OTHER TRANSACTION FOR ADVANCED RESEARCH (OTAR)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 DEVHOPMENT AUTHORITY
O' NEILL HOUSE OFFICE BUILDINGWASHINGTON, DC 20515

CONCERNING

1Agreement No.: HHSO100201800012C
Total Amount of the Agreement: S....
fb_)(4_>_ _ _ ____Jkb)(4)

Total Estimated Government Funding of the Agreement: SL...._______.
Total Estimated Recipient Funding of the Agreement: S....
~b-)(4_) _ _ _~Funds Obligated: Sl._<b_><4_>_ _ _~Effective Date of Agreement: September 21, 2018
Period of Performance: September 21, 2018 - December 31, 2024r~~•

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

of Accounting and Appropriation:

This Agreement is entered into between the United States of America, hereinafter called theGovernment, represented by the Department of Health and Human Services (HHS) and the
JANSSEN RESEARCH & DEVELOPMENT, LLC, hereinafter called the Recipient, pursuant to andunder U.S. Federal law.

FOR JANSSEN RESEARCH & DEVELOPMENT, LLC

FOR THE UNITED STATES OF AMERICA
BIOMEDICAL ADVANCED RESEARCHDEVELOPMENT AUTHORITY,CONTRACTS MANAGEMENT AND
ACQUISITION, ASSISTANT SECRETARY FOR
PREPAREDNESS AND RESPONSE(b)(6)

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Table of Contents

ARTICLE I:SCOPE OF THE AGREEMENT ............................................................................................................ 4

ARTICLE II:

TERM ................................................................................................................................................ 9

ARTICLE Ill:

AMENDMENTS ............................................................................................................................... 10

ARTICLE IV:

MANAGEMENT OF THE PROGRAM ................................................................................................ 11

ARTICLE V:

AGREEMENT ADMINISTRATION ..................................................................................................... 15

ARTICLE VI:

COST SHARING ............................................................................................................................... 16

ARTICLE VII:OBLIGATION AND PAYMENT ......................................................................................................... 18

ARTICLE VIII:DISPUTES ........................................................................................................................................21

ARTICLE IX:

PATENT RIGHTS .............................................................................................................................. 22

ARTICLE X:DATA RIGHTS ................................................................................................................................. 27

ARTICLE XI:FOREIGN ACCESS TO TECHNOLOGY ............................................................................................... 28

ARTICLE XII :TITLE TO AND DISPOSITION OF PROPERTY .................................................................................... 29

ARTICLE XIII:

SUB-RECIPIENT ............................................................................................................................... 30

ARTICLE XIV:CIVIL RIGHTS ACT ........................................................................................................................... 30

ARTICLE XV:EXECUTION ..................................................................................................................................... 30

ARTICLE XVI:SPECIAL CLAUSES ........................................................................................................................... 31

ARTICLE XVII:TRANSFERS & ASSIGNMENTS ........................................................................................................ 38

ARTICLE XVIII:CONFIDENTIALITY .......................................................................................................................... 38

ATTACHMENT 1 b)(4)40

ATTACHMENT 2: REPORT REQUIREMENTS.............................................................................................................. 62
ATTACHMENT 3: b)(4). 67

ATTACHMENT 4 :.69

ATTACHMENT 5:109

ATTACHMENT 6:

115

Cl

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ARTICLE I:A.

SCOPE OF THE AGREEMENT

Background

Chemical, Biological' Radiological and Nu-clear (CBRN) threats remain important public healthconcerns. BARDNs mission is to develop and procure needed medical countermeasures against
a broad array of public health threats, whether natural or intentional in origin. The CBRN
program within BARDA spans a number of threats and focus areas such as Anthrax, Smallpox,
Botulinum Toxin, Ebola, Broad Spectrum Antimicrobials, Chemical Medical Countermeasures,
Thermal Burn Medical Countermeasures and Radiological and Nuclear Countermeasures.
Within the CBRN division, the Radiation and Nuclear group focus' on developing medical
countermeasures to address nuclear detonation that result in radiation-induced illness~thermal
and radiation burns, and trauma. l(h)(4>I[b)(4-)

The current portfolio envisioned Under this Agreement includes those assets described in
Attachment 1:fb)C4J
The potential programs/p~atforms that may be
developed under this OTA have novel modes of action that may be developed as single or
combination therapies t hat have the potential to address areas of high unmet medical need forbiodefense. The portfolio covered under this Agreement may be augmented with additional
molecules or devices and in-licensing drug, device or vaccine candidates.

I

Collaboration between BARDA and the Consortium Members Under this Agreement will
provide the parties the flexibility to execute a portfolio approach to funding in the complex and
uncertain environment of drug and medical device development. To maximize the potential toach ieve the objectives of this Agreement, other medical countermeasure candidates that
Consortium Members develop or in-license during the term of the Agreement may beconsidered by the Joint Oversight Committee {JOC) for inclusion in the portfolio.
For theJbl!4)!assets listed in Attachment 1: fb)f4}
lno definitive commitment
has yet been made by either party to fund their development. The Consortium Members andBARDA wil,I explore the inclusion of potential assets beyond !(b){4)Once more clearly definedproject plans, scope and budget have been developed they will be presented to the JOC for
decision on their inclusion under this Agreement.

I

4

B.

Definitions

Affiliate: Any entity that controls, is controlled by, or is under common control with, a party tothis 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 another entity; or (2) power of
one entity to direct the management or policies of another entity, by contract or otherwise.
Agreement: The body of th is Agreement and all attachments and modifications thereto,
including Attachments 1- 6 are expressly incorporated in and made a part of the Agreement.
Asset: Project or projects related to a drug, device or other technology Which if successfully
developed has the potential to be utilized as a medical countermeasure against CBRN threats.
Biobanking: A biobank is a type of repository that stores biological samples for use in research.
Business Day: A day that is not: a Saturday or Sunday; a Federal holiday in the United States; abank holiday or national public holiday In the Netherlands or in any couhtry Where a
Consortium Member is located.
Confidential Information: Non-public information, including but not limited to business,strategic, or management information, or data of a personal nature about an individual, or
proprietary techn ical information, manufacturing information1 trade secrets financial,administrative, cost, or pricing information, submitted to the Government by or on behalf ofRecipient or by the Government to the Recipient in connection with, or during performance of
the Agreement, whether or not either Party required or requested that such information besubmitted . "Confidential Information" does not include "Data" as defined below.
Consortium: That group of Consortium Members that are; (i) Affiliates of one another; and (il)have agreed with one another to collaborate to perform the o bjectives and obligations set forthin this Agreement.
Consortium Member:f)C4)

Data: Recorded information first created in performance of the Program, regardless of form or
method of recording, which includes but is not limited to, technical data and software, but does
not include Subject Inventions, trade secrets, data of a personal nature about an indivtdual, or
f inancial, administrative, cost, pricing, or management information.
Effective Date: The date of execution of this Agreement by the Parties. If this Agreement is
executed in counterparts, the Effective Date sha ll be the date of the last signature.

5

Field: Means the development and use as medical countermeasure to address CBRN threats aswell as emerging infectious diseases and bacterial infections.
Foreign Firm or Institution: A firm or institution organized or existing under the laws of acountry other than the United States, its territories, or possessions. The term includes, forpurposes of this Agreement, any agency or instrumentality of a foreign government; and firms,
institutions or business organizations which are owned or substantially controlled by foreign
governments, firms, institutions, or individuals.
Government: The United States of America, as represented by HHS/BARDA. For purposes ofthis Agreement, the Government and HHS and BARDA may be used interchangeably.
Invention: Any invention or discovery which is or may be patentable under Tit le 35 of theUnited States Code.
Know-How: Information, practical knowledge, techniques, and skill development.
Limited Rights : The rights to use, modify, reproduce, perform, display, or disclose Data, inwhole or in part, within the Government solely for its research purposes in the Field.
Other Transaction Agreement Officer (OTAO): Is the responsible government official

authorized to bind the government by signing this agreement and bilateral modifications
Other Transaction Agreement Specialist (OTAS): Is a supporting official that executes

agreement modifications on behalf of the Other Transaction Agreement Officer
Other Transaction Agreement Technical Representative (OTTR): Is the primary government

official for all technical matters on the Agreement
Party: Either Recipient or Government, and "Parties" means both Recipient and Government.
Practical Application: With respect to a Subject Invention, to manufacture, in the case of acomposition of product or a medical device; to use in manufacturing, in the case of an invention
useful in manufacturing; to practice, in t he case of a process or method, or to operate, in thecase of a machine or system; and, in each case, under such conditions so as to establish that the
Subject Invention is capable of being utilized.
PMO Steering Committee: The Project Management Organization Steering Committee consistsof individuals appointed by the Recipient for the dual responsibilities of day-to-day
management and execution of the overall Program and providing technical and administrative
infrastructure to ensure all executory functions in the accomplishment of the current
Statement of Work.
Project: Work activities within the overall Program, focused on specific assets or support ofthose assets and/or the overall Program.
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Program: Research and development that is conducted by or on behalf of the Consortium

Under this Agreement, as set forth in Article I., Section C (Scope).
Program Plan: A written document to be delivered to the Government by the Recipient onbehalf of the Recipient and all members of the Consortium that outlines the impacts of risks inrelation to the cost, schedule and performance objectives of the Agreement with respect to thespecific Assets under development at time of plan submission. The plan shall include risk
mitigation strategies. Each risk mitigation strategy will capture how the corrective action will
reduce impacts on cost, schedule and performance. For purposes of this plan, a risk will bedefined as a significant deviation from the anticipated schedule and associated costs outlined in
the first Program Plan submitted to the Government with respect to Assets under development
obtaining regulatory licensure within the United States.
Property: Any tangible personal property, other than property consumed or generated during

the execution of work in performance of the Program.
Recipient: JRD acting on its own behalf and on behalf of the Consortium and each Consortium

Member.
Sub-recipient: All entities (supplier, distributor, vendor, consultant or firm) from which goods

or services are procured by Recipient or its Affiliates (Reference Attachment 6 for complete
listing), acting on its behalf or the Consortium, or a Consortium Member, to execute technicalor operational requirements of this Agreement. These terms do not include agreements with
the Recipient or Consortium Members of a type that are not customarily treated as
subcontracts under a Government agreement. The Recipient, its Affiliates and Consortium
Members (Reference Attachment 6 for complete listing) are not considered to be Subrecipients .
Subject Invention: Any Invention that (i) has utility in the Field; and (ii) where the conceptionof such Invention and either (a) the first actual reduction to practice or (b) constructive
reduction to practice of such Invention occurs in performance of the Program.
Subject Invention (SI) Intellectual Property Rights: Patent rights controlled by Recipient

covering a Subject Invention and necessary for such use in the Field.
Technology: Discoveries, innovations and Know-How, whether patentable or not, including

computer software, recognized under U.S. law as intellectual creations to which rights ofownership accrue, including, but not limited to, patents, trade secrets, and copyrights firstcreated in the Program and that have not been disclosed to the public, but does not include any
Subject Invention.
Total Aggregate Resource Contribution: The amount of cash plus non-cash/in-kind

contributions by both Recipient and Government during the course of the period of
perform anee of this Agreement.
7

Under this Agreement: Means activities conducted pursuant to this Agreement that are BARDA
funded or Binding Cost Share by Recipient.

USO: Abbreviation for the United States Dollar, the official currency of the United States ofAmerica and its overseas territories.
C.

Scope

1.
The Consortium Members shall perform an advanced research anddevelopment program to develop medical countermeasures to address CBRN
threats as well as emer in infectious diseases and bacterial infections."'"~""'}(4.,).,. - - - .
l)(4}(0)(4}(b){4_ti_)~4_>_ _ _ _ _ _ _ _ _ _ _ Attachment 2, Report Requirements.

2.

Recipient shall be paid for work performed Under this Agreement upon
submission of invoices on a quarterly basis. The agreement payments will be based
upon accumu lation of expenses incurred by the Consortium Members.

3.
The Government and Recipient anticipate that the work described in the SOWof this Agreement can only be accomplished with an estimated Consortium
aggregate resource contribution ofl(b)C4}
wh ich represents af(b)<4} !:ost
share of the total estimated project costs from the effective date of this Agreement
through seventy-five (75) months thereafter. By entering into this Agreement,
Recipient intends and sha ll undertake to cause these funds to be provided to theConsortium Members for the purpose of performing the obligations described in thisAgreement. At all times during this agreement, the Recipient aggregate resource
contribution shall be no less than fbX4} bf t he total estimated project costs. This
amount may be increased by mutual agreement between The Government andRecipient depending on the outcome of accomplishments and milestones resulting
from the operation of t his agreement by decision of the JOC and modification to theagreement executed by the OTAO. If either HHS or The Recipient is unable toprovide its respective total contribution, the other Party may reduce its projectfunding by a proportional amount.

I

4.

The Government will have certain rights to Data and Subject Inventions as
stated in this Agreement. The Government acknowledges that Recipient engages inother research and development activities, alone or with third parties, that ate
directed to products and materials that have similar or the same productcharacteristics, may perform essentially the same function and/or could be utilized8

in combination with one or more Subject Inventions and that such activities and any
intellectual property rights resulting therefrom that were not funded pursuant to
the terms of this Agreement are not subject to the terms and conditions of thisAgreement.

5.

This Agreement is an "other transaction" pursuant to Section 319L{c)(S) of the
Public Health Service Act, 42 USC 247d-7e(c)(S). The Parties agree that the principal
purpose of this Agreement is to support commercially reasonable efforts inachieving the goals of the Program, and not solely for the acquisition of property orservices for the direct benefit or use of the Government.

ARTICLE II: TERM
A.

Term of this Agreement:

The Agreement commences on the date of the last signature hereto and continues for a
21 month period (the "Base Period") with options to extend the term of the Agreement(each an "Option") for a further four years and six months until 31 December 2024. The
Government will provide the Recipient a preliminary written notice of its desire to
exercise each Option at least ninety {90) days before the expiration of (i) one year
following the commencement of the Agreement (for the first Option) and (ii) each
Option term thereafter, as applicable. The preliminary notice does not commit theGovernment to an extension; however, if the Government issues a preliminary notice toRecipient and subsequently elects not to proceed to exercise the Option, theGovernment shall notify Recipient of this decision not less than thirty (30) days prior to
expiration of the term. The Recipient may decline any Option but allow the preexisting
Base Period activities or previously executed Options for other Assets to continue. The
Parties may agree mutually to extend the term of this Agreement and its Options bymodifying the agreement on or before the expiration of the base period or exercised
Options.
B.

Termination Provisions

Either Party may terminate this Agreement by providing ninety (90) days written noticeto the other Party, provided that such written notice is preceded by consultation
between the Parties at the level of the JOC. In the event of a termination of theAgreement, it is agreed that disposition of Data developed Under this Agreement, shallbe in accordance with the provisions set forth in Article X, Data Rights. The Government
and the Recipient will negotiate in good faith a reasonable and timely adjustment of all
outstanding issues between the Parties resulting from termination, including dispositionof animals acquired for research use. Failure of the Parties to agree to a reasonableadjustment will be resolved pursuant to Article VIII, Disputes. The Government has no
obligation to pay the Recipient for activities performed after the date of agreement9termination with the exception of any non-cancellable obligations which may have beenentered into in the course of performing the approved scope of work. For purposes ofthis clause, termination expenses shall be those expenses identified in Federal
Acquisition Regulation 31.205-42 but do not include re-procurement costs.
C.

Extending the Term

The Parties may extend by mutual written agreement the term of this Agreement if
activities performed during the extension do not exceed funding obligated to theAgreement and research opportunities reasonably warrant an extension. Any extension
shall be formalized through modification of the Agreement by the OTAO and theConsortium Project Management Lead {PML). If the Recipient desires an extension to
the period of performance of this Agreement, the Recipient shall submit a request to
extend the period of performance in writing to the OTAO. Any request for an extension
should include the justification for an extension, a revised milestone/project schedule {ifapplicable), and an updated budget that illustrates how the remaining funds will cover
the extended period of performance.
ARTICLE Ill:

AMENDMENTS

A.
Recommendations for Modifications
As a result of quarterly meetings, annual in-performance reviews, JOC meetings or at
any time during the term of the Agreement, research progress or results may indicatethat a change in the SOW would be beneficial to Program objectives. Any modification
to the Agreement, excluding minor modifications discussed below, shall be by mutual
written agreement of the Parties. Recommendations for modifications, including
justifications to support any changes to the SOW, will be documented in a letter andsubmitted by the PML to the OTTR with a copy to the OTAO and OTAS. This letter will
detail the technical, chronological, and financial impact {if any) of the proposed
modification to the Program.
B.

Minor Modifications

Notwithstanding the foregoing, minor non-material Agreement modifications that do
not affect the obligations of Recipient or Consortium Members, the Government or theterms and conditions of this Agreement {e.g. changes in the paying office orappropriation data, Government or the Recipient's changes to personnel identified in
the Agreement, etc.), may be made by either Party with one (1) working-day written
notice to the other Party. Failure of the other Party to respond within ten {10) Business
Days from submission of the request to either Party will be deemed concurrence that
subject modification is minor non-material. If Parties do not reach agreement as towhether a modification is minor non-material, then the process identified Article Ill,
Section C will apply.

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C.

Modifying the Agreement

The OTAO shall be responsible for agreeing to any modifications to this Agreement onbehalf of the Government. The Principal Investigator (Pl) and PML shall be responsible
for agreeing to any modifications to this Agreement on behalf of the Consortium. No
modification, however, is effective unless in writing and signed by the Parties. The OTAO
and/or the OTAS are the only signatories that can execute modifications on behalf of theGovernment. All modifications to this agreement shall take precedence over all priorversions and will be dated.

ARTICLE IV:A.

MANAGEMENT OF THE PROGRAM
Project Organization and Management Structure

1. Joint Oversight Committee: The joint oversight committee ("Joint OversightCommittee" or "JOC") is the higher-level decision-making body that provides
guidance, direction and control to the Program Management Organization (PMO)
Steering Committee (defined below) to ensure execution of the Program according
to the SOW. The JOC shall have equal voting representation from both BARDA andthe Recipient and shall discuss and jointly approve changes to the SOW. The
responsibility of the JOC is to mutually interrogate risks and progress of assets
covered under this Agreement, endorse potential new assets and agree on
allocation of funding across activities covered Under the Agreement. Any addition
or removal of assets or Consortium Members, agreed upon by the JOC for inclusion
or removal Under this Agreement shall be added by modification to the Agreementby the OTAO.
The JOC will recommend the strategy to be covered Under this Agreement during
the subsequent funding period, as well as how Government funding will be allocatedacross these activities. The recommendations will be submitted, as appropriate, tothe relevant Consortium governance board(s) within the Consortium Members forendorsement and decision. Similar procedures will be implemented by theGovernment. If endorsed by the relevant Consortium governance boards and by
OTTR, the recommendations will be incorporated into the SOW and this Agreement
through modifications as described in ARTICLE Ill.
2. PMO Steering Committee: The project management organization steeringcommittee (the "PMO Steering Committee" or "Project Management Organization
Steering Committee") has dual responsibilities. First, it is responsible forcommunication and coordination with BARDA regarding day to day management
and execution of the Program; e.g. organizing meetings on a regular, agreed-uponbasis. Second, the PMO Steering Committee will coordinate all SOW activities andprovide the technical and administrative infrastructure to ensure efficient planning,
11

initiation, implementation, direction, management and completion of all tasks,
including the establishment of the Asset Project Management Teams (APMT). These
SOW activities will be coordinated by the Project Manager Leader (PML). The PMO
Steering Committee will assess progress and, where needed, will propose strategic
technical changes to be decided upon by the JOC. The PMO Steering Committee
consists of a group of dedicated and specialized project management experts, key
personnel (shown below) and additional specific expertise for the functions that are
required for executing the specific work scope for each proposed asset area. The
PMO Steering Committee will prepare for and participate in quarterly review
meetings in conjunction with the BARDA Technical Team including the OTTR, as
further described in Article IV, Section B of this Agreement.
3. Asset Project Management Leader. Each Asset will have an Asset ProjectManagement Leader ("Asset PML") who will oversee their specific ProjectManagement requirements. This includes conducting frequent and regular Asset
Project Management Team (APMT) meetings to ensure the accurate developing andtracking of the budget, time line and resource plan. The APMT of each Asset will also
include a technical lead, finance representative and, depending on the Asset, also a
preclinical leader, clinical leader, CMC leader, and regulatory project management
leader. Additional expertise required for executing Asset-specific work possibly
including sub-recipient may be added as part of the APMT.

[Remainder of page int entionally left blank]

12Organizat ional Chart(13)(4)B.

Project Committees and Meetings

1. Joint Oversight Committee (JOC). The JOC will meet at critical decision points inthe program, but no less than two (2) times per year, preferably face to face oralternatively by Video and/or telephone conference. Ad hoc meetings will be.
organized when urgent matters arise or prior to the exercising of an Option. The JOC
will consist of two (2) voting members each from the Consortium and BARDA andnon-voting members from the Consortium and BARDA, or other additional
Consortium or U.S. Government Members (non-voting) as may be required.
Additional, non-voting members may be assigned or invited by Recipient on an adhoc basis. Decisions to reprioritize specific projects and resources w ithin the scopeof this Agreement will be taken by consensus. In case such a decision cannot bereached in the JOC, the decision will be escalated to one BARDA and one Consortium
senior management member identified at the start of the Project or identified
through written notification t o the other Party.
2. Kic·k -off and Quarterly PMO Steering Committee. A kick-off meeting of PMO
Steering Comm ittee will be held w ithin forty-five (45) days of the Effective Date; theConsortium will provide an updated Program Plan for the Base Period within sixty(60) days of kick-off meeting. The Consortium, the OTAO and/or OTAS and BARDA
shall participate in meetings to coordinate the performance of the Agreement.
These. meetings may include. face-to-face meetings in Washington, D.C. or at work13

sites of the Consortium Members. Such meetings may include, but are not limited
to, meetings with the Consortium Members to discuss study designs, site visits toConsortium Member facilities, and meetings with the Consortium and HHS officials
to discuss the technical, financial, regulatory and ethical aspects of the program.
These meetings will also formulate and endorse the activities for the subsequent
three (3) months. In order to facilitate review of Program activities, it is expectedthat the Consortium will provide Data, reports, and presentations to groups ofoutside experts (subject to appropriate agreements to protect confidential or
proprietary data) and Government personnel as requested by the OTTR. The PML
shall provide an itinerary and agenda at least five (5) Business Days in advance of aface-to-face meeting.
3. Integrated Program Review (IPR) Meetings. On an annual basis or by an eventdriven need, and with a minimum of sixty (60) days advanced notice, prior to theexercise of additional effort to the Agreement, the Government may invite theConsortium to give a presentation at an Integrated Program Review Meeting
attended by BARDA and invited interagency representatives. The Consortium will
present Data generated Under the Agreement over the past year as needed toassess progress against portfolio milestones. Successes and challenges of the
program will be discussed and plans for the coming year will be presented.
4. Bi-Weekly Teleconferences. A conference call between the OTTR, OTAS and/or
OTAO and the Consortium PI/PML shall occur every two (2) weeks or as required, if
an urgent matter should arise. During this call, the PI/PML will discuss the activities
during the reporting period, any problems that have arisen, and the key activities
planned for the ensuing reporting period. The PI/PML may choose to include otherkey personnel on the conference call to give detailed updates on specific projects or
this may be requested by the OTTR. On an as needed basis, the OTTR or PI/PML may
assign this responsibility to a delegate.
5. Cost Share Determination (CSD) Meeting: Either by conference call or inperson, between the OTAO, and/or the OTAS, OTTR and the PI/PML will discuss andreview cost share contributions of the Agreement. During this meeting, the PI/PML
will discuss assets progression to date and provide an update on the commercial
viability of portfolio assets. These meetings will be held on annual basis and may bescheduled on an ad-hoc basis after the receipt of study data, FDA feedback and/or
future public health scenarios that will guide in the activation of future elements of
the Agreement. The recipient will submit to the Government meeting minutes and arevised budget (if applicable) as result of discussions.
C.
Document Review: Subject to other provisions specified in this Agreement (see forexample Attachment 2), the PML/PI shall notify the OTTR and OTAO of formal andinformal correspondence with the Food and Drug Administration (FDA) or otherregulatory agencies as specified in Attachment 2. The PI/PML shall provide the14Government sufficient opportun ity to review study protocols, reports, and FDA
correspondence. The Government's comments on these documents will be viewed asadvisory in nature. Specific timelines for document review and responses are outlined in
Attachment 2 - Reporting Requirements.

ARTICLE V:

AGREEMENT ADMINISTRATION

Administrative and contractual matters Under this Agreement shall be referred to the following
representatives of the Parties:
Government Points of Contact:

Other Transaction Agreement Officer (OTAO):
Francine L. Hemphill
Branch Chief, CBRN Advanced Research and Development(202) 205-9271
fra ncine.hemphill@hhs.gov
Other Transaction Agreement Specialist (OTAS):
George J. Keane, Jr.
OTAS, CBRN Advanced Research and Development(202) 260-5169
george. Kea ne@hhs.gov
Other Transaction Agreement Technical Representative (OTTR):
Ashley Cecere
Health Scientist, CBRN Division, BARDA(202) 691-2056
ashley.cecere@hhs.gov
Alternate OTTR:
Mary Homer, Ph.D.
Chief, Radiological and Nuclear Countermeasures, CBRN Division, BARDA(202) 205-8604
mary.homer@hhs.gov
Recipient Points of Contact:
b)(6)

15

(b)(6)ARTICLE VI: COST SHARING
A. Acknowledgement: The terms of this Article VI apply to the cost sharing principles as
described below. The Parties acknowledge that the activities included Under thisAgreement may change at any time due to alterations in development strategy, risk
mitigation approaches, technical challenges, or any other circumstance. Any
modification will be subject to these cost sharing principles unless otherwise agreed by
the JOC. As such, any projection of shared costs or resources will be estimates and will
be non-binding, with the exception of the Base Period costs discussed in Article VI,
Section Band Article VI, Section C below.
B. Allowable Costs: The Recipient's binding cost share will consist of reimbursable
expenses including direct labor dollars charged in the performance of activities covered
under the SOW, the indirect dollars (fringe, overhead and G&A) applicable to the direct
labor and material costs, and sub-recipient, consultant, and other costs. No fee or profit
is allowable. These costs will reasonably relate to the activities conducted under the
SOW. Budgets will be updated at least once a year to reflect changes to Consortium
Members' indirect rates, which are updated annually and shall be set at governmentapproved provisional rates for the forthcoming year. Any rate changes that increase thetota l budget ceiling for a Project under the Agreement, or beyond what was previously
agreed by the JOC and approved by the OTAO, shall require agreement by JOC andapproval by the OTAO of the budget and project scope. Rates for other sectors (Medfcal
Device or Consumer) sha ll be proposed and negotiated as these Assets are added to theAgreement, after agreement by the OTAO. Recipient agrees total cost of activities
performed under this agreement will not exceed total obligated amount. Direct labor
will be charged based on effort reports from Consortium personnel who will track theirtime in the Consortium Member's standard timekeeping system. These personnel
allocate their effort to specific projects and activities, but the time can be recorded per
standard practices of Consortium Members, and ·does not require manager review orapproval. Once Government approved provisional billing rates are established for any
given year, revised retrospective indirect rate reconciliation will not be required for thatyear.

Charges made Under this Agreement may include:

16

1.

Direct materials and supplies that are used in the performing of the work
provided for under this Agreement, including those purchased for sub-recipientsand purchase orders.
(0)(4)

2.

Labor, including supervisory, that is properly chargeable directly to theAgreement, and inclusive of fringe benefits

3.

Indirect Costs

Other items as agreed upon by the Parties may be included by modification to thrs
Agreement.
C. Global Cost Share: The Global Cost represents the estimated total cost for activities
under the SOW that support the development of the assets described above during theterm of the base and option periods of the Agreement. The Recipient Global Cost Shareo~epresents the Recipient's estimated contribution as a percentage of the Global
Cost during the Base Period of the Agreement. At no time on an annual basis during thisAgreement will the Recipient's Global Cost Share be belowkW4) !of the total estimatedcost of the Agreement. Upon mutual decision between The Government and theRecipient, the Recipient's Global Cost Share may increase due to accomplishments
and/or milestones being performed Under this Agreement. The table as shown below
represents the Recipient's tota l estimated cost share under the SOW for the Base Period
and the proposed option periods of this Agreement. The cost share estimates would
need to be re-established under any of these scenarios through a CSD meeting. A
schedule outlining the cost share of each CUN exercised under this Agreement will be
submitted to the OTAO/OTAS before exercise of those respective CUNs. This schedule
will be reviewed by the OTAO/OTAS and accepted in writing in advance of any CUN
being exercised.

17

(0)(4)

D. Financial Reporting: In lieu of earned value management reporting Consortium will
provide quarterly Business Status report found in Attachment 2, A.2. Additionally, al
least once a year, in alignment with the timing of a JOC meeting and the timing forexercise of Options, Recipient will provide financial information to the OTAO identifying
the total charges made during the performance of this Agreement with a budget update
forfuture periods. This report is for informational purposes only. Consortium Members'
accounting for Government-reimbursed and Recipient costs shall be in accordance with
Consortium Members' accounting practices but must comply with Generally Accepted
Accounting Principles or other international standards. The Cost Accounting Standards
and the cost principles at Federal Acquisition Regulation Subpart 31 are not applicable
to costs incurred Under this Agreement.

ARTICLE VII:A.

OBLIGATION AND PAYMENT

Obligation
1.
The Government's obligation to make payments to Recipient is limited toonly those funds described in the Agreement or by modification t~o_t_h_e_ _ _~
Agreement. The Government is obligated to fund the amount of b_)<4_>_ _ _____.
(USO) for the work to be performed during the Base Period. The Government
and Recipient are not obligated to fund work that is to be performed during the
Option periods until an Option is exercised and not declined by Recipient.
Recipient is not obligated to perform work beyond that which has been fundedby the Government.

f. .

2.
If modification of the payment terms or schedule becomes necessary inperformance of this Agreement, pursuant to Article 111, Section C, the ASPR OTAO
and PML/PI Administrator shall execute a revi sed Statement of Work consistent
with the then current Program Plan.

18

B.

Payments

Recipient has an established and agrees to maintain an accounting system which
complies with Generally Accepted Accounting Principles and international standards as
required, and shall ensure that appropriate arrangements have been made forreceiving, distributing and accounting for the funds dispersed Under this Agreement. An
acceptable accounting system is one in which all cash receipts and disbursements arecontrolled and documented properly.
Properly prepared invoice(s) shall be submitted by Recipient for payment not more thanonce per quarter in Adobe Acrobat (.pdf) format. The invoice shall be uploaded to ashared electronic file server, with an email copy to the OTAO, OTAS and OTTR cited
below. The invoice shall be accompanied by adequate documentation as may berequired to support the payment. After verification of the accomplishment of the work,
the OTAS and OTTR will forward the invoice(s) to the payment office. Each invoice must
contain the following information in order to be deemed properly prepared:a.

Name and address of Recipientb.

Invoice Date and Invoice Numberc.

Agreement Numberd.

Description, quantity, unit of measure, unit price, and extended pricee.

Recipient Cost Sharef.

Name and address of OTAR official to whom voucher is to be sentg.

Name, title, phone number, and mailing address of person to notify in the eventof a defective invoice.

h.

Taxpayer Identification Number (TIN)i.

Electronic Funds transfer (EFT) banking information

Documents should be delivered electronically to the OTAO, OTAS and OTTR. Unlessotherwise specified by the OTAO all deliverables and reports furnished to theGovernment under the resultant Agreement (including invoices) shall be addressed to
the OTAO, OTAS and OTTR.
Quarterly invoices must include the cumulative total expenses to date, adjusted (asapplicable) to show any amounts suspended by the Government.

19

The Recipient will convert foreign currency costs to US Dollars each quarter using the
spot exchange rate p.ublished by Reuters at 4 PM ET on the last working day of eachquarter as specified in the invoice submitted for reimbursement.
The Recipient Will email the invoice to PSC Jnvoices@psc.hhs.gov promptly after
receiving email approval from the OTAO or OTAS that the invoices has been reviewed
and approved for further processing.
The Recipient agrees to promptly notify the OTAO and OTAS in writing if there is ananticipated overrun (any amount) .or unexpended balance (greater than 10 percent) of
the estimated costs for the base segment or any option segment(s) and the reasons forthe variance.
The Government will pay all proper invoices in US dollars within '30 days of receipt or
pay interest on any amounts due in accordance with the Prompt Payment Act.
C.

Limitation of Payments

It is herein understood and agreed that Government funds and funds identified as
Recipient contributions are to be used solely for Agreement-related expenditures thatare reasonable in nature. and amount, and allocable to this Agreement.
D.

Financial Records and Reports:

The Recipient shall maintain adequate records to account for its expenditure of all
funding Under this Agreement. Upon completion or termination of this Agreement,
whichever occurs earlier, the Recipient Administrator shall furnish to the OTAO a copyof the Final Report required by Attachment 2, Part E. Recipient's relevant financial
records are subject to examination or audit by the Government for a period not toexceed three (3) years after expiration of the term of this Agreement. The OTAO ordesignee shall be provided direct access to sufficient records and information of
Recipient, to ensure accountability for funding Under this Agreement. Such audit,
examination, or access shall be performed during business hours on business days uponprior written notice and shall be subject to the security requirements of the audited
party.
E.

Comptroller General Access to Records

To the extent that the total Government payment Under this Agreement exceeds$5,000,000, the Comptroller General, at its discretion, shall have access to and the rightto examine records of any Consortium Member participating in the performance of t his
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 the20performance of the Agreement that has not entered into any other Agreement(contract, grant, cooperative agreement, or "other transaction") that provides for accessby a Government entity in the year prior to the date of this Agreement. This paragraphonly applies to any record that was created or maintained in the ordinary course ofbusiness or pursuant to a provision of law in the performance of the Agreement.
Recipient and Consortia Members shall ensure that their sub-recipients' agreements are
consistent with t his Article.

ARTICLE VIII:DISPUTESA.

GeneralThe Parties shall communicate with one another in good faith and in a timely andcooperative manner when raising issues under this Article.

B.

Dispute Resolution Procedures

1.
Any claim or dispute between HHS and Consortium concerning questionsof fact or law arising from or in connection with this Agreement, and, whether or
not involving an alleged breach of this Agreement, shall only be raised under this
Article.

2.
Whenever legal disputes or claims arise, the Parties shall attempt toresolve the issue(s) by discussion and come to mutual agreement on a resolution
as soon as practicable. In no event shall a dispute, disagreement or
misunderstanding t hat arose more than three (3) months prior to thenotification made under Article VIII, sub-section B.3 of this article constitute thebasis for relief under this article unless one level above t he OTAO, in theinterests of justice, waives this requirement.
3.
Failing resolution by mutual agreement, the aggrieved Party shalldocument the dispute, disagreement, or misunderstanding by notifying theother Party (through the OTAO or Consortium's Administrator, as the case maybe) in writing of the relevant facts, identifying unresolved issues, and specifyingt he clarification or remedy sought. Within ten (10) working days after providing
notice to the other Party, the aggrieved Party may, in writing, request a joint
decision by the Assistant Secretary for Preparedness and Response (ASPR) Headof Contracting Activity, and senior executive appointed by Consortium. 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 ASPR Head of Contracting Activity (HCA) and the recipient senior executive
shall conduct a review of the matter(s) in dispute and render a decision in writing
within thirty (30) calendar days of receipt of such written position. Any suchjoint decision is final and binding.

21

4.
In the absence of a joint decision, upon written request to the Senior
Procurement Executive (SPE) made within thirty (30) calendar days of the
expiration of the time for a decision under Article VII I, sub-section B.3 above, thedispute shall be further reviewed. The SPE may elect to conduct this review
personally or through a designee or jointly with a senior executive appointed byConsortium. Following the review, the Chief Acquisition Officer or designee will
resolve the issue(s) and notify the Parties in writing. Such resolution shall befinal and binding.

5.
The Parties agree that the Agreement satisfies the elements of a"contract" for jurisdiction under the Tucker Act. After appropriate exhaustion of
the administrative and other remedies identified in this Agreement, recipient
shall have the right to appeal or pursue any Agreement dispute arising Undert his Agreement at the Court of Federal Claims or, if applicable, the Court ofAppeals for the Federal Circuit or the Supreme Court.
C.

Escalation Procedure for Technical Matters

In the event of a technical disagreement the procedures for resolution are
depicted in Attachment 3, Technical Escalation Procedure
D.

Limitation of Damages

Claims for damages of any nature whatsoever pursued Under this Agreement
shall be limited to direct damages only up to the aggregate amount of HHS
funding disbursed as of the time the dispute arises. In no event shall either Partybe liable for claims for consequential, punitive, special and incidental damages,
claims for lost profits, or other indirect damages.

ARTICLE IX:
A.

PATENT RIGHTS
Allocation of Principal Rights

Unless Recipient notifies the Government that Recipient does not intend toretain title, Recipient or its designee shall retain the entire right, title, andinterest throughout the world to each Subject Invention and patent rightst hereon consistent with the provisions of this Article and 35 U.S. § 202.
Recipient or its designee shall retain title of all other Inventions and patent rights
thereon made in the performance of this Agreement.
B.

Invention Disclosure, Election of Title, and Filing of Patent Application

1.
Recipient shall identify Subject Inventions in the annual report and thefinal report as specified in Attachment 2, which shall be in sufficiently complete

22technical detail to convey a clear understanding to the extent known at the timeof the disclosure, of the nature, purpose, operation, and the physical, chemical,
biological, or electrical characteristics of the Subject Invention.

2.

If Recipient determines that neither it nor its designee intends to file any
patent applications on a Subject Invention, Recipient shall notify HHS, in writing,within two (2) years of disclosure of such Subject Invention to HHS. However, in
any case 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, the period for such notice may be shortened by HHS to a date thatis no more than sixty (60) calendar days prior to the end of the statutory period.

3.
Recipient shall file its initial patent application on a Subject Invention towhich it retains title 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. Recipient may elect to file patent applications in additional countries(including the European Patent Office and the Patent Cooperation Treaty) at its
discretion.
C.

Conditions When the Government May Obtain Title
Upon HHS's written request, Recipient shall convey title to HHS:

1.
Of any patent or patent applications solely claiming Subject Inventions, if
Recipient fails to disclose the Subject Invention within the times specified in
Article IX, Section B; provided, that HHS may only request title if HHS gives
written notice to Recipient of Recipient's failure to report within sixty (60)calendar days after learning of the failure of Recipient to disclose within thespecified times, and Recipient fails to report such Subject Invention within sixty(60) calendar days of such written notice (the "Cure Period"). HHS shall havesixty (60) days from the end of the Cure Period in which to claim title. For the
avoidance of doubt, disclosure under this paragraph shall be deemed to haveoccurred at the time of Recipient's written notification to the Government of a
Subject Invention regardless of whether such disclosure meets the standards set
forth in Article IX, sub-section B.1 above.
2.
Of a patent application or patent that solely claims Subject Inventions, as
the case may be, in any country in which Recipient decides not to continue theprosecution of such patent application, or to pay the maintenance fees on or
defend in reexamination or opposition proceedings of such a patent.

23

D.

Minimum Rights to Consortium and Protection of Consortium's Right to File
1.
Recipient shall retain a nonexclusive, royalty-free license throughout theworld in each Subject Invention and patents and patent applications claiming a
Subject Invention to which the Government obtains title under Article IX, Section
C. The Recipient license extends to the Recipient's Affiliates, and includes theright to grant licenses of the same scope to the extent that Recipient was legallyobligated to do so at the time the Agreement was awarded or at the time of the
Subject Invention was invented. The license is transferable only w ith theapproval of HHS, except when transferred to the successor of that part of thebusiness to which the Subject Invention pertains. HHS approval for licensetransfer shall not be unreasonably withheld.
2.
The Recipient license may be modified by HHS to the extent necessary toachieve diligent Practical Application of the Subject Invention pursuant to an
application for an exclusive or non-exclusive license submitted consistent withappropriate provisions at 37 CFR Part 404 if Practical Application of such Subject
Invention has not already been achieved or is not likely to be achieved by
Recipient, its Affiliates or licensees.

3.

Before modification of the license, HHS shall furnish Recipient a written
notice of its intention to modify the license, and Recipient shall be allowed sixty(60) 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.
E.

Action to Protect the Government's Interest

1.
Recipient agrees to execute or to have executed and promptly deliver to
HHS all instruments necessary to (i) establish or confirm the rights theGovernment has throughout the world in those patents claiming Subject
Inventions to which Recipient elects to retain title, and (ii) convey title to HHS
when requested under section D of this Article and to enable the Government toobtain patent protection throughout the world in that Subject Invention.
2.
Recipient agrees to require, by written agreement, its employees, otherthan clerical and non-technical employees, to disclose promptly in writing, topersonnel identified as responsible for the administration of patent matters andin a format suggested by Recipient, each Subject Invention in order that
Recipient can comply with the disclosure provisions of Article IX, Section C.
Recipient 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 US
statutory bars.

24

3.
Recipient shall notify HHS 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 thirty (30) calendar days before theexpiration of the response period required by the relevant patent office.
4.
Recipient shall include, Within the specification of any United States
patent application and any patent issuing thereon claiming a Subject Invention,
the following statement: "This invention was made with Government support
under Agreement HHSO100201800012C, awarded by HHS. The Government hascertain rights in the invention."F.

Lower Tier Agreements

Recipient sha ll include the substance of Article IX, suitably modified, in its
agreements with sub-recipients for experimental, developmental, or research
work Under this Agreement.
G.

Reporting on Utilization of Subject Inventions

1.
Recipient shall submit, during the term of the Agreement, in the annual
report as specified in Attachment 2, information on the utilization of Subject
Inventions or on efforts at obtaining such utilization that are being made by oron behalf Recipient or its licensees or assignees. Such reports will include
information regarding the status of development, date of first commercial saleor use, and such other data and information as HHS may reasonably specify.
Recipient shall provide additional reports as may be requested by HHS inconnection with any march-in proceedings undertaken by HHS in accordancewith section Hof this Article. Consistent w ith 35 U.S.C. § 202(c) (5), HHS agrees it
shall not disclose such information to persons outside t he Government without
permission of Recipient. No such reporting shall be required for Subject
Inventions if all patents or patent applications claiming such Subject Inventions
have been abandoned, or if both Recipient and Government elect not to file apatent application on such Subject Invention.
2.

All required reporting shall be submitted to the OTAS, OTAO, and OTTR.

3.
Where the Subject Invention is a drug or a vaccine, or a method of
manufacturing, administering or using a drug or vaccine, Practical Application isachieved with respect to:4a. such drug or vaccine, ...
rb_){_)_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ __,l(bX4)f; or25

b. such method of use, if the method of use is employed in manufacture,f. .

administration or use .of such drug or vaccine in connection 11_)<4_l_ _ ____.
fb)(4}

Where the Subject Invention is a biologic or medical device as regulatedby the Food and Drug Administration that requires a clinical study for approval,
or a method of manufacturing, administering or using such a biologic or medical
device, Practical Application is per se achieved with respect to:4.

4a. such biologic, ....
lfb_)< _} _ _ _ _ _ _ _- - - - . - - - - - . - - - - - - - - - - - 'lru1r11 0 ,I or
b. .such method of use, if the method of use is employed in manufacture,administration or use of such biologic in connection "l(b.;_" )l4_>_ _ _ _ _ _ __.
ICb1(4)Ic. s'uch medical device,r>...._>r4_) _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _~I or!(b)f4}d. such method of use, if the method of use is employed in manufacture,administration or use of such medical device._fb_)(4_>_ _ _ _ _ _ _ _ _ ___.
!<bJ (4l_, I
I
I

5.
Failure to complete a._K§_1(4_J_ _ _ _ _ _____.
, Idoes not per se constitute a
failure to achieve Practical Application.

H.

March-in Rights
Recipient agrees that, with respect to any Subject Invention in which it hasretained title, HHS may request Recipient, an assignee, or exclusive licensee of a
Subject Invention to grant a non-exclusive license within the Field to a
responsible third party, upon terms that are reasonable under thecircumstances. If Recipient, assignee, or exclusive licensee refuses such arequest, HHS has the right to require Recipient to grant such a license if HHS
determines that:
1. Such action is necessary because Recipient, assignee their licensees or their
Affiliates have not taken steps, consistent with the intent of this Agreement, toachieve Practical Application of the Subject Invention; or

2. such action is net essary to alleviate the following urgent health or safety
needs that effect the United States and that are not reasonably satisfied by
Recipient, assignee, or their licensees or their Affiliates:
a. declaration for Public Health Emergency by the Secretary of HHS;

26

b. determination that there is a significant potential for a public Healthemergency that has a significant potential to effect a national or healthsecurity of U.S. citizens as determined by the Secretary of HHS; orc. declaration by WHO Director General of a public health emergency ofinternational concern.

3. Where the circumstances described in subsection H.2 are met, Recipient willact promptly to negotiate in good faith with the responsible third party a nonexclusive 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 the relevant Subject Invention in the Field tothe extent necessary to alleviate the public health emergency in the UnitedStates.

ARTICLE X:A.

DATA RIGHTS
Allocation of Principal Rights

1. The Government will receive Limited Rights in Data delivered in theperformance of the SOW that is marked with the "Limited Rights" legend
required by Article X, Section C below. Any delivered Data which is part of apatent application claiming a Subject Invention will be subject to the disclosureand release restrictions set forth in Article IX, Section B of this Agreement.

2. The Government may not, without the prior written permission of Recipient,release or disclose Data outside the Government, use Data for competitive
procurement or manufacture, release or disclose Data for any purpose, or
authorize Data to be used by another party. The Government will be able toshare Data within the Government provided that the Government recipient is
obligated to keep the information confidential. The Government shall inform all
Government recipients of Data of the relevant restrictions of this Agreement.
Data in any document which is a part of a patent application that would disclosea Subject Invention will be subject to Limited Rights until publication of patentapplication in accordance with Article IX of this Agreement.
3. Recipient agrees to retain and maintain in good condition all Data necessary
to achieve Practical Application of any Subject Invention in accordance with the
Recipient's established record retention practices. In the event of exercise of theGovernment's March-in Rights as set forth under Article IX, Section H, Recipientagrees, upon written request and with adequate additional support from theGovernment, as mutually agreed between the Parties, to deliver Data necessary
to achieve Practical Application with respect to use of the Subject Invention in27

the Field within one-hundred and twenty {120) calendar days from the date of
the written request.
4. Recipient's right to use Data is not restricted and includes the right under
Recipient's established business policies to make public research data (especiallyhuman 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.
B.

IDENTIFICATION AND DISPOSITION OF DATA

Recipient shall keep copies of all Data required by the Food and Drug
Administration (FDA) relevant to this Agreement for the time specified by the FDA
and provide such Data to OTAO. HHS reserves the right to review any other Data
determined by HHS to be relevant to this Agreement. Recipient shall provide
regulatory data to the OTTR and OTAS in accordance with Attachment 2:
Reporting Requirements.
C.

M arking of Data
Pursuant to Article X, Section A above, any Data delivered Under this Agreement
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 Agreement HHSO100201800012C between the Government
and Recipient, and those restrictions do not permit disclosure
to any party outside the Government without prior agreementof Recipient. Any reproduction of this Data or portions thereof
must be marked with this legend."

D.

Lower Tier Agreements
Recipient shall include the substance of this Article in all agreements with subrecipients for experimental, developmental, or research work performed Under
this Agreement.

ARTICLE XI:FOREIGN ACCESS TO TECHNOLOGY

a. Except as authorized by the Office of Foreign Assets Control {OFAC) in the
Department of the Treasury, the Recipient shall not acquire, for use in the performanceof this Agreement, any supplies or services if any proclamation, Executive order, or
statute administered by OFAC, or if OFAC's implementing regulations at 31 CFR chapter

28

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, and Sudan areprohibited, as are most imports from Burma or North Korea, into the United States or its
outlying areas. Lists of entities and individuals subject to economic sanctions areincluded 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 Recipient shall insert this clause, including this paragraph (c), in all subagreements.
ARTICLE XII:A.

TITLE TO AND DISPOSITION OF PROPERTY

Title to Property

Title to each item of Property acquired Under this Agreement with an acquisition valueof $50,000 or less shall vest in Recipient upon acquisition with no further obligation of
the Parties unless otherwise determined by the OTAO. Should any item of Property
with an acquisition value greater than $50,000 be required, Recipient shall obtain priorwritten approval of the OTAO. Title to this Property shall also vest in Recipient and HHS
upon acquisition in accordance with the cost share of the acquisition. Recipient shall be
responsible for the maintenance, repair, protection, and preservation of all Property at
its own expense. For all property generated during the execution of work in
performance of the Program, title will vest with the Government, unless in the case ofclinical samples the site performing the clinical trials has Biobanking requirements. In
the event the Recipient requests a transfer of title from the Government to the
Recipient during the course of the Agreement, a written request will be sent to the
OTAO for consideration and transfer will only take place after agreement in writing by
the OTAO. Disposition at the end of the Agreement of property generated during thecourse of the Agreement will be handled in the same manner described in Article XII,
Section B.
B.

Disposition of Property

At the completion of the term of this Agreement, items of Property with an acquisition
value greater than $50,000 shall be disposed of in the following manner:

1.
Purchased in full by Recipient at a price that the parties agree represents
fair market value of the property at the time of purchase with an agreed upon
markdown due to the Recipients care of the property, with the proceeds of thesale being returned to HHS; or
29

2.
Transferred to a Government research facility with title and ownership
being transferred to the Government; or3.
Donated to a mutually agreed university or technical learning center for
research purposes; or
4.

Any other HHS-approved disposition procedure.

ARTICLE XIII: SUB-RECIPIENTI

For any Sub-recipient in excess o~b)(4)that will be refmbursed Under thfs Agreement,
Recipient will prov'ide BARDA the opportunity to review the subject Sub-recip1ent agreementten (10) Business Days before. execution. The Sub-recipient agreement shall include the natureof the work that the Sub-recipient is going to perform, an estimated period of performance andthe proposed costs for the work. Recipient will provide OTTR, OTAO, OTAS and OTTS with anelectronic copy of the Sub-recipient agreement. For avoidance of doubt, once the ten (10)Business Days review period has expired the Recipient is not required to wait any further for
the Government comments before executing an Agreement with a Sub-recipient. If theGovernment does provide comments within 10 Business Days the Recipient will not proceedwith the Sub-recipient Agreement until agreement between Recipient and Government isreached.

ARTICLE XIV: CIVIL RIGHTS ACTPerformance of this Agreement in the US is subject to the compliance requirements of Title VIof the Civil Rights Act of 1964 as amended (42 U.S.C. 2000-d) relating to nondiscrimination inFederally assisted programs. Recipient has signed an Assurance of Compliance with thenondiscriminatory provisions of the Act.

ARTICLE XV:EXECUTION

This Agreement constitutes the entire agreement of the Parties and supersedes all prior andcontemporaneous agreements, understandings, negotiations and discussions among theParties, whether oral or written, with respect to the subject matter hereof. This Agreement
may be revised only by Written consent of Recipient and the OTAO. This Agreement, or
modifications thereto, may be executed in counterparts each of which shall be deemed asoriginal, but all of which taken together shall constitute one and the same instrument.

30

ARTICLE XVI: SPECIAL CLAUSES
A.

Inspection and Acceptance1.
The OTAO or the duly authorized representative will perform inspection
and acceptance of deliverables to be provided Under this Agreement2.
For the purpose of this Section, the designated OTTR is the authorized
representative of OTAO. The OTTR will assist in resolving technical issues thatarise during performance. The OTTR; however, is not authorized to change any
Agreement terms or authorize any changes in the Statement of Work or modify
or extend the period of performance, or authorize reimbursement of any costs
incurred during performance.
3.
or at:

Inspection and acceptance will be performed at the Recipient's facilities

Biomedical Advanced Research and Development Authority (BARDA) and/or
Contract Management and Acquisition (CMA) under the Office of the Assistant
Secretary for Preparedness and Response U.S. Department of Health and Human
Services
B.

PROTECTION OF HUMAN SUBJECTS1.
The Recipient agrees that the rights and welfare of human subjects
involved in research Under this Agreement shall be protected in accordance with
45 CFR Part 46 and with the Recipient's current Assurance of Compliance on filewith the Office for Human Research Protections (OHRP), Office of Public Healthand Science (OPHS). The Recipient further agrees to provide certification at least
annually that the Institutional Review Board has reviewed and approved theprocedures, which involve human subjects in accordance with 45 CFR Part 46
and the Assurance of Compliance.
2.
The Recipient shall bear full responsibility for the performance of all workand services involving the use of human subjects Under this Agreement and shallensure that work is conducted in a proper manner and as safely as is feasible.
The Parties hereto agree that the Recipient retains the right to control and direct
the performance of all work Under this Agreement. Nothing in th is Agreement
shall be deemed to constitute the Recipient or any sub Recipient, agent or
employee of the Recipient, or any other person, organization, institution, orgroup of any kind whatsoever, as the agent or employee of the Government. The
Recipient agrees that it has entered into this Agreement and will discharge its
obligations, duties, and undertakings and the work pursuant thereto, whether

31requiring professional judgment or otherwise, as an independent consortium
while holding the Government harmless for the acts of the Recipient, any
subrecipients, or their employees.

3.
If at any time during the performance of this Agreement, the ASPR OTAO
determines that the Consortium is not in compliance with any of therequirements and/or standards stated in Article XVI, Section B, subsections 1 and2 above, the ASPR OTAO may immediately suspend, in whole or in part, workand further payments Under this Agreement until the Recipient corrects thenoncompliance. Notice of the suspension may be communicated by telephoneand confirmed in writing. If the Consortium fails to complete corrective action
within the period of time designated in the OTAO's written notice of suspension,
the ASPR OTAO may terminate this Agreement in whole or in part, and theRecipient's name may be removed from the list of those consortiums withapproved Health and Human Services Human Subject Assurances.
C.

HUMAN MATERIALS (ASSURANCE OF OHRP COMPLIANCE)1.
The acquisition and supply of all human specimen material (including
fetal material) used Under this Agreement shall be obtained by the Recipient infull compliance with applicable federal, state and local laws and the provisions of
the Uniform Anatomical Gift Act in the United States, and no undue
inducements, monetary or otherwise, will be offered to any person to influence
their donation of human material.

2.

The Recipient shall provide written documentation that all humanmaterials obtained as a result of research involving human subjects conducted
Under this Agreement, by collaborating sites, or by sub-recipients identified
Under this Agreement, were obtained with prior approval by the OHRP of an
Assurance to comply with the requirements of 45 CFR 46 to protect humanresearch subjects. This restriction applies to all collaborating sites without OHRPapproved Assurances, whether domestic or foreign, and compliance must be
ensured by the Recipient.

3.
Provision by the Recipient to the ASPR OTAO's of a properly completed"Protection of Human Subjects Assurance ldentification/lRB
Certification/Declaration of Exemption", Form 0MB No. 0990-0263(formerly
Optional Form 310), certifying IRB review and approval of the protocol fromwhich the human materials were obtained constitutes the written
documentation required. The human subject certification can be met bysubmission of a self-designated form provided that it contains the information
required by the "Protection of Human Subjects Assurance ldentification/lRB
Certification/Declaration of Exemption", Form 0MB No. 0990-0263(formerly
Optional Form 310).
32

D.

RESEARCH INVOLVING HUMAN FETAL TISSUE
All research involving human fetal tissue shall be conducted in accordance with
the Public Health Service Act, 42 U.S.C. 289g-1 and 289g-2. Implementing
regulations and guidance for conducting research on human fetal tissue may befound at 45 CFR 46, Subpart Band http://grants1.nih.gov/grants/guide/noticefiles/not93-235.html and any subsequent revisions to this NIH Guide to Grants
and Contracts ("Guide") Notice. The Recipient shall make available, for audit by
the Secretary, HHS, the physician statements and informed consents required by
42 USC 289g-1(b) and (c), or ensure HHS access to those records, if maintainedby an entity other than the Recipient.

E.

NEEDLE EXCHANGE
The Recipient shall not use Agreement funds to carry out any program of
distributing sterile needles or syringes for the hypodermic injection of any illegal
drug.

F.

CARE OF LIVE VERTEBRATE ANIMALS
1.
Before undertaking performance of any Agreement involving animal
related activities, the Recipient shall register with the Secretary of Agriculture of
the United States in accordance with 7 U.S.C. 2136 and 9 CFR 2.30 through 2.38.
Recipient shall furnish evidence of the registration to the OTAO.

2.
The Recipient agrees that the care and use of any live vertebrate animals
used or intended for use in the performance of this Agreement will conform with
the U.S. Public Health Service (PHS) Policy on Humane Care of Use of Laboratory
Animals, the current Animal Welfare Assurance, the Guide for the Care and Useof Laboratory Animals prepared by the Institute of Laboratory Animal Resources
and the pertinent laws and regulations of the United States Department ofAgriculture ( see 7 U.S.C. 2131 et seq . and 9 CFR Subchapter A, Parts 1- 4). In
case of conflict between standards, the more stringent standard shall be used.
3.
If at any time during performance of t his Agreement, the ASPR OTAO'sdetermines, in consultation with the Office of Laboratory Animal Welfare(OLAW), National Institutes of Health (NIH), that the Recipient is not incompliance with any of the requirements and/or standards stated in paragraphs(1) through {3) above, the ASPR OTAO's may immediately suspend, in whole or inpart, work and further payments Under this Agreement until the Recipient
corrects the noncompliance. Notice of the suspension may be communicated by
telephone and confirmed in writing. If the Recipient fails to complete corrective
action within the period of time designated in the OTAO's written notice ofsuspension, the ASPR OTAO's may, in consultation with OLAW, NIH, terminate
33

this Agreement in whole or in part, and the Recipient's name may be removed
from the list of those consortiums with approved PHS Animal Welfare
Assurances.
Note: The Recipient may request registration of its facility and a current listing oflicensed dealers from the Regional Office of the Animal and Plant Health Inspection
Service (APHIS), USDA, for the region in which its research facility is located. The
location of the appropriate APHIS Regional Office, as well as information concerning thisprogram may be obtained by contacting the Animal Care Staff, USDA/APHIS, 4700 River
Road, Riverdale, Maryland 20737.
Office of Laboratory Animal Welfare Number _ _ _ _ _ _ _ _ _ _ _ _ (FILL IN)
G.

ANIMAL WELFARE

All research involving live, vertebrate animals shall be conducted in accordance with the
Public Health Service Policy on Humane Care and Use of Laboratory Animals. This policy
may be accessed at: http://grantsl.nih.gov/grants/olaw/references/phspol.htm
H.

PROTECTION OF PERSONNEL WHO WORK WITH NONHUMAN PRIMATES

All personnel who work with nonhuman primates or enter rooms or areas containing
nonhuman primates shall comply with the procedures set forth in NIH Policy Manual
3044-2, entitled, "Protection of NIH Personnel Who Work with Nonhuman Primates,"
located at the following URL:
http://wwwl.od.nih.gov/oma/manualchapters/intramural/3044-2/
I.

INFORMATION ON COMPLIANCE WITH ANIMAL CARE REQUIREMENTS

Registration with the U.S. Dept. of Agriculture (USDA) is required to use regulated
species of animals for biomedical purposes. USDA is responsible for the enforcement of
the Animal Welfare Act (7 U.S.C. 2131 et. seq.),
http://www.nal.usda.gov/awic/legislat/awa.htm.
The PHS Policy is administered by the Office of Laboratory Animal Welfare {OLAW)
http://grants2.nih.gov/grants/o1aw/o1aw.htm. An essential requirement of the PHS
Policy http://grants2.nih.gov/grants/olaw/references/phspo1.htm is that every
institution using live vertebrate animals must obtain an approved assurance from OLAW
before they can receive funding from any component of the U. S. Public Health Service.
The PHS Policy requires that Assured institutions base their programs of animal care anduse on the Guide for the Care and Use of Laboratory Animals
http://www.nap.edu/readingroom/books/labrats/ and that they comply with theregulations (9 CFR, Subchapter A) http://www.nal.usda.gov/awic/legislat/usdalegl.htm
issued by the U.S. Department of Agriculture (USDA) under the Animal Welfare Act. The
34

Guide may differ from USDA regulations in some respects. Compliance with the USDA
regulations is an absolute requirement of this Policy.
The Association for Assessment and Accreditation of Laboratory Animal Care
International (AAALAC) http://www.aaalac.org is a professional organization that
inspects and evaluates programs of animal care for institutions at their request. Thosethat meet the high standards are given the accredited status. As of the 2002 revision of
the PHS Policy, the only accrediting body recognized by PHS is the AAALAC. While
AAALAC Accreditation is not required to conduct biomedical research, it is highly
desirable. AAALAC uses the Guide as their primary evaluation tool. They also use the
Guide for the Care and Use of Agricultural Animals in Agricultural Research andTeaching. It is published by the Federated of Animal Science Societies
http://www.fass.org.

J.

APPROVAL OF REQUIRED ASSURANCE BY LAW

Under governing regulations, federal funds which are administered by the Department
of Health and Human Services, Office of Biomedical Advanced Research andDevelopment Authority (BARDA) shall not be expended by the Recipient for research
involving live vertebrate animals, nor shall live vertebrate animals be involved inresearch activities by the Recipient under this award unless a satisfactory assurance ofcompliance with 7 U.S.C. 2316 and 9 CFR Sections 2.25-2.28 is submitted within 30 daysof the date of this award and approved by the Office of Laboratory Animal Welfare(OLAW). Each performance site (if any) must also assure compliance with 7 U.S.C. 2316
and 9 CFR Sections 2.30-2.38 with the following restriction: Only activities which do notdirectly involve live vertebrate animals (i.e. are clearly severable and independent fromthose activities that do involve live vertebrate animals) may be conducted by the
Recipient or individual performance sites pending OLAW approval of their respective
assurance of compliance with 7 U.S.C. 2316 and 9 CFR Sections 2.25-2.28. Additional
information regarding OLAW may be obtained via the Internet at
http://grants2. n ih .gov/grants/ olaw/references/phspol. htm
K.
REGISTRATION WITH THE SELECT AGENT PROGRAM FOR WORK INVOLVING
THE POSSESSION, USE, AND/OR TRANSFER OF SELECT BIOLOGICAL AGENTS OR TOXINSWork involving select biological agents or toxins shall not be conducted Under thisAgreement until the Recipient and any affected sub Recipients are granted a certificate
of registration or are authorized to work with the applicable select agents.
For prime or sub-recipient awards to domestic institutions who possess, use, and/ortransfer Select Agents under this sub-recipient, the institution must complete
registration with the Centers for Disease Control and Prevention (CDC), Department of
Health and Human Services (DHHS) or the Animal and Plant Health Inspection Services(APHIS), U.S. Department of Agriculture (USDA), as applicable, before performing work35

involving Select Agents, in accordance with 42 CFR 73. No Government funds ca n be
used for work involving Select Agents, as defined in 42 CFR 73, if the final registration
certificate is denied.
For prime or sub-recipient awards to foreign institutions who possess, use, and/ortransfer Select Agents Under this Agreement, the institution must provide information
satisfactory to the Government that a process equivalent to that described in 42 CFR 73(http://www.cdc.gov/od/sap/docs/42cfr73.pdf) for U.S. institutions is in place and will
be administered on behalf of all Select Agent work sponsored by these funds before
using these funds for any work directly involving the Select Agents. The Recipient must
provide information addressing the following key elements appropriate for the foreign
institution: safety, security, training, procedures for ensuring that only
approved/appropriate individuals have access to the Select Agents, and any applicablelaws, regulations and policies equivalent to 42 CFR 73. The Government will assess thepolicies and procedures for comparability to the U.S. requirements described in 42 CFRPart 73. When requested by the OTAO, the consortium shall provide key information
delfneating any laws, regulations, policies, and procedures applicable to the foreign
institution for the safe and secure possession, use, and transfer of Select Agents. This
includes summaries of safety, security, and training plans, and applicable laws,
regulations, and policies. For the purpose of security risk assessments, the consortium
must provide the names of all individuals at the foreign institution who will have acces-s
to the Select Agents and procedures for ensuring that only approved and ·a ppropriate
individuals have access to Select Agents under the Agreement.
Listings of HHS select agents and toxins, biologic agents and toxins, and overlap agentsor toxins as well as information about the registration process, can be obtained on the
Select Agent Program Web site at http://www.cdc.gov/od/sap/.

L.

MANUFACTURING STANDARDSThe Current Good Manufacturing Practice Regulations (cGMP) (21 CFR 210-211) will be
the standard applied for manufacturing, processing and packing of any products to beadministered to human subjects Under this Agreement.
If at any time during the life of this Agreement, the Recipient fails to comply with cGMPin the manufacturing, processing and packaging of the products and such failure. results
in a material adverse effect on the safety, purity or potency of the products (a material
failure) as identified by CBER and CDER, the Recipient shall have thirty (30) calendar
days from the time such material failure is identified to cure such material failure. If theRecipient fails to take such an action within the thirty (30) calendar day period, then theAgreement may be terminated.

36

M.

PRODUCT APPROVALThe Recipient agrees to comply with cGMP guidelines (21 CFR Parts 210-211,600) for
manufacturing, processing and packing of drugs, chemicals, biological, and reagents.
The Recipient agrees to advise the ASPR OTAO and OTTR promptly of any relocation of
their prime manufacturing facility or the relocation of any sub consortium's facility
during the term or this Agreement. The Recipient also agrees to advise the ASPR OTAO's
and OTTR immediately if at any time during the term of this Agreement, the items
Under this Agreement fail to comply with cGMP guidelines and/or the facility receives anegative FDA Quality Assurance Evaluation (Form 483).
N.

ANTI-BRIBERY AND ANTI-CORRUPTION

Each Party agrees to perform its obligations Under this Agreement in accordance withthe 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 in accordance with the terms of thisAgreement, to terminate this Agreement immediately on written notice to the otherParty, if the other Party fails to perform its material obligations in accordance with this
Article XVI, Section M.
0.

GOVERNMENT OBSERVER IN RECIPIENT FACILITY

With seven (7) days advance notice to the Recipient in writing from the OTAO/OTAS, theGovernment may place an observer in a Recipient facility, who shall be subject toRecipient's policies and procedures regarding security and facility access at all times
while in the Recipient's facility. As determined by federal law, 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 t hat person in the course of
employment or official duties performed while stationed in a Recipient facility.
P.

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.dhhs.gov and the mailing address is:
Office of Inspector General
Department of Healthand Human Services
37

TIPS HOTLINE
P.O. Box 23489
Washington, D.C. 20026
Q.

PROHIBITION ON SUB-RECIPIENT INVOLVEMENT WITH TERRORIST ACTIVITIESThe 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
the legal responsibility of the Recipient to ensure compliance with these Executive
Orders and Laws. This clause must be included in all sub-agreements issued Under thisAgreement.

ARTICLE XVII: TRANSFERS & ASSIGNMENTS

Any transfer or assignment will be conducted in a manner consistent with the Assignment ofClaims Act (31 U.S. Code§ 3727) and the Prohibition on transfer of Agreement and certain
allowable assignments (41 U.S.C.A. § 6305, the "Anti-Assignment Act"). In the event there is atransfer to an independent 3 rd Party who is not a consortium member, then the provisions of
FAR 42.1204 would apply.

ARTICLE XVIII: CONFIDENTIALITY

It is recognized by the parties that success of the Agreement is enhanced by sharing ofConfidential Information to inform the Government and Recipient of developments outsideof, but potentially relevant to, the scope of work being performed under the Agreement.
The Parties may use Confidential Information submitted hereunder for purposes of theAgreement, but for no other purpose. It is expressly agreed that the Government is notgranted Limited Rights hereunder to Confidential Information .

Confidential Information shall be subject to the same prohibitions on disclosure asprovided for under FAR Part 24.202 and shall not be disclosed by the Government or its
representatives or Recipient without the prior written consent of the providing Party except
to the extent such disclosure is required by law. Further, any reproduction of Confidential
Information or portions thereof that is disseminated within the Government or Recipient,shall be shared strictly on a need to know basis for the purposes of the Agreement, and issubject to the restrictions of this provision.

38

In addition to the above, Confidential Information is subject to the protections of theTrade Secrets Act as well as any other remedies available Under this Agreement or the law.

In order to be subject to the provisions of this Article XVIII, the providing Party shallidentify Confidential Information as confidential or proprietary at the time of disclosure,either by separate written communication or by use of an appropriate stamp or legend; orshall provide written notice to the receiving Party within t hirty (30) days of disclosure of
the information's confidential or proprietary nature. Any disclosure of Confidential
Information by either Party or its representatives prior to receipt of such notice of its
confidential or proprietary nature shall not constitute a breach of this Article XVIII. It is theRecipient's responsibility to identify that information which is deemed confidential.
Notwithstanding the foregoing, information of a personal nature about an individual shall betreated as Confidential Information even if not so marked.

Recipient shall mark Confidential Information with the following legend or similar:"Business Confidential and Proprietary. This information is confidential and proprietary. The receiving party may
not use, modify, reproduce, perform, display or disclose this information except within the receiving party's
organization on a need to know basis for the purposes ofAgreement HHS0100201800012C, and may not disclose
to any party outside the receiving party's organization without prior agreement of the providing party. Any
reproduction of this information or portions thereof must be marked with this legend."
The obligations of this ARTICLE XVIII shall survive expiration or termination of the Agreement.

39

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ATTACHMENT 2: REPORT REQUIREMENTS

Item Description

1. Monthly Technical Progress Report
describing project progress over theprevious month.
Business status update will be provided
on a quarterly basis consistent with t heinvoice cycle.

Delivery Date

The 15 of each month, except
on the Agreement anniversary
month when an Annual
Report is to be submitted inlieu of a mohthly report.

2. Quarterly Invoices

Within sixty (60) calendar daysof the end of each quarter

3. Bi-Weekly Conference Call Minutes

Proposed agenda two (2)Business Days prior to call.
Minutes within seven (7)Business Days following eachconference call

4. Quarterly PMO Steering Committee/
Site Visit Minutes

Within ten (10) Business Days
foll owing each PMO Steering
Committee /site visit

5. Bi-annually JOC minutes

Within ten (10) Business Days
foll owing each JOC

6. Bi-annual Cost Share Determination
revised budget and meeting minutes

Within ten (10) Business Days
foll owing each Cost Share
Determination meeting

7. Portfolio Progress Milestone
Presentation. Annual or event driven
review of program

No later than ten {10)business days before
Milestone Review at JOC

8. Study Protocols for each non-clinicalNo later than ten (10)Business Days before
submission to the FDA

or clin.ical trial

Deliver Toth

OTAO/OTAS and OTTR via
e-mail. Additionally, email
invoices to
PSC_lnvoices@psc.hhs.gov

OTAO/OTAS and OTTR
via e-mail and, if
requested, CD-ROM

9. Study Reports for each non-clinical or
clinical trial

No later than fifteen (15)Business Days before
submission to the FDA

10. M anufacturing Campaign Reports
for Agreement funded clinical trial
material and registration lots

No later than fifteen (15)Business Days before
submission to the FDA

11. Technical Documents from
Agreement fwnded activities such as
Process Development Report, Assay
Validation Plan/Report, Assay Technology
Transfer Report, Batch Records, SOPs,

With in ten (10) Business Days
upon request by CO/COR or
fifteen (15) Business Daysprior to submission to FDA*

12. QA Audit Reports including findings,
results and next steps. BARDA reserves
the right to participate in the audits.

Within five (5) Business Daysof report completion

13. Formal FDA Submissions for
activities to be performed Under the
Agreement

No later than ten (10)Business Days before.
submission to the FDA. BARDA
will coordinate with Recipient
for reviewing NDA sections

14. Memo with Date and Time of
Scheduled Meetings with FDA. Pertaining
to activities to be performed Under the
Agreement.

As soon as possible afterscheduling, but no later than 2Business Days

15. Communications from FDA pertain ing
to activities Under the Agreement

Within two (2) Business Daysof receipt from FDA

16. Minutes for Formal Meetings with FDA Within two (2) Business Days
pertaining to activities Under theof receipt from FDA
Agreement
17. Draft Final Report

No later than forty-five (45)Business Days prior toAgreement expiration

OTAO/OTAS and OTTR via
e-mail.

18. Final Report

No later t han Agreement
expiration

19. Incident.Report for any critica lprogrammatic concerns, risks or potentialrisks

W ithin ninety-six (96) hours of·i ncident

OTAO/OTAS and OTTR via
e-mail or telephone

20. Raw Data and Analysis Pertaining
generated in the performance of t he
Program

W ithin a reasonable t ime after
request Within industry
standards

OTAO/OTAS via e-mail21. Weekly Clinical Report during
Active Enrollment Periods

The Monday following theweek being reported

OTTR via email

22. Clinical Site EnrolJment Reportingand Updates to support the BARDA
Clinical Trial Database

Submitted monthly as part oftechnical report

23. Quality Agreements with SubRecipients

W ithin ten (10) Business Days
upon request by OTAO/OTTR

OTAO/OTAS and OTTR via
e-ma il

24. Publications/Presentations

No later t han thirty {30).calendar days before
submission for publications
and fifteen (15) calendar daysth
Due on or before the 30 of
the month following each 12month period of performance

OTAO/OTAS and OTTR via
email

Due on or before forty-five(45) days after award of
Agreement . Documents to bepresented at the meeting due
seven (7) Business Days
before occurrence of meeting

OTAO/OTAS and OTTR via
e-ma il.

25. Subject Invention Report / Annual
Utilization Report

26. Kick-Off Meeting

OTAO/OTAS and OTTR Via
e-mail.

27 .Program ~IanDue sixty {60) days after
Agreement award. Updated
version of the plan due thirty(30) calendar days following
an IPR. The program plan shallbe delivered at l'east once
during a 12-month period.

OTAO/OTAS and OTTR via
e-ma il.

28. Regulatory Strategy Plan

Due ninety {90) days after
Agreement award. Updated
version of the plan to be on
annual basis within 15
Business days after the award
date of the Agreement.

OTAO/OTAS and OTTR via
e-mail.

A.

(Vloothly/Quarterty Reports

On or before ninety (90) calendar days after the Effective Date and monthly thereafter
throughout the term of the Agreement, Recipient shall Sl!bmit or otherwise provide a monthly
report. Two (2) copies shall be submitted or otherwise provided to the HHS Program Manager(or OTTR), one (1) copy sha ll be submitted or otherwis-e provided to the ASPR OTAO. The
report will have two (2) major sections.
1. Technical Status Report . The technical status report will detail technical progress to dateand report on all problems, technical issues, major developments, and the status of external
collaborations during the reporting period.
2. Business Status Report. The Business Status Report wil l be provided on a quarterly basis
consistent with the invoice cycle. The business status report shall provide summarized details of
the resource status of this Agreement, includihg the status of Recipient contributions. This
report will include a quarterly accounting of current expenditures as outlined in the Annual
Program Plan. Any major deviations, over plus or minus 10%, sha ll be explained along withdiscussions of the adjustment actions proposed. The report will also include an accounting of
any interest earned on Government funds. Recipient is reminded that interest in amounts
greater than $250 per year is not expected to accrue Under this Agreement. In the event that
this interest does accrue on Government funds, Recipient is required to provide an explanation
for the accrual in the business report. Depending on the circumstances, the Payable Milestones
may requ ire adjustment.
B.

ANNUAL PROGRAM PLAN DOCUMENT, as necessary
Recipient shall submit or otherwise provide to the OTTR and OTAO one (1) copy each of areport which describes the Annual Program Plan, This document shall be submitted not laterthan thirty (30) calendar days following the Integrated Program Review as described in Article
IV, Section 8. Submission of the Annual Program Plan Document may be waived by OTAO orOTAS after a written request by the Recipient to the OTAO and OTAS.
C.

SPECIAL TECHNICAL REPORTS

As agreed to by Recipient and the OTTR, Recipient shall submit or otherwise provide to the
OTTR and OTAO one (1) copy each of special reports on significant events such as significant
target accomplishments by Recipient, significant tests, experiments, or symposia.
D.

FINAL REPORT

1.
Recipient shall submit or otherwise provide a Final Report making full disclosureof all major developments by Recipient and Subject Inventions upon completion of theAgreement or within sixty (60) calendar days of termination of this Agreement. With theapproval of the OTAO, reprints of published articles may be attached to the Final Report.
Two (2) copies shall be submitted or otherwise provided to the OTTR; one (1) copy shall be
submitted or otherwise provided to the OTAO. One (1) copy shall be submitted to the
National Technical Information Center, Attn: DTIC-BCS, 8725 John J. Kingman Road, Suite
0944, Fort Belvoir, VA 22060-0944. Evidence of submission to the National Technical
Information Center will be submitted to the OTAO/OTAS.

2.

The Final Report shall be marked with a distribution statement to denote theextent of its availability for distribution, release, and disclosure without additional approvals
or authorizations. The Final Report shall be marked on the front page in a conspicuous
place with the following marking:"DISTRIBUTION STATEMENT 8. Distribution authorized to U.S. Government agencies only toprotect information not owned by the U.S. Government and protected by a consortium's"limited rights" statement, or received with the understanding that it not be routinely
transmitted outside the U.S. Government. Other requests for this document shall bereferred to the ASPR OTAO/OTAS and OTTR."E.

EXECUTIVE SUMMARY
Recipient shall submit an executive-level summary, not to exceed two (2) pages, of the major
accomplishments of the Agreement and the benefits of using the "other transactions" authority
pursuant to Section 319L(c)(S) of the Public Health Service Act, 42 USC 247d-7e(c)(S). uponcompletion of the Agreement. This summary shall include a discussion of the actual or planned
benefits of the technologies for both the military and commercial sectors. Two (2) copies shallbe submitted to the ASPR OTAO.

322

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360
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361.Villlllekl pursuant to exemptionb)(4)orthe Freedom of Information Act

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363

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

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

365

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

366

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

367.Vllllllekl pursuant to exemptionb)(4)or the Freedom of Information Act

368
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369

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370.Vltllllekl pursuant to exemption1>)(4)or the Freedom of Information Act