(b) (4)(b) (4)(b) (4)(b) (4)(b) (4)(b) (4)(b) (4)(b) (4)(b) (4)

(b) (4)(b) (4)(b) (4)(b) (4)(b) (4)(b) (4)(b) (4)(b) (4)(b) (4), (b) (6)(b) (6)OTAO
4 APRIL 2019

Table of Contents
ARTICLE I:SCOPE OF THE AGREEMENT .............................................................................................2

ARTICLE II:

TERM .............................................................................................................................8

ARTICLE III:AMENDMENTS ............................................................................................................ 10

ARTICLE IV:

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

ARTICLE V: AGREEMENT ADMINISTRATION ..................................................................................... 15
ARTICLE VI: COST SHARING ............................................................................................................. 16
ARTICLE VII:OBLIGATION AND PAYMENT ....................................................................................... 20

ARTICLE VIII: DISPUTES ................................................................................................................... 23
ARTICLE IX:

PATENT RIGHTS ........................................................................................................... 24

ARTICLE X:DATA RIGHTS ............................................................................................................... 30

ARTICLE XI:FOREIGN ACCESS TO TECHNOLOGY .............................................................................. 31

ARTICLE XII:TITLE TO AND DISPOSITION OF PROPERTY .................................................................... 32

ARTICLE XIII: SUB-RECIPIENT............................................................................................................ 33
ARTICLE XIV: CIVIL RIGHTS ACT ....................................................................................................... 33
ARTICLE XV:EXECUTION ................................................................................................................ 34

ARTICLE XVI: SPECIAL CLAUSES ........................................................................................................ 34
ARTICLE XVII: TRANSFERS & ASSIGNMENTS ...................................................................................... 43
ARTICLE XVIII: CONFIDENTIALITY ....................................................................................................... 43
ATTACHMENT 1: STATEMENT OF WORK (SOW) .................................................................................. 45

ATTACHMENT 2: REPORT REQUIREMENTS ............................................................................................. 73
ATTACHMENT 3: (b) (4)DIAGRAMS ......................................................................... 79

ATTACHMENT 4: J&J GLOBAL TRAVEL, MEETINGS AND EXPENSE POLICY .............................................. 81
ATTACHMENT 5: J&J TRAVEL, MEETINGS & EXPENSE POLICY – UNITED STATES (b) (4)
ATTACHMENT 6: (b) (4)... 121..................................................................................................... 127

1

ARTICLE I: SCOPE OF THE AGREEMENT
A.
Background
Chemical, Biological Radiological and Nuclear (CBRN) threats remain important publichealth concerns. BARDA's 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 andfocus 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. (b) (4)(b) (4)The current portfolio envisioned Under this Agreement includes those assets describedin Attachment 1: Statement of Work (“SOW”). The potential programs/platforms that
may be developed under this OTA (b) (4)that have the potential to address areas of high unmet(b)
medical need for biodefense. (4)(b) (4)

Collaboration between BARDA and the Consortium Members Under this Agreement will
provide the parties the flexibility to implement innovative solutions and execute a
portfolio approach to funding promising assets in the complex and uncertain
environment of drug and medical device development. To maximize the potential toachieve the objectives of this Agreement, other medical countermeasure candidates2that Consortium Members develop or in-license during the term of the Agreement may
be considered by the Joint Oversight Committee (JOC) for inclusion in the portfolio.
For the (b) (4)assets listed in Attachment 1: Statement of Work, no definitivecommitment has yet been made by either party to fund their development. The
Consortium Members and BARDA will explore the inclusion of potential assets andprojects beyond (b) (4)B.

Definitions

Affiliate: Any entity that controls, is controlled by, or is under common control with, aparty to this Agreement. In this context, "control" shall mean (1) ownership by one
entity, directly or indirectly, of at least fifty percent (50%) of the voting stock of anotherentity; or (2) power of one entity to direct the management or policies of another entity,
by contract or otherwise.
Agreement: The body of this Agreement and all attachments and modifications thereto,
including Attachments 1 – 6 are expressly incorporated in and made a part of theAgreement.
Asset: Project or projects related to a drug, device or other technology or solutionbased program, which if successfully developed or implemented, has the potential to be
utilized as a medical countermeasure against CBRN threats or increase access to medical
countermeasure technologies.
Biobanking: A biobank is a type of repository that stores biological samples for use inresearch.
Business Day: A day that is not: a Saturday or Sunday; a Federal holiday in the UnitedStates; abank holiday or national public holiday in the Netherlands or in any country 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 technical information, manufacturing information, trade secrets financial,administrative, cost, or pricing information, submitted to the Government by or on
behalf of Recipient or by the Government to the Recipient in connection with, or duringperformance of the Agreement, whether or not either Party required or requested thatsuch information be submitted. “Confidential Information” does not include “Data” asdefined below.
3Consortium: That group of Consortium Members that are: (i) Affiliates of one another;and (ii) have agreed with one another to collaborate to perform the objectives andobligations set forth in this Agreement.
Consortium Member: (b) (4)(b) (4)

Data: Recorded information first created in performance of the Program, regardless ofform or method of recording, which includes but is not limited to, technical data andsoftware, but does not include Subject Inventions, trade secrets, data of a personal
nature about an individual, or financial, administrative, cost, pricing, or management
information.
Effective Date: The date of execution of this Agreement by the Parties. If thisAgreement is executed in counterparts, the Effective Date shall be the date of the last
signature.
Field: Means the development and use as medical countermeasure to address CBRN
threats as well as emerging infectious diseases and bacterial infections.
Foreign Firm or Institution: A firm or institution organized or existing under the laws ofa country other than the United States, its territories, or possessions. The term includes,
for purposes of this Agreement, any agency or instrumentality of a foreign government;
and firms, institutions or business organizations which are owned or substantiallycontrolled by foreign governments, firms, institutions, or individuals.
Government: The United States of America, as represented by HHS/BARDA. For
purposes of this Agreement, the Government and HHS and BARDA may be usedinterchangeably.
Invention: Any invention or discovery which is or may be patentable under Title 35 of
the United States Code.
Know-How: Information, practical knowledge, techniques, and skill development.
Limited Rights: The rights to use, modify, reproduce, perform, display, or disclose Data,in whole 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
4

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 andGovernment.
Practical Application: With respect to a Subject Invention, to manufacture, in the caseof a composition of product or a medical device; to use in manufacturing, in the case of
an invention useful in manufacturing; to practice, in the case of a process or method, orto operate, in the case 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
consists of individuals appointed by the Recipient for the dual responsibilities of day-today management and execution of the overall Program and providing technical andadministrative 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 supportof those assets and/or the overall Program.
Program: Research, development and other activities related to the promotion andsupport of medical countermeasure innovation conducted by or on behalf of theConsortium 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
on behalf of the Recipient and all members of the Consortium that outlines the impactsof risks in relation to the cost, schedule and performance objectives of the Agreementwith respect to the specific 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 be defined as a significant deviation from theanticipated 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.

5

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, acting on its behalf or theConsortium, or a Consortium Member, to execute technical or operational requirementsof 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 aGovernment agreement. The Recipient, its Affiliates and Consortium Members are notconsidered to be Sub-recipients.
Subject Invention: Any Invention that (i) has utility in the Field; and (ii) where theconception of such Invention and either (a) the first actual reduction to practice or (b)constructive reduction to practice of such Invention occurs in performance of theProgram.
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 towhich rights of ownership accrue, including, but not limited to, patents, trade secrets,
and copyrights first created 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
performance of this Agreement.
Under this Agreement: Means activities conducted pursuant to this Agreement that are
BARDA funded or Binding Cost Share by Recipient.
USD: Abbreviation for the United States Dollar, the official currency of the United Statesof America and its overseas territories.
C.

Scope
1. The Consortium Members shall perform an advanced research anddevelopment program related to the development of medical
countermeasures to address CBRN threats as well as emerging infectious
diseases and bacterial infections. Specifically, this Agreement includes thoseassets described in Attachment 1: Statement of Work (“SOW”). The research
related to those assets shall be carried out in accordance with the SOW,
6

which is incorporated in this Agreement as Attachment 1 and may be
modified with the approved recommendation of the JOC and an executed
modification by the OTAO.
Consortium Members shall submit or otherwise provide all documentation
required by Attachment 2, Report Requirements. The portfolio may also be
augmented by the addition of (b) (4)2. Unless otherwise provided for under this Agreement or any amendment
hereto, 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 accumulation of expenses incurred by the Consortium
Members, or other manner as may be specified from-time-to-time to reflectfunding of different Assets.
3. The Government and Recipient anticipate that, unless otherwise
stipulated, the work described in the SOW of this Agreement can only be
accomplished with an estimated Consortium aggregate resource contributionof (b) (4)which represents a (b % cost share of the total)
estimated project costs (CLINs 0001 – 0026)(4) from the effective date of thisAgreement through seventy-five (75) months thereafter. By entering into
this Agreement, Recipient intends and shall undertake to cause these funds
to be provided to the Consortium Members for the purpose of performing
the obligations described in this Agreement. At all times during thisagreement, the Recipient aggregate resource contribution shall be no lessthan (b % of the total estimated project costs. This amount may be increased)by mutualagreement between The Government and Recipient depending on(4)
the outcome of accomplishments and milestones resulting from theoperation of this agreement by decision of the JOC and modification to theagreement executed by the OTAO. The
Parties also agree that certain CLINS may be exempted from the cost-sharerequirement, and such decision would be reflected in the budget of such
CLIN and/or any statement of work related thereto. If either HHS or The
Recipient is unable to provide its respective total contribution, the otherParty may reduce its project funding by a proportional amount.
4. The Government will have certain rights to Data and Subject Inventions
as stated in this Agreement. The Government acknowledges that Recipient
engages in other research and development activities, alone or with third
parties, that are directed to products and materials that have similar or thesame product characteristics, may perform essentially the same function
7and/or could be utilized 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 this Agreement.
5. This Agreement is an “other transaction” pursuant to Section 319L(c)(5)of the Public Health Service Act, 42 USC 247d-7e(c)(5). The Parties agree thatthe principal purpose of this Agreement is to support commerciallyreasonable efforts in achieving the goals of the Program, and not solely forthe acquisition of property or services for the direct benefit or use of theGovernment.

ARTICLE II: TERM
A.

Term of this Agreement:

The Agreement commences on the date of the last signature hereto andcontinues for a 21 month period (the “Base Period”, also referred to as CLIN
0001) with options to extend the term of the Agreement (each an “Option”) for afurther 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 thecommencement 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 to Recipient and subsequently elects not to proceed to exercise the
Option, the Government 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 termof this Agreement and its Options by modifying the agreement on or before theexpiration of the base period or exercised Options.

B.

Termination Provisions

Either Party may terminate this Agreement by providing ninety (90) days written
notice to the other Party, provided that such written notice is preceded byconsultation between the Parties at the level of the JOC. In the event of a8termination of the Agreement, it is agreed that disposition of Data developed
Under this Agreement, shall be in accordance with the provisions set forth in
Article X, Data Rights. The Government and the Recipient will negotiate in goodfaith a reasonable and timely adjustment of all outstanding issues between theParties resulting from termination, including disposition of animals acquired forresearch use. Failure of the Parties to agree to a reasonable adjustment will be
resolved pursuant to Article VIII, Disputes. The Government has no obligation to
pay the Recipient for activities performed after the date of agreement
termination with the exception of any non-cancellable obligations which may
have been entered into in the course of performing the approved scope of work.
For purposes of this clause, termination expenses shall be those expenses
identified in Federal Acquisition Regulation 31.205-42 but do not include reprocurement costs.
C.

Extending the Term

The Parties may extend by mutual written agreement the term of thisAgreement if activities performed during the extension do not exceed funding
obligated to the Agreement and research opportunities reasonably warrant an
extension. Any extension shall be formalized through modification of theAgreement by the OTAO and the Consortium Project Management Lead (PML).
If the Recipient desires an extension to the period of performance of thisAgreement, 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.

9

ARTICLE III: 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 indicate that 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 and submitted 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 theProgram.
B.
Minor Modifications
Notwithstanding the foregoing, minor non-material Agreement modifications
that do not affect the obligations of Recipient or Consortium Members, theGovernment or the terms and conditions of this Agreement (e.g. changes in thepaying office or appropriation data, Government or the Recipient's changes topersonnel identified in the Agreement, etc.), may be made by either Party withone (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 toeither Party will be deemed concurrence that subject modification is minor nonmaterial. If Parties do not reach agreement as to whether a modification is minor
non-material, then the process identified Article III, Section C will apply.
C.

Modifying the Agreement

The OTAO shall be responsible for agreeing to any modifications to thisAgreement on behalf of the Government. The Principal Investigator (PI) and PML
shall be responsible for agreeing to any modifications to this Agreement onbehalf 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 the Government. All modifications
to this agreement shall take precedence over all prior versions and will be dated.

10

ARTICLE IV: MANAGEMENT OF THE PROGRAM
A.

Project Organization and Management Structure
1. Joint Oversight Committee: The joint oversight committee (“Joint

Oversight Committee” or “JOC”) is the higher-level decision-making body thatprovides guidance, direction and control to the Program Management
Organization (PMO) Steering Committee (defined below) to ensure executionof the Program according to the SOW. The JOC shall have equal voting
representation from both BARDA and the Recipient and shall discuss andjointly approve changes to the SOW. The responsibility of the JOC is tomutually interrogate risks and progress of assets covered under thisAgreement, 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 theAgreement by 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 allocated across these activities. The recommendations will be
submitted, as appropriate, to the relevant Consortium governance board(s)within the Consortium Members for endorsement and decision. Similar
procedures will be implemented by the Government. If endorsed by therelevant Consortium governance boards and by OTTR, the recommendations
will be incorporated into the SOW and this Agreement through modifications
as described in ARTICLE Ill.
From time-to-time, the JOC may also formulate joint subcommittees tooversee specific Projects Under this Agreement. The establishment,
organization, mission, oversight and make-up of any such joint subcommittee
shall be included in any corresponding statement of work added to thisAgreement in support of such Project and shall be approved by the JOC.
2. PMO Steering Committee: The project management organization

steering committee (the “PMO Steering Committee” or “ProjectManagement Organization Steering Committee”) has dual responsibilities.
First, it is responsible for communication and coordination with BARDA
regarding day to day management and execution of the Program; e.g.
11organizing meetings on a regular, agreed-upon basis. Second, the PMO
Steering Committee will coordinate all SOW activities and provide thetechnical and administrative infrastructure to ensure efficient planning,
initiation, implementation, direction, management and completion of alltasks, 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 andspecialized project management experts, key personnel (shown below) andadditional 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 inconjunction 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 and tracking of the budget, timeline and resource plan. The APMTof 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 forexecuting Asset-specific work possibly including sub-recipient may be added
as part of the APMT.

[remainder of page intentionally left blank]

12Organizational Chart(b) (6)(b) (6)(b) (6)(b) (6)

B.

Project Committees and Meetings
1. Joint Oversight Committee (JOC). The JOC will meet at critical decision
points in the program, but no less than two (2) times per year, preferably
face to face or alternatively by Video and/or telephone conference. Ad hoc
meetings will be organized when urgent matters arise or prior to theexercising of an Option. The JOC will consist of two (2) voting members eachfrom the Consortium and BARDA and non-voting members from theConsortium 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 toreprioritize specific projects and resources within the scope of thisAgreement 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 Projector identified through written notification to the other Party.
2. Kick-off and Quarterly PMO Steering Committee. A kick-off meeting of PMO
Steering Committee will be held within forty-five (45) days of the Effective
Date; the13Consortium 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 andBARDAshall participate in meetings to coordinate the performance of theAgreement. These meetings may include face-to-face meetings inWashington, D.C. or at work sites of the Consortium Members. Suchmeetings may include, but are not limited to, meetings with the Consortium
Members to discuss study designs, site visits to Consortium Member
facilities, and meetings with the Consortium and HHS officials to discuss thetechnical, financial, regulatory and ethical aspects of the program. Thesemeetings will also formulate and endorse the activities for the subsequent
three (3) months. In order to facilitate review of Program activities, it isexpected that the Consortium will provide Data, reports, and presentations
to groups of outside 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 a face-to-face meeting.
3. Integrated Program Review (IPR) Meetings. On an annual basis or by aneventdriven need, and with a minimum of sixty (60) days advanced notice,prior to the exercise of additional effort to the Agreement, the Government
may invite the Consortium 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 to assess 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 havearisen, and the key activities planned for the ensuing reporting period. The
PI/PML may choose to include other key personnel on the conference call togive 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.

14

5. Cost Share Determination (CSD) Meeting: Either by conference call orinperson, between the OTAO, and/or the OTAS, OTTR and the PI/PML will
discuss and review cost share contributions of the Agreement. During thismeeting, 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 be scheduled on an ad-hoc basis after thereceipt of study data, FDA feedback and/or future public health scenariosthat will guide in the activation of future elements of the Agreement. The
recipient will submit to the Government meeting minutes and a revised
budget (if applicable) as result of discussions.
C.
Document Review: Subject to other provisions specified in thisAgreement (see for example Attachment 2), the PML/PI shall notify the OTTR andOTAO of formal andinformal correspondence with the Food and Drug Administration (FDA) or otherregulatory agencies as specified in Attachment 2. The PI/PML shall provide theGovernment sufficient opportunity to review study protocols, reports, and FDA
correspondence. The Government’s comments on these documents will be viewed
as advisory 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 thefollowing representatives of the Parties:
Government Points of Contact:
Other Transaction Agreement Officer (OTAO):(b) (6)CBRN Advanced Research and Development(b) (6)

Other Transaction Agreement Specialist (OTAS):(b) (6)
OTAS, CBRN Advanced Research and Development(b) (6)15

Other Transaction Agreement Technical Representative (OTTR):(b) (6)
Health Scientist, CBRN Division, BARDA(b) (6)

Alternate OTTR:(b) (6)
Chief, Radiological and Nuclear Countermeasures, CBRN Division, BARDA(b) (6)

Recipient Points of Contact:(b) (4), (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 this Agreement may change at any time due to alterations indevelopment 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 sharedcosts or resources will be estimates and will be non-binding, with the exceptionof the Base Period costs discussed in Article VI, Section B and Article VI, Section C
below.
16

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. For those Consortium Members’
with government-approved rates, budgets will be updated at least once a year toreflect changes to those indirect rates, which are updated annually and shall be
set at government-approved provisional rates for the forthcoming year. Any ratechanges that increase the total 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 and approval by the OTAO of the budget andproject scope. Direct labor will be charged based on effort reports from
Consortium personnel who will track their time in the Consortium Member's
standard timekeeping system. These personnel allocate their effort to specificprojects and activities, but the time can be recorded per standard practices ofConsortium Members, and does not require manager review or approval. Once
Government approved provisional billing rates are established for any given year,
revised retrospective indirect rate reconciliation will not be required for thatyear.
Pricing for other sectors (Medical Device or Consumer) or Consortium Members
without government-approved rates, shall be proposed and negotiated as thesecompanies or Assets are added to the Agreement, after agreement by the OTAO.
Certain Assets may be added to the Agreement using non-rate-based budget
structures. Recipient agrees total cost of activities performed under thisagreement will not exceed total obligated amount.
Charges made Under this Agreement may include:
1.
Direct materials and supplies that are used in the performing of
the work provided for under this Agreement, including those purchased
for sub-recipients and purchase orders.
a. Travel Costs – Recipient will not seek reimbursement of travel
costs for the Recipient and Johnson & Johnson (J&J)
Consortium Members. The Recipient may seek reimbursementof travel costs for Subrecipients or Non-J&J Consortium
Members in accordance with the applicable J&J Travel Policy.
The current J&J Travel Policy will be provided to the OTAO on
17

an annual basis; any changes to the spending limits in the J&J
travel policy will be provided to the OTAO for information
purposes. Following OTAO review of the changes in spending
limits, OTAO may reopen negotiations regarding the allowablereimbursement of travel costs under this Agreement.
2.
Labor, including supervisory, that is properly chargeable directly
to the Agreement, and inclusive of fringe benefits
3.

Indirect Costs

Other items as agreed upon by the Parties may be included by modification tothis 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 describedin Attachment 1 during the term of the base and option periods of theAgreement. The Recipient Global Cost Share of (b % represents the Recipient's)
estimated contribution as a percentage of the Global
Cost during the Base Period(4)of the Agreement. Unless otherwise approved by the OTAO, at no time on anannual basis during this Agreement will the Recipient’s Global Cost Share be
below (b % of the total estimated cost of the Agreement. Upon mutual decision)
between
The Government and the Recipient, the Recipient’s Global Cost Share(4)
may increase due to accomplishments and/or milestones being performed Under
this Agreement. The table as shown below represents the Recipient’s total
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 reestablished under any of these scenarios through a CSD meeting. A schedule
outlining the cost share allocation of each CLIN exercised under this Agreement
will be submitted to the OTAO/OTAS before exercise of those respective CLINs.
This schedule and allocation will be reviewed by the OTAO/OTAS and accepted inwriting in advance of any CLIN being exercised.

18

(b) (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, at least once a year, in alignment with the timing of a JOC meetingand the timing for exercise of Options, Recipient will provide financial
information to the OTAO identifying the total charges made during theperformance of this Agreement with a budget update for future 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.

19

ARTICLE VII: OBLIGATION AND PAYMENT
A.

Obligation
1.
The Government’s obligation to make payments to Recipient islimited to only those funds described in the Agreement or by modification
to the Agreement. The Government is obligated to fund the amount of(b) (4)(b) (4)for CLIN 0027 for a total Government obligation of (b) (4). 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 funded by the Government.
2.
If modification of the payment terms or schedule becomes
necessary in performance of this Agreement, pursuant to Article III,
Section C, the ASPR OTAO and PML/PI Administrator shall make revisions
to this Agreement and any attachments hereto consistent with the thencurrent Program Plan.
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 havebeen made for receiving, distributing and accounting for the funds dispersed
Under this Agreement. An acceptable accounting system is one in which all cash
receipts and disbursements are controlled and documented properly.
Properly prepared invoice(s) shall be submitted by Recipient for payment not
more than once per quarter in Adobe Acrobat (.pdf) format. The invoice shall be
uploaded to a shared 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 be required 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 inorder to be deemed properly prepared:a.

Name and address of Recipient

20

b.

Invoice Date and Invoice Numberc.

Agreement Numberd.

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

Recipient Cost Sharef.
g.

Name and address of OTAR official to whom voucher is to be sent
Name, title, phone number, and mailing address of person to notify in theevent of 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.
Unless otherwise specified by the OTAO all deliverables and reports furnished to
the Government 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(as applicable) to show any amounts suspended by the Government.
The Recipient will convert foreign currency costs to US Dollars each quarter using
the spot exchange rate published by Reuters at 4 PM ET on the last working dayof each quarter as specified in the invoice submitted for reimbursement.
The Recipient will email the invoice to PSC_Invoices@psc.hhs.gov promptly after
receiving email approval from the OTAO or OTAS that the invoices has beenreviewed and approved for further processing.
The Recipient agrees to promptly notify the OTAO and OTAS in writing if there isan anticipated 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 for the variance.
The Government will pay all proper invoices in US dollars within 30 days ofreceipt or pay interest on any amounts due in accordance with the Prompt
Payment Act.

21

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 that are reasonable in nature and amount, and allocable to thisAgreement.
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 thisAgreement, whichever occurs earlier, the Recipient Administrator shall furnish to
the OTAO a copy of the Final Report required by Attachment 2, Part E.
Recipient’s relevant financial records are subject to examination or audit by theGovernment for a period not to exceed three (3) years after expiration of theterm of this Agreement. The OTAO or designee shall be provided direct access to
sufficient records and information of Recipi ent, to ensure accountability forfunding Under this Agreement. Such audit, examination, or access shall be
performed during business hours on business days upon prior written notice andshall 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 andthe right to examine records of any Consortium Member participating in theperformance of this Agreement for a period of three (3) years after final
payment is made. This requirement shall not apply with respect to any
Consortium Member that participates in the performance of the Agreement thathas not entered into any other Agreement(contract, grant, cooperative agreement, or “other transaction”) that provides
for access by a Government entity in the year prior to the date of thisAgreement. This paragraph only applies to any record that was created or
maintained in the ordinary course of business or pursuant to a provision of law inthe performance of the Agreement. Recipient and Consortia Members shallensure that their sub-recipients’ agreements are consistent with this Article.

22

ARTICLE VIII: DISPUTESA.

GeneralThe Parties shall communicate with one another in good faith and in atimely and cooperative manner when raising issues under this Article.

B.

Dispute Resolution Procedures
1.
Any claim or dispute between HHS and Consortium concerningquestions of fact or law arising from or in connection with thisAgreement, and, whether or not involving an alleged breach of thisAgreement, shall only be raised under this Article.
2.
Whenever legal disputes or claims arise, the Parties shall attempt
to resolve the issue(s) by discussion and come to mutual agreement on a
resolution as soon as practicable. In no event shall a dispute,disagreement or misunderstanding that arose more than three (3)months prior to the notification made under Article VIII, sub-section B.3of this article constitute the basis for relief under this article unless one
level above the OTAO, in the interests of justice, waives this requirement.
3.
Failing resolution by mutual agreement, the aggrieved Party shalldocument the dispute, disagreement, or misunderstanding by notifying
the other Party (through the OTAO or Consortium’s Administrator, as thecase may be) in writing of the relevant facts, identifying unresolved
issues, and specifying the 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 Secretaryfor Preparedness and Response (ASPR) Head of Contracting Activity, andsenior executive appointed by Consortium. The other Party shall submit awritten 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 shallconduct a review of the matter(s) in dispute and render a decision inwriting within thirty (30) calendar days of receipt of such written position.
Any such joint decision is final and binding.
4.
In the absence of a joint decision, upon written request to the
Senior Procurement Executive (SPE) made within thirty (30) calendar daysof the expiration of the time for a decision under Article VIII, sub-section
B.3 above, the dispute shall be further reviewed. The SPE may elect to23

conduct this review personally or through a designee or jointly with asenior executive appointed by Consortium. Following the review, theChief Acquisition Officer or designee will resolve the issue(s) and notify
the Parties in writing. Such resolution shall be final 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 thisAgreement, recipient shall have the right to appeal or pursue any
Agreement dispute arising Under this Agreement at the Court of Federal
Claims or, if applicable, the Court of Appeals for the Federal Circuit or theSupreme 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 thisAgreement 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 Party be liable for claims for consequential, punitive,
special and incidental damages, claims for lost profits, or other indirect
damages.

ARTICLE IX: PATENT RIGHTS
A.

Allocation of Principal Rights
Unless Recipient notifies the Government that Recipient does not intend
to retain title, Recipient or its designee shall retain the entire right, title,
and interest throughout the world to each Subject Invention and patentrights thereon consistent with the provisions of this Article and 35 U.S. §202.
Recipient or its designee shall retain title of all other Inventions andpatent rights thereon made in the performance of this Agreement.

24

B.

Invention Disclosure, Election of Title, and Filing of Patent Application
1.
Recipient shall identify Subject Inventions in the annual report andthe final report as specified in Attachment 2, which shall be in sufficiently
complete technical detail to convey a clear understanding to the extent
known at the time of 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 tofile 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 that is 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 to which 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 filepatent 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 withinsixty (60) calendar days after learning of the failure of Recipient todisclose within the specified times, and Recipient fails to report such
Subject Invention within sixty(60) calendar days of such written notice (the “Cure Period”). HHS shallhave sixty (60) days from the end of the Cure Period in which to claim
title. For the avoidance of doubt, disclosure under this paragraph shall bedeemed to have occurred at the time of Recipient’s written notification to
the Government of a Subject Invention regardless of whether such25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 the prosecution of such patent application, or to pay the
maintenance fees on or defend in reexamination or opposition
proceedings of such a patent.
D.

Minimum Rights to Consortium and Protection of Consortium’s Right to File
1.
Recipient shall retain a nonexclusive, royalty-free license
throughout the world in each Subject Invention and patents and patentapplications 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 the right to grant licenses of thesame scope to the extent that Recipient was legally obligated 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 with theapproval of HHS, except when transferred to the successor of that part ofthe business to which the Subject Invention pertains. HHS approval forlicense transfer shall not be unreasonably withheld.
2.
The Recipient license may be modified by HHS to the extent
necessary to achieve diligent Practical Application of the Subject
Invention pursuant to an application for an exclusive or non-exclusive
license submitted consistent with appropriate provisions at 37 CFR Part
404 if Practical Application of such Subject Invention has not alreadybeen 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 beallowed 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 the26Government 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 theGovernment to obtain patent protection throughout the world in that
Subject Invention.
2.
Recipient agrees to require, by written agreement, its employees,
other than clerical and non-technical employees, to disclose promptly in
writing, to personnel identified as responsible for the administration ofpatent matters and in 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 other suitable educational programs,
on the importance of reporting Subject
Inventions in sufficient time to permit the filing of patent applications
prior to US statutory bars.
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
the expiration of the response period required by the relevant patentoffice.
4.
Recipient shall include, within the specification of any UnitedStates patent application and any patent issuing thereon claiming a
Subject Invention, the following statement: “This invention was madewith Government support
under Agreement HHSO100201800012C, awarded by HHS. The
Government has certain rights in the invention.”F.

Lower Tier Agreements
Recipient shall include the substance of Article IX, suitably modified, in its
agreements with sub-recipients for experimental, developmental, or
research work Under this Agreement.

27

G.

Reporting on Utilization of Subject Inventions
1.
Recipient shall submit, during the term of the Agreement, in theannual report as specified in Attachment 2, information on the utilizationof Subject Inventions or on efforts at obtaining such utilization that are
being made by or on behalf Recipient or its licensees or assignees. Such
reports will include information regarding the status of development,
date of first commercial sale or use, and such other data and information
as HHS may reasonably specify. Recipient shall provide additional reports
as may be requested by HHS in connection with any march-in proceedings
undertaken by HHS in accordance with section H of this Article.
Consistent with 35 U.S.C. § 202(c) (5), HHS agrees it shall not disclosesuch information to persons outside the Government without permissionof Recipient. No such reporting shall be required for Subject Inventions if
all patents or patent applications claiming such Subject Inventions havebeen 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, andOTTR.
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 is achieved with respect to:a. such drug or vaccine, (b) (4)orb. such method of use, if the method of use is employed in
manufacture, administration or use of such drug or vaccine inconnection (b) (4).
4.
Where the Subject Invention is a biologic or medical device as
regulated by the Food and Drug Administration that requires a clinicalstudy 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:a. such biologic, (b) (4); or28

b. such method of use, if the method of use is employed in
manufacture, administration or use of such biologic in connection(b) (4).
c. such medical device, if (b) (4); ord. such method of use, if the method of use is employed in
manufacture, administration or use of such medical device (b
)
(4
)

5.
Failure to complete (b) (4)does not per seconstitute a failure to achieve Practical Application.
H.

March-in Rights
Recipient agrees that, with respect to any Subject Invention in which it
has retained 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 theirlicensees or their Affiliates have not taken steps, consistent with theintent of this Agreement, to achieve Practical Application of the Subject
Invention; or2.
Such action is necessary to alleviate the following urgent health orsafety 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;b. determination that there is a significant potential for a public
Health emergency that has a significant potential to effect a nationalor health security of U.S. citizens as determined by the Secretary of
HHS; orc. declaration by WHO Director General of a public healthemergency of international concern.
29

3.
Where the circumstances described in subsection H.2 are met,
Recipient will act promptly to negotiate in good faith with the responsible
third party a nonexclusive license on terms that are reasonable under thecircumstances under the SI Intellectual Property Rights it controls at thetime to make, have made, use, sell, offer for sale and import the relevant
Subject Invention in the Field to the extent necessary to alleviate thepublic health emergency in the United States.

ARTICLE X: DATA RIGHTS
A.

Allocation of Principal Rights
1.
The Government will receive Limited Rights in Data delivered in
the performance of the SOW that is marked with the "Limited Rights"
legend required by Article X, Section C below. Any delivered Data which ispart of a patent application claiming a Subject Invention will be subject tothe disclosure and release restrictions set forth in Article IX, Section B ofthis Agreement.
2.
The Government may not, without the prior written permission of
Recipient, release or disclose Data outside the Government, use Data forcompetitive procurement or manufacture, release or disclose Data forany purpose, or authorize Data to be used by another party. The
Government will be able to share Data within the Government provided
that the Government recipient is obligated to keep the information
confidential. The Government shall inform all Government recipients ofData of the relevant restrictions of this Agreement. Data in any document
which is a part of a patent application that would disclose a 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 inaccordance with the Recipient's established record retention practices. In
the event of exercise of the Government’s March-in Rights as set forth
under Article IX, Section H, Recipient agrees, upon written request andwith adequate additional support from the Government, as mutuallyagreed between the Parties, to deliver Data necessary to achieve Practical
Application with respect to use of the Subject Invention in the Field within

30

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 theright under Recipient's established business policies to make publicresearch data (especially human research data) by publication in thescientific literature, by making trial protocols, trial results summaries, andclinical 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.

Marking of Data
Pursuant to Article X, Section A above, any Data delivered Under thisAgreement 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 agreement of 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 withsubrecipients for experimental, developmental, or research work
performed Under this Agreement.

ARTICLE XI: FOREIGN ACCESS TO TECHNOLOGYa.
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 theperformance of this Agreement, any supplies or services if any proclamation,
31

Executive order, or statute administered by OFAC, or if OFAC’s implementing
regulations at 31 CFR chapter V, would prohibit such a transaction by a person
subject to the jurisdiction of the United States.
b.
Except as authorized by OFAC, most transactions involving Cuba, Iran, andSudan are prohibited, as are most imports from Burma or North Korea, into theUnited States or its outlying areas. Lists of entities and individuals subject toeconomic sanctions are included in OFAC’s List of Specially Designated Nationals
and Blocked Persons at http://www.treas.gov/offices/enforcement/ofac/sdn/.
More information about these restrictions, 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
sub-agreements.
ARTICLE XII: TITLE TO AND DISPOSITION OF PROPERTY
A.

Title to Property

Title to each item of Property acquired Under this Agreement with an acquisition
value of $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 prior written approval of the OTAO. Title to this Property
shall also vest in Recipient and HHS upon acquisition in accordance with the costshare of the acquisition. Recipient shall be responsible for the maintenance,
repair, protection, and preservation of all Property at its own expense. For allproperty generated during the execution of work in performance of the Program,
title will vest with the Government, unless in the case of clinical 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
the course of the Agreement will be handled in the same manner described in
Article XII, Section B.

32

B.

Disposition of Property

At the completion of the term of this Agreement, items of Property with anacquisition 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 withan agreed upon markdown due to the Recipients care of the property,
with the proceeds of the sale being returned to HHS; or
2.
Transferred to a Government research facility with title andownership 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-RECIPIENT
For any Sub-recipient in excess of $250,000 that will be reimbursed Under thisAgreement, Recipient will provide BARDA the opportunity to review the subject Subrecipient agreement ten (10) Business Days before execution. The Sub-recipientagreement shall include the nature of the work that the sub-recipient is going toperform, an estimated period of performance and the proposed costs for the work.
Recipient will provide OTTR, OTAO, OTAS and OTTS with an electronic copy of the Subrecipient 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 Governmentcomments before executing an Agreement with a Sub-recipient. If the Government
does provide comments within 10 Business Days, the Recipient will not proceed with the
Sub-recipient Agreement until an agreement between Recipient and Government isreached.

ARTICLE XIV: CIVIL RIGHTS ACTPerformance of this Agreement in the US is subject to the compliance requirements ofTitle VI of the Civil Rights Act of 1964 as amended (42 U.S.C. 2000-d) relating to33

nondiscrimination in Federally assisted programs. Recipient has signed an Assurance ofCompliance with the nondiscriminatory provisions of the Act.

ARTICLE XV: EXECUTION
This Agreement constitutes the entire agreement of the Parties and supersedes all priorand contemporaneous agreements, understandings, negotiations and discussions
among the Parties, 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 whichshall be deemed as original, but all of which taken together shall constitute one and thesame instrument.

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 thisAgreement
2.
For the purpose of this Section, the designated OTTR is theauthorized representative of OTAO. The OTTR will assist in resolving
technical issues that arise 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.
Inspection and acceptance will be performed at the Recipient’s
facilities or at:
Biomedical Advanced Research and Development Authority (BARDA)
and/orContract Management and Acquisition (CMA) under the Office of theAssistant
Secretary for Preparedness and Response U.S. Department of Health andHuman Services
34

B.

PROTECTION OF HUMAN SUBJECTS1.
The Recipient agrees that the rights and welfare of humansubjects involved in research Under this Agreement shall be protected inaccordance with 45 CFR Part 46 and with the Recipient’s current
Assurance of Compliance on file with the Office for Human ResearchProtections (OHRP), Office of Public Health and Science (OPHS). The
Recipient further agrees to provide certification at least annually that theInstitutional Review Board has reviewed and approved the procedures,
which involve human subjects in accordance with 45 CFR Part 46 and theAssurance of Compliance.
2.
The Recipient shall bear full responsibility for the performance of
all work and services involving the use of human subjects Under thisAgreement and shall ensure that work is conducted in a proper mannerand 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 this Agreement shall be deemed to constitutethe Recipient or any sub Recipient, agent or employee of the Recipient, or
any other person, organization, institution, or group of any kindwhatsoever, as the agent or employee of the Government. The Recipientagrees that it has entered into this Agreement and will discharge its
obligations, duties, and undertakings and the work pursuant thereto,whether requiring professional judgment or otherwise, as anindependent consortium while holding the Government harmless for theacts of the Recipient, any subrecipients, or their employees.
3.
If at any time during the performance of this Agreement, the ASPROTAO determines that the Consortium is not in compliance with any oftherequirements and/or standards stated in Article XVI, Section B,
subsections 1 and 2 above, the ASPR OTAO may immediately suspend, inwhole or in part, 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 theConsortium 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 the Recipient’s
name may be removed from the list of those consortiums with approved
Health and Human Services Human Subject Assurances.
35

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 in full compliance with applicable federal, state and local
laws and the provisions of the Uniform Anatomical Gift Act in the UnitedStates, and no undue inducements, monetary or otherwise, will beoffered 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 subrecipients identified
Under this Agreement, were obtained with prior approval by the OHRP ofan Assurance to comply with the requirements of 45 CFR 46 to protect
human research subjects. This restriction applies to all collaborating sites
without OHRPapproved Assurances, whether domestic or foreign, andcompliance 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 Identification/IRB
Certification/Declaration of Exemption", Form OMB No. 09900263(formerly Optional Form 310), certifying IRB review and approval of
the protocol from which the human materials were obtained constitutes
the written documentation required. The human subject certification canbe met by submission of a self-designated form provided that it contains
the information required by the "Protection of Human Subjects Assurance
Identification/IRB Certification/Declaration of Exemption", Form OMB No.
0990-0263(formerly Optional Form 310).

D.

RESEARCH INVOLVING HUMAN FETAL TISSUE
All research involving human fetal tissue shall be conducted inaccordance with the Public Health Service Act, 42 U.S.C. 289g-1 and 289g2. Implementing regulations and guidance for conducting research on
human fetal tissue may be found at 45 CFR 46, Subpart B andhttp://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

36

289g-1(b) and (c), or ensure HHS access to those records, if maintained byan 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 ofAgriculture 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 theregistration 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 Use of Laboratory Animals prepared by theInstitute of Laboratory Animal Resources and the pertinent laws andregulations of the United States Department of Agriculture ( 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 this Agreement, the ASPROTAO’s determines, in consultation with the Office of Laboratory Animal
Welfare (OLAW), National Institutes of Health (NIH), that the Recipient is
not in compliance with any of the requirements and/or standards statedin paragraphs (1) through (3) above, the ASPR OTAO’s may immediately
suspend, in whole or in part, work and further payments Under thisAgreement until the Recipient corrects the noncompliance. Notice of thesuspension may be communicated by telephone and confirmed in writing.
If the Recipient fails to complete corrective action within the period oftime designated in the OTAO’s written notice of suspension, the ASPROTAO’s may, in consultation with OLAW, NIH, terminate this Agreementin whole or in part, and the Recipient’s name may be removed from thelist of those consortiums with approved PHS Animal Welfare Assurances.

37

Note: The Recipient may request registration of its facility and a current listing oflicensed dealers from the Regional Office of the Animal and Plant HealthInspection 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 this program 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 accordancewith the Public Health Service Policy on Humane Care and Use of Laboratory
Animals. This policy may be accessed at:
http://grants1.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://www1.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 forthe 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/olaw/olaw.htm. An essential requirementof the PHS Policy http://grants2.nih.gov/grants/olaw/references/phspol.htm isthat 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 animalcare and use 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)38http://www.nal.usda.gov/awic/legislat/usdaleg1.htm issued by the U.S.
Department of Agriculture (USDA) under the Animal Welfare Act. The 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.
Those that meet the high standards are given the accredited status. As of the2002 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 primaryevaluation 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 and Development Authority (BARDA) shall not be expended by the
Recipient for research involving live vertebrate animals, nor shall live vertebrate
animals be involved in research activities by the Recipient under this award
unless a satisfactory assurance of compliance with 7 U.S.C. 2316 and 9 CFR
Sections 2.25-2.28 is submitted within 30 days of the date of this award andapproved 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
not directly involve live vertebrate animals (i.e. are clearly severable andindependent from those 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 beobtained via the Internet at
http://grants2.nih.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
this Agreement until the Recipient and any affected sub Recipients are granted a39certificate of registration or are authorized to work with the applicable selectagents.
For prime or sub-recipient awards to domestic institutions who possess, use,
and/or transfer Select Agents under this sub-recipient, the institution mustcomplete 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 work involving Select Agents, in accordance with
42 CFR 73. No Government funds can 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/or transfer 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 applicable laws, regulations
and policies equivalent to 42 CFR 73. The Government will assess the policies andprocedures for comparability to the U.S. requirements described in 42 CFR Part
73. When requested by the OTAO, the consortium shall provide key information
delineating any laws, regulations, policies, and procedures applicable to theforeign institution for the safe and secure possession, use, and transfer of SelectAgents. This includes summaries of safety, security, and training plans, andapplicable laws, regulations, and policies. For the purpose of security risk
assessments, the consortium must provide the names of all individuals at theforeign institution who will have access to the Select Agents and procedures for
ensuring that only approved and appropriate individuals have access to SelectAgents under the Agreement.
Listings of HHS select agents and toxins, biologic agents and toxins, and overlap
agents or toxins as well as information about the registration process, can beobtained on the Select Agent Program Web site at http://www.cdc.gov/od/sap/.

40

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 be administered to human subjects Under this Agreement.
If at any time during the life of this Agreement, the Recipient fails to comply withcGMP in 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 shallhave thirty (30) calendar days from the time such material failure is identified tocure such material failure. If the Recipient fails to take such an action within thethirty (30) calendar day period, then the Agreement may be terminated.
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, andreagents.
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 withcGMP guidelines and/or the facility receives a negative FDA Quality Assurance
Evaluation (Form 483).
N.

ANTI-BRIBERY AND ANTI-CORRUPTION

Each Party agrees to perform its obligations Under this Agreement in accordancewith the applicable anti-bribery and anti-corruption laws of the territory in whichsuch 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 withthe terms of this Agreement, to terminate this Agreement immediately on
written notice to the other Party, if the other Party fails to perform its material
obligations in accordance with this Article XVI, Section M.

41

O.

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, noGovernment representative shall publish, divulge, disclose or make known in any
manner, or to any extent not authorized by law, any information disclosed to that
person in the course of employment or official duties performed while stationed
in a Recipient facility.
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 tollfree number is 1-800-HHS-TIPS (1-800-447-8477). All telephone calls will behandled confidentially. The e-mail address is Htips@os.dhhs.gov and the mailingaddress is:
Office of Inspector
GeneralDepartment of
Health and Human
Services
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 provisionof resources and support to, individuals and organizations associated withterrorism. It is the legal responsibility of the Recipient to ensure compliance with42

these Executive Orders and Laws. This clause must be included in all subagreements issued Under this Agreement.

ARTICLE XVII: TRANSFERS & ASSIGNMENTS
Any transfer or assignment will be conducted in a manner consistent with theAssignment of Claims Act (31 U.S. Code § 3727) and the Prohibition on transfer ofAgreement and certain allowable assignments (41 U.S.C.A. § 6305, the “Anti-AssignmentAct”). In the event there is a transfer to an independent 3rd 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
outside of, but potentially relevant to, the scope of work being performed under the
Agreement. The Parties may use Confidential Information submitted hereunder for
purposes of the Agreement, but for no other purpose. It is expressly agreed that theGovernment is not granted 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 ofConfidential 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 theAgreement, and is subject to the restrictions of this provision.

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 thelaw.

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;or shall provide written notice to the receiving Party within thirty (30) days of disclosure43

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
the Recipient’s responsibility to identify that information which is deemed confidential.
Notwithstanding the foregoing, information of a personal nature about an individual
shall be treated 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 of Agreement HHS0100201800012C, and may notdisclose 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 theAgreement.

44

(b) (4)Non-responsive.
(b)(4)
Does not relate to COVID. (b)(4)

Non-responsive.
(b)(4)
Does not relate to COVID. (b)(4)

Non-responsive.
(b)(4)
Does not relate to COVID. (b)(4)

Non-responsive.
(b)(4)
Does not relate to COVID. (b)(4)

Non-responsive.
(b)(4)
Does not relate to COVID. (b)(4)

Non-responsive.
(b)(4)
Does not relate to COVID. (b)(4)

Non-responsive.
(b)(4)
Does not relate to COVID. (b)(4)

Non-responsive.
(b)(4)
Does not relate to COVID. (b)(4)

Non-responsive.
(b)(4)
Does not relate to COVID. (b)(4)

Non-responsive.
(b)(4)
Does not relate to COVID. (b)(4)

Non-responsive.
(b)(4)
Does not relate to COVID. (b)(4)

Non-responsive.
(b)(4)
Does not relate to COVID. (b)(4)

Non-responsive.
(b)(4)
Does not relate to COVID. (b)(4)

Non-responsive.
(b)(4)
Does not relate to COVID. (b)(4)

Non-responsive.
(b)(4)
Does not relate to COVID. (b)(4)

Non-responsive.
(b)(4)
Does not relate to COVID. (b)(4)

Non-responsive.
(b)(4)
Does not relate to COVID. (b)(4)

Non-responsive.
(b)(4)
Does not relate to COVID. (b)(4)

Non-responsive.
(b)(4)
Does not relate to COVID. (b)(4)

Non-responsive.
(b)(4)
Does not relate to COVID. (b)(4)

Non-responsive.
(b)(4)
Does not relate to COVID. (b)(4)

Non-responsive.
(b)(4)
Does not relate to COVID. (b)(4)

Non-responsive.
(b)(4)
Does not relate to COVID. (b)(4)

Non-responsive.
(b)(4)
Does not relate to COVID. (b)(4)

Non-responsive.
(b)(4)
Does not relate to COVID. (b)(4)

Non-responsive.
(b)(4)
Does not relate to COVID. (b)(4)

Non-responsive.
(b)(4)
Does not relate to COVID. (b)(4)

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 theinvoice cycle.

Delivery Date

Deliver To

th

The 15 of each month, except
on the Agreement anniversary
month when an Annual
Report is to be submitted in lieu
of a monthly 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
following each PMO Steering
Committee /site visit

5. Bi-annually JOC minutes

Within ten (10) Business Days
following each JOC

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

Within ten (10) Business Days
following 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-clinical or No later than ten (10)clinical trial
Business Days before
submission to the FDA

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

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

73

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

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

10. Manufacturing 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 funded activities such as
Process Development Report, Assay
Validation Plan/Report, Assay Technology
Transfer Report, Batch Records, SOPs,

Within 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 andnext steps. BARDA reserves the right toparticipate in the audits.

Within five (5) Business Days ofreport completion

13. Formal FDA Submissions for activities No later than ten (10)to be performed Under theBusiness Days before
Agreement
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 pertaining
to activities Under the Agreement

Within two (2) Business Days ofreceipt from FDA

16. Minutes for Formal Meetings with FDA Within two (2) Business Days ofpertaining to activities Under thereceipt from FDA
Agreement74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 than Agreement
expiration

19. Incident Report for any criticalprogrammatic concerns, risks or potentialrisks

Within ninety-six (96) hours ofincident

OTAO/OTAS and OTTR via
e-mail or telephone

20. Raw Data and Analysis Pertaining
generated in the performance of theProgramWithin a reasonable time 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 Enrollment Reporting andUpdates to support the BARDA Clinical
Trial Database

Submitted monthly as part oftechnical report

23. Quality Agreements with SubRecipients

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

OTAO/OTAS and OTTR via
e-mail

24. Publications/Presentations

No later than thirty (30)
calendar days before
submission for publications
and fifteen (15) calendar days

OTAO/OTAS and OTTR via
email

25. Subject Invention Report / Annual
Utilization Report

Due on or before the 30th ofthe month following each
12month period of
performance

OTAO/OTAS and OTTR via
e-mail.

26. Kick-Off Meeting

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-mail.

75

27.Program Plan

Due 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 least once
during a 12-month period.

OTAO/OTAS and OTTR via
e-mail.

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.

Monthly/Quarterly Reports
On or before ninety (90) calendar days after the Effective Date and monthly thereafter
throughout the term of the Agreement, Recipient shall submit 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 shall be submitted or otherwise provided to the ASPR OTAO. The reportwill have two (2) major sections.
1.
Technical Status Report. The technical status report will detail technical progress todate and report on all problems, technical issues, major developments, and the status ofexternal collaborations during the reporting period.
2.
Business Status Report. The Business Status Report will 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, including 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%, shall be
explained along with discussions of the adjustment actions proposed. The report will also
include an accounting of any interest earned on Government funds. Recipient is reminded thatinterest in amounts greater than $250 per year is not expected to accrue Under thisAgreement. In the event that this interest does accrue on Government funds, Recipient isrequired to provide an explanation for the accrual in the business report. Depending on thecircumstances, the Payable Milestones may require adjustment.

76

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 B. 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 disclosure of all
major developments by Recipient and Subject Inventions upon completion of the Agreement
or within sixty (60) calendar days of termination of this Agreement. With the approval 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 orotherwise 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 the extent 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 placewith the following marking:“DISTRIBUTION STATEMENT B. 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 be referredto 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

77

pursuant to Section 319L(c)(5) of the Public Health Service Act, 42 USC 247d-7e(c)(5). 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.

78

Non-responsive.
(b)(4), (b) (6)Does not relate to COVID. (b)(4)

BARDA (b) (4)(b) (4)

Diagram:(b) (4)(b) (6)(b) (6)(b) (4)(b) (6)(b) (6)(b) (6)(b) (4)80

ATTACHMENT 4: J&J GLOBAL TRAVEL, MEETINGS AND EXPENSE POLICY(b) (4)[Remainder of this page intentionally left blank]

81Non-responsive.
(b)(4)
Does not relate to COVID. (b)(4)

Non-responsive.
(b)(4)
Does not relate to COVID. (b)(4)

Non-responsive.
(b)(4)
Does not relate to COVID. (b)(4)

Non-responsive.
(b)(4)
Does not relate to COVID. (b)(4)

Non-responsive.
(b)(4)
Does not relate to COVID. (b)(4)

Non-responsive.
(b)(4)
Does not relate to COVID. (b)(4)

Non-responsive.
(b)(4)
Does not relate to COVID. (b)(4)

Non-responsive.
(b)(4)
Does not relate to COVID. (b)(4)

Non-responsive.
(b)(4)
Does not relate to COVID. (b)(4)

Non-responsive.
(b)(4)
Does not relate to COVID. (b)(4)

Non-responsive.
(b)(4)
Does not relate to COVID. (b)(4)

(b) (4)Non-responsive.
(b)(4)
Does not relate to COVID. (b)(4)

Non-responsive.
(b)(4)
Does not relate to COVID. (b)(4)

Non-responsive.
(b)(4)
Does not relate to COVID. (b)(4)

Non-responsive.
(b)(4)
Does not relate to COVID. (b)(4)

Non-responsive.
(b)(4)
Does not relate to COVID. (b)(4)

Non-responsive.
(b)(4)
Does not relate to COVID. (b)(4)

Non-responsive.
(b)(4)
Does not relate to COVID. (b)(4)

Non-responsive.
(b)(4)
Does not relate to COVID. (b)(4)

Non-responsive.
(b)(4)
Does not relate to COVID. (b)(4)

Non-responsive.
(b)(4)
Does not relate to COVID. (b)(4)

Non-responsive.
(b)(4)
Does not relate to COVID. (b)(4)

Non-responsive.
(b)(4)
Does not relate to COVID. (b)(4)

Non-responsive.
(b)(4)
Does not relate to COVID. (b)(4)

Non-responsive.
(b)(4)
Does not relate to COVID. (b)(4)

Non-responsive.
(b)(4)
Does not relate to COVID. (b)(4)

Non-responsive.
(b)(4)
Does not relate to COVID. (b)(4)

Non-responsive.
(b)(4)
Does not relate to COVID. (b)(4)

Non-responsive.
(b)(4)
Does not relate to COVID. (b)(4)

Non-responsive.
(b)(4)
Does not relate to COVID. (b)(4)

Non-responsive.
(b)(4)
Does not relate to COVID. (b)(4)

Non-responsive.
(b)(4)
Does not relate to COVID. (b)(4)

Non-responsive.
(b)(4)
Does not relate to COVID. (b)(4)

Non-responsive.
(b)(4)
Does not relate to COVID. (b)(4)

Non-responsive.
(b)(4)
Does not relate to COVID. (b)(4)

Non-responsive.
(b)(4)
Does not relate to COVID. (b)(4)

Non-responsive.
(b)(4)
Does not relate to COVID. (b)(4)

Non-responsive.
(b)(4)
Does not relate to COVID. (b)(4)

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Non-responsive.
(b)(4)
Does not relate to COVID. (b)(4)

Non-responsive.
(b)(4)
Does not relate to COVID. (b)(4)

Non-responsive.
(b)(4)
Does not relate to COVID. (b)(4)

Non-responsive.
(b)(4)
Does not relate to COVID. (b)(4)

Non-responsive.
(b)(4)
Does not relate to COVID. (b)(4)

Non-responsive.
(b)(4)
Does not relate to COVID. (b)(4)