Firm ("CMF") of theMedical CBRN Defense Consortium; and Janssen Pharmaceuticals, Inc., pursuant to andunder U.S. Federal law.
Janssen Pharmaceuticals, Inc.

U.S. Department of Defense

BY:

01)

NAME: Peter W. Gerhard
ITS: Agreements Officer; CCNJ-ET
DATE: 04 August 2020

DATE: 05 August 2020

The Medical Defense CBRN Defense
Consortium do
Advanced Technology International

BY:

(h\

P\

NAME: Mica Dolan
ITS: VP Contacts and Procurement
DATE: 04 August 2020

W15QKN-16-9-1002
P00081Page 6 of 89

Table of Contents
RECITALS 8
Article!.
Scope of the Project Agreement
8
SECTION 1.1 INTRODUCTION
8SECTION 1.2 DEFINITIONS
9SECTION 1.3 PROTOTYPE PROJECT, MILESTONES, AND PRICING ASSUMPTIONS AND
CONDITIONS
14SECTION 1.4 SCOPE OF P00081 MODIFICATION18SECTION 1.5 PROTOTYPE DELIVERABLES
19
SECTION 1.6 FOLLOW-ON PRODUCTION
21
Article II.
Term and Termination
21
SECTION 11.1
TERM
21
SECTION 11.2
TERMINATION21
SECTION 11.3
EXTENSION OF TERM
22
Article III. Project Management, Modifications, and Administration
22
SECTION 111.1
MANAGEMENT AND MODIFICATIONS
22
SECTION 111.2
PROJECT AGREEMENT ADMINISTRATION
23
Article IV. "PREP ACT" Coverage
24
Article V.
Obligation and Payment
25
SECTION V.1
LIMITATION OF LIABILITY
25
SECTION V.2
FIXED PRICE PAYMENT METHOD
25
ACCOUNTING SYSTEM REQUIREMENTS
SECTION V.3
26
SECTION V.4
PAYMENTS AND PAYMENT INSTRUCTIONS
26
SECTION V.5
COMPTROLLER GENERAL ACCESS TO RECORDS
27
Article VI. Disputes
27
Article VII. Confidential Information
28
SECTION VII.1 AUTHORIZED DISCLOSURE
28
SECTION VII.2 EXCLUSIONS
29
SECTION VII.3 TERM
29
Article VIII. Publication and Academic Rights
29
SECTION VI11.1 USE OF INFORMATION.
29
SECTION VIII.2 PUBLICATION OR PUBLIC DISCLOSURE OF DATA
29
Article IX. Patent Rights
30
SECTION IX.1 BACKGROUND INTELLECTUAL PROPERTY DISCLOSURES30
SECTION IX.2
ALLOCATION OF PRINCIPLE RIGHTS30
SECTION IX.3
INVENTION DISCLOSURE, ELECTION OF TITLE, AND FILING OFPATENT APPLICATION30SECTION IX.4 CONDITIONS WHEN THE GOVERNMENT MAY OBTAIN TITLE
32
SECTION IX.5 MINIMUM RIGHTS TO JANSSEN'S CONSORTIUM AND PROTECTION OF
JANSSEN'S CONSORTIUM'S RIGHT TO FILE.
32
SECTION IX.6
ACTION TO PROTECT JPEO-CBRND'S INTEREST33
SECTION IX.7 REPORTING ON UTILIZATION OF SUBJECT INVENTIONS33
SECTION IX.8 MARCH-1N RIGHTS34
SECTION IX.9
BACKGROUND INFORMATION
35
Article X.
Data Rights
35
SECTION X.1
DATA CATEGORIES37
SECTION X.2
ALLOCATION OF PRINCIPLE RIGHTS38
SECTION X.3
IDENTIFICATION AND DISPOSITION OF DATA
39
Article Xl. Export Control40

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Article XII. Government Furnished Property
Article XIII. Civil Rights Act
Article XIV. Small Business Affiliation
Article XV. Antitrust
Article XVI. Security and Operations Security ("OPSEC")
Article XVII. Safety
Article XVIII. Representations and Warranties
SECTION XVIII.1 REPRESENTATIONS AND WARRANTIES OF ALL PARTIESSECTION XVIII.2 LIMITATIONSArticle XIX. General Provisions
SECTION XIX.1 FEESSECTION XIX.2 WAIVERSECTION XIX.3 SECTION HEADINGSSECTION XIX.4 SEVERABILITYSECTION XIX.5 EXCUSABLE DELAY
SECTION XIX.6 REGULATORY RIGHTSSECTION XIX.7 FAILURE TO PROVIDE PROTOTYPE PRODUCTSECTION XIX.8 RADIOACTIVE MATERIALSSECTION XIX.9 RECOMBINANT DNA
SECTION XIX.10 REQUIRED COMPLIANCE FOR USE OF LABORATORY ANIMALSSECTION XIX.11 REQUIRED COMPLIANCE FOR USE OF HUMAN SUBJECTSSECTION XIX.12 REQUIRED COMPLIANCE FOR USE OF HUMAN ANATOMICALSUBSTANCESSECTION XIX.13 COMPLIANCE WITH GOOD MANUFACTURING PROCESSESSECTION XIX.14 REGISTRATION WITH SELECT AGENT PROGRAMSECTION XIX.15 DUTY FREE ENTRY
Article XX. Assignment of Agency
Article XXI. Order of Precedence
Article XXII. Execution
Article XXIII. Antibribery and Anti-Corruption
Article XXIV.Inspection, Acceptance, & Delivery
Article XXV. Foreign Access to Technology
Article XXVI.Government Observer in Recipient Facility
Article XXVII.
Reporting Matters Involving Fraud, Waste and Abuse
Article XXVIII.
Prohibition on Contractor Involvement with Terrorist Activities
Article XXIX.Survival
SECTION XXIX.1 CLOSE-OUT PROCEDURE

40
40
40
40
40
41
41
41
41
41
41
41
42
42
42
43
44
45
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RECITALSThis Project Agreement is an "Other Transaction for Prototype" pursuant to 10
U.S.C. § 2371b. For the avoidance of doubt, this Project Agreement is not a procurement
contract, grant, or cooperative agreement. The Federal Acquisition Regulation ("FAR")
and the Defense Federal Acquisition Regulation Supplement ("DFARS") do not apply tothis Project Agreement except for any provision expressly referenced herein.
This Project Agreement is being entered between the United States Government,
as represented by the U.S. Department of Defense, Joint Program Executive Office for
Chemical, Biological, Radiological, and Nuclear Defense ("JPEO-CBRND"), the U.S.
Department of Health and Human Services, Biomedical Advanced Research andDevelopment Authority ("BARDA"); and Janssen Pharmaceuticals, Inc. on behalf of itself
and the Janssen Consortium Members, as defined in 1.2 herein.
Whereas the Public Readiness and Emergency Preparedness Act ("PREP Act")authorizes the Secretary of Health and Human Services (the "Secretary") to issue a
Declaration to provide liability immunity to certain individuals and entities ("Covered
Persons") against any claim of loss caused by, arising out of, relating to, or resulting fromthe manufacture, distribution, administration, or use of medical countermeasures("Covered Countermeasures").
Whereas the Secretary has issued a PREP Act Declaration on 10 March 2020, as
amended, (herein referred to as "Secretary's COVID-19 PREP Act Declaration") anddeclared that the spread of novel Coronavirus ("SARS-CoV-2") or a virus mutating
therefrom and the resulting disease, Coronavirus Disease ("COVID-19"), constitutes apublic health emergency.
Now therefore, the Parties agree as follows:
Article I.

Scope of the Project Agreement

Article I of the Agreement is hereby superseded by the following terms and conditions of
this Project Agreement.
Section 1.1

Introduction

The development of a safe and effective SARS-CoV-2 vaccine is considered critical tocontain the current COVID-19 pandemic and declared health emergency, and help toprevent future outbreaks. Working with its partners under BARDA OTA No.
HHS0100201700018C ("BARDA OTA"), Janssen has generated Ad26.COV2.S, an
adenovirus Type 26 ("Ad26") replication-incompetent recombinant vector expressing astabilized SARS-CoV-2 vaccine, Ad26.COV2.S, recombinant ("Ad26.COV2.S").
Ad26.COV2.S has been shown to induce high levels of neutralizing antibodies against
SARS-CoV-2 after immunization with a single dose of the vaccine candidate in different
animal species. Furthermore, efficacy against SARS-CoV-2 infection has been shown inWI 5QKN- 16-9-1002
P00081Page 9 of 89

Syrian hamsters. Additional preclinical results will be generated over the coming months,
e.g. protection in Non-Human Primates ("NHP"). Clinical studies will start soon with thegoal to demonstrate safety, immunogenicity and efficacy. Ad26.COV2.S will be
manufactured on PER.C6® TetR cells and large-scale manufacturing will be needed toaddress the large demand for vaccination of large parts of the population.
The following efforts, while integral to the overall Ad26.COV2.S program, are outside thescope of this Project Agreement:
•

•

•
•
•
•

Chemistry, Manufacturing, and Controls ("CMC") development, including
manufacturing of Drug Substance ("DS") and Drug Product ("DP") and nonclinicaland clinical development of Ad26.COV2.S, partially funded by BARDA OTA No.
HHS0100201700018C;
Large-scale manufacturing DS capacity established at a Janssen facility in Leiden,
Netherlands, as well as with a Contracting Manufacturing Organization ("CMO"),
Emergent BioSolutions, which is located in Rockville, MD;
DP capacity established at Catalent in Bloomington, IN;
Facility construction and modification, equipment purchase, qualification, andtechnical transfer activities to manufacture both DS and DP domestically;
Preparation and submission of applications for an Emergency Use Authorization("EUA") and Biologics License Application ("BLA"); andMonitoring, reporting, and healthcare worker, public education, andcommunications activities related to EUA distribution, which will be discussed anddetermined during the pre-EUA discussion period, as defined in applicableguidance documents.

For the avoidance of doubt, Catalent and Emergent, described above, are not considered
subcontractors under this Project Agreement.
Article I, Section 2 of the Agreement, hereby adopts the following terms and conditions of
the Project Agreement. If there is a conflict between the Agreement and the Project
Agreement, the Agreement is hereby superseded by the following terms and conditionsof this Project Agreement.
Section 1.2

Definitions

Academic Research Institution: This term/condition is not applicable to this Project
Agreement, and it is hereby self-deleting from the MCDC Base OTA No. W150KN-16-91002.
Affiliate: Any entity that controls, is controlled by, or is under common control with, aParty to this Project Agreement. In this context, "control" shall mean (1) ownership by one
entity, directly or indirectly, of at least fifty percent (50%) of the voting stock of anotherentity; or (2) power of one entity to direct the management or policies of another entity,
by contract or otherwise.

WI 5QKN- 16-9-1002
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Agreement: Reference back to Article I, Section 2 of the MCDC Base OTA No. W150KN16-9-1002.
Agreements Officer ("AO"): Reference back to Article I, Section 2 of the MCDC BaseOTA No. W15QKN-16-9-1002.
Agreements Officer's Representative ("AOR"): Reference back to Article I, Section 2of the MCDC Base OTA No. W15QKN-16-9-1002.
Background Invention: Background Invention means any Invention, or improvement to
any Invention, other than a Subject Invention, that was conceived, designed, developed,
produced, and/or reduced to practice prior to performance of the Agreement or thisProject Agreement, or outside the scope of work performed under the Agreement or thisProject Agreement.
Basket: This term/condition is not applicable to this Project Agreement, and it is hereby
self-deleting from the MCDC Base OTA No. W150KN-16-9-1002.
Cash Contribution: This term/condition is not applicable to this Project Agreement, and
it is hereby self-deleting from the MCDC Base OTA No. W15QKN-16-9-1002.
Confidential Information: Reference back to Article VIII, Section 1 of the MCDC BaseOTA No. W15QKN-16-9-1002.
Consortium Management Firm ("CMF"): Reference back to Article I, Section 2 of the
MCDC Base OTA No. W15QKN-16-9-1002.
Cost Share: This term/condition is not applicable to this Project Agreement, and it is
hereby self-deleting from the MCDC Base OTA No. W15QKN-16-9-1002.
Contracting Activity: Reference back to Article I, Section 2 of the MCDC Base OTA No.
W15QKN-16-9-1002.
Date of Completion: The date on which the period of performance ends.
Data: Recorded information first created in performance of the Project, regardless of formor method of recording, which includes but is not limited to, technical data and software,
but does not include Subject Inventions, production/manufacturing know-how, trade
secrets, clinical data, or financial, administrative, cost, pricing or management
information.
Deliverable(s): Any documentation (e.g. report, Executive Summary, Letter) given to theGovernment by Janssen to provide the Government with insight into "Janssen's
Manufacturing Capability" (as defined herein) as described in the second column of Table
1-5 in Article I, Section 5 under the heading "Deliverables."WI 5QKN- 16-9-1002
P00081Page I 1 of 89

Development: This term/condition is not applicable to this Project Agreement, and it is
hereby self-deleting from the MCDC Base OTA No. W150KN-16-9-1002.
Disclosing Party: Reference back to Article VIII, Section 1 of the MCDC Base OTA No.
W15QKN-16-9-1002.
Effective Date: The date of execution of this Project Agreement by the Parties. If thisProject Agreement is executed in counterparts, the Effective Date shall be the date of thelast signature.
Field: Means the development and use of a vaccine to protect against COVID-19 diseasecaused by SARS-CoV-2 infection.
Government: Reference back to Article I, Section 2 of the MCDC Base OTA No.
W15QKN-16-9-1002. Also referred to as "USG."
Government Fiscal Year: Reference back to Article I, Section 2 of the MCDC Base OTA
No. W150KN-16-9-1002.
Government Purpose Rights: The rights to (i) use, modify, reproduce, release, perform,
display, or disclose Data within the Government without restriction; and (ii) release or
disclose Data outside the Government and authorize persons to whom release or
disclosure has been made to use, modify, reproduce, release, perform, display, or
disclose that Data for Government purposes. Government purposes include competitive
procurement, but do not include the rights to use, modify, reproduce, release, perform,
display, or disclose Data for commercial purposes or authorize others to do so.
In Kind Contribution: This term/condition is not applicable to this Project Agreement,
and it is hereby self-deleting from the MCDC Base OTA No. W15QKN-16-9-1002.
Invention: Any invention or discovery which is or may be patentable under Title 35 of theUnited States Code.
Janssen Consortium: That group of Janssen Consortium Members that are: (i) Affiliates
of one another; and (ii) have agreed with one another to collaborate to perform theobjectives and obligations set forth in this Project Agreement.
Janssen Consortium Member: Janssen Pharmaceuticals, Inc. ("JPI") acting on behalfof itself and as an agent of JOM Pharmaceutical Services, Inc. ("JOM"), Janssen
Research & Development, LLC ("JRD"), Janssen Vaccines & Prevention B.V. ("JV&P"),
Janssen Products, LP ("JPLP") and its other affiliates involved in the work under thisProject Agreement, propose to come together to form a consortium to work together with
the Government. For purposes of this Project Agreement, JPI will act as the contract
holder and liaise with the Government as the point of contact for the other Janssen
entities. The Consortium Members include each of JPI, JOM, JRD, JV&P, JPLP and their

WI 5QKN- 16-9-1002
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Affiliates involved in the work under this Project Agreement, and are collectively referredto throughout the proposal as "Janssen."
Janssen Manufacturing Capability: Janssen's Manufacturing Capability ("JMC") is thecommercial manufacturing capability that Janssen either owns, operates, manages,
leases, rents or contracts with another party at various locations and facilities in order toproduce commercial products entirely at private expense for performance of this Project
Agreement. The Government has no license in any background intellectual property,
background technical data, or other information that is generated to either scale-up or tooperate the JMC.
Janssen Prototype Product Rights: All patent, copyright, trade secret, FDA regulatory
filings and rights in data within Janssen's possession and control to sublicense without
infringement of third-party intellectual property or agreements, necessary to make, use,
offer for sale and sell the Prototype Product within the US market.
Know-How: Information, practical knowledge, techniques, and skill development createdby Recipient in performance of the Prototype Project necessary for the Practical
Application of a Subject Invention within the Field.
Limited Rights: The rights to use, modify, reproduce, perform, display, or disclose Dataor other information, in whole or in part, within the Government solely for research
purposes for the Field. The Government will ensure that disclosed information issafeguarded in accordance with the restrictions of this Project Agreement. The
Government may not, without the prior written permission of Recipient, release or disclose
Data or other information outside the Government, use Data or other information forcompetitive procurement or manufacture, release or disclose Data or other information
for commercial purposes, or authorize Data or other information to be used by anotherparty.
Milestone: Each event identified in the second column of Table 1-1.
Medical CBRN Defense Consortium ("MCDC"): Reference back to Article I, Section 2of the MCDC Base OTA No. W15QKN-16-9-1002.
MCDC Executive Committee: Reference back to Article I, Section 2 of the MCDC BaseOTA No. W15QKN-16-9-1002.
MCDC Members: Reference back to Article I, Section 2 of the MCDC Base OTA No.
W15QKN-16-9-1002.
Nontraditional Defense Contractor: Reference back to Article I, Section 2 of the MCDC
Base OTA No. W150KN-16-9-1002.
Other Transaction Agreement ("OTA"): Reference back to Article I, Section 2 of the
MCDC Base OTA No. W15QKN-16-9-1002.

WI 5QKN- 16-9-1002
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Other Transactions for Prototype Projects: Reference back to Article I, Section 2 of
the MCDC Base OTA No. W150KN-16-9-1002.
Party: Each of All as the CMF, Janssen, and the Government (collectively, "Parties").
Payable Milestone: The obligation of the Government, and ATI as the CMF, acting asan agent on the Government's behalf, to pay Project Agreement Holder/Janssen, in
accordance with Article V herein, when Janssen has triggered a payment in accordancewith Table 1-1 in Article I, Section 3 of this Project Agreement.
Period of Performance: Contract Award through January 31, 2022.
Practical Application: With respect to a Subject Invention, to manufacture, in the caseof a composition of product; to practice, in the case of a process or method, or to operate,in the case of a machine or system; and, in each case, under such conditions so as toestablish that the Subject Invention is capable of being utilized.
Program Manager: This term/condition is not applicable to this Project Agreement, and
it is hereby self-deleting from the MCDC Base OTA No. W150KN-16-9-1002.
Project: Defined in Article III, Section 1 of this Project Agreement.
Project Agreement ("PA"): Refers to this P00081 Modification of the MCDC OTA No.
W15QKN-16-9-1002 entered into amongst: Janssen Pharmaceuticals, Inc., on behalf of
the Janssen Consortium Members, herein defined; the U.S. Army Contracting CommandNew Jersey; and ATI as the MCDC CMF, including the Statement of Work as defined in
Article I, Sections 3-6, all attachments and modifications thereto, which are expressly
incorporated into and made a part of the Project Agreement. Also referred to as Project
Agreement/Statement of Work.
Project Agreement Holder ("PAH"): The MCDC member is Janssen which was issued
the Project Agreement by the CMF and ACC-NJ.
Project Management Lead (PML): This is the individual at Janssen responsible formanagement of this Project.
Prototype Product: At least one of the 100 million Regimens of SARS-CoV-2 vaccine,
Ad26.COV2.S recombinant resulting from the Prototype Project ("Ad26COV2.S").
Prototype Project: Janssen's demonstration of its capacity to perform large scale
manufacturing domestically, utilizing the Janssen Manufacturing Capability of up to 100
million Regimens of Ad26.COV2.S.
Receiving Party: Reference back to Article VIII, Section 1 of the MCDC Base OTA No.
W150KN-16-9-1002.

WI 5QKN- 16-9-1002
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Recipient: Janssen Pharmaceuticals, Inc. acting on its own behalf and on behalf of theJanssen Consortium and each Janssen Consortium Member.
Regimen: A "vaccine regimen" or "regimen" is either: two separate injections of 5x101°
viral injections (single/low doses/.25m1) or one single injection of 1x1011 viral particles(double/high dose/.5m1). If clinical trials support a different dosing or administration
regimen, the Parties will discuss how to proceed and may agree to modify this Project
Agreement in response.
Subject Invention ("SI"): Any Invention (ii) where the conception of such Invention andeither (a) the first actual reduction to practice or (b) constructive reduction to practice ofsuch Invention occurs in performance of the Project.
Subject Invention ("SI") Intellectual Property Rights: Patent rights controlled by
Recipient that are necessary to practice the Subject Invention in the Field.
Technical Direction Letter ("TDL"): This term/condition is not applicable to this Project
Agreement, and it is hereby self-deleting from the MCDC Base OTA No. W150KN-16-91002.
Technology: Discoveries, innovations and Know-How, whether patentable or not,including computer software, recognized under U.S. law as intellectual creations to whichrights of ownership accrue, including, but not limited to, patents, trade secrets, andcopyrights first created in the Project and that have not been disclosed to the public, butdoes not include any Subject Invention.
Third-Party Licensee: A US-based entity whose primary business is contract
manufacturing for third parties, and is not currently or in the future controlled or affiliatedwith any entity or business that sells vaccines or pharmaceutical products directly to
consumers, pharmacies, health care providers or Governmental entities.
United States Army Contracting Command — New Jersey Contracting Activity("ACC-NJ"): Reference back to Article 1, Section 2 of the MCDC Base OTA No.
W15QKN-16-9-1002.
White Paper: Reference back to Article 1, Section 2 of the MCDC Base OTA No.
W15QKN-16-9-1002.
Other capitalized terms used in this Project Agreement, but not defined herein, shall havethe meaning set forth in the MCDC Base OTA No. W15QKN-16-9-1002.
Section 1.3 Prototype Project, Milestones, and Pricing Assumptions andConditions

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Prototype Project. The scope of this Prototype Project is the demonstration by Janssenof the rapid, large scale supply and logistics capability to manufacture and deliver to theGovernment, 100M Regimens of the Ad26.COV2.S vaccine. Consistent with theGovernment's objectives under Operation Warp Speed ("OWS"), Janssen intends toemploy its proprietary manufacturing technology and processes, in a manner compliant
with applicable laws and regulations, including 21 CFR 210 and 211 and the Drug Supply
Chain Security Act ("DSCSA") (to the extent required for COVID-19 medical
countermeasures, as defined by relevant U.S. Food and Drug Administration ("FDA")
guidance), to manufacture and deliver the Ad26.COV2.S vaccine. The successfulprovision of these Regimens shall establish the effectiveness of a technology capable ofpotentially providing immediate and long-term solutions to coronavirus infections. While
preclinical and clinical activities are described in the Introduction section of this Statementof Work, the Parties acknowledge and agree that such activities are not related to thelarge-scale manufacturing demonstration and are out-of-scope for this Prototype Project.
This effort constitutes a prototype project because it will be used to evaluate the technicalfeasibility of completion of the Prototype Project during the ongoing COVID-19 pandemic
and unprecedented threats to several components of the Prototype Project. In addition,
this is a prototype project because Janssen will demonstrate and prove-out the at-scale,multi-lot proprietary manufacturing activities in order to assess the feasibility to support
the necessary quantity of safe and effective regimens required for vaccination of the U.S.
population. Successful completion of the Prototype Project will demonstrate Janssen's
capability to rapidly manufacture product, which can be further scaled-up to meet mutuallyagreed to surge requirements with limited advance notification.
Milestones/Payments. One hundred million Regimens of Ad26.COV2.S vaccine will be
provided by Janssen to the Government on a Firm Fixed Price ("FFP") per Regimen basis
in accordance with the Milestone Payment Schedule. Due to variances in fill/finish yield,
Janssen shall invoice for and the Government, through the CMF, shall pay for actual
quantities delivered, at a rate of $10.00 per Regimen. Janssen shall use its reasonably
diligent efforts to provide the Government the full 100M Regimens on or before the final
delivery date. The Government will be under no obligation to receive or pay for any
Regimens that are not made available for delivery according to the schedule defined inTable 1-1, except that (a) deliveries will be considered to be timely made according to theschedule to the extent that they are made up to 30 calendar days after the applicabledelivery date, due to delays related to manufacturing, testing, or release, and (b) the
Government will be obligated to accept and pay for Regimens that are not timely deliveredby an initially applicable delivery date or within the alternative delivery windows identified
in this paragraph, to the extent that any delay in delivery is solely attributable to an
Excusable Delay Event as defined in Article IX, Section 4 of this Project Agreement. The
Government will, at its discretion, have unilateral authority to extend future delivery dates
before they have passed to the extent that any of the 100M Regimens are not expected
to be delivered according to the schedule defined in Table 1-1; however, Janssen will be
under no obligation to deliver Regimens after December 31, 2021, unless mutually agreed
to by both Janssen and the Government. For the avoidance of doubt, to the extent there
is a shortfall in the amount of Regimens delivered by any given delivery date, which is not

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excused or extended by the terms of this paragraph, then Janssen shall be free to disposeof such shortfall in its sole discretion.
Janssen's current production plan contemplates 100% of release of finished Regimens in2020 and January and February of 2021 will occur in the US. If Janssen changes thisplan in any substantial way, it will discuss with the Government adjustments to this Project
Agreement that are consistent with the principles established in this section.
On a month-by-month basis, for any Regimen that Janssen manufactures and releases
in the United States in excess of the number of Regimens that Janssen planned to releasein the United States for delivery under this Project Agreement from January through June
2021 (irrespective of the source of drug substance), the Government will have an option:(i) for the months of January and February 2021, to purchase 100 percent of such excess;and (ii) for all remaining months, to purchase 20 percent of such excess Regimens at a
price of, in each case, $10/Regimen and agrees that Janssen may allocate or sell theremaining amount of such excess at Janssen's sole discretion. For each delivery monthidentified in Table 1-1, Janssen will notify the Government about any such excess
Regimens on or before the 15th of that month, and the Government will have 5 working
days after receiving such notice in which to exercise its option. If the Government
exercises its option, Janssen will provide the ordered excess Regimens by the delivery
date identified in Table 1-1 for the month in which Janssen provided its notice. Any
excess Regimens that are delivered in a particular month will be subtracted from thenumber of Regimens that Janssen would otherwise be required to deliver in the last monthof scheduled deliveries as reflected in Table 1-1. In the event that, as the result of thepurchase of excess Regimens as contemplated under this paragraph, no delivery is duein the last month of scheduled deliveries as reflected in Table 1-1, any excess Regimensthat are delivered in a particular month will be subtracted from the number of Regimensthat Janssen would be required to deliver in what would then be the final month in which
deliveries under this Project Agreement will take place. Notwithstanding the foregoing,
the Government's option may not be exercised in a way that would require Janssen todeliver more than 100 million Regimens under this Project Agreement.
In the event that Janssen is able to commence delivery of Regimens manufactured andreleased in the United States prior to January of 2021, the Government shall have a rightof first refusal to purchase such Regimens as set forth in this Paragraph. The
Government's right shall cover hundred (100) percent of such Regimens. Janssen will
notify the Government about the availability of such Regimens within fifteen (15) calendar
days after learning of their availability. The Government will then have five (5) working
days after receiving such notice in which to exercise its right of first refusal. Janssen may
allocate or sell any Regimens that the Government does not elect to purchase in its sole
discretion. Any purchased Regimens shall be subtracted from the quantity of Regimens
Janssen is required to deliver in the last month of scheduled deliveries as reflected inTable 1-1. In the event that any such subtraction results in Janssen being required todeliver no Regimens in the last month of deliveries as reflected in Table 1-1, any
additional or subsequent early deliveries will be subtracted from what would then be thefinal month in which deliveries under this Project Agreement will take place.

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Notwithstanding the foregoing, the Government's rights may not be exercised in such a
way that would require Janssen to deliver more than 100 million Regimens under thisProject Agreement.
Janssen is currently pursuing external validation of its not-for-profit calculation approachfor the pricing of its Regimens to ensure it meets its commitment to make the Regimens
available on a not-for-profit basis for use in the emergency pandemic, and Janssen isdeveloping a framework under which any profit would be returned to purchasers of theRegimens. The Parties agree that the Government will benefit from the application ofthese procedures. This Project Agreement will not be closed out until at least one external
validation is complete such that an appropriate credit can be completed if the final notfor-prof it price per Regimen is determined to be less than $10. In no case shall the priceper Regimen exceed $10.
Table 1-1: Milestone Payment Schedule
Milestone
Number

1
2
3
4
5
6
7

Milestone Description
2M Regimens of Ad26.COV2.S
10M Regimens of Ad26.COV2.S
25M Regimens of Ad26.COV2.S
25M Regimens of Ad26.COV2.S
25M Regimens of Ad26.COV2.S
13M Regimens of Ad26.COV2.S
Long-term Storage of Drug
Product (Option)
Total (FFP)
Date of Final Delivery

Delivery Date

Value

On or before 1/31/2021
On or before 2/28/2021
On or before 3/31/2021
On or before 4/30/2021
On or before 5/31/2021
On or before 6/30/2021$20,000,000$100,000,000$250,000,000$250,000,000$250,000,000$130,000,000$1,650,000$1,001,650,000
6/30/2021

Pricing Assumptions and Conditions
1) Short-term storage not to exceed 30 days and delivery to no more than 10 sites
in the continental United States, are included in the $10/Regimen pricing.
2) At the discretion of the Government, Janssen shall provide the Government
with up to twelve (12) months storage of up to 100M Regimens of
Ad26.COV2.S (Milestone Number 7), (b) (4) (b) (2)The Government shall pay Janssen the full FFP amount,
as identified in Table 1-1, distributed evenly across each month ordered forlong-term storage capacity, with payment for each month due at the end of theapplicable month. As applicable, Janssen will invoice the Government less permonth for storage to the extent necessary to reflect Janssen storage vendor
charges that are lower than expected for each month.

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Section IA

Scope of P00081 Modification

Subject to Article I, Section 1, the following efforts are included in the scope of this Project
Agreement/Statement of Work:
Current Good Manufacturing Practice ("cGMP") manufacturing, fully compliant with
21 CFR 210 and 211 subject to any guidance from, enforcement discretion
exercised by, or formal waiver issued by the FDA in connection with COVID-19, of
100M Regimens of Ad26.COV2.S for distribution by the Government upon EUA
under Section 564 of the Food, Drug, and Cosmetics ("FD&C") Act or a biologics
licensure granted under Section 351(a) of the Public Health Service ("PHS") Act
by the FDA, including:
O Final DP vaccine presentation will be subject to evaluation and discussion
with the appropriate regulatory authorities under the BARDA OTA No.
HHS0001201700018C. As such, the Parties understand and agree thatthe vaccine presentation may change during performance.
O Labeling of EUA Regimens using the date of manufacture, and not expiry,
in order to ensure continuous supply of Ad26.COV2.S, recombinant vaccine
is maintained and not disrupted when FDA licensure is received.
O Storage of up to 100 million Regimens of Ad26.COV2.S at Janssen or
vendor facility.
O Compliance with the DSCSA Sections 581-585 of PL 113-54 (Nov 27,2013), including product verification, serialization (serialization
requirements need to be further evaluated and may impact timelines fordelivery), traceability and detection and response requirements, unless
exempted under DSCSA or other applicable legal exception, subject to any
guidance from, enforcement discretion exercised by, or formal waiverissued by the FDA in connection with COVID-19.
O Shipping, if required, to up to ten (10) USG directed destinations.
O In coordination with the Government, Janssen will conduct a demonstrationof the vaccine shipping process prior to the first delivery of doses at a timemutually agreed to by the Parties. Janssen agrees to share specifications
and details associated with the shipping process and containers to enable
the Government to adequately plan and prepare for potential distribution of
the vaccine.

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Section 1.5

Prototype Deliverables

Table 1-5: Prototype Deliverables
Deliverable
NumberDeliverable Description

1

Project Kickoff Materials

2

Phase 2/3 Clinical Trial
Synopsis

3

Provision of PL 115-92(optional)

4
5

Weekly Production
Updates / Regimen Tracker
Monthly Business andHigh-Level Technical
ReportDue Date

FormatData Rights

Within 30 calendar
days after award
Within 7 calendar
days after FDA
approval

Agenda, PPT
Slides, etc.
Janssendetermined
formatGovernment
Purpose Rights

10/31/2020

n/a

Weekly, uponaward

Template to beprovided by USG
Janssendetermined
formatJanssendetermined
formatJanssendetermined
formatOn or before the15th of each month

6

EUA Filing

7

BLA Filing

8

Delivery of 100M
Regimens

Within 7 calendar
days after
submission to FDA
Within 7 calendar
days after
submission to FDA
According to Table
1-1

9

Release documentation fordelivered Regimens

According to Table
1-1

10

Supply Chain Resiliency
Plan or Janssen EquivalentWithin 30 calendar
days after award

11

Manufacturing Data
Requirement or Janssen
EquivalentWithin 30 calendar
days after award

12

Product Development
Source Material

13Work Location Report or
Janssen Equivalent

14

Facility Security Plan or
Janssen Equivalent

15
16

17

Confirmation ofRegistration and Listingwith FDA
Formal Written Responses
from the FDA
FDA Inspection andCompliance Notices,
Observations andResponses

Within 30 calendar
days after award
Within 30 calendar
days after award
Within 30 calendar
days after award
Within 7 calendar
days of receipt

n/aJanssendetermined
formatJanssendetermined
formatJanssendetermined
formatJanssendetermined
formatJanssendetermined
formatJanssendetermined
formatJanssendetermined
formatGovernment
Purpose Rights
As Describedin Agreed upon
Letter_Government
Purpose Rights _Government
Purpose Rights
LimitedRights***LimitedRights***n/a
Government
Purpose Rights
Government
Purpose Rights
Government
Purpose Rights
Government
Purpose Rights
Government
Purpose Rights
Government
Purpose Rights
Government
Purpose Rights

Within 7 calendar
days of receipLn/aGovernment
Purpose Rights

Within 7 calendar
days of receipt

n/aGovernment
Purpose Rights

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18

Manufacturing
Development Plan*

Within 7 calendar
days of completion

19

Quality Management
Plan**

Within 7 calendar
days of completion

20

Shipping Specifications
and Details

Within 7 calendar
days of completion

Janssendetermined
formatJanssendetermined
formatJanssendetermined
formatLimitedRights***LimitedRights***Government
Purpose Rights

Manufacturing Development Plan. Janssen will, in the level of detail and format that Janssen
solely elects (provided such format provides a reasonable and industry-standard level of detail), describe
the manufacturing process for the vaccine product to ensure conformity with §501(a)(2)(B) of the Food,
Drug, and Cosmetics Act (FD&C Act, Title 21 United States Code ("U.S.C.") §351 (a)(2)(B)), regarding
GMP. This plan shall describe as such information becomes available to Janssen, but is not limited to,planned or completed drug substance studies; list of excipients and information to support the safety of
excipients that, when appropriate, shall be cross-referenced; drug product and formulation development
summary from initial concept through final design; physicochemical and biological properties;
manufacturing process development and validation program documents; container closure system
documents; microbiological attributes documents and plans; compatibility documents (e.g., precipitation);assay development and validation, stability plan; and any associated risks.
**

Quality Management Plan. Janssen will, in the level of detail and format that Janssen solely
elects (provided such format provides a reasonable and industry-standard level of detail), provide a quality
management plan which may include, but is not limited to, the quality policy and objectives, management
review, competencies and training, process document control, feedback, evaluation, corrective action andpreventive action, process improvement, measurement, and data analysis processes. The framework isnormally divided into infrastructure, senior management responsibility, resource management, lifecycle
management, and quality management system evaluation.
***

Both parties agree that in addition to USG funding for advanced research and development ofJanssen's potentially viable vaccine for COVID-19, Janssen independently invested significantly more overa course of decades to develop the platform technology and capability. Accordingly, in recognition of thedisproportionate levels of investment, the government accepts limited rights to use certain data that was
predominantly developed at Janssen's expense.

All Deliverables intended for the Agreements Officer's Representative ("AOR") shall bedelivered.
At least one copy of all data Deliverables shall be sent to: usarmy.detrick.dod-jpeocbrnd.mbx.otadeliverable@mail.mil.

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Section 1.6

Follow-on Production

This Project Agreement/Statement of Work hereby is eligible for the award of a follow-on
production contract for Ad26.COV2.S subject to the requirements of 10 U.S.C. § 2371b(f)(2)(A) and (B) and (f)(3). In accordance with 10 U.S.C. § 2371b(f), and upon successful
demonstration of the Prototype Project or at the accomplishment of particularly favorable
or unexpected results that would justify transitioning to production (e.g., EUA or BLA),
additional production of up to 200M Regimens, may be awarded to partially or completely
meet the USG objective of supplying a safe and effective Ad26.COV2.S to the entire US
population. This Project Agreement includes options that are priced at Janssen's global
not-for-profit price of $10/Regimen as described in Article I, Section 3 above, for followon production, not to exceed 200 million Regimens. During the performance of the Project
Agreement, the Government and Janssen will finalize the scope of production. If thePrototype Project is successful, as described in this Article I, Section 6, the Government
may then enter into follow-on production by executing these options through a separate
stand-alone production agreement.
Article II.

Term and Termination

Section 11.1 Term
The Period of Performance for this Project Agreement/Statement of Work is from the dateof contract award through January 31, 2022.
Section 11.2 Termination
Termination for Vaccine Discontinuation. In the event that (a) Janssen notifies theGovernment that, as a result of significant emerging safety or efficacy data, Janssen isceasing efforts to develop the Ad26.COV2.S, or (b) such a vaccine receives U.S.
regulatory approval or authorization on or prior to expiration of the period of performanceof this Project Agreement, but such approval or authorization is subsequently withdrawn
and, after a reasonable amount of time, the Government determines that the authorization
will not be restored or approval will not be granted, the Government will notify Janssen of
its intent to terminate this Agreement. Under (a), if Janssen notifies the Government ingood faith of a significant safety or efficacy issue, and the Government does not respondwithin a reasonable amount of time, then Janssen has the right to terminate the Project
Agreement.
Janssen shall have no liability to repay the Government for Regimens delivered prior to
the notification of termination. Janssen shall be entitled to full payment for Regimens forwhich manufacturing has been completed, but which have not yet been delivered to theGovernment. With respect to Regimens for which manufacturing has been initiated but
not completed, Janssen shall be entitled to payment of a proportion of the $10/Regimen
price based on a percentage of the work performed toward release and delivery of such
Regimens, plus reasonable charges that Janssen can demonstrate to the satisfaction of
the Government using its standard record keeping system to have resulted from the

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termination, but not to exceed $10/Regimen. By way of example, these costs may
include, but are not necessarily limited to, costs associated with non-cancellable
agreements with vendors to obtain manufacturing capacity or supplies in the performanceof this Project Agreement. Janssen shall not be required to comply with the costaccounting standards or contract cost principles for this purpose. This paragraph does
not give the Government any right to audit Janssen's records. Janssen shall not be paid
for any work performed or costs incurred which reasonably could have been avoided.
From and after the effective date of any such termination, Janssen shall have no further
obligation to deliver any vaccine Regimens, and the Government shall have no further
obligation to accept any such Regimens for delivery. After termination of this Project
Agreement, Janssen may sell or transfer to a third party any Regimens that have not beendelivered to the Government.

Stop Work Orders. Except as required by applicable law or regulation, or judicial oradministrative order, the Government shall not have the authority to issue a stop workorder to halt the work contemplated under this Statement of Work.
Section 11.3 Extension of Term
The Parties may extend by mutual written agreement the term of this Project Agreement
if funding availability and research opportunities reasonably warrant. Any extension shallbe formalized through modification of the Project Agreement by the Agreements Officer("AO") and the Janssen Project Manager ("PM"). If the Recipient desires an extension to
the period of performance of this Project Agreement, the Recipient shall submit a request
in writing to the AO. Any request for an extension should include a revised
milestone/project schedule (if applicable).
Article III.

Project Management, Modifications, and Administration

Section 111.1 Management and Modifications
Technical and project management of the manufacture and delivery of up to 100 million
Regimens of Ad26.COV2.S ("Project") and the anticipated follow-on activities describedin Article I, Section 6 above, established under this Project Agreement, shall be managed
as detailed in this Article.

a. Project Governance. Janssen is responsible for the overall management of
the Prototype Project and related decisions. The Government and Janssen
are bound to each other by a duty of good faith in achieving the Prototype
Project objectives as defined in Article I. As such, the Government will havecontinuous involvement with Janssen. Janssen shall provide project results inaccordance with the Deliverables schedule identified in Article I.
b. Project Management. Janssen and the Government will each designate anindividual responsible for facilitating the communications, reporting, andWI 5QKN- 16-9-1002
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meetings between the Parties. For Janssen the individual will serve as PM,
and for the Government the individual will be the AOR.
c. Project Reviews. Janssen and the Government will hold periodic projectreview meetings as determined by the Janssen Project Manager and AOR,
however, these meetings shall not occur more frequently than every fourteen(14) calendar days.
d. Reviews Resulting in Modifications. During the performance of this Project
Agreement, as described above, it may be necessary to modify the Statementof Work or delivery timeframes. No communications, whether oral or in writing,that purport to change this Project Agreement are valid unless a modification
is issued by the AO. The Parties hereby agree that any mutually agreed upon
written request for modification shall be executed in an expedited timeframe.
e. Bilateral Modifications.
Janssen or the Government may propose
modifications to this Project Agreement. A modification that materiallychanges the obligations of either the Government or Janssen must be inwriting and signed by the AO and Janssen's authorized official. Janssen's
requests for modifications shall detail the technical and chronological impactof the proposed change on the Statement of Work or delivery timeframes.
f. Unilateral Modifications. The AO may ONLY issue minor or administrative
modifications, which do not change the obligations of Janssen in any adverse
manner, such as changes to the paying office or appropriations data, orchanges to Government personnel identified in the Project Agreement.
Unilateral modifications will only be signed by the AO.
Section 111.2 Project Agreement Administration
Government Points of Contact:
AO
NAME: (b) (6)
MAILING ADDRESS: Phipps Rd, Picatinny Arsenal, NJ 07806-5000
EMAIL: (b) (6)
PHONE: (b) (6)
AGENCY NAME/DIVISION/SECTION: CCNJ-ET
AOR
NAME: (b) (6)EMAIL: (b) (6)
PHONE: (b) (6)
AGENCY NAME/DIVISION/SECTION: HHS/ASPR/BARDAWI 5QKN- 16-9-1002
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Janssen Points of Contact:
CLM
NAME:
MAILING ADDRESS:EMAIL:
PHONE:(will be provided within 30 calendar days after award)PM
NAME:
MAILING ADDRESS:EMAIL:
PHONE:(will be provided within 30 calendar days after award)
ATI:
Advanced Technology International
MCDC Contracts
315 Sigma Drive
Summerville, SC 29486
Article IV.

"PREP ACT" Coverage

In accordance with the Public Readiness and Emergency Preparedness Act ("PREP
Act"), Pub. L. No. 109-148, Division C, Section 2, as amended (codified at 42 U.S.C.
§ 247d-6d and 42 U.S.C. § 247d-6e), as well as the Secretary of Health and Human
Service's ("HHS") Declaration Under the Public Readiness and Emergency Preparedness
Act for Medical Countermeasures Against COVID-19, 85 Fed. Reg. 15198 (Mar. 17, 2020,
effective Feb. 4, 2020), and amended on April 15, 2020, 85 Fed. Reg. 21012, and on
June 8, 2020, 85 Fed. Reg. 34740 (together, the "Prep Act Declaration"):(i)This Project Agreement is being entered into for purposes of facilitating the
manufacture, testing, development, distribution, administration, and use of"Covered Countermeasures" for responding to the COVID-19 public healthemergency, in accordance with Section VI of the PREP Act Declaration;(ii)

Janssen's performance of this Project Agreement falls within the scope of the"Recommended Activities" for responding to the COVID-19 public healthemergency in accordance with Section III of the PREP Act Declaration; andWI 5QKN- 16-9-1002
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Janssen is a "Covered Person" per Section V of the PREP Act Declaration.

Therefore, in accordance with Sections IV and VII of the PREP Act Declaration, as wellas the PREP Act (42 U.S.C. § 247d-6d), the Department of Defense contracting via
assisted acquisition on behalf of the HHS, expressly acknowledges and agrees that the
HHS Declaration cited above, specifically its language providing immunity from suit andliability is applicable to this Project Agreement, as long as Janssen's activities fall within
the terms and conditions of the PREP Act and the PREP Act Declaration.
The Government may not use, or authorize the use of, any products or materials provided
under this Project Agreement, unless such use occurs in the United States (or a U.S.
territory where U.S. law applies such as embassies, military installations and NATOinstallations) and is protected from liability under a declaration issued under the PREP
Act, or a successor COVID-19 PREP Act Declaration of equal or greater scope. Any use
where the application of the PREP Act is in question will be discussed with Janssen prior
to use and, if the parties disagree on such use, the dispute will be resolved according to
Article VI, "Disputes."
If the Government agrees to provide any additional clarity about the applicability of
PREP Act immunity to any maker of a vaccine or pharmaceutical product to prevent or
treat SARS-CoV-2, COVID-19, or mutations therefrom, the Government will provide thesame clarity to Janssen under this Project Agreement.
Article V. Obligation and Payment
Section V.1 Limitation of Liability
In no case shall the Parties' financial liability for performance exceed the amountobligated under this Project Agreement/Statement of Work.
Section V.2 Fixed Price Payment Method
Payments shall be made in accordance with the payment schedule of this Project
Agreement/Statement of Work, as shown in Article I, Section 3 above, provided thedesignated AOR has verified compliance with the Statement of Work andaccomplishment of the stated effort. An acceptable invoice for FFP payments is one that(on the invoice):
a. contains the date of invoice and the base Agreement number and Project
Agreement number;b. identifies any associated technical milestones and the progress toward
completion of each milestone; andc. lists the price contained in each Project Agreement.

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Section V.3 Accounting System Requirements
Prior to the submission of invoices, Janssen shall have and maintain an establishedaccounting system which complies with Generally Accepted Accounting Principles("GAAP") and the requirements of this Project Agreement. Consistent with thisstipulation, an acceptable accounting system will be one in which all cash receipts anddisbursements are controlled and documented properly.
Section V.4 Payments and Payment Instructions
a. The Parties agree that fixed payments will be made for delivery of product orstorage. These payments reflect the value received by the Government toward
the accomplishment of the goals of this Project Agreement.
b. Janssen shall submit an original invoice as described in Article V, Section 2,
Payment terms are NET 30 days
above, via (b) (4)after CMF's receipt of an invoice that meets the conditions of Article V, Section
2 above.
c. In accordance with Article XII, herein, the Government shall inspect, accept or
reject the work as promptly as practicable after submission or completion,
unless otherwise specified in this Project Agreement/Statement of Work.
Government failure to inspect, accept or reject the work shall not relieve
Janssen from responsibility, nor impose liability on the Government, fornonconforming work. Work is nonconforming when it is defective in material orworkmanship or is otherwise not in conformity with contract requirements. The
remedy for nonconforming is rework by Janssen within reasonably revised
timelines.
d. The Parties hereby agree that reasonable delays in performance of this Project
Agreement/Statement of Work shall not be considered nonconforming work, as
defined above. The Parties hereby further agree that Janssen has provided
timelines based on its best estimates in accordance with the Government's
accelerated
timeframes
and
that
the
natureofvaccineproduction/manufacturing is inherently complex and in order to ensure
appropriate quality, safety and efficacy standards are met, some delays areunavoidable and these delays will be addressed by the Parties under theGovernance structure of Article III of this Project Agreement/Statement ofWork, as the circumstances dictate at that time. Each delivery identified inTable 1-1 will be made independent of the other deliveries, and a failure to
make one or more deliveries will not impact the Parties' obligations with respect
to the other deliveries as long as Janssen continues to make reasonably
diligent efforts to make each delivery under this Project Agreement.

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Section V.5 Comptroller General Access to Records
To the extent that the total Government payment under this Project Agreement exceeds$5,000,000, the Comptroller General, at its discretion, shall have access to and the rightto examine records relevant to the work hereunder of any Consortium Member
participating in the performance of this Project Agreement for a period of three (3) years
after final payment is made. This requirement shall not apply with respect to any
Consortium Member that participates in the performance of the Project Agreement thathas not entered into any other Project Agreement (contract, grant, cooperative
agreement, or "other transaction") that provides for access by a Government entity in theyear prior to the date of this Project Agreement. This paragraph only applies to any recordthat was created or maintained in the ordinary course of business or pursuant to a
provision of law in the performance of the Project Agreement.
Article VI.

DisputesA. General
The Parties shall communicate with one another in good faith and in a timely,
responsive, and cooperative manner when raising issues under this Article.
B. Dispute Resolution Procedures
1. Any claim or dispute between the Government and Janssen concerningquestions of fact or law arising from or in connection with this Project
Agreement, and, whether or not involving an alleged breach of this Project
Agreement, shall be raised and resolved under this Article.
2. Whenever legal disputes or claims arise, the Parties shall attempt to resolve
the issue(s) by discussion and come to mutual agreement on a resolution assoon as practicable.
In no event shall a dispute, disagreement or
misunderstanding that arose more than three (3) months prior to thenotification made under sub-section B.3 of this article constitute the basis forrelief under this article unless one level above the AO, in the interests ofjustice, waives this requirement.
3. Failing resolution by mutual agreement, the aggrieved Party shall document
the dispute, disagreement, or misunderstanding by notifying the other Party(through the AO or Janssen's POC, as the case may be) in writing of therelevant facts, identifying unresolved issues, and specifying the clarification
or remedy sought. Within five (5) working days after providing notice to theother Party, the aggrieved Party may, in writing, request a joint decision by
the ACC-NJ Division Chief for Emerging Technologies and senior executive
appointed by Janssen. The other Party shall submit a written response on
the matter(s) in dispute within thirty (30) calendar days after being notified
that a decision has been requested. The Division Chief and the RecipientWI 5QKN- 16-9-1002
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senior executive shall conduct a review of the matter(s) in dispute and attempt
to render a mutually agreeable decision in writing within thirty (30) calendar
days of receipt of such written position. Any such joint decision is final andbinding.
4. In the absence of a joint decision, upon written request to the ACC-NJ
Associate Director made within thirty (30) calendar days of the expiration of
the time for a decision under sub-section B.3 above, the dispute shall befurther reviewed. The Associate Director may elect to conduct this review
personally or through a designee or jointly with a senior executive appointed
by Janssen. Following the review, the Associate Director or designee will
resolve the issue(s) and notify the Parties in writing. This decision may be
appealed to any federal court of competent jurisdiction.
5. Notwithstanding any other provisions of this Article, the Parties agree that
Janssen shall have the right to pursue any contract dispute arising under thisProject Agreement in any federal court of competent jurisdiction, including theappropriate Court of Appeals, or the Supreme Court, at any time without any
administrative exhaustion requirements, and the timing requirements
described above will not limit any claim in such tribunals. For the avoidanceof doubt, the Parties agree that this Project Agreement satisfies all elementsof an agreement.
C. Limitation of Damages
Claims for damages of any nature whatsoever pursued under this Project
Agreement shall be limited to direct damages only up to the aggregate amount ofGovernment funding obligated as of the time the dispute arises, except withrespect to violations of the confidentiality, data rights, intellectual property, or
PREP Act provisions of this Project Agreement.
Article VII. Confidential Information
Section VIL1Authorized Disclosure
The Receiving Party shall not directly or indirectly, divulge or reveal to any person or entity
any Confidential Information of another Party without the Disclosing Party's prior writtenconsent, or use such Confidential Information except as permitted under this Project
Agreement. Confidential Information shall be subject to the same prohibitions on
disclosure as provided for under FAR Part 24.202. Further, any reproduction ofConfidential Information or portions thereof that is disseminated within the Government,
CMF, or Janssen, shall be shared strictly on a need to know basis for the purposes ofthis Project Agreement and is subject to the restrictions of this provision. In addition to
the above, Confidential Information is subject to the protections of the Trade Secrets
Act as well as any other remedies available under this Project Agreement or the law.

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Section VII.2Exclusions
Such obligation of confidentiality shall not apply to information which the Receiving Party
can demonstrate through competent evidence: (i) was at the time of disclosure in the
public domain; (ii) has come into the public domain after disclosure through no breach ofthis contract; (iii) was known to the Receiving Party prior to disclosure thereof by theDisclosing Party; (iv) was lawfully disclosed to the Receiving Party by a Third Party which
was not under an obligation of confidence to the Disclosing Party with respect thereto; or(v) was approved for public release by prior written permission of the Disclosing Party.
Section VII.3Term
The obligations of the Receiving Party under this Article shall continue for a period ofseven (7) years from conveyance of the Confidential Information.
Article VIII. Publication and Academic Rights
Section VI11.1

Use of Information.

Janssen shall have the right to publish or otherwise disclose information and/or data
generated under the Project. Janssen shall include an appropriate acknowledgement of
the funding of the Project by the Government in any publication. Notwithstanding theabove, the Parties shall not be deemed authorized by this paragraph, alone, to disclose
any Confidential Information of another Party to this Project Agreement.
Section VIII.2

Publication or Public Disclosure of Data

Review and Approval of Data for Public Release.
(1) At least 30 days prior to the scheduled release date, Janssen shall submit
to the AOR a copy of the Data to be released.
(2) An acknowledgment similar to the following shall be required in any
publication of any Data, based or developed under this Project Agreement:"Effort funded in part by the U.S. Government under P00081 Modification to
Other Transaction Number W150KN-16-9-1002 between the Janssen
Pharmaceuticals, Inc., MCDC, and the Government."(3) Parties to this Project Agreement are also responsible for assuring thatevery publication of material funded under this project contains the following
disclaimer:"The views and conclusions contained herein are those of the authors and do not
be represent the official policies or endorsements, either expressed or implied,of the U.S. Government."

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Article IX.

Patent Rights

Section IX.1 Background Intellectual Property Disclosures
Janssen asserts full title to all background intellectual property relevant to its performanceof this statement of work and listed at Attachment 1. Janssen hereby conveys anonexclusive, nontransferable, irrevocable, paid-up license to practice or have practiced
for or on behalf of the United States to the "Licensed Patents" throughout the world forthe prevention, diagnosis and treatment of COVID-19 caused by Severe Respiratory
Syndrome-Coronavirus-2 (SARS CoV-2). "Licensed Patents" means US Provisional
Patent Application Serial Nos. (b) (4)as well as any and all patent applications
and patents (including any counterparts, PCT's, national stage applications, divisionals,
continuations, or the like thereof, and any extensions thereof), wherever filed in the world,that claim priority to US Patent Application Serial No.
The Parties agree that nothing
in this Project Agreement will otherwise alter the existing patent rights of the Parties
unless expressly agreed upon.
Section IX.2 Allocation of Principle Rights
If Janssen elects to retain title to a Subject Invention, Janssen or its designee shall retain
the entire right, title, and interest throughout the world to each Subject Invention
developed under this Project Agreement consistent with the provisions of this Article and35 U.S.0 § 202 subject to the retention by the Government of a nonexclusive,
nontransferable, irrevocable, paid-up license to practice or have practiced on behalf of
the United States any Subject Invention. The license retained by the Government does
not include the right to use or allow others to use the Subject Invention for commercial
purposes.
Section IX.3 Invention Disclosure, Election of Title, and Filing of Patent
Applicationa. Janssen shall disclose each Subject Invention to the Government within two(2) months of the Subject Invention being disclosed in writing to the person
responsible for Janssen patent matters. The Subject Invention shall be
disclosed in writing to the Government, via appropriate filings in the iEdison
system or its replacement/alternative system, with a copy of said reporting
being sent to JPEO-CBRND. Further, Janssen shall elect in writing whether or
not to retain title to any such invention by notifying the Government within 6months of disclosure to the Government.
b. Where publication, sale, or public use has initiated the one (1)-year statutory
period wherein valid patent protection can still be obtained in the United States,

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the period for such notice of election may be shortened by the Government toa date that is no more than sixty (60) calendar days prior to the end of thestatutory period.
c. If electing title, Janssen will file its initial patent application on a Subject
Invention to which it elects to retain title within one year after election of title,or, if earlier, prior to the end of the statutory period wherein valid patent
protection can be obtained in the United States after a publication, or sale, or
public use.
d. Foreign Patent Filing Requirements: Janssen may elect to file corresponding
patent applications in additional countries outside the U.S. (including but notlimited to the European Patent Office and the Patent Cooperation Treaty) at its
discretion. To enable the Government to protect patent rights in Subject
Inventions in all potential countries, Janssen shall inform the Government of
which countries Janssen shall NOT file patents applications in for all elected
Subject Inventions at least 3 months prior to the filing deadline therein (e.g., in
PCT national stage applications, at least 3 months prior to the PCT national
stage filing deadline). Janssen understands that, in case the Government
decides to file in a particular country following a notice provided under thepreceding sentence, all ownership and interest in Subject Inventions in saidcountries (where Janssen shall not file patent applications in) are thereby
automatically conveyed to the Government, and Janssen agrees to timely
execute any documentation required to effectuate this conveyance, so as toenable the Government to perfect patent filing in said countries, always subject
to the license described in Article IX, Section 5(a).
e. If Janssen does not elect title via the process described above, or determinesthat neither it nor its designee intends to file any patent applications on a Subject
Invention, Janssen shall notify the Government, in writing, within 6 months ofdisclosure of such Subject Invention to the Government. Janssen agrees, insuch case, to permit the Government to elect title to said Subject Invention, andthereby have full rights and ownership therein, at least 3 months PRIOR to theend of the one (1)-year statutory period wherein valid patent protection can still
be obtained in the United States after any publication, sale, or public use.
f. In addition to the reporting required above, Janssen shall identify Subject
Inventions in an annual report and the final report, which shall be in sufficiently
complete technical detail to convey a clear understanding to the extent knownat the time of the disclosure, of the nature, purpose, operation, and the physical,
chemical, biological, or electrical characteristics of the Subject Invention.
g. Neither Party will publicly disclose any Subject Invention until a patentapplication describing the Subject Invention is filed, or a reasonable period oftime has passed in the event that a patent application is not filed, in order toprotect the patentability of the invention pursuant to 35 U.S.C. § 205.

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Section IX.4 Conditions When the Government May Obtain Title
Upon JPEO-CBRND's written request, Janssen shall convey title to theGovernment:a. Of any Subject Invention, if Janssen fails to disclose the Subject Invention orelects not to retain title to the Subject Invention within the times specified in
Article IX, Section 3(a) and (b), the Government may request title for a periodof up to 60 calendar days after learning of the failure of Janssen to disclose
within the specified times. For the avoidance of doubt, disclosure under thisparagraph shall be deemed to have occurred at the time of Janssen's
notification to JPEO-CBRND of a Subject Invention regardless of whether suchdisclosure meets the standards set forth in Article IX, Section 3(a) above.
b. Of a patent application or patent that claims a Subject Invention, as the casemay be, in any country in which Janssen decides not to continue theprosecution of such patent application, or to pay the maintenance fees on or
defend in reexamination or opposition proceedings such a patent.
Section IX.5 Minimum Rights to Janssen's Consortium and Protection of
Janssen's Consortium's Right to File.
a. Janssen shall retain a nonexclusive, royalty-free license throughout the worldin each Subject Invention to which JPEO-CBRND obtains title under Article IX,
Section 8. The Janssen license extends to the Janssen's Affiliates, andincludes the right to grant licenses of the same scope to the extent that Janssen
was legally obligated to do so at the time the Project Agreement was awarded
or at the time of the Subject Invention was invented. The license is transferable
only with the approval of JPEO-CBRND, except when transferred to thesuccessor of that part of the business to which the Subject Invention pertains.
JPEO-CBRND approval for license transfer shall not be unreasonably withheld.
b. The Janssen license may be revoked or modified by the Government to theextent necessary to achieve expeditious Practical Application of the Subject
Invention pursuant to an application for an exclusive or non-exclusive licensesubmitted consistent with appropriate provisions at 37 CFR Part 404.
c. Before modification of the license, JPEO-CBRND shall furnish Janssen awritten notice of its intention to revoke or modify the license, and Janssen shallbe allowed thirty (30) calendar days (or such other time as may be authorized
for good cause shown) after the notice to show cause why the license should
not be modified.

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Section IX.6 Action to Protect JPEO-CBRND's Interest
a. Janssen agrees to execute or to have executed and promptly deliver to JPEOCBRND all instruments necessary to (i) establish or confirm the rights JPEOCBRND has throughout the world in those Subject Inventions to which Janssen
elects to retain title, and (ii) convey title to JPEO-CBRND when requested
under Section 4 of this Article IX and to enable JPEO-CBRND to obtain patent
protection throughout the world in that Subject Invention.
b. Janssen agrees to require, by written agreement, its employees, other thanclerical and non-technical employees, to disclose promptly in writing, topersonnel identified as responsible for the administration of patent matters andin a format suggested by Janssen, each Subject Invention in order that Janssen
can comply with the disclosure provisions of Section 3 of this Article IX.
Janssen shall instruct employees, through employee agreements or othersuitable educational programs, on the importance of reporting Subject
Inventions in sufficient time to permit the filing of patent applications prior to
U.S. or foreign statutory bars.
c. Janssen shall notify JPEO-CBRND of any decisions not to continue theprosecution of a patent application claiming a Subject Invention, pay
maintenance fees on a patent claiming a Subject Invention, or defend in a
reexamination or opposition proceedings on a patent claiming a Subject
Invention, in any country, not less than sixty (60) calendar days before theexpiration of the response period required by the relevant patent office.
d. Janssen shall include, within the specification of any United States patentapplication and any patent issuing thereon claiming a Subject Invention, thefollowing statement: "This invention was made with Government support under
Agreement [W15QKN-19-6-1002, 2011-004], awarded by JPEO-CBRND.
JPEO-CBRND has certain rights in the invention."
Section IX.7 Reporting on Utilization of Subject Inventions
a. Janssen shall submit, during the term of the Project Agreement, an annual
report on the utilization of Subject Inventions or on efforts at obtaining such
utilization that are being made by or on behalf of Janssen or its licensees orassignees. Such reports will include information regarding the status ofdevelopment, date of first commercial sale or use, and such other data andinformation as the agency may reasonably specify. Janssen shall provide
additional reports as may be requested by JPEO-CBRND in connection withany march-in proceedings undertaken by the Government in accordance with
Article IX, Section 8 of this Project Agreement. Consistent with 35 U.S.C.
§ 202(c) (5), JPEO-CBRND agrees it shall not disclose such information topersons outside JPEO-CBRND without permission of Janssen.

WI 5QKN- 16-9-1002
P00081Page 34 of 89b. All required reporting shall be submitted to the AO and AOR.
c. Where the Subject Invention is a drug or a vaccine, or a method of
manufacturing, administering or using a drug or vaccine, Practical Applicationin view of the March-in Rights in Article IX, Section 8 below is achieved withrespect to:i. such drug or vaccine, if a Phase Ila clinical study is completed that studies
such drug or vaccine; orii. such method of use, if the method of use is employed in manufacture,administration or use of such drug or vaccine in connection with a PhaseIla clinical study.
d. Failure to complete a Phase Ila clinical study does not per se constitute a failure
to achieve Practical Application.
Section IX.8 March-in Rights
Janssen agrees that, with respect to any Subject Invention in which it has acquired
title, the Government may request Janssen, an assignee, or exclusive licensee ofa Subject Invention to grant a non-exclusive license, within the Field of use to a
responsible US-based third party, upon terms that are reasonable under thecircumstances. If Janssen, assignee, or exclusive licensee initially refuses such arequest, the Government may obligate Janssen to grant such a license subject to
Article IX, Section 8(c) below if the Government determines that:a. Such action is necessary because Janssen or assignee has not taken steps(or is not expected to take within a reasonable time), consistent with theintent of this Project Agreement, to achieve Practical Application of the
Subject Invention; orb. Such action is necessary to alleviate the following urgent health or safety
needs not reasonably satisfied by the contractor that affect the UnitedStates and that are not reasonably satisfied by Janssen, assignee, or theirlicensees:i. declaration for Public Health Emergency by the Secretary of theGovernment;
ii. determination that there is a significant potential for a public Healthemergency that has a significant potential to affect the national
security or public health of U.S. citizens as determined by the
Secretary of the Government; oriii. declaration by WHO Director General of a public health emergency of

WI 5QKN- 16-9-1002
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international concern.
c. Where the circumstances described in Article IX, Section 8(a) and or (b) are
met, Janssen will act promptly to negotiate in good faith with the responsible
US-based third party a non-exclusive license on terms that are reasonable
under the circumstances under the SI Intellectual Property Rights it controls
at the time to make, have made, use, sell, offer for sale and import therelevant Subject Invention in the Field to the extent necessary to alleviate
the public health emergency in the United States.
Section IX.9 Background Information
Janssen shall retain the entire right, title, and interest throughout the world to each such
Invention and Patent that Janssen has brought to the Prototype Project issued under thisProject Agreement/Statement of Work and the Government shall not have any rights
under this Project Agreement/Statement of Work to such Inventions and Patents unlessidentified herein. Attachment 1 to the Project Agreement contains non-exhaustive
overview of Janssen's Background Patents, patent applications and Inventions at the
Effective Date. Table 10-1 in Article X "Data Rights" provides a non-exhaustive overview
of Data Rights, information and Technical Data that Janssen will bring to the Project
Agreement at the Effective Date. The Government shall have no rights to these
Background Inventions, Patents, information and Technical Data and any further
Background Inventions, Patents, information and Technical Data identified during theTerm of the Project Agreement or afterwards.
Article X.

Data Rights

Table 10-1: Janssen Background Information, Data Rights and Technical Data
Technical Data to be Furnished
Basis for Assertion
Asserted
Name ofwith Restrictions
Rights
PersonAsserting
Category
Restrictions
A(b) (4)
Janssen(b) (4)A

Janssen(b) (4)A

Janssen(b) (4)A

Janssen(b) (4)A

JanssenW15QKN-16-9-1002
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Technical Data to be Furnishedwith Restrictions

Basis for Assertion

Asserted
RightsCategoryA

Name of
PersonAssertingRestrictions
JanssenA

JanssenJanssenA

JanssenA

JanssenA

JanssenA

JanssenA

JanssenWI 5QKN- 16-9-1002
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Section Xi Data Categories
Article XI of the Agreement, is hereby superseded by the following terms and conditions:
There are two (2) categories of Data or other information established under this Project
Agreement as listed below.
a. Category A is Data or other information to which Janssen retains all rights.
Category A Data shall include, but not be limited to:i.

Data as defined in the Project Agreement, background (i.e., pre-existingor generated outside the scope of this Project Agreement) information
and Technical Data identified in Table 10-1 and Attachment 1(background Patents, patent applications and Inventions), and any
designs or other material provided by Janssen for this Project
Agreement which was not developed in the performance of work under
this project, and to which Janssen retains rights.

ii.

The Parties hereby mutually agree that any information developed
outside of this Project Agreement whether or not developed with any
Government funding in whole or in part under a Government agreement,
contract or subcontract shall have the rights negotiated under such prioragreement, contract or subcontract; the Government shall get no
additional rights in such information.

b. Category B is any Data developed exclusively with Government funds under
this Project Agreement.
i.

The Government will have Government Purpose Rights in Datadeveloped exclusively with Government funds under this Project
Agreement.

ii.

The Government shall have unlimited rights in Data:(a) Otherwise publicly available or that has been released ordisclosed by Janssen without restrictions on further use, releaseor disclosure, other than a release or disclosure resulting from thesale, transfer, or other assignment of interest in the Data to
another party or the sale or transfer of some or all of a business
entity or its assets to another party;(b) Data in which the Government has obtained unlimited rights
under another Government contract or as a result of negotiations;or(c) Data furnished to the Government, under this or any otherWI 5QKN- 16-9-1002
P00081Page 38 of 89

Government contract or subcontract thereunder, with1. government purpose rights or limited rights and therestrictive condition(s) has/have expired; or
2. Government purpose rights and Janssen's exclusive right touse such Data for commercial purposes under such contract
or subcontract has expired.
iii.

However, any Data or other information developed outside of this OTA
whether or not developed with any Government funding in whole or inpart under a Government agreement, contract or subcontract shall havethe rights negotiated under such prior agreement, contract or
subcontract; the Government shall get no additional rights in such Dataor other information.

Section X.2 Allocation of Principle Rights
a. The Government shall have no rights to Category A Data or other information,
but shall have rights to Deliverables as described in Table 1-5.
b. The Government will receive Government Purpose Rights in Data or otherinformation exclusively funded by the Government and otherwise Limited
Rights in any data delivered in the performance of the SOW. To the extent that
the Parties mutually agree that there will be Data subject to Government
Purpose Rights, Data subject to Government Purpose Rights may only beshared with parties outside the Government when such parties are subject tothe non-disclosure agreement at DFARS 227.7103-7 with respect to the dataor are receiving the data under a Government contract subject to DFARS
252.227-7025. Any delivered Data or other information which is part of a patentapplication claiming a Subject Invention will be subject to the disclosure andrelease restrictions set forth in Article X, Section 2 of this Project Agreement.
c. Data or other information in any document which is a part of a patent applicationthat would disclose a Subject Invention will be subject to Limited Rights until
publication of patent application in accordance with Article X of this Project
Agreement/Statement of Work.
d. Janssen agrees to retain and maintain in good condition all Data necessary toachieve Practical Application of any Subject Invention in accordance with theJanssen's established record retention practices. In the event of exercise of
the Government's March-in Rights as set forth under Article X, Janssen agrees,
upon written request and with adequate additional support from theGovernment, as mutually agreed between the Parties, to deliver Data
necessary to achieve Practical Application within one-hundred and twenty(120) calendar days from the date of the written request.

W I5QKN- 16-9-1002
P00081Page 39 of 89e. Janssen's right to use Data is not restricted and includes the right under
Janssen's established business policies to make public research data
(especially human research data) by publication in the scientific literature, by
making trial protocols, trial results summaries, and clinical studies reports
publicly available, and by making trial patient-level data available for third-party
analysis. The Government agrees that the materials, if any, being developed
under this Project Agreement/Statement of Work are being developed for both
civilian and military applications.
Section X.3 Identification and Disposition of Data
Janssen shall keep copies of all Data required by the FDA relevant to this Project
Agreement for the time specified by the FDA and provide such Data to AO. The
Government reserves the right to review any other Data determined by theGovernment to be relevant to this Project Agreement/Statement of Work subject toLimited Rights.
a. Marking of Data
Pursuant to section A above, any Data delivered under this Project
Agreement/Statement of Work that is subject to Government Purpose Rights shallbe marked with the following legend or similar:"GOVERNMENT PURPOSE RIGHTS: The Government's right to use,
modify, reproduce, perform, display or disclose this Data is restrictedby P00081 Modification to the MCDC OTA No. W15QKN-16-9-1002
between the Government, ATI and Janssen, and those restrictions do
not permit disclosure to any party outside the Government unless suchdisclosure is for government purposes and not facilitating commercial
sale beyond the government. Any reproduction of this Data or portions
thereof must be marked with this legend."b. Pursuant to section A above, any Data delivered under this Project
Agreement/Statement of Work that is subject to Limited Rights shall be marked
with the following legend or similar:"LIMITED RIGHTS: The Government's right to use, modify, reproduce,
perform, display or disclose this Data is restricted by P00081
Modification to the MCDC OTA No. W150KN-16-9-1002 between the
Government, ATI and Janssen, and those restrictions do not permit
disclosure to any party outside the Government without prioragreement of Recipient. Any reproduction of this Data or portions
thereof must be marked with this legend."

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Article XI.

Export Control

This term/condition is not applicable to this Project Agreement.
Article XII. Government Furnished Property
It is not anticipated that any Government furnished equipment, materials, information, orother property will be provided to Janssen nor will Janssen procure any property intended
to be Government furnished under this Project Agreement.
Article XIII. Civil Rights Act
Reference back to Article XIV of the MCDC Base OTA No. W15QKN-16-9-1002.
Article XIV. Small Business Affiliation
This term/condition is not applicable to this Project Agreement.
Article XV. Antitrust
This term/condition is not applicable to this Project Agreement.
Article XVI. Security and Operations Security ("OPSEC")
To the extent that Janssen does not meet any requirements in this Article XVI or
Attachment 2 at the time of award of this Project Agreement, Janssen will notify theGovernment and will have 180 days to work with the Government to develop a plan towhich Parties agree to address such requirements, Janssen will be entitled to an
equitable adjustment to account for costs associated with implementing the plan agreed
to by the Parties.
The OPSEC provisions included in Attachment 2 are hereby incorporated into thisProject Agreement.
All PAH shall comply with DFARS 252.204-7012 (Oct 2016): Safeguarding Covered
Defense Information and Cyber Incident Reporting when applicable.
Covered Defense Information ("CDI") will be identified at the Project Agreement level.
The MCDC Member shall comply with DFARS 252.204-7012 (Oct 2016): Safeguarding
Covered Defense Information and Cyber Incident Reporting, which includes
implementing on its covered contractor information systems the security requirements
specified by DFARS 252.204-7012. Nothing in this paragraph shall be interpreted toforeclose the MCDC Member's right to seek alternate means of complying with thesecurity requirements in National Institute of Standards and Technology ("NIST") Special
Publication (SP) 800-171 (as contemplated in DFARS 252.204-7008 (Compliance with

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Safeguarding Covered Defense Information Controls) (Oct 2016) and DFARS 252.2047012 (Safeguarding Covered Defense Information and Cyber Incident Reporting (Oct2016)).
(1) For all Project Agreements, the following statement shall be flowed to the MCDC
member entities unless otherwise stated within the Project Agreements.
a) Classification guidance for requirement - "The security level for this agreement
is UNCLASSIFIED."
Article XVII.Safety
This term/condition is not applicable to this Project Agreement.
Article XVIII.

Representations and Warranties

Reference back to Article XIX of the MCDC Base OTA No. W15QKN-16-9-1002.
Section XVIII.1

Representations and Warranties of All Parties

Each Party to this Project Agreement represents and warrants to the other Parties that(1) it is free to enter into this Agreement; (2) in so doing, it will not violate any otheragreement to which it is a party; and (3) it has taken all action necessary to authorize theexecution and delivery of this Project Agreement and the performance of its obligations
under this Project Agreement.
Section XVIII.2

Limitations

Except as expressly provided herein, no Party to this Project Agreement makes any
warranty, express or implied, either in fact or by operation of law, by statute or otherwise,
relating to (1) any research conducted under this Project Agreement, or (2) any invention
conceived and/or reduced to practice under this Project Agreement, or (3) any otherintellectual property developed under this Project Agreement or noninfringement, andEACH PARTY TO THIS PROJECT AGREEMENT SPECIFICALLY DISCLAIMS ANYIMPLIED WARRANTY OF MERCHANTABILITY OR WARRANTY OF FITNESS FOR A
PARTICULAR PURPOSE.
Article XIX. General Provisions
Section XIX.1 Fees
This term/condition is Not Applicable to this Project.
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Reference back to Article XXI, Section 2 of the MCDC Base OTA No. W15QKN16-9-1002.
Section XIX.3 Section Headings
Reference back to Article XXI, Section 3 of the MCDC Base OTA No. W150KN16-9-1002.
Section XIX.4 Severability
If any provision of this Project Agreement, or the application of any such provision
to any person or set of circumstances, is determined to be invalid, unlawful, voidor unenforceable to any extent, the remainder of this Project Agreement, and theapplication of such provision to persons or circumstances other than those as towhich it is determined to be invalid, unlawful, void or unenforceable, will not be
impaired or otherwise affected and will continue to be valid and enforceable to thefullest extent permitted by law.
Section XIX.5 Excusable Delay
Neither Party will be liable to the other Party for failure or delay in performing its
obligations hereunder if such failure or delay arises from circumstances beyond thecontrol and without the fault or negligence of the Party (an "Excusable Delay Event").
Examples of such circumstances are: authorized acts of the Government in its
sovereign capacity (or failure to take reasonably expected acts), war, insurrection,
freight embargos, fire, flood, or strikes. The Party asserting Excusable Delay as an
excuse must take reasonable steps to minimize delay or damages caused byunforeseeable events. The Government may not identify any aspect of the COVID19 pandemic as an Excusable Delay Event relieving it of its responsibilities under
this Project Agreement.

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Section XIX.6 Regulatory Rights
a. The Parties understand and hereby acknowledge that BARDA OTA No.
HHS0100201700018C ("BARDA OTA") governs Janssen's responsibilities
and obligations with regards to IND activities regarding Janssen's
Ad26.COV2.S vaccine, specifically, Work Package 6.14, "Regulatory Support"of the BARDA OTA. Under the BARDA OTA, Janssen leads regulatory
activities with the FDA. Janssen manages all regulatory communications,documentation, and submissions with health authorities. Janssen provides
BARDA with all communications and summaries thereof, both formal andinformal, to or from FDA regarding the Investigational New Drug ("IND")
activities regarding Janssen's Ad26.COV2.S vaccine and will invite the
BARDA/JPEO-CBRND representatives to participate in any formal meetings
between FDA and Janssen. Additionally, for this Project Agreement, Janssen
will authorize BARDA to share information with the United States Departmentof Defense, JPEO-CBRND, as BARDA deems appropriate, in accordance with
the Data Rights requirements of BARDA OTA No. HHS0100201700018C.
b. The Parties also understand that PL-115-92 allows the DoD to request, and
FDA to provide, assistance to expedite development and the FDA's review of
products to diagnose, treat, or prevent serious or life-threatening diseases orconditions facing American military personnel. Janssen recognizes that only
the DoD is authorized to invoke PL-115-92. If Janssen, the DoD, and BARDA
agree that the circumstances exist under the BARDA OTA to warrant DoD's
involvement, Janssen and BARDA may request DoD to utilize its authority
under PL-115-92 to engage the FDA.
If DoD, in its sole discretion, determines that it will engage with the FDA, theParties agree that DoD will only invoke this authority in order to assist or
facilitate Janssen in obtaining the necessary FDA approvals or authorizations.
Notwithstanding any other provision in this Project Agreement, the BARDA
OTA, or PL-115-92, the Parties agree that DoD shall not use its authority to
become a "sponsor," co-sponsor, or "applicant" as defined in the regulations
cited in this Article. Further, the Parties hereby agree that any information
provided to DoD by Janssen, to facilitate with the FDA under PL-115-92, will
be provided with Limited Rights pursuant to the BARDA OTA.
c. Rights of Reference. In the event that all of the conditions described in Article
19, Section 7(1) are met, Janssen will grant the Government a right of reference
to any regulatory application submitted to the FDA in support of this Project
Agreement/Statement of Work. Separately, upon the DoD's request, Janssen
will grant the DoD a right of reference to any regulatory application submitted
to the FDA in support of this Project Agreement/Statement of Work for the
DoD's regulatory filings involving (a) the use of a product to treat or prevent
COVID-19 or (b) one of the material threats identified in Attachment 3, in eachcase for which the DoD is identified as the filing sponsor. DoD may request a

WI 5QKN- 16-9-1002
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right of reference to additional material threats identified by the Government
under Section 319F-2(c)(2)(A)(ii) of the Public Health Service Act, and Janssen
may consent to provide such a right of reference with the agreement that its
consent will not be unreasonably withheld. For clarity, the rights of reference
identified in this paragraph will only authorize the FDA to cross-reference
regulatory applications and will not provide the DoD or any other party with aright to access or review any such applications or information included in suchapplications.
Section XIX.7 Failure to Provide Prototype Product1.
In recognition of the Government's need to provide sufficient quantities of asafe and effective Prototype Product to protect the United States population, theGovernment shall have the remedy described in this section to ensure sufficient
supply of the Prototype Product to meet the needs of the public health or national
security when the following conditions are met:a. Janssen gives written notice (which it hereby agrees to do) to theGovernment no later than 15 business days following:i. except as permitted under Article I, Section 3 or in connection with atermination of this Project Agreement under Article II, Section 2
above, any formal management decision to terminate manufacturingof the Prototype Product prior to delivery of 100 million Regimens of
the Prototype Product to USG; orii. except as permitted under Article I, Section 3 or in connection with atermination of this Project Agreement under Article II, Section 2
above, any formal management decision to discontinue sale of thePrototype Product to the Government prior to delivery of 100 million
Regimens of the Prototype Product to USG; oriii. any filing that anticipates Federal bankruptcy protection of Janssen
prior to the delivery of 100 million Regimens of the Prototype
Product; andb. Janssen
i. is authorized to supply the Prototype Product under an Emergency
Use Authorization under §564 of the FD&C Act; orii. has an FDA approval to market the Prototype Product in the U.S.
under the provisions of §351(a) of the Public Health Service Act(PHSA).

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2. If both conditions listed in subsection (1) occur, Janssen, during the emergency
pandemic for COVID-19 issued under §319 of the PHSA, upon the written requestof the Government, will act promptly to license a Third-Party Licensee all Janssen
Prototype Product Rights on reasonable terms for the continuation and/or initiationof manufacturing of the Prototype Project at the Government's expense.
3. This Article will survive the acquisition or merger of Janssen with a third party.
This Article will survive the expiration of this Project Agreement unless the Project
Agreement was terminated under Article II, Section 2(a).
Section XIX.8 Radioactive Materials
This term/condition is not applicable to this Project Agreement.
Section XIX.9 Recombinant DNA
This term/condition is not applicable to this Project Agreement.
Section XIX.10

Required Compliance for Use of Laboratory Animals

This term/condition is not applicable to this Project Agreement.
Section XIX.11

Required Compliance for Use of Human Subjects

This term/condition is not applicable to this Project Agreement.
Section XIX.12
Substances

Required Compliance for use of Human AnatomicalThis term/condition is not applicable to this Project Agreement.
Section XIX.13

Compliance with Good Manufacturing Processes

The cGMP (21 CFR 210-211) will be the standard applied for manufacturing,processing and packing of any products to be administered to human subjects under
this Project Agreement subject to any applicable guidance from, or enforcement
discretion exercised by, the FDA in connection with COVID-19 subject to any
applicable guidance from, or enforcement discretion exercised by, the FDA inconnection with COVID-19.
If at any time during the life of this contract, the Recipient fails to comply with cGMPin the manufacturing, processing and packaging of the products subject to the
exception noted above and such failure results in a material adverse effect on thesafety, purity or potency of the products (a material failure) as identified by Center
for Biologics Evaluation and Research and Center for Drug Evaluation andResearch, the Recipient shall have thirty (30) calendar days from the time suchWI 5QKN- 16-9-1002
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material failure is identified to cure such material failure. If the Recipient fails to takesuch an action within the thirty (30) calendar day period, then the contract may beterminated.
The Recipient agrees to comply with cGMP guidelines (21 CFR Parts 210-211,600)
for manufacturing, processing and packing of drugs, chemicals, biological, andreagents subject to any applicable guidance from, or enforcement discretion
exercised by, the FDA in connection with COVID-19.
The Recipient agrees to advise the AO and AOR promptly of any relocation of theirprime manufacturing facility or the relocation of any sub consortium's facility during
the term or this Project Agreement. The Recipient also agrees to advise the AO and
AOR immediately if at any time during the term of this Project Agreement, the items
under this OTA fail to comply with cGMP guidelines and/or the facility receives anegative FDA Quality Assurance Evaluation (Form 483).
Section XIX.14

Registration with Select Agent ProgramThis term/condition is not applicable to this Project Agreement.
Section XIX.15

Duty Free Entry

Reference back to Article XXI, Section 14 of the MCDC Base OTA No. W15QKN16-9-1002.
Article XX. Assignment of Agency
Neither this Project Agreement nor any rights or obligations of any Party hereunder shallbe assigned or otherwise transferred by any Party without the prior written consent of theother Parties, except that Janssen may assign to an Affiliate or to a third party to whom it
transfers the portion of its business applicable to this Project Agreement, in each case,without prior written consent.
Article XXI. Order of Precedence
In the event of any inconsistency between the general terms of this Project Agreement
and the Agreement, the inconsistency shall be resolved by giving precedence in thefollowing order: (1) the Scope/Statement of Work of the Project Agreement; (2)Attachments to the Project Agreement; (3) the Project Agreement terms and conditions;(4)documentation (including but not limited to Janssen's proposal selected for funding by
the Government); (5) the general terms and conditions of the Agreement. In any event,specifically negotiated Project Agreement terms will govern over general terms of theAgreement.
The Parties mutually agree that any terms and conditions that have been identified withthe following statement "This term/condition is Not Applicable to this ProjectWI 5QKN- 16-9-1002
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Agreement" shall have no effect and are expressly excluded from the MCDC Base OTA
No. W150KN-16-9-1002. The terms and conditions in the MCDC Base OTA No.
W150KN-16-9-1002, that have been changed within this Project Agreement, are hereby
superseded by the language in this Project Agreement. As such, those sections from the
MCDC Base OTA No. W150KN-16-9-1002 shall no longer remain operative with regards
to this Project Agreement/Statement of Work. Any terms and conditions that have notbeen changed or have not been identified with the above statement remain unchanged
and in full force and effect.
Article XXII.Execution
This Project Agreement constitutes the entire agreement of the Parties and supersedes
all prior and contemporaneous agreements, understandings, negotiations anddiscussions among the Parties, whether oral or written, with respect to the subject matterhereof. This Project Agreement may be revised only by written consent of Janssen and
the AO. This Project Agreement, or modifications thereto, may be executed incounterparts each of which shall be deemed as original, but all of which taken together
shall constitute one and the same instrument.
Article XXIII.

Antibribery and Anti-Corruption

The Government acknowledges that it has received and read Recipient's 'Prevention of
Corruption - Third Party Guidelines.' Each Party agrees to perform its obligations under
this Project Agreement in accordance with the applicable anti-bribery and anti-corruption
laws of the territory in which such Party conducts business with the other Party as set
forth herein. Each Party shall be entitled to exercise its termination right, under and inaccordance with the terms of this Project Agreement, to terminate this Project Agreement
immediately on written notice to the other Party, if the other Party fails to perform its
material obligations in accordance with this Article XXIII.
Article XXIV.

Inspection, Acceptance, & Delivery

A. Acceptanceo Upon acceptance by the AOR of any lot of vaccine under this Project
Agreement and confirmation from the AO, title to such vaccine will transfer
upon (a) delivery of DP to vendor-managed inventory ('VMI"), or delivery to asite designated by the Government, as initially applicable, and (b) the
Government's corresponding written acceptance of each delivery. Storage as
VMI may only take place up to twelve months after I ) 141 (b) ( 2 )0 Any deviations, out of specification ("OOS") results, or other product issues,
shall be reported to the USG within 3 calendar days after initial delivery.

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0

When held in VMI, these materials should be maintained in Janssen's or its
designated representative's quality and inventory systems.
Delivered
Regimens are intended for clinical use or use under Emergency Use
Authorization or a BLA. Product held in VMI is subject to the following
requirements:•

Provide temperature controlled storage at the manufacturer's site
approved by the Government, according to cGMP and productspecifications.

•Store Project Agreement products physically segregated from otherproducts.

•

Ensure proper labeling of stored materials as USG property.

•

Execute stability testing of stored material in a manner consistent withthe stability testing plan approved by the Government. Report interim
data and results to the Government on a monthly basis.

•

Appropriately identify reserve samples that are representative of drug
product shall be retained. The reserve samples consist of at least twice
the quantity necessary for all tests required to determine whether the
drug product meets its established specifications including a minimumof 60 months of stability testing.

•

Provide the Government access to review the security systems in place
and request updates as needed.

•

Include in monthly report inventory for drug product (number of vials),
including inventory quantity changes, current quantity, storage
facility/location, manufacturing date, latest stability result for potency,
date of next expected stability result and the current expiration date (ifapplicable).

•

Ensure that material being relocated for Janssen's convenience isadequately insured at no cost to the government and with AO approval.

•

Conduct testing necessary to ensure continued use of the stored
material for pandemic response.

•

Make appropriate updates to the regulatory documentation supportingthe continued use of the stored material for pandemic response.

•

If using a storage site, provide the quality agreement, specify thelocation and terms of the storage contract and receive approval by theGovernment.

WI 5QKN- 16-9-1002
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O Notification must be made to the AO and AOR at least 10 calendar days prior
to initial delivery. Exceptions are permitted if approved by the AO.
O The Government shall accept product that conforms to contract requirements
based on Certificates of Analysis and certificate(s) of cGMP conformity
provided by Janssen. The Government's acceptance of product will bedeemed to have occurred if the Government does not provide written notice of
acceptance or rejection within fourteen (14) calendar days of Janssen's
provision of all applicable certificates.
O Upon receipt of the provided certificates and any inspection that was timely
requested (physical or representative, i.e., pictures), the AOR will review andrecommend acceptance or rejection; the AO will correspondingly notify
Janssen of acceptance or rejection.
O Upon delivery of product, notification of delivery quantities and any movement
must be made to the AOR and Government representatives.
O Upon request before storage in VMI or, if storage was initially ordered, after
storage in VMI, unless otherwise mutually agreed upon by the Parties, DP shallbe shipped, trackable by GPS, to the Government-designated sites within thecontinental United States.
O Janssen will retain physical risk of loss for all product stored as VMI until
subsequent delivery to the Government at the Government-designated site. If
product is initially delivered to a Government site instead of VMI, risk of loss
will transfer upon delivery and acceptance at the Government-designated site.
Notwithstanding either of the foregoing sentences, Janssen shall not be liable
for loss of or damage to supplies caused by the negligence of officers, agents,
or employees of the Government acting within the scope of their employment.
O Janssen will notify the AO and AOR of any storage or quality deviation for
product held in VMI, within 3 calendar days.
O To the extent that Janssen is responsible for the correction, repair or
replacement of Government property held in VMI and replacement upon loss
or damage is feasible, the Government will accept replacement of suchproperty.
O Vendor-managed storage of product manufactured under this Project
Agreement is supported for up to twelve months after (b) (4). (b) (2)and, assuch, the Government must either (a) take possession on or before the end of
this period and provide Janssen with disposition instructions in sufficient timeto transfer physical material from Janssen by this date or (b) bilaterally modify

WI 5QKN- 16-9-1002
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this Project Agreement to extend the period of vendor management of storageprior to this date.
0 The Government understands that prices identified in this contract include
insurance costs applicable to material that will become Government property,
including product stored as VMI.
0 Janssen cannot reclaim title to product upon acceptance by the Government.
Prior to expiration or termination of this Project Agreement, the Government
may affect final distribution of any vaccines remaining in storage by any one or
combination of the following methods:•

The Government may elect to require shipment of the vaccine to US
Government facilities.

•

The Government may direct Janssen to destroy all quantities remaining
in storage. In this case, a letter of disposition will be provided to the
USG.

B. Inspection
USG right to inspect product: The AO and/or the AOR may perform inspection ofmaterials and services. Inspections of material created under this Project Agreement
may be made by a duly authorized Government representative, and with reasonable
notice (i.e., not less than 24 hours).
Article XXV. Foreign Access to Technology(a) Except as authorized by the Office of Foreign Assets Control ("OFAC") in the
Department of the Treasury, the Contractor shall not acquire, for use in the performanceof this contract, any supplies or services if any proclamation, Executive order, or statuteadministered by OFAC, or if OFAC's implementing regulations at 31 CFR chapter V,
would prohibit such a transaction by a person subject to the jurisdiction of the UnitedStates.
(b) Except as authorized by OFAC, most transactions involving Cuba, Iran, andSudan are prohibited, as are most imports from Burma or North Korea, into the UnitedStates or its outlying areas. Lists of entities and individuals subject to economic sanctions
are included in OFAC's List of Specially Designated Nationals and Blocked Persons at
http://www.treas.gov/offices/enforcement/ofac/sdn/. More information about theserestrictions, as well as updates, is available in the OFAC's regulations at 31 CFR chapter
V and/or on OFAC's website at http://www.treas.gov/offices/enforcement/ofac.
(c) The Contractor shall insert this clause, including this paragraph (c), in all
subcontracts.

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Article XXVI.Government Observer in Recipient Facility
With seven (7) days advance notice to the Recipient in writing from the AO, theGovernment may place an observer in a Recipient facility that is being used for work
hereunder, who shall be subject to Recipient's policies and procedures regarding security
and facility access at all times while in the Recipient's facility and who shall limit its
activities to observing work related to this Project Agreement. As determined by federal
law and as required under this Project Agreement/Statement of Work, no Government
representative shall publish, divulge, disclose or make known in any manner, or to any
extent not authorized by law, any information disclosed to that person in the course of
employment or official duties performed while stationed in a Recipient facility.
Article XXVII.

Reporting Matters Involving Fraud, Waste and Abuse

Anyone who becomes aware of the existence or apparent existence of fraud, waste andabuse in ASPR funded programs is encouraged to report such matters to the HHS
Inspector General's Office in writing or on the Inspector General's Hotline. The toll-freenumber is 1-800-HHS-TIPS (1-800-447-8477). All telephone calls will be handled
confidentially. The e-mail address is Htips@os.dThe Government .gov and the mailingaddress is:
Office of Inspector General
Department of
Health and Human
Services TIPS
HOTLINE
P.O. Box 23489
Washington, D.C. 20026
Article XXVIII.

Prohibition on Contractor Involvement with Terrorist Activities

The Recipient acknowledges that U.S. Executive Orders and Laws, including but notlimited to E.0.13224 and P.L. 107-56, prohibit transactions with, and the provision of
resources and support to, individuals and organizations associated with terrorism. It is thelegal responsibility of the Recipient to ensure compliance with these Executive Orders
and Laws. This clause must be included in all subcontracts issued under this Project
Agreement.
Article XXIX.Survival
Articles IV (PREP Act); V (Payment); VI, Sections (B) & (C) (Disputes and Limitations on
Damages); VII (Confidential Information), IX (Patent Rights), X (Data Rights) and this
Article XXIX shall survive the termination provisions in Article II, Section 2.
Section XXIX.1 Close-out ProcedureWI 5QKN- 16-9-1002
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If the Government funds an individual Project Agreement and then subsequently
terminates the agreement or the requirements of the Project Agreement are met, thefollowing closeout procedures apply:(a) Definitions.
(i)"Closeout" — the process by which the Government and CMF determinethat all applicable administrative actions and all required work have been
completed by Janssen.

(ii)"Date of Completion" — the date on which all work is completed or thedate on an amendment thereto on which the period of performanceends.

(b) Upon request, the Government shall make prompt payments to Janssen
through the CMF for outstanding payments and reimbursements under the
Project Agreement being closed out.
(c) Janssen shall immediately refund any balance of unobligated (unencumbered)cash that the CMF has paid and that is not authorized to be retained by Janssen
for use in the performance of the Project Agreement.
(d) The CMF shall obtain from Janssen within 180 calendar days after the date ofcompletion of an Project Agreement all financial, performance, and otherreports required as a condition of the Project Agreement. The CMF may grant
extensions when requested by Janssen.
(e) Reserved.
(f) Quick close-out procedures similar to FAR 42.708 shall be followed.
(g) Janssen shall account for any property received from the Government.

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ATTACHMENT 1:
Janssen's Background Patents, Patent Applications and Inventions
Listed Janssen Background Intellectual Property and Technical Data
Attachment 1 comprises a table with the full list of pending and granted patents in the patent families
listed below that, to the best of Janssen's knowledge, is accurate as of July 9, 2020. Janssen makes norepresentations or warranties with regards to the accuracy or completeness of that information. The
Parties mutually agree that Janssen is not obligated to maintain the currency or accuracy of theinformation provided in the table.
Certain patent applications / patents on this list are registered at the patent office with Crucell Holland
B.V. as the applicant. Crucell Holland B.V. was acquired by Johnson & Johnson in 2011 and subsequently
changed its name to Janssen Vaccines & Prevention in 2016.
Certain patents on this list are owned by

Janssen holds a license to these patents.

COVID Vaccination and Dosage Regimen:
Janssen has filed patent application(s), or is the assignee or licensee of pending patent applications
including those listed below which contain(s) claims that are related to COVID Vaccines and Dosage
regimens•

All patent applications and/or resulting patents (including any foreign counterparts, divisionals,
continuations, or the like thereof, and any extensions thereof) that include a priority claim to.

(4)
PER.C6® Technology and/or AdVac® Technology:

Janssen has filed patent application(s), or is the assignee or licensee of pending patent applications and/or issued
patent(s), including those listed below which contain(s) claims that are related to PER.C6@ technology and/or
AdVac@ technology.

W15QKN-16-9-1002
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W15QKN-16-9-1002
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Table X: Janssen Assertion of Data Rights Technical Data
Technical Data to be Furnished With
Restrictions

Basis for Assertion

Asserted

Name of Person

RightsAsserting

Category

Restrictions

A

JanssenA

JanssenA

JanssenA

JanssenA

JanssenA

JanssenA

JanssenA

JanssenA

JanssenA

JanssenW15QKN-16-9-1002
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Technical Data to be Furnished With
Restrictions

Basis for Assertion

Asserted
RightsCategoryA

Name of Person
AssertingRestrictions
JanssenA

JanssenA

JanssenW15QKN-16-9-1002
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Table: List of pending and granted background patents as of July 9, 2020.

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ATTACHMENT 2:
Additional OPSEC Requirements

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ATTACHMENT 3:
Material Threats

Biological Threats
1 Bacillus anthracis (anthrax) and Multi-drug resistant B. anthracis (MDR anthrax)
2 Burkholderia mallei (glanders) and Burkholderia pseudomallei (melioidosis)
3 Clostridium botulinum toxin (botulism)
4 Ebola virus (Ebola hemorrhagic fever)
5 Francisella tularensis (tularemia)
6 Marburg virus (Marburg hemorrhagic fever)
7 Pandemic influenza
8 Rickettsia prowazekii (typhus)
9 Variola virus (smallpox)
10 Yersinia pestis (plague)
Chemical Threats
A. Acetylcholinesterase inhibitor nerve agents
B. Chlorine
C. Cyanide salts (potassium and sodium cyanide)
D. Hydrogen cyanide
E. Phosgene
F. Vesicants

SECTION B - SUPPLIES OR SERVICES AND PRICES

CLIN 0058
The CLIN extended description has changed from:PLACE HOLDER - RPP 20-11 Objective 20-11 is being authorized under CLIN 0058 for"Janssen's COVID-19 Vaccine — Large Scale Domestic Production." The total approved cost by
the Government for this effort is not to exceed $1,010,000,000.00. The total amount authorized
to Janssen is $1,001,650,000.00. The total amount authorized to ATI is $8,350,000.00 (broken
out as $8,350,000.00 Cost and $0.00 Fixed Fee).

To:
RPP 20-11 Objective 20-11 is being awarded under CLIN 0058 for "Janssen's COVID-19
Vaccine — Large Scale Domestic Production." The total approved cost by the Government forthis effort is not to exceed $1,010,000,000.00. The total amount awarded to Janssen is

W15QICN-16-9-1002
P00081Page 88 of 89$1,001,650,000.00. The total amount authorized to ATI is $8,350,000.00 (broken out as$8,350,000.00 Cost and $0.00 Fixed Fee).

SUBCLIN 005802 is added as follows:
ITEM NO005802

SUPPLIES/SERVICESQUANTITY

UNIT

UNIT PRICEAMOUNT$0.00

Funding for CLIN 0058
CPFF
Funding is being added to CLIN 0058 in the amount of $999,999,999.99. The
total amount awarded to Janssen is $999,999,999.99. The total amount awarded
to ATI is $0.00 (broken out as $0.00 Cost and $0.00 Fixed Fee).
PURCHASE REQUEST NUMBER: 0011532810
ESTIMATED COST
FIXED FEE

$0.00
$0.00
$0.00

TOTAL EST COST + FEE
ACRN GT
CIN: GFEBS001153281000001$999,999,999.99

SUBCLIN 005803 is added as follows:
ITEM NO005803

SUPPLIES/SERVICESQUANTITYUNIT

AMOUNT$0.00

UNIT PRICE

Funding for CLIN 0058
CPFF
Funding is being added to CLIN 0058 in the amount of $1,650,000.01. The total
amount awarded to Janssen is $1,650,000.01. The total amount awarded to ATI
is $0.00 (broken out as $0.00 Cost and $0.00 Fixed Fee).
PURCHASE REQUEST NUMBER: 0011532810

$0.00
$0.00

ESTIMATED COST
FIXED FEE

$0.00

TOTAL EST COST + FEE
ACRN GU
CIN: GFEBS001153281000002$1,650,000.01

SECTION E - INSPECTION AND ACCEPTANCE
The following Acceptance/Inspection Schedule was added for SUBCLIN 005802:
INSPECT AT
INSPECT BY
ACCEPT AT
N/A
N/A
N/A

ACCEPT BY
N/AW15QKN-16-9-1002
P00081Page 89 of 89

The following Acceptance/Inspection Schedule was added for SUBCLIN 005803:
INSPECT AT
INSPECT BY
ACCEPT AT
N/A
N/A
N/A

ACCEPT BY
N/A

SECTION G - CONTRACT ADMINISTRATION DATA
Accounting and Appropriation
Summary for the Payment Office
As a result of this modification, the total funded amount for this document was increased by $1,001,650,000.00
from $6,328,970,669.79 to $7,330,620,669.79.
SUBCLIN 005802:
Funding on SUBCLIN 005802 is initiated as follows:
ACRN: GT
CIN: GFEBS001153281000001
Acctng Data: 0212020202120400000664643255

S.0074658.5.14

6100.9000021001

S.0074658.5.14.1

6100.9000021001

Increase: $999,999,999.99
Total: $999,999,999.99
Cost Code: A5XAHSUBCLIN 005803:
Funding on SUBCLIN 005803 is initiated as follows:
ACRN: GU
CIN: GFEB5001153281000002
Acctng Data: 0212020202120400000664643255
Increase: $1,650,000.01
Total: $1,650,000.01
Cost Code: A5XAH(End of Summary of Changes)