DEPARTMENT OF THE ARMY
U.S. ARMY CONTRACTING COMMAND — NEW JERSEYPICATINNY ARSENAL, NEW JERSEY 07806-5000
REPLY TOATTENTION OF
30 July 2020

Army Contracting Command — New Jersey
ACC-NJ, Building 10
Picatinny Arsenal, NJ 07806
SUBJECT: Technical Direction Letter for Medical CRBN Defense Consortium (MCDC), Request forPrototype Proposals (RPP) 20-11, Objective PRE-20-11 for Undefmitized "Adjuvanted Recombinant COVID19 Vaccine Development" Sanofi Pasteur, Inc. (Sanofi)
REF: Sanofi Request for Technical Direction Letter, RPP 20-11 under OTA WI 5QKN-16-9-1002 for
Objective PRE-20-11, dated 30 July 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 20-11 on 09 June 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 Sanofi as the awardee. The Government
requests that a combination Cost/Firm-Fixed Price Project Agreement be issued to Sanofi to award this
proposal under Other Transaction Agreement W15QKN-16-9-1002, to be performed in accordance with theattached Government Statement of Work (SOW).
The Government received the undefinitized Rough Order of Magnitude (ROM) proposal update on 24 July
2020, and reviewed the costs and documentation accordingly. Based upon the acceptable update of Sanofi's
proposal for "Adjuvanted Recombinant COVID-19 Vaccine Development" and 1) The Project Agreement
Recipient's concurrence with the requirements included in the Government SOW; 2) An acceptable milestoneschedule that meets SOW requirements, and; 3) The ROM that has been analyzed and concurred to by theGovernment, you are hereby directed to issue a Undefmitized Project Agreement to Sanofi for the subject
project. The total project value will be determined fair and reasonable via a subsequent modification to theproject agreement.
The total approved cost to the Government for this effort is not to exceed (b) (4)The break-outof the costs is as follows: $1,769,013,470 to erform iroect efforts include • m le SOW (b) (4)This modification obligates • e 111 amount oee rate A wo • • e sue un icr norm circumstances. i ould the Government determine that a special
allocation rate is applicable to projects in support of Operation Warp Speed, the Government will unilaterally
deobligate the funds which represent the delta between All's standard rate and the agreed upon special
allocation rate. While the identified amounts are incorporated into the OTA, they are subject to the limitationsin the undefinitized addendum. Specifically, member funding is limited to 50% of the member ceiling. The
COVID-19 work shall be tracked separately using the funding obligated via modification P00078. It is notedthat this project has a base period of performance of forty-eight (48) months, with a projected completion dateof 30 September 2024.
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 of business status
certifications submitted as part of the proposal are hereby incorporated into the agreement. The contractor shallnotify 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.
As this project agreement is undefinitized. please see Attachment 2 of this letter for conditions to be includedin the project agreement.
The Sanofi Project Agreement shall contain the following language:"The contractor consents and agrees that while this Agreement is executed between Sanofi and MCDC,
because of the involvement of the Government in selection, award, and the funding process, and because thework of the contractor directly benefits the Government, the contractor is in direct privity with the Government
and agrees to resolve any dispute not otherwise resolved though operation of the Disputes clause directly with
the Government in a competent court of Federal jurisdiction."
In accordance with 10.U.S.C. 2371b(f), and upon a determination that the prototype project for this transaction
has been successfully completed, this competitively awarded prototype OTA may result in the award of afollow-on production contract or transaction without the use of competitive procedures.
Points of Contact:

Ai eements S • ecialist(b) (6)E-mai (b) (6)Phone: (b) (6)Au eements Officer:(b) (6)-mai : (b) (6)Phone: (b) (6)Regards,

A el

Attachments:
Attachment 1: MCDC RPP 20-11 Sanofi SOW
Attachment 2: UPA Addendum - MCDC RPP 20-11 — Sanofi

rlf-F; n rStatement of WorkFor Adjuvanted Recombinant COVID-19 Vaccine Development
RPP #: 20-11
Project Identifier: MCDC2011-005
Consortium Contractor: Sanofi Pasteur
Title of Proposal: Adjuvanted Recombinant COVID-19 Vaccine Development
Requiring Activity: Joint mission between the Department of Health and Human
Services and Department of Defense to combat COVID-19

11.0 INTRODUCTION, SCOPE, AND OBJECTIVES
1.1
Introduction
The overall objective of this contract is to advance the development of a vaccine prototype as acountermeasure for the prevention of Novel Coronavirus COVID-19. A COVID-19 vaccine
prototype development is required jointly by the US Department of Defense and the Department
of Health and Human Services. The objective of the project is to quickly and thoroughly
develop and test an effective vaccine for licensed application against COVID-19 and provide
rapid manufacturing capability of vaccine doses to serve public health and national security
needs. In addition to protecting the American public, prevention of highly contagious andvirulent COVID-19 outbreaks is a crucial force protection effort, facilitating US Armed Forces
deployed, at sea, or CONUS in maintaining the required OPTEMPO and executing all assigned
joint mission essential tasks. This project is for the Rapid Advanced Research and Development(ARD) and Large-Scale Manufacturing of a state-of-the-art vaccine against Pandemic COVID19.
1.2
Scope of the Prototype ProjectThis is a prototype project, consistent with 10 USC 2371b, because the Contractor will 1)
develop an adjuvanted recombinant vaccine to evaluate efficacy in the generation of immunity
antigens against COVID-19 viral infections (Product Development) and 2) rapidly expand its
manufacturing capability to accomplish production at a scale necessary to respond to thepandemic (Manufacturing Capability). The manufacturing described below will comply withCurrent Good Manufacturing Practices (cGMP) regulations at 21 CFR 210 and 211. Production
and distribution will comply with the Drug Supply Chain Security Act where applicable, taking
into account FDA's regular guidance for the public health response. The following describes the
prototype project in greater detail:
Sanofi Pasteur will achieve obtaining Emergency Use Authorization (EUA) under requirements
to be determined by FDA, and/or a reasonable chance of moving to Phase III clinical trials by
January 2021 with the goal of achieving FDA licensure in 2021 for Adults and Pediatricindication by September 2023. The objectives encompass all development plans and efforts,
including manufacturing as part of this prototype project. Sanofi Pasteur will demonstratecapability to manufacture, stockpile, and distribute large quantities of MCM to respond whenneeded. Sanofi Pasteur will perform non-clinical and clinical advanced development and/or atscale prototype manufacturing and fill-finish of a SARS-CoV-2 Medical Countermeasure(MCM). Manufacturing shall take place in a US-based facility, with assurance of sourcing ofadequate material for production. Production shall occur using cGMP validated manufacturing
process, fully compliant with 21 CFR 210 and 211, for bulk drug substance and fill and finisheddrug product, with a ramp-up capacity that provides doses sufficient for the government tovaccinate the US population. The provision of vaccine doses will be compliant with applicableprovisions of the Drug Supply Chain Security Act (DSCSA) Sections 581-585 of PL 113-54(Nov 27, 2013).
The scope of this prototype project includes clinical material manufacturing, preclinical, clinical,
regulatory, and industrialization activities that fall into the following areas: non-clinical efficacy
and toxicity studies; phase III clinical activities; manufacturing scale up activities; and all2

associated regulatory, quality assurance, management, and administrative activities. The scope
the prototype project is broken into the following phases, which are discrete work segments:
I. Regulatory Planning
II. Clinical Materials Manufacturing
III. Non-Clinical Activities
IV. Clinical Development
V. Commercial Scale Drug Substance
VI. Commercial Scale Formulation and FillingVII. Management and Reporting
1.3
Follow-on Production
In accordance with 10 U.S.C.2371b(f), and upon a determination that the Product Development
or Manufacturing Capability portions of the prototype project for this transaction have beensuccessfully completed, this competitively awarded prototype OTA may result in the award of afollow-on production contract or transaction without the use of competitive procedures. The
prototype vaccine candidate will undergo Clinical Studies through Phase III ultimately
supporting FDA licensure of the vaccine and cGMP manufacturing process.
This prototype project will be successfully completed if the Contractor meets the key technicalgoals of the project, as listed within this document, meets the success metrics established by thisagreement or, or at the accomplishment of particularly favorable or unexpected results thatjustifies transition to production. Key Technical goals include, but are not limited to, achieving
regulatory milestones with the US Food and Drug Administration (FDA) such as emergency use
authorization (EUA) under 564 of the FD&C Act or a biologics licensure granted under Section
351(a) of the Public Health Service Act, The manufacturing of 100,000,000 doses will
demonstrate the success of the Manufacturing Capability portion of the prototype effort.
This prototype project includes unpriced options for follow-on production. During theperformance of the prototype project, the Government, Project Agreement Holder and (b) (4)will
negotiate the scope, price and timing of production. Any pricing for the (b) (4) adjuvant shall bebased on commercial item terms and price. If the prototype project is successful, theGovernment may then enter into follow-on production by executing these options through aseparate stand-alone production agreement. The Follow-on production is estimated to be
sufficient quantities of drug product to vaccinate up to 300,000,000 people, based on a two-dose
regimen (additional 500M doses).
1.4
Caveats and Risks
Due to the rapid development of this vaccine program and the multiple unknowns associatedwith SARS-CoV-2 and the pandemic the following items (but not limited to) are recognized as
potential impacts on this clinical development plan:• Certain assumptions are based on US Government contracting with partners and suppliers
and those contracts may impact this timeline.
• Sanofi recognizes the proposed clinical development plan in the SoW is based on
currently available information, could change as prototype development progresses, that
this could result in changes to the SoW and project costs. These changes will be agreed
to between both parties and the SoW will be modified.
3

1.5
PREP ActIn accordance with the Public Readiness and Emergency Preparedness Act ("PREP Act"), Pub. L. No.
109-148, Division C, Section 2, as amended (codified at 42 U.S.C. § 247d-6d and 42 U.S.C. § 247d-6e),
as well as the Secretary of HHS's Declaration Under the Public Readiness and Emergency
Preparedness Act for Medical Countermeasures Against COVID-19, 85 Fed. Reg. 15198 (Mar.
17, 2020, effective Feb. 4, 2020), and amended on April 15, 2020, 85 Fed. Reg. 21012 (together,the "Prep Act Declaration"):This Agreement is being entered into for purposes of facilitating the manufacture,
testing, development, distribution, administration, and use of "Covered
Countermeasures" for responding to the COVID-19 public health emergency, in
accordance with Section VI of the PREP Act Declaration;(ii)
Contractor's performance of this Agreement falls within the scope of the"Recommended Activities" for responding to the COVID-19 public healthemergency, to the extent it is in accordance with Section III of the PREP Act
Declaration; and(iii) Contractor is a "Covered Person" to the extent it is a person defined in Section V of
the PREP Act Declaration.
(i)

Therefore, in accordance with Sections IV and VII of the PREP Act Declaration as well as the
PREP Act (42 U.S.C. § 247d-6d), the Department of Defense contracting via assisted acquisition
on behalf of the HHS, expressly acknowledges and agrees that the HHS Declaration cited above,
specifically its language providing immunity from suit and liability is applicable to thisacquisition as long as Contractors activities fall within the terms and conditions of the PREP Act
and the PREP Act Declaration.
2.0

APPLICABLE REFERENCES

21-CFR-600 through 680
21 CFR 210, 211 (Current Good Manufacturing Practices or "cGMPs")
21 CFR 312 (Investigational New Drug Application)
21 CFR 50, 54, and 56 (Human Subject Protections)
P.L. 115-91 (Expedited Approval for Military Medical Priorities)
3.0

REQUIREMENTS

3.1
Regulatory Planning
The Contractor will target the FDA approval of an adjuvanted recombinant SARS-CoV-2 protein
vaccine to be presented in multi-dose vials. The Contractor will submit a new vaccine
application to be developed for individuals 6 months of age and older. Owing to the accelerated
timelines of a COVID-19 vaccine development program, the Contractor will initially pursue an
indication in adults only with first approval in healthy adults >18 years of age, including theelderly population, as well adults with pre-disposing co-morbidities. The Contractor will initiate
pediatric studies following the successful demonstration of vaccine efficacy in the adult pivotal
Ph III efficacy trial and registration in the pediatric population will be proposed as the4supplement to the initial approval. The Contractor will request CBER agreement to defer vaccine
development in the pediatric population to post-licensure.
The Contractor already shared with the Center for Biologics Evaluation and Research (CBER)
the Phase III concept protocol for the safety and efficacy study in adults as part of the pre-IND
interaction in May 2020 and received written answers on June 3rd. The Contractor will submit
the pre-final protocol with the main design features except for the dose & dosing schedule will
be submitted to the FDA at least 60 days before the initiation of the Phase III trial in an
amendment to the corresponding IND. The final protocol cannot be submitted 60 days inadvance as the Contractor will not know the final dose or dosing schedule. The final approved
protocol should have also been reviewed and approved by the regulatory authorities of thecountries selected for this clinical trial before the initiation of the trial.
The Contractor will request expedited CBER review time to allow a seamless progression to
Phase III following Phase I/II key data availability (Safety, Neutralizing antibodies, Cell
mediated immunity) currently planned in December/January 2021 and the completion of nonclinical studies performed in parallel to the Phase I/II (Toxicology rabbit study, animal challenge
models). The Contractor will negotiate the same accelerated approval of the clinical trial
application with the other countries included in this Phase III study.
The Contractor will request "Fast Track" designation by CBER to allow the rolling submissionof sections of the BLA as soon as they are completed with an Accelerated Approval, Priority
Review or Breakthrough Therapy designation following the submission of the last BLA
components.
Post-licensure commitments will be required by the FDA for approval of the vaccine. The
requirements will be definitized as directed by the FDA after BLA submission.
3.2
Clinical Materials Manufacturing
The host cell line that has been used for the generation of the recombinant baculovirus
expression vector harboring the CoV2 preS dTM gene and will be used as a substrate for therecombinant CoV2 preS dTM protein manufacturing is a serum-free Lepidopteran insect cell line
designated expresSF+0 (hereafter referred to as "SF+"). The SF+ cell line is maintained inserum-free cultivation medium, Protein Sciences Formulary Medium (PSFM) and is used for the
production of Sanofi Pasteur's licensed Flublok® seasonal influenza vaccine.
The following activities are being performed under an existing HHS contract, and will becompleted in preparation for the subsequent work described here:
•
•

3.2.1

Baculovirus Working Virus Bank
Working Virus Bank Testingo Three cell in vitro assay for adventitious viruseso Sterility of Working Virus Banko Virus titer to determine WVB potencyo Verification of the DNA identity of the coding sequence inserted in WVBo Western blot to confirm protein identity
Description of Clinical Drug Substance Manufacturing
5For cGMP manufacturing of the COVED-19 vaccine for Phase ED clinical studies, the licensed
Flublok influenza vaccine manufacturing platform (BLA STN 125285) is being leveraged asmuch as possible. The CoV2 preS dTM Spike protein drug substance manufacturing processitself is still under development, however it will be a hybrid process taking advantage of Sanofi
Pasteur's licensed Flublok arocess and srior work with the manufacture of the SARS-CoV ATM#14811. (b) (4)S vaccine I

The DS manufacturing process comprises two major process blocks, the Upstream Process(USP), which includes cell culture expansion and protein production in the bioreactor, and theDownstream Process (DSP), which includes separation and concentration of the bioreactor
supernatant and purification of the CoV2 preS dTM protein.
The production process for the CoV2 preS dTM will follow the licensed Flublok rocess from
amplification of the WVB until the harvest of the production bioreactor. (b) (4)Upstream Process Development: The Contractor will conduct upstream process development
activities to support vaccine production at the (b) (4). Activities will include:• Cell Culture Expansion• WVB Expansion• Protein Production
Downstream Process: The Contractor will conduct downstream process development activities tosupport manufacturing at a scale o (b) (4) Activities will include:• (b) (4)• (b) (4)(b) (4)••••(b) (4)(b) (4)(b) (4)(b) (4)3.2.2 Description of Late Phase Clinical Drug Product Manufacturing
Formulation and filling COVD3-19 vaccine containing antigen in multi-dose vials at 3 mL fillvolume and manufacture the two formulations (51.tg and 15pg) supporting the clinical protocol
from the Sanofi Pasteur Swiftwater manufacturing site.
• COVID-19 vaccine drug substance material derived from purified recombinant CoV2
preS dTM Protein manufactured under aseptic conditions will be formulated and filled
into multi-dose vials• Following cGMP practices formulate up to 150L drug product which will be filled inbuilding 77 Line 9, or alternate site. Validation of the formulation and filling process
will be conducted post clinical manufacturing and part of the concurrent to thecommercial manufacturing of the COVID-19 vaccine doses• Aseptic process development will be required along with change parts for Line 9 to
6

•
•
•

•
•

support the MDV. The change parts will be C&Q prior to use for manufacturing
Manufacture required buffer material to be used for the formulation process
Automated Inspection will occur for the filled containers
Labelling will occur in B37 can cell pack styled packaging will be used for the finishedgoods.

Sanofi Pasteur will furnish the necessary services, qualified personnel, materials,
supplies, equipment and facilities not otherwise provided by the U.S. Government asneeded to manufacture the clinical doses

The Contractor will conduct downstream process development activities to support
manufacturing including:• Formulation• Filling• Visual Inspection• Clinical Labelling and Packaging
3.2.3 Description of Drug Product Testing
3.2.3.1
In-Process I uali Control Sampling - All Antigen specific testing will be at(b) (4)The AQL inspection testing and safety testing will be
performed at (b) (4)site using established procedures and acceptance criteria.
3.2.3.2
Stabili Testin - For the duration of Stability Testing, the material reserved will
be maintained at (b) (4)All unlabeled FCs aside from clinicalmaterial or Stabi ity Testing matena wi I secure at that location under conditions to be
determined.
Any reporting of stability results will be done by Sanofi (b) (4)3.3
Non-Clinical Activities
In addition to studies accomplished under a previously awarded HHS contract, non-Clinicalactivities will be performed to support Ph ifi studies and licensure. Some activities are expected
to be required to document the vaccine mechanism of action. In vivo studies will be performed to
explore the biomarkers for protection and the persistence of the immune responses.
In vitro studies are proposed to evaluate the role of neutralizing antibodies in an in vitro lungmodel in order to assess the potential for antibody-dependent enhancement (ADE).
3.3.1 Immunogenicity study to explore mechanism of action / biomarkers of protection(study 7): In a permissive rodent model, such as human ACE2 Receptor expressing mice, therole of the Ab and the CD4/CD8 T cells in protection will be explored. A mouse model would
allow to study the role of both the Ab and the cellular responses. If the human ACE2 mice were
not suitable to assess protection, other models such as hamster or ferrets could be used to study
the role of Abs.
3.3.2 Immunogenicity study to explore Ab persistence/duration of immune response &
protection (study 8): The longevity of the immune responses (Ab, T and B cells), and the7duration of protection will be analyzed in a CoV2-permissive animal model such as ferrets,
hamsters or NHPs. These species have a sufficient half-life to allow for Ab decay.
3.3.3 Evaluation of the vaccine antibody enhancement in vitro: The Abs elicited by thevaccine in animal models or humans, will be assessed in vitro on a human lung cell model
developed at VxD. This system will allow to measure both the neutralization of viral entry
through blockade of S attachment and fusion and the potential facilitating role of Ab through Fcdependent viral entry and infection.
3.3.4 Developmental & Reproductive Toxicity Testing (DART): Considering the target age
range of the vaccine candidate, and to support the vaccination of Women of Child Bearing
Potential (WOCBP), it is considered to conduct a combined DART study to evaluate female
fertility, as well as any potential effect of the vaccine on mating performance, on all stages ofembryo-fetal development and on the post-natal development of the pups (over the lactation
period). These potential effects could be evaluated in a single study plan, designed in compliancewith applicable WHO guidelines on preclinical testing of adjuvanted vaccines and vaccine
adjuvants (2005, 2013). The study will be most likely carried out at Charles River, Montreal,
Canada, test facility and conducted in compliance to Good Laboratory Practices (GLP)
regulations. The DART study can be performed in parallel of Phase DI clinical study, using
Phase III clinical batches.
As for the standard repeated dose toxicity study, the rabbit will be selected as the toxicity
species. Each injection will consist of one intended human dose and dose volume (0.5 mL). The
number of injections would be as follows:• Premating period: 2 injections in female parent rabbits: 24 days and 10 days before
mating• Gestation period: 3 injections of the dams (GD6, GD12 and GD27)
During the study, the immune response to the test vaccine will be determined through ELISA
testing in:• In all dams per sub-group during pretest, 3 days before the start of mating, and either on
Day 29 post-coitum or on Day 35 post-partum• In all fetuses from all dams in the caesarean sub-group on G29 (pool fetus sera)• In all pups from all dams in the littering sub-group on L35 (not pooled)
The study group composition is summarized in 3.3.4 below:
Table 3.3.4
Study
Gps

1
1

3*
4*

DART Study Group Composition

Study
Subsets

Treatment

C-subset
L-subset
C-subset
L-subset
C-subset
L-subset
C-subset
L-subset

Control(0.9%NaC1)
Antigen alone(Protein S = Ag)
Ag + AF03
Ag +(b) (4 )Dose-level(Dose-volume)
per injection
1HD(0.5 niL)
11-1D(0.5 mL)
1HD(0.5 mL)
1HD(0.5 mL)

Total # of
injections# ofanimals

Date of sacrifice

5
5
5
5
5
5
5
5

/5

30
25
30
25
30
/5
30

Day 29 p.c.
Day 35 p.p.
Day 29 p.c.
Day 35 p.p.
Day 29 p.c.
Day 35 p.p.
Day 29 p.c.
Day 35 p.p.
8

HD: Human Dose; C-subset: caesarean subset; L-subset: littering subset; p.c.: post-coitum;
p.p.: post-partum; *inclusion of both groups needs to be confirmed
3.4
Clinical Development
The development plan targets the FDA approval of an adjuvanted recombinant SARS-CoV-2
vaccine for pandemic use with antigen to be presented in unit dose or multidose vials andadjuvant presented in multidose vials. The vaccine will be developed for adults. Pediatricdevelopment will be performed, although is not planned to be completed prior to licensure inadults.
As part of a funded Task Order from BARDA, a Ph I/II clinical trial in adults 18 years of age andolder to evaluate safety and immunogenicity of different recombinant protein vaccine
formulations with two different adjuvants (AF03 and (b) (4) is planned. This Ph I/II trial will
evaluate two different doses of recombinant protein antigen administered as either a single
vaccination or two vaccinations 21 days apart. Immunogenicity assessment includes Neutralizing
antibodies to wild-type SARS-CoV-2, binding antibodies measured by ELISA & cellularimmune responses for Thl/Th2 immune response characterization. SP is planning to conduct ananalysis on data collected up to 21 days after the final vaccination and submit a limited data
package for FDA review prior to progression to later phase clinical development. Supplemented
by non-clinical studies, this safety and immunogenicity data will be the basis for selecting one of
the formulations to progress to the later stage of clinical development.
The Contractor will conduct 3 clinical trials in this proposal as part of the later stage of clinicaldevelopment:• VATO2 - a pivotal Ph III efficacy trial in adults 18 years of age and older for registration,with interim analyses that may result in early demonstration of efficacy and subsequent
licensure.
• VATO3 - Safety and immunogenicity trial in children 6 months to 17 years of age tosupport licensure in the pediatric population. This safety and immunogenicity trial to seek
approval in the pediatric population is dependent on endorsement by the Regulatory
Authorities. Given the lack of an established pathway for licensure in this population, it isstill possible that an efficacy trial may be required by the regulators.
• VATO4 - Lot-to-lot consistency trial in adults, if required by Regulatory authorities in theevent that pharmaceutical bio-comparability data is considered insufficient.
The Contractor will include the selected candidate vaccine formulation (b) (4)in the Ph III efficacy trial in which it will be compared against placebo. A placebo-controlled
trial may not be appropriate if a vaccine is approved and available in the countries and at the timeof conduct of the trial. If an approved vaccine was available, three alternative paths to licensure
will be considered: 1) The possibility of performing a safety and immunogenicity study aiming atdemonstrating that the immune responses with Sanofi Pasteur's vaccine are comparable to thoseof the licensed vaccine, in the event there is a suitable biomarker accepted by Regulatory
authorities; 2) The possibility of still conducting the efficacy study but in geographies where avaccine is not licensed/available; 3) The possibility of performing a larger study aiming atdemonstrating non-inferior efficacy against the licensed vaccine. Recognizing these three9scenarios as possibilities, the expanded narrative in section 3.4.1. focuses on the assumption thata placebo-controlled trial with the objective of demonstrating efficacy will be conducted.
3.4.1 Clinical Plan for Adults and Elderly — Phase HI Efficacy Study
The Phase III trial in adults is designed to support regulatory licensure based on statisticallypowered efficacy endpoints and an adequate safety database. The dose of the recombinant
protein antigen and whether it is administered as a single injection or two injections 21 days
apart will be determined based on safety and data on neutralizing antibodies observed in the
Phase I/11 study and on aggregated data from non-clinical studies. For the purposes of this
proposal it is assumed that the study will require participants to receive a schedule with 2
injections.
VATO2 will be a Phase DI, randomized, modified double-blind, placebo-controlled, multicenter
study to be conducted in 34,656 adults 18 years of age and older to evaluate the efficacy, safety
and immunogenicity of SARS-CoV-2 recombinant protein with (b) (4)versus a placebo. The
study groups and sample size are described in Table E.1.1 below.

10(b) (4)

11

12

13

14

3.4.2 VATO3 - Clinical Plan for Pediatric Development
Assuming success in the demonstration of satisfactory safety and efficacy in adults in the pivotal
Ph III study, a clinical trial for licensure in the pediatric population will be initiated. It is
assumed that the pediatric trial will be conducted after initial approval in the adult population.
This will be a randomized, modified double-blind, placebo-controlled trial to assess safety andimmunogenicity in children 6 months to 17 years of age. Approximately 350 participants will beenrolled and randomized in a 6:1 ratio to receive 1 or 2 injection(s) of either the investigational
product (SARS-CoV-2 Recombinant Protein investigational study vaccine with (b) (4 ) or
placebo (300 participants in the vaccine group and 50 participants in placebo group). For the
purposes of this proposal it is assumed all subjects will require 2 vaccinations. The enrollment
will be stratified by age groups (6mo-35mo of age, 3-8 years of age and 9-17 years of age). The
duration of the follow-up would be 1 year with safety follow-up conducted over the duration of
the study period.
(b) (4)15

3.4.3 VATO4 - Clinical Plan for Lot-to-Lot consistency
A safety and immunogenicity trial in adults is planned to demonstrate comparability of three lotsof manufactured product if required by Regulatory authorities based on availability androbustness of pharmaceutical bio-comparability data. It is assumed that participants will beadministered two injections.
This will be a randomized, modified double-blind trial to assess safety and immunogenicity inadults 18 years of age and older. The primary objective would be to demonstrate equivalence of
immune response across all three lots for the vaccine candidate. Participants would have blood
samples collected at D1 and D43 for assessment of neutralizing antibodies and binding
antibodies by ELISA to the Spike protein to address the primary objective.

3.5
Commercial-Scale Drug Substance
The Drug Substance Manufacturing Process will be locked concurrently with the Phase DI
clinical manufacturin rocess. Phase DI clinical manufacturin . will occur (b) (4)will commence with commercial roduction at risk. (b) (4)e irst ots o I rug u stance wi I se tesignate. or
Plase III C mica stu y matenal and the remaining manufacturing will be designated for follow
on production.
3.5.1 Commercial-Scale Drug Substance Manufacturing Process will be as outlined in
section 3.2.
3.5.2

Technolo

Transfer(b) (4)16

A comparability study will be conducted, concurrently with PPQ batch manufacturing, todemonstrate the product and process comparability between the two (2) Drug Substancemanufacturing locations.
3.5.3 Analytical Transfer
In order to streamline the transfer activities and to minimize the chan es between (b) (4)sites one 1 anal ical testin reference site will be utilized. (b) (4)e exceptions to • s strategy are time sensitive tests i.e.
micro ) an m-process controls (IPCs). These tests will be transferred to the Drug SubstanceCM° following standard analytical transfer methodology.
3.6
Commercial-Scale Drug Product
Formulation and filling COVID-19 vaccine containing anti en in multi-dose vials at 3 mL fillvolume and deliver 100 M doses to the US Government (b) (4)•••COVID-19 vaccine drug substance material derived from purified recombinant CoV2
preS dTM Protein manufactured under aseptic conditions will be formulated and filled
into multi-dose vials.
Followin cGMP s ractices formulate us to 500 L drip iroducts (b) (4)non o e orm anon an
mg at commercia sc. ew I ,e con. ucte
concurrently to the commercial manufacturing.
Aseptic process development will be required along with change b) (4)support the filling of the MDV. The change parts will be C&Q prior to use for
17

•
•
•

•
•

manufacturing.
Manufacturing of buffer will be required to be used for the formulation process.
Automated Inspection will occur for the filled containers.
Labelling will occur ( b ) (4)in cell pack styled packaging will be used for thefinished goods.

Sanofi Pasteur will furnish the necessary services, qualified personnel, materials,
supplies, equipment and facilities not otherwise provided by the U.S. Government asneeded to fill the required number of doses.

Assumptions Regarding Manufacturing Requirements• Drug substance yields are (b) (4) (Sanofi Pasteur assumes risk of achieving targetedyield)• Cycle time o (b) (4)• Fuji capacity (b) (4)• Tech transfer (b) (4)• Start of Commercial DS in PR (cell amplification as soon as bioreactors free up fromhase
roduction••

No serialization at the vial level•

Specific packaging requirements for fmal Finished Goods (antigen and adjuvant) will be
determined through discussion with USFDA and the agreement will be modified toreflect those costs, if required•

3.6.1 Formulation
The antigen formulations will be manufactured at (b) (4)site usina the urified
recombinant CoV2 preS dTM Protein along with (b) (4)All formulation activities will follow SP standard operatingprocedures under cGMP conditions. Formulation of the purified recombinant CoV2 preS dTM
Protein will be done to support the 20 pg /mL (5tig/dose) protein content.
3.6.2 Filling
The finished good vaccine Final Containers will be filled (b) (4)following qualified aseptic filling procedures under protoco , a slienng to cGMP. SP
will target till quantities in support of the 500L formulation batch size requirements. Final
Container fill volume will target a 3.0 mL fill volume.
3.6.3 Inspection
The Filled final containers will be subjected to individual automated inspection per established
SP procedures to verify conformity to specification and to identify, remove, and categorize any
non-conforming Filled final containers.
18

3.6.4 In-Process Quality Control Sam i lin
All Antigen specific testing will be ( b ) (4)testing and safety testing will be pe ormed (b) (4)procedures / acceptance criteria.

The AQL inspection
usmg established3.6.5 Stability Testing
For the duration of Stability Testing, the material reserved will be maintained (b) (4)All unlabeled FCs Stability Testing material will be secured at that location
under conditions to be determined.
3.6.6 Documentation / Reporting
SP will provide regulatory documents to support an lND (IB, LOA to cross reference BMF,
stability, Module 3 CMC documents, etc.).
3.6.7 Production and Storage of 100 million doses of Drug Product Final Container
Lon -lead time materials will be ordered to ensure that drug substance roduction can start in(b) (4)The estimate includes any acceleration fees that might be needed to ensure suppliers deliver
within the required time frame.
In order to meet the delivery schedule for the 100 million proposed in the table below, selectionof the dose at which the drug substance will be made at risk based on non-clinical data inconsultation with BARDA and • • eration Warp Speed Leadership so that fill finishing of doses
can be initiated ( b ) (4). The pricing proposal is based on the assumption that a
5ttg dose will be se ecte . I a decision was made not to initiate formulation and fill finish of thedoses based on the available data, drug substance would continue to be produced but the delivery
schedule for drug product would be delayed.

3.6.8 Shipping Demonstration
In coordination with the Government, Sanofi will conduct a demonstration of the vaccine(adjuvant + antigen) shipping process prior to the first delivery of doses at a time mutuallyagreed by the Parties. As set forth in Section 4.0 (Deliverables), Sanofi agrees to sharespecifications and details associated with the shipping process and containers to enable theGovernment to adequately plan and prepare for potential distribution of the vaccine. For
19

planning purposes, the Government intends to have the vaccine shipped to [USG designatedDistribution Centers and/or USG designated administration sites].

3.7
Management and Reporting
3.7.1 Project Management
As in the numerous projects Sanofi Pasteur has undertaken in partnership with HHS/BARDA
since 2004, SP will assign a Principal Investigator (PI) responsible for leading the effort of the
project team representatives to achieve the desired outcome. The project team Contractors are
responsible for the activities of their respective functional areas. The PI directs the project teamContractors using the work plan, project schedules, and progress reports. The PI communicatesthe project objectives to the project team representatives and keeps the team tasks within thescope of the project. The PI facilitates communication and resolves conflict among project teamContractors and negotiates for any resources required. The PI works to see that the overall
objective of the project is delivered on time, on budget, and with the right level of quality. The
PI updates the Executive Sponsor on the progress of the project and any obstacles in achieving
project objectives. The PI will have an assigned Project Manager (PM) who, along with Sanofi
Pasteur Finance, will track activities and spending according to a Work Breakdown Structure(WBS). Sanofi Pasteur will share the WBS and communicate the status and progress towards
completion of deliverables and milestones. The Project will be managed on the USG side by aninteragency Project Coordination Team that will be part of the Operation Warp Speed program
and will serve as a conduit for information between the company and all elements of the program
to maximize the probability of success for this project. Sanofi Project Managers will work with
the PCT to establish mechanisms and practices that ensure a level of communication that iscommensurate with the urgent and highly accelerated pace that is demanded by the public healthneed for this vaccine. This will include maintaining detailed project plans/timelines that can becoordinated with Integrated Master Schedules maintained by OWS.
3.7.2 Technical Progress Reports
The Contractor will submit monthly technical progress reports on the 15th day of each month, to
the Agreements Officer's Representative (AOR) describing activities performed during theprevious calendar month. The appropriate formats for the Technical Progress Report andExecutive Summary will be provided by the Government. The Technical Progress Reports will
include project timelines and summaries of product manufacturing, testing, and clinicalevaluation activities. A Technical Progress Report will not be required for the month in which
the Final Report is due. The Contractor will be required to submit an electronic copy to the AOR.
The Contractor should inform the AOR in advance if the delivery of a Technical Progress Reportwill be delayed.
3.7.3 Final Report
By the end date of the project period of performance, the SP will submit a draft comprehensive
Final Report that details, documents, and summarizes the results of all work performed under thecontract. A draft Final Report will be submitted to the US Government for review and comment,
after which the Final Report will be submitted. SP will communicate the Final Reportelectronically as directed by the US Government Agreements Officer.
3.7.4 Meetings
SP will participate in regular meetings to coordinate and oversee the contract effort as directedby the US Government. Participants and frequency will be jointly agreed upon to ensure
20

efficient communication necessary to achieve optimal project progress and coordination withOperation Warp Speed.
The Agreements Officer's representative and the Contractor will hold monthly calls, or as
directed by the Agreements Officer's representative. During this call the PI will discuss theactivities performed and deliverables achieved during the reporting period, any problems thathave arisen and the activities planned for the ensuing reporting period. The first reporting period
consists of the first full month of performance plus any fractional part of the initial month.
Thereafter, the reporting period will consist of each calendar month. SP may include other key
personnel on the conference call to give detailed updates on specific projects and/or at therequest of the Agreements Officer's representative.

(b) (4)Monthly reports on project status shall be submitted no later than the 15th of the subsequentmonth for the prior reporting period. Monthly reporting will include a summary of work
performed, work anticipated in the next reporting period, schedule and financial status (monthly
forecast and incurred to date), variance explanations, and an updated risk matrix.
4.0

DELIVERABLES

Sanofi Pasteur shall provide all data deliverables in electronic format; file name format shall be:
Project # - Deliverable Description. (ex. 19-13-001 Quarterly Technical and Business Status
Re ort .
Name

FinishMilestone
Reference

SOW

Govt
Role

4.1

Mechanism of Action Study Report (Non-Clinical)

5/28/2021

5.1

3.3.1

Recipient

4.2

Antibody Persistence Study Report (Non-Clinical)

1/15/2021

5.2

3.3.2

Recipient

4.3

DART Report

4/9/2021

5.3

3.3.4

Recipient

4.4

CoA Completed DS PET

4.5

Certificates of Compliance DP PIII

4.6(b) (4)

4.7
4.8
4.9
4.10

PIII Supply & Regulatory Support

Final Tech Transfer Comparability Report with
Stability with Fujifilin Diosynth
100 Million Doses DP Available
DS and DP Industrial-Scale Validation Report
Temporary Storage of Final Drug Product 10-dose

Vials (as FFP) (est. 6 months)

12/4/2020

5.4

3.2.1

Recipient

Data Rights,
Unlimited
RightsUnlimited
RightsUnlimited1

RightsUnlimited
RightsUnlimited
Rights1

12/6/2020

5.5

3.2.9

Recipient

8/31/2022

5.6

3.4

Recipient

2/22/2021

5.7

3.6

Recipient

2/28/2021

5.8

3.6

Recipient

N/A

1
1

(b) (4)
Unlimited
Rights

6/30/2021

5.9

3.6

RecipientUnlimited
Rights

6/30/2021

5.10

3.6

RecipientUnlimited
Rights

4.11

Final CTD / BLA Document Submitted

9/29/2023

5.11

3.6.6

RecipientUnlimited
Rights

4.12

Clinical Trial Activities (VAT02)

8/28/2022

5.12

3.4.1

RecipientUnlimited
Rights

21

,
,

,

4.13

Clinical Trial Activities (VAT03)*

8/11/2023

5.13

3.4.2

Recipient

4.14

Clinical Trial Activities (VAT04)

6/4/2022

5.14

3.4.2

Recipient

4.15

Final PM Report

9/29/2023

5.15

3.7.3

Recipient

4.16

Manufacturing Development Plan**

9/29/2023

N/A

3.7.1

Recipient

4.17

FDA communications, meeting minutes, records

9/29/2023

N/A

3.1

Recipient

4.18

FDA inspection and enforcement documents (e.g.,
notice of violations, 483s, foreign inspection
reports, etc.)

9/29/2023

N/A

3. 1

Recipient

4.19

Confirmation of FDA Registration and Listing

9'29/2023

N/A

3.1

Recipient

9/29/2023

N/A

4.1

Recipient

9/29/2023

N/A

7.4

Recipient

10.0
Appendix1
10.0
Appendix1
10.0
Appendix1
10.0
Appendix1
10.0
Appendix
1

Recipient

4.20
4.21

Lot Release and cGMP certification prior to
shipment/Government acceptance.
PL 115-92 Authorization Letter for DoD Medical
Priorities

4.22

Supply Chain Resiliency Plan or Sanofi Equivalent

4.23

Manufacturing Data Requirement or Sanofi
Equivalent

4.24

Product Development Source Material &Manufacturing Reports and Projections

4.25

Work Location Report

4.26

Facility Security Plan or Sanofi Equivalent

4.27

Quarterly Technical and Business Status Report

Within 30
days after
award
Within 30
days after
award
Within 30
days after
award
Within 30
days after
award
Within 30
days after
award

Mar 31, Jun
30th, Dec 31si

5.17,
5.18,
5.19,
5.21,
5.22,

Unlimited.
RI lilts
Unlimited
RightsUnlimited

RightsUnlimited
RightsUnlimited
RightsUnlimited
RightsUnlimited
RightsUnlimited
RightsUnlimited
RightsLimitedRightsRecipient

LimitedRightsRecipient

LimitedRightsRecipient

LimitedRightsRecipient

LimitedRightsRecipient

GPR

Recipient

GPR

Recipient

GPR

5.23,
5.25,

5.26,
5.27,
5.29,
5.30, 5.31
4.28

Annual Technical and Business Status Report

Annually Sept
30th

4.29

Monthly Status ReportMonthly

5.16,
5.20,
5.24,
5.28, 5.32
N/A

Period of Performance: 48 months
22

*Although the cost quoted is for an efficacy study, the finish date is based on the immunogenicity trial described in
the SoW and would change in the event an efficacy trial were required.
** The Manufacturing Development Plan will describe the manufacturing process for the drug/biologic product toensure conformity with §501('a,) (2,)(B) of the Food, Drug, and Cosmetics Act (FD&C Act, Title 21 United States
Code (USC) §351 (a)(2)(B)), regarding good manufacturing practices (GMP). This plan shall describe, but is not
limited to planned or completed drug substance studies; list of excipients and information to support the safety of
excipients that, when appropriate, shall be cross-referenced; drug product and formulation development summaty
from initial concept through final design; physicochemical and biological properties; manufacturing processdevelopment and validation program documents; container closure system documents [description, choice,rationale]; microbiological attributes documents and plans; compatibility documents (e.g., precipitation); assay
development and validation, stability plan; and any associated risks.

4.1 Acceptance of Vaccine Doses•

BARDA's standard operating procedure (SOP) for product acceptance will be followed
for any product accepted regardless of the method of delivery; stockpile (SNS),
distribution location, held in vendor managed inventory (VMI), or others as defined at afuture date.
o Upon acceptance by the Agreements Officer Representative (AOR) of any lot of
vaccine under this contract, title to such vaccine will transfer upon delivery of drug
product to vendor-managed inventory and the Government's corresponding written
acceptance of the delivery of each such lot of drug product. AOR will not withhold
acceptance solely based on lack of product license or lack of approval for use underEUA.
o Any deviations, out of specification (00S) results, or other product issues shall bereported to the USG within 3 calendar days.
o These materials should be maintained in the contractor's quality and inventory
systems, ready for use in the continued manufacture of bulk material or finalcontainer doses intended for clinical use or use under Emergency Use Authorizationor use under a BLA.
o Notification must be made to the AOR or designated government representative for
product acceptance at least 10 calendar days prior to delivery. Exceptions are
permitted if approved by the AO.
o The Government shall accept product that conforms to contract requirements basedon Certificates of Analysis and Certificate(s) of Current Good Manufacturing
Practices (cGMP) Conformity provided by Contractor.
o Any product produced or stored under this contract is subject to inspection by a duly
authorized US Government (USG) representative, and with reasonable notice (i.e.,
not less than 24 hours).
o Upon receipt of Final Report and inspection (physical or representative, i.e., pictures),the AOR will review and recommend acceptance or rejection; the AOR willcorrespondingly notify the Contractor of acceptance or rejection. the USG reserves
the right to audit, either by the USG and/or Government designee(s), the facilities
used under this contract and all records related to the manufacture, testing, andstorage of the product.
o Upon delivery of product, notification of delivery quantities and any movement must
be made to the AOR and government representatives (i.e., AOR and BARDA
Regulatory and Quality Affairs Quality Branch).
23•o Unless otherwise mutually agreed upon by the parties, drug product shall be shipped,
trackable by GPS, to the Government-designated sites within the continental UnitedStates.
o Contractor will retain physical risk of loss for all product stored as vendor-managed
inventory until delivery and accepted by Government at government-designated site.
o Contractor will notify government (AO, AOR, and BARDA RQA Quality Branch) of
any storage or quality deviation for product held in VMI, within 3 calendar dayso To the extent that Contractor is responsible for the correction, repair or replacementof Government property held in vendor-managed inventory and replacement upon
loss or damage is feasible, the Government will accept replacement of such property.
o Vendor-managed storage of product manufactured under this agreement is supported
through 30 June 2021, and, as such, the USG must either (a) take possession on or
before this date and provide Contractor with disposition instructions in sufficient timeto transfer physical material from Contractor by this date or (b) bilaterally modify thisagreement to extend the period of vendor management of storage prior to this date.
o The USG understands that prices identified in this contract include insurance costs
applicable to material that will become Government property, including productstored as vendor-managed inventory.
USG right to inspect product: The AO and/or the AOR may perform inspection of materials
and services. Inspections of material created under this contract may be made by a duly
authorized USG representative, and with reasonable notice (i.e., not less than 24 hours). The
USG reserves the right to conduct an audit, either by Government and/or Government
designee(s), of the facilities used under this contract and all records related to the
manufacture, testing, and storage of the product.
o The manufacturer will make the necessary efforts to arrange and hold Final Drug
Product (FDP) at a facility under their control. In this case, the manufacturer will:• Provide temperature-controlled storage at the manufacturer's site approved by
the USG, according to cGMP and the Contractor's product specifications.
• Store bulk lots and final containers physically segregated from other products• Ensure proper labeling of stored materials as USG property.
• Execute stability testing of stored material in a manner consistent with thestability testing plan approved by the AOR. Report interim data and results to
the AOR on a monthly basis.
• Appropriately identify reserve samples that are representative of each lot ofdrug substance and drug product shall be retained. The reserve samples
consist of at least twice the quantity necessary for all tests required todetermine whether the drug substance and drug product meets its establishedspecifications including a minimum of 60 months of stability testing.
• Ensure stored materials are compliant with the Contractor's internal quality
control system and are ready for use in further cGMP governed manufacturingof clinical material or licensed doses as directed by the USG.
• Provide the government access to review the security systems in place andrequest updates as needed.
• Include in monthly report inventory for drug substance and/or drug product(lot number, number of lots, number of vials), including inventory quantitychanges, current quantity, storage facility/location, manufacturing date, latest
24

•

•

•
•

stability result for potency, date of next expected stability result and thecurrent expiration date (if applicable).
• Ensure that material being relocated for the contractors' convenience isadequately insured at no cost to the government and with AOR approval.
• Conduct testing necessary to ensure continued use of the stored material forpre-pandemic preparation, pandemic response and, where appropriate,
manufacture of licensed doses.
• Make appropriate updates to the regulatory documentation supporting thecontinued use of the stored material for pre-pandemic preparation, pandemic
response and, where appropriate, manufacture of licensed doses.
• If using a subcontracted storage site, provide the quality agreement, specify
the location and terms of the storage contract and receive approval by theAOR.
The contractor may request to arrange and hold FDP at a USG contracted facility (e.g., SNSfacility). In this case the provisions immediately above still apply with the addition that the
manufacturer enter into a quality agreement with the USG contracted facility. All costs tomove FDP to the USG contracted facility remain with the manufacturer. Title remains withthe manufacturer.
The manufacturer may invoice for costs incurred while in VMI and prior to delivery andacceptance of services and/or product. Product in VMI that falls into any of the following
categories shall be replaced by the contractor at no cost to the USG:
o If product does not meet any criterion outlined in this contract.
o If product is deemed to be recalled for any reason, as outlined in the Product Recalls,
Including Removal and corrections published by U.S. Department of Health andHuman Services, Food and Drug Administration, Office of Regulatory Affairs; orbased upon Chapter 7 of the Regulatory Procedures Manual of March 2007.
The contractor may invoice upon USG delivery and acceptance of services and/or product. In
this case, the terms outlined in Responsibility for Supplies below apply.
The Contractor cannot reclaim title to product upon acceptance by the USG. Prior to
expiration or termination of this contract, the USG may affect final distribution of any
vaccines remaining in storage by any one or combination of the following methods:
o The USG may elect to require shipment of the vaccine to USG facilities or to stateand local health agencies and/or other providers.
o The USG may direct the Contractor to destroy all quantities remaining in storage. In
this case, a letter of disposition will be provided to the USG.

If, for whatever reason, the USG takes possession while in VMI, these instructions will bedefined as FOB-origin. Any vaccine lot under this contract, title to such vaccine will transfer
upon delivery of drug product to VMI and the Government's corresponding written acceptanceof the delivery of each such lot of drug product. These materials should be maintained in thecontractor's quality and inventory systems, ready for use in the continued manufacture of bulk
material or final container doses intended for clinical use or use under Emergency Use
Authorization or use under a BLA as outlined above. The elements outlined above remain in
effect. The difference being that the USG bears responsibility and associated costs with25

transportation to fmal destination and cost to replace product for losses en route to finaldestination.
Responsibility for Supplies(a) Title to supplies furnished under this contract shall pass to the Government upon formal
acceptance, regardless of when or where the Government takes physical possession, unless thecontract specifically provides for earlier passage of title.
(b) Unless the contract specifically provides otherwise, risk of loss of or damage to supplies shallremain with the Contractor until, and shall pass to the Government upon -(1) Delivery of the supplies to a carrier, if transportation is f.o.b. origin: or(2) Acceptance by the Government or delivery of the supplies to the Government at thedestination specified in the contract, whichever is later, if transportation is f.o.b. destination.
(c) Paragraph (b) of this section shall not apply to supplies that so fail to conform to contract
requirements as to give a right of rejection. The risk of loss of or damage to such nonconforming
supplies remains with the Contractor until cure or acceptance. After cure or acceptance,
paragraph (b) of this section shall apply.
The contractor shall provide all data deliverables in electronic format, file name format shallbe: Project # - Deliverable Description. (example. 2011-005 Quarterly Technical andBusiness Status Report).
The USG will provide acceptance of all data deliverables within sixty (30) days of receipt of
the final version. Drafts will be reviewed and comments provided to the contractor within
30 days.
5.0

MILESTONE PAYMENT SCHEDULE

Milestone
Reference
5.1
5.2

Name
Mechanism of Action Study Report(Non-Clinical)
Antibody Persistence Study Report(Non- Clinical)

Deliverable
Reference

Finish4.1

5/28/2021

4.2

1/15/2021

5.3

DART Report

4.3

4/9/2021

5.4

CoA Completed DS PIII

4.4

12/4/2020

Certificates of Compliance DP PHI

4.5

12/6/2020

4.6

8/31/2022

5.5
5.6
5.7
5.8

(b) (4) PIII Supply & Regulatory
SupportFinal Tech Transfer Comparability
Report with Stability with Fujifilm
Diosynth
100M Doses DP Available (as FFP —Firm Fixed Price)

Total Cost(b) (4).
4.7

2/22/2021.

4.8

2/28/2021

26

5.12

DS and DP Industrial-Scale
Validation Re • ort
Temporary Storage of Final Drug
Product 10-dose Vials (as FFP) (est. 6
months)*Final CTD / BLA Document
Submitted
Clinical Trial Activities (VAT02)

5.13

5.9
5.10
5.11

4.9

6/30/2021

4.10

6/30/2021(b) (4)

9/29/2023
4.11

8/28/2022

Clinical Trial Activities (VAT03)**

4.12

8/11/2023

5.14

Clinical Trial Activities (VAT04)

4.13

6/4/2022

5.15

Final PM Report
Annual Technical and Business Status
ReportQuarterly Technical and Business
Status Report
Quarterly Technical and Business
Status Report
Quarterly Technical and Business
Status Report
Annual Technical and Business Status
ReportQuarterly Technical and Business
Status Report
Quarterly Technical and Business
Status Report
Quarterly Technical and Business
Status Report
Annual Technical and Business Status
ReportQuarterly Technical and Business
Status Report
Quarterly Technical and Business
Status Report
Quarterly Technical and Business
Status Report
Annual Technical and Business Status
ReportQuarterly Technical and Business
Status Report
Quarterly Technical and Business
Status Report
Quarterly Technical and Business
Status Report
Final Technical and Business Status
Report4.14

9/29/2023

4.28

9/30/2020

$0

4.27

12/31/2020

$0

4.27

3/31/2021

SO

4.27

6/30/2021

$O

4.28

9/30/2021

SO

4 27

12/31/2021

SO

4.27

3/31/2022

SO

4.27

6/30/2022

SO

4.28

9/30/2022

SO

4.27

12/31/2022

SO

4.27

3/31/2023

SO

4.27

6/30/2023

50

4.28

9/30/2023

50

4.27

12/31/2023

50

4.27

3/31/2024

50

4.27

6/30/2024

$0

4.28

9/30/2024(b) 4i

Total:$1,769,013,470

5.16
5.17
5.18
5.19
5.20
5.21
5.22
5.23
5.24
5.25
5.26
5.27
5.28
5.29
5.30
5.31
5.32

Cost, No

Period of Performance - 48 months

Fee* Insurance costs to be determined.
**Although the cost quoted is for an efficacy study, the finish date is based on the immunogenicity trial described in
the SoW and would change in the event an efficacy trial were required.

27

5.1

Most Favored Nation ClauseDue to the exceptional and unprecedented nature of the COVED-19 threat to(i)global public health and in recognition of the long historical partnership between the U.S.
Government and Sanofi Pasteur working on global pandemic solutions, as well as theinvestments made towards the development of a safe and effective vaccine against COVID-19,
Sanofi Pasteur agrees that it will not sell any COVID-19 vaccine licensed under this Agreement
to any nation that is a member of the Group of Seven plus Switzerland ("Covered Nation") at a
price that is more favorable than those set forth in this Project Agreement.
(ii)
If, at any time prior to December 31, 2021, Sanofi Pasteur enters into any
agreement with a Covered Nation to sell COVID-19 vaccine doses at a price lower than the pricecurrently paid by the U.S. Government for the same COVID-19 vaccine doses, Sanofi Pasteur
shall provide notice within 30 days to the U.S. Government and the U.S. Government may elect,
at its discretion, to receive the benefit of this provision and receive COVID-19 vaccine doses atthat lower price.
(iii) Upon any such election by the U.S. Government, this Project Agreement shall bedeemed to have been amended and modified such that, from the date on which the morefavorable pricing was first provided to any Covered Nation (the "Amended Pricing Effective
Date"), the U.S. Government will receive that lower price for all orders of COVID-19 vaccine
doses following that Amended Pricing Effective Date.
(iv) Additionally, Sanofi Pasteur will provide a credit, expressed as a cost share,
towards future U.S. Government payments made under this Project Agreement in the amountthat the U.S. Government paid above the more favorable pricing for any purchases of COVID-19
vaccine doses placed prior to the Amended Pricing Effective Date. In the event the credit
exceeds the remaining payments due Sanofi Pasteur under this Project Agreement, the parties
agree to negotiate how best to protect the Government's interest as part of the Close-out
Procedures specified in Section 2.05 of Other Transaction Agreement number W15QKN-16-91002.
(v)
Any price reductions provided hereunder are not intended as an inducement or
reward for any procurement or purchasing decisions by the U.S. Government of any Sanofi
Pasteur product.
6.0

SHIPPING PROVISIONSThe contactor shall submit Quarterly, Annual, and final reports in accordance with the Base
Agreement to deliverables.mcdc@ati.org. All deliverables intended for the AOR shall bedelivered electronically to the AOR identified below.
A copy of all data deliverables shall be sent tousarmy.detrick.dod-jpeo-cbrnd.mbx.otadeliverable@mail.mil.
Shipping information shall be provided upon acceptance of the manufactured product.
7.0

INTELLECTUAL PROPERTY and REGULATORY RIGHTS
28

7.1
Patent Rights
Patent rights and rights in any Subject Invention, as that term is defined in Article X Sections
10.01-10.13 of Other Transaction Agreement number WI5QKN-16-9-1002, shall be governed
by Article X of the OTA and consistent with W15QKN-16-9-1002. These patent rights andrights in any Subject Invention include, but are not limited to, the Government's retention ofcertain licensure rights in subject inventions and applicability of the Government's March-In
rights. Specifically, with respect to any Subject Invention in which Sanofi retains title and as set
forth in Article X Section 10.02, the Government shall have a non-exclusive, nontransferable,
irrevocable, paid-up license to practice or have practiced on behalf of the United States the
Subject Invention throughout the world. Furthermore, Sanofi agrees that, with respect to any
Subject Invention in which it has retained title, the Government, has the right to require Sanofi
to obtain and grant a non-exclusive license to a responsible applicant or applicants, upon terms
that are reasonable under the circumstances as set forth in Article X, Section 10.10.

7.2
Technical Data Rights
Sanofi Pasteur grants the Government Unlimited Rights, as that term is defined DFARS
227.2013, in all Sanofi Pasteur data (excluding with respect to (b) (4) data) that is delivered to
the Government under this Project Agreement.
7.3

Confidential Information

7.3.1 General
Neither Party, as the Receiving Party, shall, directly or indirectly, divulge or reveal to any personor entity any confidential information of the other Party without the Disclosing Party's priorwritten consent, or use such Confidential Information except as permitted under this Project
Agreement.
7.3.2 Exclusion
Such obligation of confidentiality shall not apply to information which the Receiving Party candemonstrate 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 contract; (iii) was
known to the Receiving Party prior to disclosure thereof by the Disclosing Party; (iv) was
lawfully disclosed to the Receiving Party by a Third Party which was not under an obligation ofconfidence to the Disclosing Party with respect thereto; or (v) was approved for public release byprior written permission of the Disclosing Party.
Regulatory Rights
7.4
This Project Agreement involves research with an investigational drug, biologic or medical
device that is regulated by the U.S. Food and Drug Administration (FDA) and requires FDA premarket approval or clearance before commercial authorization. It is expected that this contract
will result in the FDA authorization, clearance, and commercialization of Sanofi's Adjuvanted
Recombinant COVID-19 Vaccine as a Vaccine for SARS-CoV-2 Coronavirus (the"Technology"). The Contractor is the Sponsor of the Regulatory Application (an investigational
new drug application (IND), investigational device exemption (IDE), emergency use
29authorization (EUA), 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 this contract. As theSponsor of the Regulatory Application to FDA (as the terms "sponsor" and "applicant" aredefined or used in at 21 CFR §§3.2(c), 312.5, 600.3(t), 812.2(b), 812 Subpart C, or 814.20), theContractor has certain standing before the FDA that entitles it to exclusive communications
related to the Regulatory Application.
The Parties agree that Contractor has invested significant time and resources in its platform andIP and is the best company situated to manage production of the Adjuvanted Recombinant
COVID-19 Vaccine. At the same time, the Parties acknowledge that the Government has madesignificant investments in the prototype. Accordingly, the Contractor and the Government agree
to the following:a. Communications. Contractor will provide the Government with all communications andsummaries thereof, both formal and informal, to or from FDA regarding the Technology andensure that the Government representatives are invited to participate in any formal or informal
Sponsor meetings with FDA;
b. DoD Medical Product Priority. PL 115-92 allows the DoD to request, and FDA to provide,assistance to expedite development of products to diagnose, treat, or prevent serious or lifethreatening diseases or conditions facing American military personnel. The Awardee recognizes
that only the DoD can utilize PL 115-92. As such, the Awardee will work proactively with theGovernment to leverage this law to its maximum potential under this Project Agreement. The
Awardee shall submit Public Law 115-92 Sponsor Authorization Letter that will be delivered tothe designated OWS POC(s) within 30 days of award.
c. Rights of Reference. To the extent necessary or useful to exercise the Government's rights
under the license grants in Section 7 of this Project Agreement and subject to the restrictions set
forth in that section, Sanofi Pasteur hereby grants to the Government and its permitted
sublicensees a limited "right of reference or use" (as that term is defmed in 21 C.F.R. § 314.3(b),as amended from time to time) strictly for COVID-19 or other Material Threat (as defined at
Section 319 of the Public Health Service Act) Purposes to Sanofi Pasteur's filings to the FDA inconnection with the Regulatory Application (excluding such right of reference or use for (b) (4)and Sanofi Pasteur shall provide appropriate notification of the Government's access andreference rights to the applicable regulatory authorities requested by the Government for thelimited purposes described above. Sanofi Pasteur agrees to provide a letter of cross-reference to
the Government and file such letter with the appropriate FDA office. This provision is inaddition to any rights in technical data described earlier in this document, excluding with respect
to (b) (4)8.0

ENSURING SUFFICIENT SUPPLY OF THE PRODUCT

1. In recognition of the Government's significant funding for the development andmanufacturing of the product in this Project Agreement and the Government's need to provide
sufficient quantities of a COVID-19 vaccine to protect the United States population, the30Government shall have the remedy described in this section to ensure sufficient supply of the
product to meet the needs of the public health or national security. This remedy is not available
to the Government unless and until both of the following conditions are met:a. Sanofi gives written notice, required to be submitted to the Government no later than
15 business days, of:i. any formal management decision to terminate manufacturing of this productvaccine prior to delivery of 100 million doses to USG, or;ii. any formal management decision to discontinue sale of this product vaccine to
the Government prior to delivery of 100 million doses to USG; oriii. any filing that anticipates Federal bankruptcy protection; andb. Sanofi has submitted an Emergency Use Authorization under §564 of the FD&C Act
or a biologics license application provisions of §351(a) of the Public Health Service Act (PHSA).
2. If both conditions listed in section (a) occur, Sanofi, upon the request of the Government,
shall provide the following items necessary for the Government to pursue manufacturing of thisproduct vaccine with a third party for exclusive sale to the U.S. Government:a. a writing evidencing a non-exclusive, nontransferable, irrevocable (except for cause),
royalty-free paid-up license to practice or have practiced for or on behalf of the U.S. Government
any Sanofi Background Patent, Copyright, other Sanofi Intellectual Property, Sanofi Know-How,
Sanofi Technical Data rights necessary to manufacture or have manufactured the vaccine;b. necessary FDA regulatory filings or authorizations owned or controlled by Sanofi
related to this product vaccine and any confirmatory instrument pertaining thereto (excluding
with respect to ( b) (4)); andc. any outstanding Deliverables contemplated or materials purchased under this Project
Agreement.
3. This Article shall be incorporated into any contract for follow-on activities for theGovernment to acquire and use additional doses of the product. Per section 1.3, the estimatedquantity for follow-on production/procurement is sufficient quantities to vaccinate approximately
300 million people.
4. This Article will survive the acquisition or merger of the Contractor by or with a third party.
This Article will survive the expiration of this agreement.
9.0

PUBLICATION POLICY

9.1
Publication of Clinical Data Related to the Trial
Any publication or presentation related to the clinical trial must be submitted to SP (b) (4) for
review before submission of the manuscript. After publication of the results of the tna , any
participating center may publish or otherwise use its own data provided that an publication ofdata from the trial gives recognition to the trial group. In addition, SP (b) (4) shall be offeredan association with all such publications, it being understood that SP (b) (4) are each entitled
to refuse the association.
31

SP (b) (4) must have the opportunity to review all proposed abstracts, manuscripts, orpresentations regarding these trials at least 30 da s g. rior to submission for publication /presentation. Any information identified by SP (b) (4) as confidential must be deleted prior to
submission, it being understood that the results of this trial are not to be considered confidential,
provided that an • ublication of data from the trial gives recognition to the trial group. In
addition, SP (b) (4) shall be offered an association with all such publications, it being
understood that SP ( b ) (4) are each entitled to refuse the association.

9.2
Publication of nonclinical Subject Data
Publication of an nonclinical Subject Data shall be prohibited without the express permission of
Sanofi Pasteur (b) (4)10.0 SECURITY
The security classification level for this effort is UNCLASSIFIEDThe Attached Appendix 1 is hereby incorporated in this SOW.
11.0

MISCELLANEOUS REQUIREMENTS (SAFETY, ENVIRONMENTAL, ETC.)

11.1

Associate Contractor Agreement (ACA)

In the following clause "Contractor" shall mean "subcontractor/supplier" anda) It is recognized that success of the Adjuvanted Recombinant COVID-19 Vaccine
Development research effort depends in part upon the open exchange of information between thevarious Associate Contractors involved in the effort. This clause is intended to insure that there
will be appropriate coordination and integration of work by the Associate Contractors to achievecomplete compatibility and to prevent unnecessary duplication of effort.
By executing this contract, the Contractor assumes the responsibilities of an Associate
Contractor. For the purpose of this clause, the term Contractor includes subsidiaries, affiliates,and organizations under the control of the contractor (e.g. subcontractors).
(b) Work under this contract may involve access to proprietary or confidential data from an
Associate Contractor. To the extent that such data is received by the Contractor from any
Associate Contractor for the performance of this contract, the Contractor hereby agrees that any
proprietary information received shall remain the property of the Associate Contactor and shallbe used solely for the purpose of the Adjuvanted Recombinant COVID-19 Vaccine Development
research effort. Only that information which is received from another contractor in writing andwhich is clearly identified as proprietary or confidential shall be protected in accordance withthis provision. The obligation to retain such information in confidence will be satisfied if theContractor receiving such information utilizes the same controls as it employs to avoid
disclosure, publication, or dissemination of its own proprietary information. The receiving
Contractor agrees to hold such information in confidence as provided herein so long as suchinformation is of a proprietary/confidential or limited rights nature.
32

(c) The Contractor hereby agrees to closely cooperate as an Associate Contractor with the other
Associate Contractors on this research effort. This involves as a minimum:(1) Maintenance of a close liaison and working relationship;(2) Maintenance of a free and open information network with all Government-identified
Associate Contractors;(3) Delineation of detailed interface responsibilities;(4) Entering into a written agreement with the other Associate Contractors setting forth thesubstance and procedures relating to the foregoing, and promptly providing the Agreements
Officer/Procuring Contracting Officer with a copy of same; and,(5) Receipt of proprietary information from the Associate Contractor and transmittal ofContractor proprietary information to the Associate Contractors subject to any applicable
proprietary information exchange agreements between associate contractors when, in either case,those actions are necessary for the performance of either.
(d) In the event that the Contractor and the Associate Contractor are unable to agree upon any
such interface matter of substance, or if the technical data identified is not provided as scheduled,
Sanofi Pasteur shall promptly notify the Agreements Officer Representative and OTA Program
Manager. The Government will determine the appropriate corrective action and will issue
guidance to the affected Contractor.
(e) The Contractor agrees to insert in all subcontracts hereunder which require access toproprietary information belonging to the Associate Contractor, a provision which shall conform
substantially to the language of this clause, including this paragraph (e).
11.2 (a) The Contractor should enter into Associate Contractor Agreements (ACA) for any
portion of the contract requiring joint participation in the accomplishment of the Government s
requirement. The agreements should include the basis for sharing information, data, technicalknowledge, expertise, and/or resources essential to the integration of the Adjuvanted
Recombinant COVID-19 Vaccine Development, to ensure the greatest degree of cooperation forthe development of the program to meet the terms of the contract. Associate contractors are listedin (g) below.
(b) ACAs should include the following general information:(1) Identify the associate contractors and their relationships.
(2) Identify the program involved and the relevant Government contracts of the associate
contractors.
(3) Describe the associate contractor interfaces by general subject matter.
(4) Specify the categories of information to be exchanged or support to be provided.
33

(5) Include the expiration date (or event) of the ACA.
(6) Identify potential conflicts between relevant Government contracts and the ACA;
include agreements on protection of proprietary data and restrictions on employees.
(c) Provide a copy of such agreement to the Contracting Officer for review before execution of
the document by the cooperating contractors.
(d)The Contractor is not relieved of any contract requirements or entitled to any adjustments tothe contract terms because of a failure to resolve a disagreement with an associate contractor.
(e) Liability for the improper disclosure of any proprietary data contained in or referenced by any
agreement rests with the parties to the agreement, and not the Government.
(f) All costs associated with the agreements are included in the negotiated cost of this contract.
Agreements may be amended as required by the Government during the performance of thiscontract.
(g) The following contractors are associate contractors with whom agreements are required:

Contractor

Address(b) (4)
Sanofi Pasteur.

Program / Contract
OWS Project Entitled:
Adjuvanted Recombinant
COVID-19 Vaccine
Development,(b) (4)(b) (4)(b) (4)
12.0

GOVERNMENT FURNISHED PROPERTY/MATERIAL/INFORMATION
on behalf of the Government shall srovide as GFM 100M doses of Ad'uvant(b) (4)(b) (4)13.0

AGREEMENTS OFFICER'S REPRESENTATIVE (AOR) AND ALTERNATEAOR CONTACT INFORMATION

AOR
NAME: (b) (6)EMAIL (b) (6)
PHONE (b) (6)
AGENCY NAME/DIVISION/SECTION: Department of Health and Human Services,
Biomedical Advanced Research and Development Agency
34

Appendix 1: Clause for MCDC Consortium Other Transaction
Authority Agreements
Standard Language OWS for Consortium OTA

Required MCDC Base A2reement Modifications
The Medical CBRN Consortium (MCDC) Base Agreement, Article XVII, SECURITY & OPSEC shall apply to thisProject Agreement. In addition, the below language shall replace Paragraph 6 of Article XVII of the MCDC Base
Agreement.
(6) Access and General Protection/Security Policy and Procedures. This standard language text is applicable to ALL
PAH employees working on critical program information or covered defense information related to Operation Warp
Speed (OWS), and to those with an area of performance within an Army controlled installation, facility or area.
PAH employees shall comply with applicable installation, facility and area commander installation/facility accessand local security policies and procedures (provided by government representative). The PAH also shall provide all
information required for background checks necessary to access critical program information or covered defense
information related to OWS, and to meet installation access requirements to be accomplished by installation Provost
Marshal Office, Director of Emergency Services or Security Office. The PAH workforce must comply with all
personal identity verification requirements as directed by DOD, HQDA and/or local policy. In addition to thechanges otherwise authorized by the changes clause of this agreement, should the Force Protection Condition(FPCON) at any individual facility or installation change, the Government may require changes in PAH security
matters or processes.

Required SOW Lan2ua2e for Deliverables (in body of SOW or Deliverables Section)
Information Security
Classification guidance for Operation Warp Speed - The security level for this agreement is UNCLASSIFIED.
"Controlled technical information," "covered contractor information system," "covered defense information," "cyberincident," "information system," and "technical information" are defined in DFARS Clause 252.204-7012, Safeguarding
Covered Defense Information and Cyber Incident Reporting.
Personnel Security
In addition to the industry standards for employment background checks, The Contractor must be willing to have
key individuals, in exceptionally sensitive positions, identified for additional vetting by the United States
Government.
Supply Chain Resiliency Plan
The contractor shall develop and submit within 30 calendar days after contract award, a comprehensive Supply
Chain Resiliency Program that provides identification and reporting of critical components associated with thesecure supply of drug substance, drug product, and work-in-process through to finished goods.
a) A critical component is defined as any material that is essential to the product or the manufacturing
process associated with that product. Included in the definition are consumables and disposables
associated with manufacturing. NOT included in the definition are facility and capital equipment.

35

Consideration of critical components includes the evaluation and potential impact of raw materials, excipients,
active ingredients, substances, pieces, parts, software, firmware, labeling, assembly, testing, analytical andenvironmental componentry, reagents, or utility materials which are used in the manufacturing of a drug, cell banks,
seed stocks, devices and key processing components and equipment. A clear example of a critical component is one
where a sole supplier is utilized.
The contractor shall identify key equipment suppliers, their locations, local resources, and the associated control
processes at the time of award. This document shall address planning and scheduling for active pharmaceuticalingredients, upstream, downstream, component assembly, finished drug product and delivery events as necessary forthe delivery of product.
a) Communication for these requirements shall be updated as part of an annual review, or as necessary, as partof regular contractual communications.
b) For upstream and downstream processing, both single-use and re-usable in-place processing equipment,
and manufacturing disposables also shall be addressed. For finished goods, the inspection, labeling,
packaging, and associated machinery shall be addressed taking into account capacity capabilities.
c) The focus on the aspects of resiliency shall be on critical components and aspects of complying with thecontractual delivery schedule. Delivery methods shall be addressed, inclusive of items that are foreignsourced, both high and low volume, which would significantly affect throughput and adherence to thecontractually agreed deliveries.
The contractor shall articulate in the plan, the methodology for inventory control, production planning, schedulingprocesses and ordering mechanisms, as part of those agreed deliveries.
a) Production rates and lead times shall be understood and communicated to the Contracting/Agreement
Officer or the Contracting/Agreement Officer's Representative as necessary.
b) Production throughput critical constraints should be well understood by activity and by design, andcommunicated to contractual personnel. As necessary, communication should focus on identification,
exploitation, elevation, and secondary constraints of throughput, as appropriate.
Reports for critical items should include the following information:a) Critical Materialb) Vendorc) Supplier, Manufacturing / Distribution Locationd) Supplier Lead Timee) Shelf Life
0 Transportation / Shipping restrictions
The CO and COR reserve the right to request un-redacted copies of technical documents, during the period of
performance, for distribution within the Government. Documents shall be provided within ten (10) days after CO
issues the request. The Contractor may arrange for additional time if deemed necessary, and agreed to by the CO.
Manufacturing Data Requirements:
The Contractor shall submit within 30 calendar days after award detailed data regarding project materials, sources,
and manufacturing sites, including but not limited to: physical locations of sources of raw and processed material bytype of material; location and nature of work performed at manufacturing, processing, and fill/finish sites; andlocation and nature of non-clinical and clinical studies sites. The Government may provide a table in tabular format
for Contractor to be used to submit such data which would include but not be limited to the following:•
Storage/inventory of ancillary materials (vials, needles, syringes, etc.)•
Shipment of ancillary materials (vials, needles, syringes, etc.)•
Disposal of ancillary materials (vials, needles, syringes, etc.)•
Seed development or other starting material manufacturing•
Bulk drug substance and/or adjuvant production•
Fill, finish, and release of product or adjuvant•
Storage/inventory of starting materials, bulk substance, or filled/final product or adjuvant

36

•
•
•

Stability information of bulk substance and/or finished product
Shipment of bulk substance of final productDisposal of bulk substance or final productProduct Development Source Material and Manufacturing Reports and Projections:
The Contractor shall submit a detailed spreadsheet regarding critical project materials that are sourced from alocation other than the United States, sources, and manufacturing sites, including but not limited to: physicallocations of sources of raw and processed material by type of material; location and nature of work performed at
manufacturing sites; and location and nature of non-clinical and clinical study sites.

The Contractor will provide manufacturing reports and manufacturing dose tracking projections/actuals utilizing the"COVID-19 Dose Tracking Templates", on any contract/agreement that is manufacturing product•Contractor will submit Product Development Source Material Reporto Within month of contract awardo Within 30 days of substantive changes are made to sources and/or materialso Or on the 6111 month contract anniversary.
•
Contractor will update the Dose Tracking Template weekly, during manufacturing campaigns and COVID
response, with the first deliverable submission within 15 days of award/modification•
The Government will provide written comments to the Product Development Source Material and
Manufacturing Report within 15 business days after the submission•
If corrective action is recommended, Contractor must address all concerns raised by the Government inwriting
Contractor Locations:
The contractor shall submit detailed data regarding locations where work will be performed under this contract,
including addresses, points of contact, and work performed per location, to include sub-contractors.
Contractor will submit Work Locations Report:•
Within 5 business days of contract award•
Within 30 business days after a substantive location or capabilities change•
Within 2 business days of a substantive change if the work performed supports medical countermeasuredevelopment that addresses a threat that has been declared a Public Health Emergency by the HHS
Secretary or a Public Health Emergency of International Concern (PHEIC) by the WHO

Required SOW Language for Security Section
This project requires an OPSEC Plan and a Security Plan.
The contractor shall develop a comprehensive security program that provides overall protection of personnel,
information, data, and facilities associated with fulfilling the Government requirement. This plan shall establish
security practices and procedures that demonstrate how the contractor will meet and adhere to the security
requirements outlined below prior to the commencement of product manufacturing, and shall be delivered to theGovernment within 30 calendar days of award. The contractor shall also ensure all subcontractors, consultants,
researchers, etc. performing work on behalf of this effort, comply with all Operation Warp Speed and Project
Agreement security requirements and prime contractor security plans.
a) The Government will review in detail and submit comments within ten (10) business days to theContracting Officer (CO) to be forwarded to the Contractor. The Contractor shall review the Draft Security
Plan comments, and, submit a Final Security Plan to the U.S. Government within thirty (10) calendar days
after receipt of the comments.
b) The Security Plan shall include a timeline for compliance of all the required security measures outlined by
the Government.
c) Upon completion of initiating all security measures, the Contractor shall supply to the Contracting Officer aletter certifying compliance to the elements outlined in the Final Security Plan.
37

At a minimum, the Final Security Plan shall address the following items:

Security Requirements:
1.

Facility Security Plan

Description: As part of the partner facility's overall security program, the contractor shall submit a written
security plan with their proposal to the Agreement Officer for review and approval by Operation Warp Speed
security subject matter experts. The performance of work under the Project Agreement will be in accordance withthe approved security plan. The security plan will include the following processes and procedures at a minimum:•
Security Administration

Personnel Security

Physical Security Policies
and Procedures••organization chart and responsibilities
written security risk assessment for sitethreat levels with identification matrix (High, Medium, or Low)•••enhanced security procedures during elevated threatsliaison procedures with law enforcement
annual employee security education and training program

•
•
•
•

policies and procedures
candidate recruitment process
background investigations process
employment suitability policy

•
•
•
•

employee access determination
rules of behavior/ conduct
termination procedures
non-disclosure agreements•internal/external access control
protective services
identification/badging
employee and visitor access controls
parking areas and access control
perimeter fencing/barriers
product shipping, receiving and transport security procedures

•
•
•
•
•
•
•
•
•
•
•

Information Security

facility security lighting
restricted areas•••

signageintrusion detection systems
alarm monitoring/response
closed circuit television
product storage security
other control measures as identified

•
•
•
•
•

identification and marking of sensitive information
access control
storage of information
document control procedures
retention/ destruction requirements

38

Information
Technology/Cyber Security
Policies and Procedures

2.

•
•
•
•
•

intrusion detection and prevention systems
threat identification
employee training (initial and annual)encryption systems
identification of sensitive information/media

•
•
•
•
•
•
•
•
•
•
•
•

password policy (max days 90)
lock screen time out policy (minimum time 20 minutes)
removable media policy
laptop policy
removal of IT assets for domestic/foreign travel
access control and determination
VPN procedures
WiFi and Bluetooth disabled when not in use
system document control
system backup
system disaster recovery
incident response••

system audit procedures
property accountability

Site Security Master Plan

Description: The partner facility shall provide a site schematic for security systems which includes: main accesspoints; security cameras; electronic access points; IT Server Room; Product Storage Freezer/Room; and biocontainment laboratories.

3.

Site Threat / Vulnerability / Risk Assessment

Description: The partner facility shall provide a written risk assessment for the facility addressing: criminal
threat, including crime data; foreign/domestic terrorist threat; industrial espionage; insider threats; natural
disasters; and potential loss of critical infrastructure (power/water/natural gas, etc.) This assessment shall include
recent data obtained from local law enforcement agencies. The assessment should be updated annually.

4.

Physical Security

Description:
Closed Circuit Television(CCTV) Monitoring

a)

b)

c)
d)
e)

Facility Lighting

f)
g)
a)
b)

Layered (internal/external) CCTV coverage with time-lapse video
recording for buildings and areas where critical assets are processed orstored.
CCTV coverage must include entry and exits to critical facilities,
perimeters, and areas within the facility deemed critical to the executionof the contract.
Video recordings must be maintained for a minimum of 30 days.
CCTV surveillance system must be on emergency power backup.
CCTV coverage must include entry and exits to critical facilities,
perimeters, and areas within the facility deemed critical to the executionof the contract.
Video recordings must be maintained for a minimum of 30 days.
CCTV surveillance system must be on emergency power backup.
Lighting must cover facility perimeter, parking areas, criticalinfrastructure, and entrances and exits to buildings.
Lighting must have emergency power backup.
39

c)Lighting must be sufficient for the effective operation of the CCTV
surveillance system during hours of darkness.

Shipping and Receivinga)Must have CCTV coverage and an electronic access control system.

b)Must have procedures in place to control access and movement ofdrivers picking up or delivering shipments.

c)

Must identify drivers picking up Government products by government
issued photo identification.

Access Controla)Must have an electronic intrusion detection system with centralized
monitoring.

b)c)Responses to alarms must be immediate and documented in writing.
Employ an electronic system (i.e., card key) to control access to areas
where assets critical to the contract are located (facilities, laboratories,
clean rooms, production facilities, warehouses, server rooms, records
storage, etc.).

d)

The electronic access control should signal an alarm notification ofunauthorized attempts to access restricted areas.

e)Must have a system that provides a historical log of all key accessf)transactions and kept on record for a minimum of12 months.
Must have procedures in place to track issuance of access cards toemployees and the ability to deactivate cards when they are lost or an
employee leaves the company.

g)

Response to electronic access control alarms must be immediate anddocumented in writing and kept on record for a minimum of 12 months.

h)Should have written procedures to prevent employee piggybacking
accessi)

to critical infrastructure (generators, air handlers, fuel storage, etc.)
should be controlled and limited to those with a legitimate need foraccess.

j)Must have a written manual key accountability and inventory process.

k)Physical access controls should present a layered approach to critical

Employee/Visitora)Should issue company photo identification to all employees.

Identificationb)

Photo identification should be displayed above the waist anytime theemployee is on company property.

c)Visitors should be sponsored by an employee and must present
government issued photo identification to enter the property.

d)Visitors should be logged in and out of the facility and should beassets within the facility.

escorted by an employee while on the premises at all times.
Security Fencing

Requirements for security fencing will be determined by the criticality of the
program, review of the security plan, threat assessment, and onsite security
assessment.

Protective Security Forces

Requirements for security officers will be determined by the criticality of the
program, review of the security plan, threat assessment, and onsite security
assessment.

Protective Security Forces
Operations

a)
b)
c)

Must have in-service training program.
Must have Use of Force Continuum.
Must have communication systems available (i.e., landline on post, cell
phones, handheld radio, and desktop computer).

d)Must have Standing Post Orders.

e)Must wear distinct uniform identifying them as security officers.
40

S.

Security Operations

Description:
Information Sharing

Training
Security Management

6.

a) Establish formal liaison with law enforcement.
b) Meet in person at a minimum annually. Document meeting notes andkeep them on file for a, minimum of 12 months. POC information for LE
Officer that attended the meeting must be documented.
c) Implement procedures for receiving and disseminating threat
information.
a) Conduct new employee security awareness training.
b) Conduct and maintain records of annual security awareness training.
a) Designate a knowledgeable security professional to manage the securityof the facility.
b) Ensure subcontractor compliance with all Government security
requirements.

Personnel Security

Description:
Records Checks
Verification of social security number, date of birth, citizenship, education
credentials, five-year previous employment history, five-year previous residence
history, FDA disbarment, sex offender registry, credit check based upon position
within the company; motor vehicle records check as appropriate; andlocal/national criminal history search.
Hiring and Retention
Standards

7.

a) Detailed policies and procedures concerning hiring and retention of
employees, employee conduct, and off boarding procedures.
b) Off Boarding procedures should be accomplished within 24 hour of
employee leaving the company. This includes termination of all network
access.

Information Security

Description:
Physical Document Control

Document Destruction
8.

a) Applicable documents shall be identified and marked as procurement
sensitive, proprietary, or with appropriate government markings.
b) Sensitive, proprietary, and government documents should bemaintained in a lockable filing cabinet/desk or other storage device andnot be left unattended.
c) Access to sensitive information should be restricted to those with aneed to know.
Documents must be destroyed using approved destruction measures (i.e,shredders/approved third party vendors / pulverizing / incinerating).

Information Techno ogy & Cybersecurity

Description:
Identity Managementa) Physical devices and systems within the organization are inventoried
and accounted for annually.
b) Organizational cybersecurity policy is established and communicated.
c) Asset vulnerabilities are identified and documented.
d) Cyber threat intelligence is received from information sharing forums
and sources.
41

e)
f)
g)

Access Control

a)
b)
c)

Trainingd)a)Audit and Accountability

a)

b)
c)
d)

Configuration Managementa)b)Contingency Planninga)

Incident Responsea)Media and Information
Protectiona)b)

Physical and Environmental
Protection

c)
d)
a)
b)
c)
d)

Threats, vulnerabilities, likelihoods, and impacts are used to determine
risk.
Identities and credentials are issued, managed, verified, revoked, andaudited for authorized devices, users and processes.
Users, devices, and other assets are authenticated (e.g., single-factor,
multifactor) commensurate with the risk of the transaction (e.g.,
individuals' security and privacy risks and other organizational risks)
Limit information system access to authorized users.
Identify information system users, processes acting on behalf of users,
or devices and authenticate identities before allowing access.
Limit physical access to information systems, equipment, and serverrooms with electronic access controls.
Limit access to/ verify access to use of external information systems.
Ensure that personnel are trained and are made aware of the security
risks associated with their activities and of the applicable laws, policies,
standards, regulations, or procedures related to information technology
systems.
Create, protect, and retain information system audit records to theextent needed to enable the monitoring, analysis, investigation, andreporting of unlawful, unauthorized, or inappropriate system activity.
Records must be kept for minimum must be kept for 12 months.
Ensure the actions of individual information system users can be
uniquely traced to those users.
Update malicious code mechanisms when new releases are available.
Perform periodic scans of the information system and real time scans offiles from external sources as files are downloaded, opened, or
executed.
Establish and enforce security configuration settings.
Implement sub networks for publically accessible system componentsthat are physically or logically separated from internal networks.

Establish, implement, and maintain plans for emergency response,
backup operations, and post-disaster recovery for information systems
to ensure the availability of critical information resources at all times.
Establish an operational incident handling capability for information
systems that includes adequate preparation, detection, analysis,containment, and recovery of cybersecurity incidents. Exercise thiscapability annually.
Protect information system media, both paper and digital.
Limit access to information on information systems media to authorizedusers.
Sanitize and destroy media no longer in use.
Control the use of removable media through technology or policy.
Limit access to information systems, equipment, and the respective
operating environments to authorized individuals.
Intrusion detection and prevention system employed on IT networks.
Protect the physical and support infrastructure for all information
systems.
Protect information systems against environmental hazards.
42

Network Protectione) Escort visitors and monitor visitor activity.
Employ intrusion prevention and detection technology with immediate analysis
capabilities.

9. Transportation Security
Description: Adequate security controls must be implemented to protect materials while in transit from theft,destruction, manipulation, or damage.
Drivers

Transport Routes

Product Securitya) Drivers must be vetted in accordance with the Government Personnel
Security Requirements.
b) Drivers must be trained on specific security and emergency procedures.
c) Drivers must be equipped with backup communications.
d) Driver identity must be 100 percent confirmed before the pick-up of any
Government product.
e) Drivers must never leave Government products unattended, and two
drivers may be required for longer transport routes or critical products
during times of emergency.
f) Truck pickup and deliveries must be logged and kept on record for aminimum of 12 months.
a) Transport routes should be pre-planned and never deviated from except
when approved or in the event of an emergency.
b) Transport routes should be continuously evaluated based upon new
threats, significant planned events, weather, and other situations thatmay delay or disrupt transport.
a) Government products must be secured with tamper resistant seals
during transport, and the transport trailer must be locked and sealed.
•
Tamper resistant seals must be verified as "secure" after the
product is placed in the transport vehicle.
b) Government products should be continually monitored by GPS
technology while in transport, and any deviations from planned routes
should be investigated and documented.
c) Contingency plans should be in place to keep the product secure during
emergencies such as accidents and transport vehicle breakdowns.

10. Security Reporting Requirements

Description: The partner facil'ty shall notify the Agreement Officer within 24 hours of any activity or incident
that is in violation of established security standards or indicates the loss or theft of government products. The
facts and circumstances associated with these incidents will be documented in writing for government review.

11. Security Audits

Description: The partner facility agrees to formal security audits conducted at the discretion of the government.
Security audits may include both prime and subcontractor.

43

MCDC2011-001

UNDEFINITIZED PROJECT ACTION
MCDC2011-005 is a hybrid Cost/Fixed Price Agreement that will be awarded under W15QICN-16-9-1002 (hereinafter"Agreement"). Due to urgency concerns, this Undefinitized Project Action (UPA) is being issued to Sanofi Pasteur,
Inc. (hereinafter "Contractor") for Adjuvanted Recombinant COVID-19 Vaccine Development. The following ishereby incorporated as part of this Agreement.
1.

DEFINITIZATION:a) This Agreement covers a hybrid Cost/Fixed Price UPA that awards prototype project MCDC2011-005.
The Contractor agrees to promptly begin negotiating with the Agreements Officer on the terms of adefinitive Agreement for the project, which will include: (1) all mutually agreeable terms and conditions
related to this Agreement, and (2) all other terms and conditions required by law. The Contractor will be
required to submit a qualifying cost proposal with all necessary supporting documentation, in order toallow for a full evaluation of costs.
b) The schedule for definitizing this Agreement is as follows:i.
Receipt of Qualifying Proposal: 10 September 2020
ii.
Estimated Start of Negotiations: 01 October 2020
iii.
Estimated Date of Definitization: 09 December 2020c) If a definitive Agreement is not finalized to supersede this UPA by the target date in paragraph 2(b)(iii),
or within any extension granted in writing by the Agreements Officer, the Agreements Officer may, withthe approval of the Army Contracting Command-New Jersey, Senior Contracting Official, unilaterally
determine a fair and reasonable price. This determination is subject to Contractor appeal, as provided forin the Disputes article of W15QICN-16-9-1002, but the Contractor shall not cease performance of thisAgreement while proceeding through the dispute process.
d) After the Agreements Officer's determination of a fair and reasonable price, the Agreement shall begoverned by all of the terms and conditions of the definitive Agreement. Furthermore, all the terms andconditions of this UPA shall continue in effect, except for those that by their nature apply only to UPAs.
e) The Government and Contractor agree that this UPA will include a ceiling in the amount of$1,769,013,470. This ceiling may be adjusted only by the written agreement of both parties.

2.

PAYMENT OF ALLOWABLE COSTS BEFORE DEFINITZATION:
Prior to definitization of this Agreement, the Government will reimburse the Contractor for all allowable andallocable costs up to 50% of the approved Not-To-Exceed (NTE) Price of $1,769,013,470. At any time before
a payment, the Agreements Officer may have the Contractor's invoices or vouchers audited. Any payment
may be (1) reduced by any amounts found by the Agreements Officer not deemed authorized in accordancewith the Statement of Work, or (2) adjusted for overpayments made on preceding invoices or vouchers.

3.

LIMITATIONS ON OBLIGATIONS:The Government will not obligate more than 50 percent of the NTE Price before definitization.

4.

LIMITATION OF GOVERNMENT LIABILITY:a) In performance of this Agreement, the Contractor is not authorized to make expenditures or incur
obligations exceeding $1,769,013,470 dollars.
b) The maximum amount for which the Government shall be liable if this Agreement is terminated is$1,769,013,470 dollars.

5.

EXECUTION AND COMMENCEMENT OF WORK:
Upon acceptance by both parties, the Contractor shall proceed with performance of the Statement of Work,
including the purchase of any necessary materials.

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