OTHER TRANSACTION FOR ADVANCED RESEARCH (OTAR)
Agreement No.: HHSO100201800012C
BETWEENJANSSEN RESEARCH & DEVELOPMENT, LLC
920 ROUTE 202
RARITAN, NJ 08869, USAANOTHE UNITED STATES OF AMERICA
DEPARTMENT OF HEALTH AND HUM AN SERVICES
BIOMEDICAL ADVANCED RESEARCH AND DEVELOPMENT AUTHORITYO'NEILL HOUSE OFFICE BUILDINGWASHINGTON, DC 20515
CONCERNING-·•• =•••==••>Modification No. 0004
Effective Date of Modification: Upon Last Signature in Section Il lr)(4)

Tota l Amount of the Agreement: is left unchanged at .__ _ _ _____.
Government Funding of t he Agreement: is left unchanged at l_b_)( _ _ _ _~1 41

Tota l Estimated Recipient Funding of the Agreement: is left unchanged atl_(b_)f4_>_ _ _~Funds Obligated: with the exercise of !fb)(4)lt he tota l Funds Obligated is increased byt blf4}
ltrom ~b)(4)lto....
l(b_)f4_>_ _ __,Period of Performance:• Period of Performance for added jfb)(4)~COVID-19 Antiviral Library screeningscope) - effective date of Modification through 31 July 2020.
Period of Performance for ~ J(4)~ May 1, 2020 through 31 March 31, 2021 .

.

l

Authority: Section 319L(c}(S) of the Public Health Service Act, 42 USC 247d -7e(c)(S).
Line of Accounting and Appropriation:
CUN

Title

Requisit ion (OS) I CAN

D1( 4-)(b'.)(4)I Obj.Class I ~ mt. (GovtI£hanged(b)C4}

COVID-19 Antiviral

Library screening scope:ri)(4)

l•u

Total

I.

AMENDMENT PURPOSE: The purpose of this modification is to accomplish the following:a. (b)(4)b.

In response to the current novel coronavirus ("COVID-19") outbreak, adds an additional
Asset ICbX4)ICOVID-19 Antiviral program) to perform compound library screening
to Identify and develop new biological and chemical entities with anti-coronavlrus effect,c.

incorporates a realigned Global Cost Share around jfb)( /4,

Antiviral program
asset. This structure aligns with decisions made at the joint BARDA Flu OTA, CBRNb){4)2

(TPOm) and Janssen JOC committee member meeting on February 3. 2020. The
redirected funding and associated tasks from the R0>I4J• •!O>)C4J!are subject to future government funding and JOC recommendations.
d.

updates the Statement of Work (Attachment 1) to adjust current ICl"i)(4} ~ ork scope tobetter align work packages to achieve program objectives while also supporting theredirection of funding in support of the COVI D-1 9 Antiviral activities being added to theagreement. This updated SOW also includes the COVID-19 Antiviral Program, work
packages, 10.1 and 10.2. These additional Antiviral Program work packages areconsidered added and funded non -severable 1ndependent work packages as of the dateof this amendment. For additional clarity, CLIN 0001~)(4)lw111 havecorresponding tasks performed under WP 10.1 High Throughput Screening (HTS) ofJanssen Libraries will be at anpiK4)
cost share and tasks performed
under (WBS 10.2) HTS of non-Janssen libraries will be at an ~b)(4}cost shareIe.

modifies the Project Organization and Management Str.ucture, Organization Chart to add
the respective COVID-19 Antiviral BARDA and Janssen Technical Representatives, andreflect other recent changes and additions; and,adds the essential consiqerations in paragraph 11.d below.

II.

AMENDMENT CHANGESa.

I

Article VI Cost Sharfng, paragraph C, Global Cost Share schedule Is deleted andreplaced With the following:

Remainer of page intentionally left blank3

Cost Share Estimates for the activities covered under the SOW for .__Kb_)C41_ _ _ _ _ _ _ _ _ ____.
blt4'1COVID-19 Antiviralprogram):(ll)(4)

Cost Estimates to Establish and Operate J,_b_)(4_} _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ ______.

Remainer of page intentionally left blankCost Share Estimates for the activities covered under the SOW for2019 AnOviral Activities)- (b)f4}r.·.

41_J( _ _ _ _ ____.lfcoV/D-b)(4}b.

Updated the Statement of Work
1. The Statement of Work shall be replaced to reflect adjustments to theKb)(4)
Iwork packages and update to include the new asset structure. The
updated SOW for incorporation in the OT A is included in Attachment , _c.

Article IV, Management of the Program, Organization Chart is deleted and replaced with
the Updated chart as shown below(b)!4)

dEssential Considerations - Due to the urgency presented by the current threat and to assure
Janssen is able to expeditiously and compliantly execute the SOW, BARDA/ASPR agree toexercise their statutory authority to the maximum extent practical to negotiate additionalterms and waivers of existing OTA terms, laws and regulations, as listed below or as may
arise during perlormance of this additional work, to enable Janssen, as a nontraditional5

government contractor, to execute performance consistent with 1ts commercial practices.
These provisions represent the underlying assumptions upon which the estimated cost andschedule have been developed.

1.

Adherence to commercial practices when engaging subcontractors , including
relief frorn flow down provisions that otherwise may apply..

2.

(b)(4}

3.
As it Is not known at this time what the final composition and manufacturing
technology of the therapeutic product shall be, any IP (patent or technical data) rights(including third party rights) that are needed to fully launch/deploy the final therapeutic
product may be subject to pre-existing or other obligations and as well as negotiation by
the appropriate parties at that time. The final negotiated rights shall, at a minimum, beconsistent with the USG's IP rights specified under Articles IX and X of the OTA.
4.
Due to the emerging nature of this threat, it is not possible to know the full extent
of the threat, its impact, or the necessary resources required to control the virus. To theextent other parties, such as other agencies, international organizations, governments orNGOs, seek Janssen's participation .in the effort to develop solutions to counter the threatof the coronavirus, BARDA will not place undue restrictions on Janssen's ability tocollaborate with these other parties, including receipt of funding, use of Janssen'stechnology, or any other support or collaboration that Janssen determines is needed.
BARDA's intellectual property rights will be consistent with the terms within Articles IX
and X of the OTA.
5.
Reporttng Requirements of the above referenced OTAs will include only thoserequirements necessary to maintain sufficient updating during this dramaUcallyaccelerated therapeutic development program.
6.
To expedite the negotiation of 3rd party agreements and cons·i stent with
BARDA's flexibilities, the Government's right to audit financial records be limited to therecords of those Parties that are relevant for performance of this Agreement for a period
not to exceed three years after the expiration of the term of this Agreement.

Remainer of page intentionally left blank

6Ill.

SIGNATURES

Acknowledged, accepted, and agreed for
JANSSEN RFsEARCH & DEVELOPME:nT, LLC

U.S. DE.PARl'MENT OF llEALm & HUMAN
SElMCES

Omce oF THE AssISTANT SECRETARY FORb)(6)

P!w>AREDNESS & R.i:5PONSE
BIOMEDICAL ADVANCED REsEARCH &,DEVBLOPMENT AUTHOIUTYITS: OrnF.R. TRANSACTION AGREEMENT OFFICER
DATE:7I'iI2JJ:;.

2,L)

ATTACHMENT 1: STATEMENT OF WORK (SOW)STATEMENT OF WORK- PREAMBLE
Independently, and not as an agent of the government, the recipient shall furnish all necessary services;qualified professional, technical, and administrative personnel; and material, equipment, and facilities nototherwise provided by the government under the terms of this Agreement as heeded to perform the tasks
set forth below, The government reserves t he right to modify the budget, progress, schedule, or milestones
to add or delete processes, schedules, or deliverables if the need arises. Because of the nature of thisresearch and development (R&D) agreement and the complexities inherent i n this and prior programs, atdesigriated milestones the government will evaluate whether work should be redirected or removed, orwhether schedule or budget adjustments should be made, The government will collaborate with therecipient to arrive at mutually agreeable potential future decisions to change the product, process,schedule, or events to add or delete part or all of these elements as the need arises.
(b)(4)e po en 1a programs pa arms or ec no ogyerw1se suppo
1s
OTA have novel modes of action with the potential to address areas of high unmet medical need forbiodefense in the areas of treatment, detection and response.
The Recipient may propose to augment the portfolio by replacing molecules or devices listed in this SOW
with backup molecules or devices from their ongoing research programs. With support from the JOC, theConsortium may also consider In-licensing or other approaches to access, promote, support and/or develop
drugs, devices, or vaccine candidates to supplement the Program's portfolio of medical countermeasuresin the Field. Recipient may also add Consortium Members as may be appropriate or complimentary to theperformance and goals of this Agreement.

1

Objectives for Agreement Lead Asset - l(b)(41{b}(4)other Potential Assets for Agreement

Other potential Assets may Include but are not limited to the following;,2

(l,11r

Dellve,al,J~~i;t,11,1 ,204
ltllllek:1 pursuant to exemption1>)(4)Of the Freedom of Information Act

205
ltlllleld pursuanl to exemptionb)(4)or the Freedom of Information Act

~'(ll_)f4_>_ _~~ Corona Virus ("COVID-19") (WBS -Task 10)
The goal of this Task is to develop a therapy for the treatment of patients ihfected with CoV infection.
Therefore, High Throughput Screening (HTS) of drug libraries will be performed. These libraries containapprovedkb>{4), ,This task was added to this OTA in 1Q20 and resides in fbJ(4)!for the l(b)(.f)~b)(4)

lis being redirected to this Task subject to future government funding and JOC!(1)){4)recommendations.

High Throughput Screening (HTS) of Janssen drug libraries (WBS 10.1)
An HTS CoV assay will be implemented to assess the antiviral activities of libraries of compounds againstcovlO>)f4>Kb){4)~x~,,,...,.,..,.,....-,,----------~I This screening as-say will be performed at the BSL-3 lab of t ~~--P){4}!Rega Inst itute, University of Leuven).

----

ed with a Box-in-a-lab HTS latform enablin the screen in of hi hi

Deliverable: Report summarizing the results of the HTS activities
High Throughput Screening (HTS) of non-Janssen drug libraries (WBS 10.2)

6

An HTS CoV assay may be> implemented to assess tbe antjvjral actjvjtjes of agajnst non-Janssen libraries ofcompounds against cov.lCb)(4}}(4)""'l(b"")(...
4)....__ _ _ _ _..,.-..,.--:...,.-:----_-_-_-_-_-_-_-..,------------'trhis screening assay w ill be performedat the BSL-3 lab of ...
~-'K_4}_ _ _ ___,1Kega Institute, University of Leuven).
Deliverable: Report summarizing the results of the HTS actfvlties

OTA Review Meetings

Participate in regular meetings to coordinate and oversee the effort. Such meetings may include, but
are n.ot limited to, meeting to discuss manufacturing progress, assay development, preclinical/clinicalstudies and regulatory progress.
•Participate in teleconferences every two weeks to review technical progress. Teleconferences oradditional face-to-face meetings shall be more frequent at the request of BARDA.

(b)(4)

M onthly and Annual Reports

Deliver Project Status Reports on a monthly basis. The reports shall address the items below crossreferenced to the WBS, SOW and IMS:
Executive summary highllghtfng the progress, issues, and relevant activities In manufacturing, nonclinical,clinical, and regulatory;
Progress in meeting OTA milestones, detailing the planned progress and actual progress during thereporting period, explaining any differences between the two and corrective steps;

7l.))f4J

Data Management

Develop and implement data management and quality control systems/procedures, Including transmission,storage, confidentiality, and retrieval of all OTA data.
(b)(4)EARLV-MID•STAGE ACTIVITIES(b}t4}g.

MID-STAGE ACTIVITIES

9210
ltllllek:1 pursuant to exemption1>)(4)Of the Freedom of Information Act211

kl pursua111 to exemptionb)(4)or the Freedom of Information Act

212
ltlllleld pursuant to exemption1>)(4)Of the Freedom of Information Act

213
ltllllekl pursuant to exemption1>)(4)Of the Freedom of Information Act

214

itnl'lek:1 pursuant to exemption1>)(4)or the Freedom of Information Act

215
llllllekl pursuant to exemption1>)(4)or the Freedom of Information Act

216
ltllllekl pursuant to exemption1>)(4)or the Freedom of Information Act•(1!1(4)BARDA POCs for reporting/status updates etc.

17218ltlllleld pursuant to exemption1>)(4)or the Freedom of Information Act

219

Nltlllleld pursuant to exemption1>)(4)of the Freedom of Information Act

220
ltlllleld pursuant to exemptionb)(4)of the Freedom oflnformatlonAct

:IJ)(4)TasK 10.1
Task 10.2

High througt:iput screening ot Janssen
libraries for Coron-a Virus activity

I High throughput screening of non-Janssen
libraries for Corona Virus activities.

Reportsummari·zing the outcome ot t he Hign'Throughput Screening activitiesi

Report summarizing the outcome of the HighThroughput Screening activities

21

:1>H<tl

CLIN High Throughput Modification
0001 A Screening (HTS} startof Janssen
Librar.ies (WBS

Report summariz.ing theoutcome of\he HighThroughput Screen1ng
actiVlt les• If Hits are identified this wlll be
reviewed by the JOC for adecision on further act ivities

New CUN withscope estimatedcosts to be22

bl(t>I

1:iu. 1.1 ar,a non-aertnellJ -ana

Janssen libraries{WBS 10.2 )negotiatedI{b)~)'

23

224
ltlllleld pursuant to exemption1>)(4)or the Freedom of Information Act

225
lllllleld pursuant to exemptionb)(4)of the Freedom oflnformatlonAct

226
ltllllekl pursuanl to exemptionb)(4)

Of the Freedom of Information Act

221ltllllek:1 pursuant to exemption1>)(4)of the Freedom of Information Act

228
ltlllleld pursuant to exemption1>)(4)or the Freedom of Information Act

m.Vltlllleld pursuant to exemption1>)(4)or the Freedom of Information Act