JANSSEN RESEARCH & DEVELOPMENT, LLC

Other Transaction Agreement No. HHSO100201700018C
Amendment No, 0008

*The information provided herein is considered JRD, LLC trade secrets, commercial or financial information that JRD,
LLC customarily holds close and treats as confidential. The information is being provided under the assurance that the
U.S. Department of Health and Human Services and all of its agencies, including the Assistant Secretary for
Preparedness and Response, Biomedical Advanced Research and Development Authority, will 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
provided herein is exempt from disclosure under Exemption 4 of the Freedom of Information Act (''FOIA ").

AMENDMENT OF OTHER TRANSACTION AGREEMENT {OTA)OTHER TRANSACTION FOR ADVANCED RESEARCH (OTAR)
Agreement Number HHSO100201700018C
Effective Date of Agreement: August 15, 2017
BETWEENJANSSEN RESEARCH & DEVELOPMENT LLC

920 ROUTE 202
RARITAN, NJ 08869, USAAND
THE UNITED STATES OF AMERICA
DEPARTMENT OF HEALTH AND HUMAN SERVICES
BIOMEDICAL ADVANCED RESEARCH AND DEVELOPMENT AUTHORITYO'NEILL HOUSE OFFICE BUILDINGWASHINGTON, DC 20515
CONCERNINGINFLUENZA PORTFOLIO AND OTHER EMERGING PATHOGENS DEVELOPMENT CANDIDATES
Amendment No. 0008

Effective Date of Modification: Upon Last Signature in Section Ill
Total Amount of the Agreement is increased by ~b){4)~or addition COVID l(b1<4)
eii1,4\
1ost share adjustment from $715,837,436.~t-o- - ~!lb)f4},Nr1cludes Recipient and Government Funding).
Government Share of Total Amount of the Agreement is increased by ~~b_)(4_J_ _ _-l from
1(9)(4}~o !(b)(4}I
Recipient Share of Total Amount of the Agreement is increased by""'!lb=l(.....
4)_ _ __.lfor scope
increase and fb)(4)fOSt share adjustment frortj(b)(4}~oKii>£4J

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Other Transaction Agreement No. HHSO100201700018C
Amendmen t No, 0008

Current Government commitment: with the scope/cost estimate adjustment to Work Packages("WP") 6.1- 6.7 and the addition and authorization of WPs 6.8-6.10 and 6.13- 6.16, the total
Funds Obligated is increased by $456,237,081 from $233,288,786 to $689,525,867.
Current Recipient commitment: with the scope/cost estimate adjustment to WPs 6.1- 6.7, theaddition and authorization of WPs 6.8 - 6.10 and 6.13 - 6.16 of l(b)f4}
land the ._l
<b_
)f4_
>_~
4
fbl( }~he total Recipient Funds Obligated is increased by~bX4)
fromf1<4)~o l<b)(4)I

I

Authority: Section 319L{C)(5) of the Public Health Service Act, 42 USC 247d-7e(C)(5) .
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I.

Other Transaction Agreement No. HHSO100201700018C
Amendment No, 0008

AMENDMENT PURPOSE
This Amendment seeks to utilize Recipient's expertise to perform research and development for
vaccine and therapeutic candidates for the current COVID-19 pandemic and declared publichealth emergency.
By the Parties' mutual agreement and within the existing Agreement's general scope, thisAmendment No. 0008 bilaterally:i.

replenishes funding=1('""4l' - - - - - - - - - - - - - - - - - - - - - - - - ' t o
the COVID-19 vaccine efforts added to Amendment 0006;

ii.

incorporates the scope of work previously added via Amendment 0006 for Pre-clinicalthru Clinical Phase 1 Study, WPs 6.1- 6.7, which will be removed from Amendment 0006
and will be added to this Amendment 0008;

iii.

adjusted Work Packages 6.1- 6.7 to reflect tln updated scope and budget;iv.

exercises Work Package 6.7;v.

adds Work Packages 6.8 - 6.16;
updates the Statement of Work (Exhibit-A) to reflect COVID-19 Vaccine, Work Packages(WP) 6.1 - 6.16. The COVID-19 Vaccine Work Packages 6.1- 6.10 and 6.13 - 6.16 as
described in the Exhibit-A, Statement of Work are considered added and funded nonseverable independent work packages as of the date of this amendment; Work Packages
6.11 (Pediatric Study) and 6.12 (High-risk Populations are identified as Options to be
exercised at a future date based on (i) JOC recommendation, (ii) availability of fundingand (iii) a signed amendment between the Parties.

vii.

updates the Essential Considerations in paragraph lf.C. below;

viii.

Article IV: Management of the Project, Section A (3) Organizational Chart, is updated toinclude the respective Technical Leads for the COVID-19 program;ix.

Within Agreement Number HHS0100201700018C, Article XVI : Special Clauses theSection R, Public Readiness and Emergency Preparedness Act ("PREP ACT") Coverage, isadded.

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Other Transaction Agreement No. HHSO100201700018C
Amendment No, 0008

AMENDMENTS TO AGREEM ENT

II.

A. Incorporate new Cost Shar.e Estimates/Budget Summary and Budget Allocation/Workplan
Structure (Exhibit B) to reflect the COVID-19 Vaccine estimated costs and cost shares.
1) Pursuant to Agreement Article Vl(C), the budget allocation summary of assets is hereby
replaced to incorporate the following.
(b)(4)

2) Budget Allocation/Workplan Structure (also included as Exhibit B) reflects the budget allocation
summary and provides details for the budget incorporated in this Amendment 0008. This updated
Exhibit B reflects the adjusted WPs 6.1- 6.7 cost estimates, adds the new WPs (6.8 - 6.16) andreplenishes funding _Cb~)M-1_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ __lfb)(4}I

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other Transaction Agreement No. HHSO100201700018t
Amendment No, 0008

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Other Transaction Agreement No. HHSO100201700018C
Amendment No. 0008

B.

Updated the Statement of Work - The Statement of Work shall be replaced to reflect the
new COVID-19 Vaccine, Work Packages (WP) 6.1 - 6.16. The updated SOW for
incorporation in the OTA is included in Exhibit A.

C.

Essential Considerations as added via Amendment 0006 and amended herein and madeapplicable to Amendments 0007 (COVID-19 Antiviral) and 0008 (COVID-19 Vaccines):
By the Parties' mutual agreement and within the existing Agreement's genera l scope, thisAmendment No. 0008 bilaterally acknowledges the Parties' agreement that:i.

Recipient will adhere to commercial practices when engaging subcontract ors,
including, if necessary, relief from OTA flow down provisions that otherwise may
apply;

ii.

Recipient will use reasonable efforts to include rights for BARDA consistent with its IP
rights specified under Articles IX and X of the OTA in negotiations with third parties
controlling such IP rights. In the circumstance that 1) a sub-contractor is not willing toagree to the flow-down terms regarding IP and data rights in Articles IX and X of the
Flu OTA, and 2} the sub-contractor's proposed terms are materially less than thescope of the flow-down IP and data rights in Articles IX and X of the Flu OTA, then
Recipient will confer with BARDA (OTAO, OTTR, and Respective Asset Lead} in writing(email is acceptable) to gain alignment on the sub-contractor IP and data rights that
BARDA believes are necessary in the specific instance. Such alignment on BARDA'sconcerns with Recipient's sub-contractor's IP and data rights shall be provided withina reasonable timeframe based upon the urgency of the situation at that time. Ifalignment on sub-contractor IP and data rights reaches an impasse and BARDA isunable to accept any lesser rights than those for which it is entitled to under the Flu
OTA, Recipient and BARDA agree that no government funds shall be used for the
impacted scope of work, however, Recipient may proceed at its own cost. Such
activities conducted at Recipient's own cost are not subject to the terms andconditions of this OTA; however, any impacted deliverables will be aligned to ensure
program continuity;iii.

BARDA shall not restrict Recipient's engagement or collaboration with other parties,
such as other agencies, international organizations, governments or NGOs, seeking
Recipient's participation in the effort to develop solutions to counter the threat of
the coronavirus, including receipt of funding (to the extent that Recipient is notreceiving funding from multiple sources for the exact same work it is performing here
under), use of Recipient's technology, or any other support or collaboration that
Recipient determines is needed; andiv.

Reporting Requirements of the above referenced OTAs will include only thoserequirements necessary to maintain sufficient updating during these dramaticallyaccelerated development programs.

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other Transaction Agreement No. HHSO100201700018C
Amendment No, 0008

Tl-IE REMAINDER OF THIS PAGE INTENTIONALLY LEFT BLANK

D. Article IV: Management of the Project Section A (3) Organizational Chart is deleted andreplaced with the following;(b)(4)

E, Article Xlll: Subcontracting is amended to add a supplemental section for COVID-19
initiatives;b.)(4)THE REMAINDER OF nus PAGE INTENTIONALLY LEFT BLANK*Privileged & Confidential i n Accordance with Notice on CoverJANSSEN RESJ:ARCH & DEVELOPMENT, LLC

Other Transaction Agreement No. HHSO100201700018C
Amendment No, 0008

F.

Article XVI: Special Clauses t he following clauses are added:.
L

Section R, Public Readiness and Emergency Preparedness Act ("PREP ACT") Coverage, isadded:

R. Public Readiness and Emergency Preparedness Act ("PREP ACT") Coverage
The Federal Government may not use, or authorize the use of, any products or materials
provided under either this agreement or any future purchase from Recipient's domestic
manufacturing capacity unless such use occurs in the United States and is protected fromliability under a declaration issued under the Public Readiness and Emergency
Preparedness Act, 42 U.S.C. § 247d-6d.
Except as provided in this Amendment, all terms and conditions of the Agreement, unless previously
changed, remain unchanged and in full force and effect.

Ill.

SIGNATURES

Acknowledged, accepted, and agreed for

Janssen Research & Development. LLCb)161

U.S. Department of Health & Human Services
Office of the Assistant Secretary for
Preparedness & Response
Biomedical Advanced Research &Development Authority

James Harris -5

Olglt,11y,1g11e<JbyJainesH1>trls s

BY: _ _ _ _ _ _ _ _o_,t•_:i_oi_.o.0_3._11_,fi_,,1_,10_--0_, ·no_·_
NAME: James Harris
ITS: Other Transaction Agreement Officer
DATE:*Privileged & Confidential in Accordance with Notice on CoverJANSSEN RESEARCH & DEVELOPMENT, LLC

OtherTransaction Agreement No, HHSO100201700018C
Amendment No. 0008

*The information provided herein is considered JRD, LLC trade secrets, commercial or financial information that JRD,
LLC customarily holds close and treats as confidential. The information is being provided under the assurance that the
U.S. Department of Health and Human Services and all of its agencies, including the Assistant Secretary for
Preparedness and Response, Biomedical Advanced Research and Development Authority~ will maintain theconfidentiality of the informatton 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
provided herein is exempt from disclosure under Exemption 4 of the Freedom of Information Act (''FOIA ").

ATTACHMENT 1: TASK DESCRIPTION DOCUMENT (SOW)Overall Objectives and Scope
Seasonal and pandemic influenza remains one of the most important public health threats despite
current vaccine and therapeutic options. The Consortium is de.v eloping a broad portfolio of
innovative and novel countermeasures against influenza and other emerging infectious diseases
comprising small molecules, biologics and vaccines. The portfolio employsl(bJ<4) !nodes of action
complementary to current Standard of Care treatments to develop single or combination therapies
that have the potential to increase therapeutic benefit and preclude the rapid emergence of drug
resistance. TheKblM)
laims to @)C4}~ the influenza vaccine field by providing
broad protection for both seasonal and pandemic influenza.
Specifically; t his Agreement includes: an influenza ._l(b_){_4)_ ___.l that is now ready for ....
ffi...
lia.
___l _ ___.
..._Vh.....
v""'
in...._'--,------1/ a b I )influenza A or B viruses; (11)(4-)(b)(4)In addition, Recipient may propose to augment the portfolio by replacing molecules listed in thisSOW with backup molecules from their ongoing research programs. With support from the JOC,
the Consortium may also consider in-licensing drug or vaccine candidates to supplement theProgram's portfolio of emerging infectious disease medical countermeasures in the Field. Recipient
may also add Consortium Members as may be appropriate or complimentary to the performanceand goals of this Agreement.

1* Privileged & Confidential i n Accordance with Notice on CoverJANSSEN RESEARCH & DEVELOPMENT, LLC

OtherTransac;tion Agreement No, HHSO100201700018C
Amendment No. 0008

b)(4)

2

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Other Transaction Agreement No. HHSO100201700018C.Amendment No. 0008

bJ(4)

6

Novel Coronavirus ("2019-nCoV") Vaccine

6.1 Antigen design, manufacturability testing and preMVS manufacturing
Activities

•

•

14
DNA encoding for several designs of the SARS-CoV~2 spike protein will be~lfb_l _) -~lat
multiple CROs
Research batches of Ad26~""
vectors
with p i)[-t)(b.,..,,)(4,.,...
) _ _ ___.__...,..__ _ _ _ _ _ _ _ _ _ _ _ ___,l(bl(•O(b)f4lI of the spike proteiI• (b)(4)s:

3*Privileged & Confidential ln Accordance with Notice on CoverJANSSEN RESEARCH & DEVELOPMENT, LLC•

Other Transaction Agreement No. HHSO100201700018C,Amendment No. 0008

Several critical reagents such as expression plasm ids, soluble proteins, peptide pools
and detection antibodies will be generated or ordered

WP6.2 Pre-Clinical Immunology (Performed at Janssen

orf. .b_.ll

4_) _ __.

Activities(b)l4}

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OtherTransaction Agreement No. HHSO100201700018C.Amendment No. 0008

lb)(4)

WP6.3 CMC Development until First in Human ("FLH")b)<41

WP6.4 Clinical Development and Regulatory Activities to Start First In Human Study

Activities•

Setup of immunological assays at CROs or at Janssen:

I[(b)J~)•

Writing of protocol elements document (PED)•

Protocol writing•

Writing and submission of prelND document•

Writing and submission of IND documents•

Contracting with vendors
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Other Transaction Agreement No. HHSO100201700018C,Amendment No. 0008

WP6.S GLP Toxicology
Activities(b)(4)•

WP6.6 GMP Manufacturing to Enable CUnical Trials

Activities until First in Human ("FIH")• Master Virus Seed manufacturing and release6*Privileged & Confidential in Accordance with Notice on CoverJANSSEN RESEARCH & DEVELOPMENT, LLC

Other Transaction Agreement No. HHSO100201700018C,Amendment No. 0008b)(4)WP6.7 Phase 1/2a Clinical Trial

Activities•

i. . .

__.I double bl1nd study in healthy adu lt

Randomized, placebo-cont rolled, lb_H4_) _ _ _volunt eers 18-55yrs, 65 and older.

7*Privileged & Confidential In Accordance with Notice on CoverJANSSEN RESEARCH & DEVELOPMENT, LLC

OtherTransaction Agreement No. HHSO100201700018C
Amendment No. 0008•

Primary objective w ill be assessment of safety and reactogenicity. Secondary andexploratory endpoints will evaluate vaccine-induced immune responses to SARS-CoV-2.

•

b)(4)

•
• r b)(4}

I18-55 yr old, l(bXlf.J!b)(4)(b1{4)lfb)(4)I

I 18-55' vr lfb){4>II.
l(b)t4-)in 65 or older:Il(ll)f4l(b)(4)~ged 18-55 adults pi>(4)[b)(4)(b)(4)DE

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OtherTransaction Agreement No. HHSO100201700018C,Amendment No. 0008

WP6.8 CMC Development and GMP Manufacturing Process to Enable Large Scale
Manufacturing and Launch to Support the Regulatory filing

Activities;lb) 4)

•

:r.,
•

•

Studies to enable launch and support licensure will be assessed and executed as
appropriate.
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Other Transaction Agreement No. HHSO100201700018C
Amendment No. 0008b)f4}

WP6.9 Toxicology Studies
A Phase 1 enabling GLP toxicology study is described under WP6.5. l(b)(4}[b)(4lActivities•

Conduct developmental and reproductive toxicit't' (DART) study(b)f4}

WPG.10 Phase 3 Study Adurts

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OtherTransaction Agreement No, HHSO100201700018C.Amendment No. 0008

A variety of factors including manufacturing and CMC considerations, precl inical data 1 the stateof the COVID-19 pandemic and primarily the safety and the immunogenicity of the vaccine asdemonstrated inl(b)f<l)
lw ill be considered before proceeding to4__,Phas~ 3 studies. ,.__b){ )___________________________b)(4)The Phase .3 pivotal efficacy studyl!blf4)
adults l(bJ(4>l will be a randomized placebo-controlled study in(b)(,t.)b)t4)International agencies are contemplating comparative t rials between vaccine candidates and thisw ill be considered at the time of proceeding to Phase 3.
OPTION - WP6.11 Pediatric Study

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OtherTransaction Agreement No, HHSO100201700018C
Amendm ent No. 0008

Clinical studies with immunologic endpoints will be performed in children P1)(-4-)
Sample size will be calculated ~b)(4)I

I(b)(4)OPTION - WP6.12 High-risk Populations

WP6.13 Other Clinical Studies
Phase 3 Consistency Lot Study

A Phase 3 consistency lot trial comparing ~ consecutive manufactured lots of the vaccine plus
potentially a lot used in the Phase 3 efficacy trial (if consistency lot material is not utilized in theefficacy trial) will be performed. The objective of the study is to demonstrate that the immune
responses to the (b){4)
ots are non-inferior to each other based on a mar in acce table4
to regulatory agencies. _(b_)r_)_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ ___,

Phase 3 End Expiry Study

A Phase 3 end expiry study will be performed to determine that the v accine at the end of the
shelf life is still immunogenic at -a level that it elicits immune res onses that are ex ected to beprotective. b)f4)
ICbX4>IThe vaccine will then be tested at a dose.that is consistent With thismodel for the end of shelf life, taking assay variation and stability into account. f._b_)(4_>_~____,

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Other Transaction Agreement No. HHSO100201700018C.Amendment No. 0008[b)[41

Phase 3 Concomitant Use Trial

Phase 3 concomitant use trials may be performed. P,)r4~
IOJ(4)

WP6.14 Regulatory Support

Activities to est ablish an IND for an Ad26-based COVID-19 vaccine will involve an arrangement ofa pre-IND meeting with CSER before the intended IND submission f ti)(4)(b)t4)The pre-IND and lND preparation to enable Phase 1 will be le~ by RA. Further regulatory activities
beyond Phase I are interactions w ith FDA to support the development of the vaccine up to
regulatory submission {to be discussed: pre-EUA and/or SLA submission, or other pathways as
per Agency's guidance). This involves an end-of-Phase 2 meeting and a pre-BLA meeting. Type C.meetings Will be scheduled on an as-needed basis. Pediatric requirements will be discussed asper Agency's requirements.
Annual reports will be prepared and submitted to CSER according to the foreseen timelines after
the IND comes into effect. Development of regulatory intelligence with respect to development
and licensing of a COVID-19 vaccine will carefully be monitored,
13*Privileged & Confidential in Accordance with Notice on CoverIJANSSEN RESEARCH & DEVELOPMENT, LLC

OtherTransaction Agreement No, HHSO100201700018C
Amendment No. 0008

Discussions with other regulatory Agencies as required by the program and in particular to allow
for a harmonized approach from a CMC, non-clinical and clinical development perspective, andfacilitate multi-country trials as required per discussion with the Agencies, may also have to be
conducted and will then be covered under WP6.14.
WPG.15 Project Management Support

This WP includes the Program Management activities associated With de.v elopment of an Ad26based COVID-19 vaccine. The program wi ll have an ._.llh.,.it,..
11,1~ - . . . , . _ ~ ~ -.....
0 ,_......~-~-"0-T-~__,~ who will oversee their specific@JC4)

requirements. This includes conducting,I meetings to ensure the accurate

frequent and regular l!b)(4~developing and tracking of the budget, timeline and resource
plan. The fb}(4)I..;...;,.,.;::.._:____....::....!::=:::::::;----;:;:::::;::;::;:;::==;--'
4
4
team of each asset will also include relevant functional llb)( )and a i(bJ( )4i(b1(4)
The Program will also have an .fb.__
Jc _l _ _ _ _ _ _ _ __,l who will oversee

I

I

I

-----~

their specific Technical requirements. This includes conducting frequent and regular b\!4)!(b)(4}!meetings to define the overal l development strategy. Th b)(4) of each
asset will include, but is not limited to, the Technical Lead, Preclinical Leader, Clinical Leader, the
CMC Leader and, the Regulatory Leader. Clin ical Team and Trial teams will oversee clinicalprogram qnd trial execution. These teams include operational staff, Operational Leader sandrepresentatives of operational departments such as data management; GCO; medical writing,programming, stats. Additional expertise required for executing asset-specific work possibly
including subcontractors may be added as part ot !£b)f4) 1and~WPG.16 Dissecting the Evolution of SARS-CoV-2 and Specific Humeral and Cellular Immunity
Following Infection

Activities• The understanding of the roles thatj(b)(4)
I responses to SARS-CoV-2 arethought to play in protection, disease resolution, or enhancement of disease are evolving
with the assessment of patients with varying disease outcomes. -1Cb_)C4_)_ _ _ _ _~•Identification of antigen-specific biomarkers of disease trajectory (surviva l, disease,
death) and SARS-CoV-2 s ecific immune responses a ainst the virus b'l_b)_C4_
} -----~
approaches b)i 4)
using samples frompreviously and prospectively collected, longitudinal cohorts at thelfb){4)

I

14*Privileged & Confidential in Accordance with Notice on CoverfJ<4>,___________.

23
ltllheld pursuant to exemption1>)(4)of the Freedom oflnformatlonAct

24

ittmekl pursualll to exemptionb)(4)of the Freedom oflnformatlonAct

JANSSEN RESEARCH & DEVELOPMENT, LLC

Other Transaction Agreement No. HHSO100201700018C,Amendment No. 0008

b)(4)

8

Project Managementrw
8.1

Joint Oversight Committee

The Joint Oversight Committee (JOC) is the larger decision-making body that provides
guidance, direction and control to the projects to ensure execution of the projects
according to the SOW. The Joe will discuss and approve any changes to the SOW. To that
extent, the JOC will meet at critical decision points In the program, but no less than twotimes per year, preferably face to face or alternatively by Web Ex or telephone conference.
Ad hoc meetings will be organized when urgent matters arise. The JOC will consist of voting
and non-voting members from BARDA and Janssen. Additional, non-voting members can be
assigned or invited on an ad hoc basis. Decisions to reprioritize specific projects andresources as the need arises will be taken by consensus. In case such a decision cannot be

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OtherTransaction Agreement No. HHSO100201700018C
Amendment No. 0008

reached in the JOC, the decision will be escalated to one BARDA and one Janssen senior
management member identified at the start of the project.
8.2

PMO Steering Committee

The PMO (Program Management Organization) steering committee has dual
responsibilities. One area of responsibility is the communication and coordination with
BARDA regarding day to day management and execution of the project e.g. organizing
meetings on a regular agreed basis. In addition, the PMO Steering Committee will
coordinate all SOW activities and provide the technical and administrative infrastructure toensure efficient planning, initiation, implementation, direction, management andcompletion of all tasks. This will be coordinated by the Project Manager Leader (PML). The
Steering Committee will assess prngress and where needed will work out strategic changes
to be decided upon by the JOC. The Steering Committee consists of a group of dedicatedand specialized Project Management experts, key personnel and additional specificexpertise for the functions that are required for executing the specific work scope for each
proposed asset area.
8.3

Asset Project Management (WP 2.5, WP 5.5, WP 6.15, WP 7.6.1, and 7.6.2)

These WPs include the Program Mana ement activities associated with each of theassets. Each asset will have an b)(4}w ho will4
oversee t heir specific P(IJ)( )equirements. This includes conducting
frequent and regular !Cb)14)
meetings to ensure the accurate
developing and tracking of the budget, timeline and resource plan. Thepi- J_<4~) - ~11;;,
4 \....
(!i)r4}
team of each asset will also include relevant functional .,..1,h...,,,.............................
....,.,.,........,I
6,__
4
and a(b)< >ach asset will also have an ._J(b_JC_4>_ _ _ _ _ __.!who willoversee t heir specific Technical requirements. This includes conducting frequent andregulad(b)(4},
meetings to define the overall
development strategy. The ~fb)(4) bf each asset will include Technical Lead, Preclinica I
Leader, Clinicar Leader, the CMC Leader and, the Regulatory Leader. Additional expertise
required for executing asset-specific work possibly including subcontractors may be
added as part of Et3nd ~I

18*Prlvileged & Confidential in Accordance with Notice on CoverThe information provided herein is considered JRD, LLC trade secrets; commercial o r financial information that JRD, LLC customarily holds close and treats as confidential. The
information is being provided under the assurance that the U.S. Department of Health and Human Services and all of its agencies, including the Assistant Secretary for
Preparedness and Response, Biomedical Advanced Research and Development Authority, will maintain the confidentiality of the information under the Trade Se crets Act,
Procurement Integrity Act other applicable statutes, regulations, rules, case law contractual provisions, protect ive orders or otherwise ond as such, the fnformation pro vided
herein Is exemot from disclosure under Exemotlon 4 of the Freedom of Information Act ("FOIA"J.
!b)(4)

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The information provided herein is considered JRD, LLC trade secrets; commercial o r financial information that JRD, LLC customarily holds close and treats as confidential. The
information is being provided under the assurance that the U.S. Department of Health and Human Services and all of its agencies, including the Assistant Secretary for
Preparedness and Response, Biomedical Advanced Research and Development Authority, will maintain the confidentiality of the information under the Trade Se crets Act,
Procurement IntegrityAc:(, other applic:able statutes, regulations, rules, case law contractual provisions, protective orders or otherwise and as such, the Tnformation provided
herein Is exempt from disclosure under Exemption 4 of the Freedom of Information Act ("FOIA").
(b)(4)

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The information provided herein is considered JRD, LLC trade secrets; commercial or financial information that JRD, LLC customarily holds close and treats as confidential. The
information is being provided under the assurance that the U.S. Department of Health and Human Services and all of its agencies, including the Assistant Secretary for
Preparedness and Response, Biomedical Advanced Research and Development Authority, will maintain the confidentiality 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 provided
herein /s exempt from disclosure under Exemption 4 of the Freedom of Information Act ("FOIA").
!b)(4)

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