DEPARTMENT OF THE ARMY
U.S. ARMY CONTRACTING COMMAND – NEW JERSEYPICATINNY ARSENAL, NEW JERSEY 07806-5000
REPLY TOATTENTION OF
01 September 2020
Army Contracting Command – New Jersey
ACC-NJ, Building 9
Picatinny Arsenal, NJ 07806
SUBJECT: Technical Direction Letter for Medical CRBN Defense Consortium (MCDC), Request
for Prototype Proposals (RPP) 20-04, Objective TRE-20-04, Definitization of “Treatment of COVID19 Using Convalescent Plasma and (b) (4)Anti-SARS-CoV-2 Immune Globulin” (Grifols
Therapeutics, LLC)
REF: Request for Updated Proposal Submitted in Response to RPP 20-04 under OTA W15QKN-169-1002 for Objective TRE-20-04, dated 06 April 2020
Advanced Technology International
ATTN: (b) (6), Sr. Contracts Manager
315 Sigma Drive
Summerville, SC 29486
Dear (b) (6),The Army Contracting Command – New Jersey (ACC-NJ), in supporting the Joint Project Manager– Medical Countermeasure Systems (JPM-MCS), issued MCDC RPP 20-04 on 19 March 2020.
Members of the MCDC submitted proposals in accordance with this RPP. The Government received
and evaluated all proposal(s) submitted and a Basis of Selection has been executed, selecting Grifols
as the awardee. The Government requests that a Firm-Fixed-Price Project Agreement be issued to
Grifols to award this proposal under Other Transaction Agreement W15QKN-16-9-1002, to be
performed in accordance with the attached Government Statement of Work (SOW).
The Government received the undefinitized Rough Order of Magnitude (ROM) proposal update on
07 April 2020, and reviewed the costs and documentation accordingly. Based on the acceptable ROM
proposal update, the Government issued an Undefinitized Project Action (UPA) on 08 April 2020. In
order to definitize the UPA, the Government finalized an analysis of the cost proposal on 31 August
2020, which focused on evaluation of the cost components and documentation. Based upon theacceptable update of Grifols’ proposal for “Treatment of COVID-19 Using Convalescent Plasma andAnti-SARS-CoV-2 Immune Globulin” and 1) The Project Agreement Recipient’s(b) (4)
concurrence with the requirements included in the Government SOW; 2) An acceptable milestoneschedule that meets SOW requirements, and; 3) The Cost Proposal that has been analyzed andnegotiated final by the Government, you are hereby directed to issue a Definitized Project Agreement
to Grifols for the subject project. The total project value has been determined fair and reasonable andGrifols’ proposal has been selected IAW the above referenced Basis of Selection

The total approved cost to the Government for this effort is not to exceed (b) (4)The breakout of the costs is as follows: $12,332,250.00 to perform project efforts included in the SOW and$(b) (4)for the Consortium Management Firm Administrative Cost. The effort is fully funded.
The prime contractor is considered a small business, nontraditional defense contractor, or nonprofit
research institution and determined to be providing a significant contribution. The affirmation ofbusiness status certifications submitted as part of the proposal are hereby incorporated into theagreement. The contractor shall notify the MCDC CMF of any deviation from the final proposed
affirmation of business status certifications that would affect the contributions of the small business,
nontraditional defense contractor, or nonprofit research institution as proposed.
In accordance with 10.U.S.C. 2371b(f), and upon a determination that the prototype project for thistransaction has been successfully completed, this competitively awarded prototype OTA may resultin the award of a follow-on production contract or transaction without the use of competitive
procedures.
In addition, ATI is advised of the implementation guidance for Section § 889(a)(1)(B) of the John S.
McCain National Defense Authorization Act (NDAA) for Fiscal Year 2019 (Pub. L. 115–232), which
prohibits executive agencies from entering into, extending, or renewing a contract with an entity thatuses any equipment, system, or service that uses covered telecommunications equipment or services
as a substantial or essential component of any system, or as critical technology as part of any system.
While the interim rule and Defense Pricing and Contracting (DPC) implementation memorandum
are directed to FAR-based contracts, the § 889(a)(1)(B) prohibition went into effect August 13, 2020,
and applies to Other Transactions (OTs) for Prototype Projects under § 2371b of title 10, UnitedStates Code (U.S.C.). Any OT for Prototype Project agreement on or after August 13, 2020 must
contain an article for the Prohibition on the Use of Certain Telecommunications and Video
Surveillance Services or Equipment that requires the offeror to represent if it uses any equipment,
system, or service that uses covered telecommunications equipment or services.
ATI must receive § 889(a)(1)(B) Certification from the MCDC member prior to executing any new
project agreements or modification to an existing project agreement. A copy of the certification should
be provided to the undersigned.
Points of Contact:
Agreements Specialist:(b) (6)E-mail: (b) (6)Phone: (b) (6)Agreements Officer:(b) (6)E-mail: (b) (6)Phone: (b) (6)Statement of WorkFor

Treatment of COVID-19 Using Convalescent Plasma andAnti-SARS-CoV-2 Immune Globulin (IG)(b) (4)
RPP #: 20-04
Project Identifier: MCDC2004-008
Consortium Member: Grifols Therapeutics LLC
Title of Proposal: Treatment of COVID-19 Using Convalescent Plasma and (b) (4)Anti-SARSCoV-2 Immune Globulin
Requiring Activity: Health and Human Services (HHS), Biomedical Advanced Research andDevelopment Activity (BARDA)
1.0

INTRODUCTION, SCOPE, AND OBJECTIVES

The focus of this project is on the plasmapheresis of Coronavirus Disease 2019 (COVID-19) convalescentdonors, production of (b) (4)anti-SARS-CoV-2 (severe acute respiratory syndrome-coronavirus-2)
immune globulin, and viral inactivation of convalescent plasma for (b) (4)The objective of this project is to rapidly advance treatment for COVID-19 in the clinic, basedon polyclonal antibodies. Previous data indicates that polyclonal antibody treatments can be efficacious
against COVID-19 with rapid clinical recovery. Production of a polyclonal antibody product with (b) (4)to COVID-19, is sought to be manufactured under Good Manufacturing Practices (GMP)(b) (4)and advanced to a COVID-19 efficacy study, likely through the National Institutes of Health (NIH) /National Institute of Allergy and Infectious Diseases (NIAID), or other adaptive randomized controlled
study. This first-in-kind prototype must be produced at levels sufficient (b) (4)with scalable production (b) (4)1.1

Introduction

Following the global spread of COVID-19, the US Government has been working feverishly to, among
other things, identify potential therapeutic candidates to address the pandemic. According to many
estimates, upwards of 50% of the US population may become infected with COVID-19 in the coming weeks
and months. With a hospital admissions rate of approximately 5%, and a mortality rate reported to be close
to 1%, this disease presents an existential challenge to the US healthcare system and many other social
institutions. Without adequate available testing, an effective vaccine or therapeutic, every effort must be
taken to blunt the impact of the disease. This includes the development of clinical therapeutics that can beused to treat those suffering in extremis, to include the warfighter.
Using expertise and resources gained in connection with previous emerging virus outbreaks, such as the2014 Ebola epidemic in West Africa, Grifols will collaborate with the US Food and Drug Administration(FDA) and NIH/NIAID to develop for clinical application, two (2) therapeutic approaches to COVID-19
that depend on the identification and plasmapheresis of individuals who have been infected with, andrecovered from, COVID-19. The two (2) therapeutic approaches include, (1) the direct transfusion of humansource plasma from convalescent donors after viral inactivation (b) (4), and (2) the administration of a (b) (4)Immune Globulin (IG) produced from convalescentdonors, that is rich in SARS-CoV-2 antibodies.
With a network of more than 250 plasma donor centers in the US, Grifols will be responsible for COVID19 convalescent donor screening and plasmapheresis, in accordance with relevant FDA guidelines and1

GMP requirements. Similarly, with its vast experience in plasma fractionation and polyclonal IG
production, Grifols will assume responsibility for the (b) (4)fractionation of convalescent plasma
obtained from donors. Donor identification and referral will be performed (b) (4).
The goal of this project is to develop sufficient human subjects data which, if demonstrative of a clinicallymeaningful benefit to patients suffering with COVID-19, can be used to support the administration of thesetwo (2) approaches in a more routine clinical setting. (b) (4)As drafted, this scope of work
assumes that Grifols bears responsibility for performing plasmapheresis of convalescent donors and either
performing viral inactivation (b) (4)of plasma for transfusion or using that plasma to producea (b) (4)anti-SARS-CoV-2 IG.
If successful, the availability of treatments derived from convalescent donor plasma, such as plasma fortransfusion and (b) (4)anti-SARS-CoV-2 IG, can offer viable treatment options that can help maintaincontinuity of Government, military readiness, and front-line healthcare providers. As the number of
COVID-19 cases in the US continues to grow exponentially, and healthcare systems already report strained
resources, it is essential to move quickly to advance the development of treatments from convalescent donor
plasma. By lending its expertise in GMP compliant plasma collection and production, Grifols offers the US
perhaps the most expedient route to test these promising therapeutics.
1.2

Scope

The scope of this project as it relates to Grifols, consists of performing plasmapheresis of prescreened
COVID-19 convalescent donors, and the subsequent production of a (b) (4)IG from that plasma. It also
includes the collection and storage of COVID-19 convalescent plasma for transfusion following viralinactivation (b) (4). In its entirety, this project proposes a collaborative among
Grifols, the FDA, NIH/NIAID, and the CDC, with a funding mechanism coordinated through the
Biomedical Advanced Research and Development Authority (BARDA). Each member in the collaborative
has predefined roles, with the ultimate objective of producing clinical therapeutics to treat COVID-19
infection.
The duration of the prototype project is not yet fully determined. However, pursuant to this agreement,
Grifols agrees to make available for a period of not more than (b) (4), its plasma collection
infrastructure and (b) (4)production facility in Clayton, North Carolina, to support National efforts tocombat COVID-19 infection. Similarly, Grifols agrees to make available its (b) (4)virus inactivation technology for plasma, for transfusion to support the same objective of combating
COVID-19 infection. Availability of Grifols plasma collection infrastructure, (b) (4)production
facility, and (b) (4), is dependent on the demand for such products, as stated by US
national authorities, including FDA, NIH/NIAID, CDC and others.
The initial term for this agreement is (b) (4), subject to extension by mutual consent. Thisagreement notwithstanding, nothing contained herein gives the US any ownership or interest in Grifols or
its assets. Further, this agreement does not confer to the US any right to demand performance under thisagreement in any respect and in particular, not to the detriment of Grifols day-to-day operations, except
insofar as Grifols and the US mutually agree.

2

1.3

Objective

The objective of this project is to utilize Grifols expertise in plasma collection and manufacturing to provide
virally in-activated convalescent plasma for transfusion, (b) (4)and (b) (4)anti-SARSCoV-2 IG, for use in the clinical setting to combat the deadly effects of the COVID-19 pandemic.
Grifols will deploy its deep expertise and vast resources to support the collection of plasma fromconvalescent donors, from among any number of its existing FDA licensed plasma donor centers. Further,production facility that operates under GMP, Grifols will produce (b) (4)using (b) (4)anti-SARS-CoV-2 IG, using as the basis for its production methodology, the FDA licensed processes for
manufacture of its commercially licensed polyvalent IG therapies.
The deliverables for this project include (b) (4)anti-SARS-CoV-2 IG ready for infusion in the clinicalsetting, and virally inactivated convalescent plasma ready for transfusion.
Initial performance timelines include:Providing virally inactivated (b) (4)convalescent plasma for transfusion (b) (4)asneeded, beginning with a target start date of (b) (4).
Clinical study support through, among other things, providing at least (b) (4)final maximum
doses of (b) (4)anti-SARS-CoV-2 IG delivered to clinical study sites, with a target start dateof (b) (4)This is a prototype project because Grifols will develop virally inactivated convalescent plasma fortransfusion (b) (4), and (b) (4)anti-SARS-CoV-2 IG, in order to evaluate the technicalfeasibility of using the treatment to combat COVID-19 infection and determine clinical efficacy. This firstin-kind prototype must be produced at levels sufficient to treat (b) (4), in order to ensure bothfeasibility.
(b) (4)
In accordance with 10.U.S.C. §2371b(f), and upon a determination that the prototype project for thistransaction has been successfully completed, this competitively awarded prototype OTA may result in theaward of a follow-on production contract or transaction without the use of competitive procedures.
Currently, the extent of any follow-on production is not known. This prototype project will be successfullycompleted if Grifols meets the key technical goals of the project, meets the success metrics established bythis agreement or unilaterally by the Government for this project, or at the accomplishment of particularly
favorable or unexpected results that justify transition to production. More specifically, this prototype projectwill be successfully completed if Grifols meets the initial production and timeline goals for this project,while demonstrating continuing proficiency in plasmapheresis of COVID-19 convalescent donors, andongoing (b) (4)production of (b) (4)anti-SARS-CoV-2 IG.
If there is a conflict between the Project Agreement and the Base Agreement, the Project Agreement
language will supersede and control the relationship of the parties.
2.0

APPLICABLE REFERENCESUS Code of Federal Regulations Title 21, Sections applicable to Source Plasma collection,
including Part 640.
Currently in force and applicable FDA Blood Guidance documents.

3




Implementing a Collection Program for Source Plasma Containing Disease-Associated and Other
Immunoglobulin G (IgG) Antibodies, FDA Guidance, August 2006.
Patent Application No (b) (4)filed (b) (4).

3.0

REQUIREMENTS

3.1

Plasmapheresis of Convalescent COVID-19 Plasma Donors

Convalescent COVID-19 plasma will be obtained from individuals referred to Grifols for plasmapheresis
at one of the Grifols network of US FDA licensed plasma donor centers. Individuals that requisite screening
processes will undergo plasmapheresis (the donor may return multiple times). The resulting plasma
donations will have samples drawn for any testing determined necessary for the convalescent COVID-19
program. Plasma donations will then be frozen to a core temperature of (b) (4) within
hours and stored
at (b) (4) until they are released and shipped to the (b) (4)that is US FDA licensed.
(b) (4)Once at the (b) (4) , plasma donations will be placed into inventory and stored at (b) (4) until they arerequested for further manufacture into anti-SARS-CoV-2 IG or requested for (b) (4)viralinactivation. Please refer to the following flowchart showing the potential process of convalescent plasmacollection from individuals who have recovered from COVID-19 and are referred to a Grifols donor center.

4

(b) (4)(b) (4)(b) (4)5

3.2

Viral Inactivation of Convalescent Plasma (b) (4)(b) (4)(b) (4)6

3.3

Production of Anti-SARS-CoV-2 IG(b) (4)7

(b) (4)8(b) (4)(b) (4)9

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

3.4

Regulatory PlanningCollection of COVID-19 convalescent plasma will be done in accordance with FDA guidance, entitled
Implementing a Collection Program for Source Plasma Containing Disease-Associated and Other
Immunoglobulin G (IgG) Antibodies, August 2006. (b) (4)anti-SARS-CoV-2 IG will be produced under
GMP, and in accordance with the protocols employed for the production of Grifols currently licensed
polyclonal IG products. This work will be performed in accordance with the requirements of 21 CFR 640.
3.5

Clinical Trial Planning10

Currently, it is expected that clinical trial planning will be the responsibility of NIH/NIAID. However, if
the responsibility for clinical trial planning falls to Grifols, the costs and timelines associated with this scopeof work, will likely increase. Grifols has deep expertise in clinical trial planning and management, inconnection with a number of licensed therapeutics. While these resources and expertise can be brought tobear on this project, it is not anticipated in this scope of work.
3.6

Regulatory Execution

Currently, it is expected that regulatory execution will be the responsibility of NIH/NIAID. However, if the
responsibility regulatory execution falls to Grifols, the costs and timelines associated with this scope ofwork, will likely increase. Grifols has deep expertise in regulatory execution and clinical trial management,in connection with a number of licensed therapeutics. While these resources and expertise can be brought
to bear on this project, it is not anticipated in this scope of work.
3.7

Clinical Trial Execution

Currently, it is expected that clinical trial execution will be the responsibility of NIH/NIAID. However, if
the responsibility of clinical trial execution falls to Grifols, the costs and timelines associated with thisscope of work, will likely increase. Grifols has deep expertise in clinical trial execution and management,in connection with a number of licensed therapeutics. While these resources and expertise can be brought
to bear on this project, it is not anticipated in this scope of work.
3.8

Clinical Trial Close Out

Currently, it is expected that clinical trial close out requirements will be the responsibility of NIH/NIAID.
However, if the clinical trial close out requirements fall to Grifols, the costs and timelines associated withthis scope of work, will likely increase. Grifols has deep expertise in clinical trial close out requirements,
in connection with a number of licensed therapeutics. While these resources and expertise can be brought
to bear on this project, it is not anticipated in this scope of work
3.9

Management and Reporting

Management and reporting requirements will be mutually agreed upon among the project collaborators,i.e., Grifols, FDA, NIH/NIAID and CDC. It is anticipated that there will be a weekly management oversightteleconference among the collaborators to review:(b) (4)(b) (4)(b) (4)Each party will designate the appropriate representatives to participate on the weekly management oversightcall. Minutes and action items from the management oversight calls will be recorded and circulated among
the participants. Financial reporting will be done (b) (4) and submitted to BARDA in a manner consistent
with the requirements of this agreement.
3.10

Mandatory Reporting

Quarterly Reports: The MCDC awardee shall prepare a Quarterly Report, which will include a TechnicalStatus Report and a Business Status Report, in accordance with the terms and conditions of the MCDC
Base Agreement.

11

Updates on (b) (4)Contractor-determined format

Provided at a frequency to be agreed by theContractor and BARDA

Contractor-determined format

Provided at a frequency to be agreed y theContractor and BARDA

Contractor-determined format

Provided at a frequency to be agreed y theContractor and BARDA

Contractor-determined format

Within 5 days of request by COR

Analytical Protocols

Contractor-determined format

Within 5 days of request by COR

Analytical Reports

Contractor-determined format

Within 5 days of request by COR

Validation Protocols

Contractor-determined format

Within 5 days of request by COR

Validation Reports

Contractor-determined format

Within 5 days of request by COR

Quality Agreements with Subcontractors

Contractor-determined format

Within 5 days of request by COR

Fill / Finish Reports

Contractor-determined format

Within 5 days of request by COR

Incident Reports

Contractor-determined format

Notification of incident within one week

Regulatory Submissions to FDA (e.g.,
meeting requests, briefing books, draft
minutes, DMFs, IND, BLAs, etc.)

Contractor-determined format

Final – Within one week after submission to
FDA

Regulatory correspondence from FDA(e.g., meeting confirmations, preliminary
responses, final meeting minutes,
notifications)Contractor-determined format

Within one week of receipt from FDA

Attendance at FDA Meetings

FDA-determined format; BARDA
allowed to have at least three (silent)
attendees

Attendance/dial-in information provided upon
meeting confirmation from FDA

Information supporting Emergency Use
Authorization (EUA) Request

BARDA-determined format

As agreed to by COR

Press Releases based on BARDAsponsored activities

Contractor-determined format, withacknowledgement of BARDA funding

Draft – As agreed to by the CORofpathogen-inactivated convalescent plasma
made available for clinical use

Contractor-determined format

As agreed to by COR (precise date pending
finalizing clinical development program).

ofhyperimmune globulin (final drug
product) made available for clinical use

Contractor-determined format

By (b) (4)Manufacturing updates (b) (4)Clinical updates(b) (4)

Manufacturing Reports(b) (4)

Draft – As agreed to by the COR(b) (4)(b) (4)

5.0

MILESTONE PAYMENT SCHEDULE

The below payment schedule reflects a fully fixed pricing structure for all portions of the project. The
payment schedule contemplates fixed pricing for the startup expenses, manufacture of anti-SARS-CoV-2

13

Any Subject Invention1 that is Made by a party under this agreement will be owned by the party having
Made the invention. For each Subject Invention Made solely by the Contractor, the Government will
receive a non-exclusive, worldwide, transferable, paid-up, royalty-free, irrevocable license to practice theinvention, including but not limited to continuing research and development related to the Subject
Invention, and eventual regulatory approval and commercialization thereof. For any Subject Invention
Made solely by the Government, the Contractor will receive a non-exclusive, worldwide, transferable, paidup, royalty-free, irrevocable license to practice the invention or allow a third party to practice the invention
for any purpose.
For each Subject Invention Made solely by the Contractor, the Contractor shall provide the Government a(b) (4). For each Subject Invention Madesolely by the Government, the Government shall provide the Contractor a (b) (4)for purposes of FDA licensure of
the technology described herein, limited to the field of use described in the product indication, subject to atermination terms substantially similar to the events described below:(b) (4)of first refusal for an exclusive license to the subject joint
invention upon terms identified above.
(b) (4)“Subject Invention” is hereby redefined as “any invention of the Government, PAH, or developed jointly by theparties, that was conceived or first actually reduced to practice in the performance of work under this Agreement.”
115

(b) (4)If there is a conflict between this Section and Article X of W15QKN-16-9-1002, the Project Agreement
language will supersede and control the relationship of the parties. Where no modifications are made bythis Section to the base terms in Article X of W15QKN-16-9-1002, those sections remain operative.
Subject Data (defined as Technical Data under Article XI, §A(13), generated, directly or indirectly, related
to the work performed under this agreement) shall be jointly owned by the Parties. Notwithstanding theforegoing, Contractor and Government shall have joint ownership of any and all data related to the donationof plasma which shall include but not be limited to (b) (4), Contractor and third party shall jointly own
all Subject Data. Each party, including the third party, upon request to the other party, shall have the rightto review and to request delivery of all Subject Data, and delivery shall be made to the requesting party, except to the extent that such Subject Data are subject to a claim of(b) (4)
confidentiality or privilege by a third party. All Deliverables, as described in the Deliverable Table within
the Statement of Work, or mentioned elsewhere in this document, are considered Subject Data under thisagreement.
Neither Party, as the Receiving Party, shall, directly or indirectly, divulge or reveal to any person or entity
any confidential information of the other Party without the Disclosing Party’s prior written consent, or use
such Confidential Information except as permitted under this agreement.
Such obligation of confidentiality shall not apply to information which the Receiving Party can demonstrate
through competent evidence: (i) was at the time of disclosure in the public domain; (ii) has come into the
public domain after disclosure through no breach of this agreement; (iii) was known to the Receiving Partyprior to disclosure thereof by the Disclosing Party; (iv) was lawfully disclosed to the Receiving Party by aThird Party which was not under an obligation of confidence to the Disclosing Party with respect thereto;or (v) was approved for public release by prior written permission of the Disclosing Party.
This agreement includes research with an investigational drug, biologic or medical device that is regulatedby the U.S. FDA and requires FDA pre-market approval or clearance before commercial marketing may
begin. It is expected this agreement will result in the FDA clearance and commercialization of product(s)(the “Technology”). The awardee may be the Sponsor of the Regulatory Application (an Investigational
New Drug Application (IND), Investigational Device Exemption (IDE), New Drug Application (NDA),
Biologics License Application (BLA), Premarket Approval Application (PMA), or 510(k) pre-market
notification filing (510(k)) or another regulatory filing submitted to FDA) that controls research under thisagreement. If the awardee is the Sponsor of the Regulatory Application to FDA (as the terms “sponsor” and“applicant” are defined or used in at 21 CFR §§3.2(c), 312.5, 600.3(t), 812.2(b), 812 Subpart C, or 814.20),
they have certain standing before the FDA that entitles it to exclusive communications related to theRegulatory Application.
8.0

SECURITY

The security classification level for this effort is UNCLASSIFIED.
9.0

MISCELLANEOUS REQUIREMENTS (SAFETY, ENVIRONMENTAL, ETC.)

16

Grifols adheres to all relevant safety and environmental control laws and regulations in the jurisdictions
where it operates. Further, work performed under or in accordance with this Statement of Work, shall becovered by the Secretary of Health and Human Services Declaration effective February 4, 2020, issued
pursuant to section 319F-3 of the Public Health Service Act (42 U.S.C. 247d-6d), to provide liability
immunity for activities related to medical countermeasures against COVID -19 caused by SARS-CoV-2 ora virus mutating therefrom (the “Declaration”). Grifols, being a covered entity as defined by the
Declaration, and engaging in countermeasures against COVID -19 caused by SARS-CoV-2 or a virus
mutating therefrom, shall be immune from suit and liability under federal and state law with respect to all
claims for loss caused by, arising out of, relating to, or resulting from the administration to or use by any
countermeasure developed by Grifols, as outlined in this scope. Per the Secretary of Health and Human
Services, the Declaration shall be effective February 4, 2020, and shall cover Grifols through and including
October 1, 2024.
10.0

GOVERNMENT FURNISHED PROPERTY/MATERIAL/INFORMATION

Insofar, as this is a collaborative undertaking, involving multiple Government agencies in a variety ofcapacities, including as regulatory authority, as research coordinator, and testing service provider, it is not
feasible to anticipate the many types of property/material/information that will be exchanged among andbetween the parties. As such, the provisions of this section will be developed as the project advances, andthe roles and responsibilities of the various parties are better understood.
11.0

AGREEMENTS OFFICER’S REPRESENTATIVE (AOR) AND ALTERNATE AORCONTACT INFORMATION

AOR
NAME: (b) (6)EMAIL: (b) (6)
PHONE: (b) (6)
AGENCY NAME/DIVISION/SECTION: HHS/BARDA

17