DEPARTMENT OF THE ARMY
U.S. ARMY CONTRACTING COMMAND – NEW JERSEYPICATINNY ARSENAL, NEW JERSEY 07806-5000
REPLY TOATTENTION OF
18 December 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 Definitized “Adjuvanted Recombinant COVID19 Vaccine Development” Sanofi Pasteur, Inc. (Sanofi)
Advanced Technology International
ATTN: (b) (6), Sr. Contracts Manager
315 Sigma Drive
Summerville, SC 29486
Dear (b) (6),The Army Contracting Command – New Jersey (CCNJ), 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. On 30 July theGovernment awarded a combination Cost/Firm-Fixed Price Undefinitized Project Agreement (UPA) and latermodified that award to adjust the Consortium Management Firm (CMF) Administrative Fee. The total
obligation for this project is $1,769,343,470 ($1,769,013,470 to perform project efforts included in the SOW
and $330,000 for the CMF Administrative Fee).
On, 10 September Sanofi submitted a proposal in response to the Government’s Request for Prototype Proposal(RPP) 20-11. The Government reviewed the proposal and determined that the proposed amount of$1,769,343,470 is appropriate for the work to be to be performed in accordance with the attached updated
Government Statement of Work (SOW). This amount remains unchanged for what was awarded under the
UPA. This letter herby authorizes performance and invoicing up to the total agreement value of$1,769,343,470.
It is noted that this project has a base period of performance of forty-eight (48) months, with a projectedcompletion date of 30 September 2024.
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:
Agreements Specialist:(b) (6)E-mail: (b) (6)Phone: ((b) (6)Statement of WorkFor Adjuvanted Recombinant COVID-19
Vaccine Development

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

This submission includes data that shall not be disclosed outside the Government and shall not be duplicated, used, or disclosed – in whole orin part – for any purpose other than to evaluate this submission. If, however, a contract modification is awarded to this offeror as a result of –or in connection with – the submission of this data, the Government shall have the right to duplicate, use, or disclose the data to the extent
provided in the resulting contract modification. This restriction does not limit the Government’s right to use information contained in thisdata if it is obtained from another source without restriction. The data subject to this restriction are contained in all sheets of this submission.
This submission contains confidential information and trade secrets subject to 5 U.S.C. 552 and 18 U.S.C. 1905.

Sanofi Pasteur - Proprietary and Company Confidential

1Statement of WorkFor Adjuvanted Recombinant COVID-19
Vaccine Development
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 a reasonable chance of moving to Phase III clinical trials by January
2021 with the goal of achieving an EUA or 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 all

Sanofi Pasteur - Proprietary and Company Confidential

2

Statement of WorkFor Adjuvanted Recombinant COVID-19
Vaccine Development
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) will
negotiate the scope, price and timing of production. Any pricing for the (b) (4) adjuvant(4)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.

Sanofi Pasteur - Proprietary and Company Confidential

3Statement of WorkFor Adjuvanted Recombinant COVID-19
Vaccine Development
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”):
(i)

(ii)

(iii)

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;
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; andContractor is a “Covered Person” to the extent it is a person defined in Section V of
the PREP Act Declaration.

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 the
supplement to the initial approval. The Contractor will request CBER agreement to defer vaccine
development in the pediatric population to post-licensure.
Sanofi Pasteur - Proprietary and Company Confidential

4Statement of WorkFor Adjuvanted Recombinant COVID-19
Vaccine Development
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.
will provide Regulatory Support for (b) (4) requirements. (see Deliverable 4.6.2)

(b)
(4)

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+® (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:••

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

3.2.1 Description of Clinical Drug Substance Manufacturing
For cGMP manufacturing of the COVID-19 vaccine for Phase III clinical studies, the licensed
Flublok influenza vaccine manufacturing platform (BLA STN 125285) is being leveraged as
Sanofi Pasteur - Proprietary and Company Confidential

5Statement of WorkFor Adjuvanted Recombinant COVID-19
Vaccine Development
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 summary from initial concept through final design; physicochemical and biologicalproperties; manufacturing process development 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.
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. (See Deliverable 4.14)
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
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)

participation in such meetings to be agreed.

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.

Sanofi Pasteur - Proprietary and Company Confidential

21

Statement of WorkFor Adjuvanted Recombinant COVID-19
Vaccine Development•

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 (OOS) 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, (b) (4)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 (photos of product on pallets), 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).
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.

Sanofi Pasteur - Proprietary and Company Confidential

24Statement of WorkFor Adjuvanted Recombinant COVID-19
Vaccine Development•

o Vendor-managed storage of product manufactured under this agreement is supported
through (b) (4)and, as such, the USG must either (a) take possession onor before this date and provide Contractor with disposition instructions in sufficient
time to transfer physical material from Contractor by this date or (b) bilaterally
modify this agreement to extend the period of vendor management of storage prior tothis 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
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.
Sanofi Pasteur - Proprietary and Company Confidential

25Statement of WorkFor Adjuvanted Recombinant COVID-19
Vaccine Development
If using a subcontracted storage site, provide the quality agreement, specify
the location and terms of the storage contract and receive approval by the
AOR.
• 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 withtransportation to final 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; orSanofi Pasteur - Proprietary and Company Confidential

26

Statement of WorkFor Adjuvanted Recombinant COVID-19
Vaccine Development
5.28
5.29
5.30
5.31

Quarterly Technical and Business
Status Report
Quarterly Technical and Business
Status Report
Quarterly Technical and Business
Status Report
Final Technical and Business Status
ReportPeriod of Performance – 48 months

4.28

12/31/2023

4.29

3/31/2024

4.30

6/30/2024

4.31

9/30/2024

Cost, No
Fee

Total:

$(
b
$(
b
$(
b
$(b)
(4)
$1,769,013,470* Work under 5.8 will be invoiced on a lot by lot basis** Insurance costs to be determined.
***Milestone 5.13 Post Licensure Clinical Trial Activities includes three studies that would be post-marketing
commitments with technical details described in SOW sections 3.4.2 thru 3.4.4.
• VAT03 pediatric efficacy• VAT04 lot to lot consistency• VAT0X pregnancy
The pediatric study, VAT03, is planned for safety and immunogenicity, however the possibility of a much larger trialbased on efficacy must be considered. It is not possible at this time to estimate trial design, protocols, subjects andother details, should they be needed. Additionally, the likelihood of VAT04 and VAT0X being conducted is
uncertain. Therefore, Milestone 5.13 is not able to be definitized currently, however the possible costs must be
reserved should these post marketing studies occur. As the likelihood of the activities become clearer, designs andother requirements defined the detailed estimates will be provided to support the execution of the work.

5.1

Most Favored Nation Clause(i)
Due to the exceptional and unprecedented nature of the COVID-19 threat to
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, as specified in Milestone 5.8, for the same COVID-19
vaccine doses, Sanofi Pasteur shall provide notice within 30 days to the U.S. Government andthe U.S. Government may elect, at its discretion, to receive the benefit of this provision andreceive COVID-19 vaccine doses at that 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 EffectiveDate”), 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

Sanofi Pasteur - Proprietary and Company Confidential

29Statement of WorkFor Adjuvanted Recombinant COVID-19
Vaccine Development
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 contractor 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

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 W15QKN-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 prior

Sanofi Pasteur - Proprietary and Company Confidential

30

Statement of WorkFor Adjuvanted Recombinant COVID-19
Vaccine Development
written 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.
7.4
Regulatory Rights
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
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. (see Deliverable 4.20)

Sanofi Pasteur - Proprietary and Company Confidential

31Statement of WorkFor Adjuvanted Recombinant COVID-19
Vaccine Developmentc. 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 defined 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, theGovernment 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.

Sanofi Pasteur - Proprietary and Company Confidential

32Statement of WorkFor Adjuvanted Recombinant COVID-19
Vaccine Development
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 Contractor 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.
(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

Sanofi Pasteur - Proprietary and Company Confidential

34

Statement of WorkFor Adjuvanted Recombinant COVID-19
Vaccine Development
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.
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 Lifef) Transportation / Shipping restrictions

Sanofi Pasteur - Proprietary and Company Confidential

37Statement of WorkFor Adjuvanted Recombinant COVID-19
Vaccine Development
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.
Supply Chain and Distribution Tracking
Distribution Concept of Operations. BARDA, CDC, and MCM Manufacturers play an important role in the
distribution of vaccines to the American people under a nationwide response. BARDA will work with the
manufacturer to monitor what is in the manufacturing pipeline using the enclosed dose tracking templates (seeabove). BARDA will relay final drug product information as it is being released to the CDC for allocation andordering by state public health departments. This information will be returned to BARDA as CDC replenishment
orders (CDC PO) on a daily basis with shipping instructions on where to send final drug product. Manufacturers
will use that information to ship vaccines or therapeutics in bulk to designated distribution centers for final
distribution to end users and end user networks. BARDA will provide the contractor with a list of distribution
centers and contact information prior to the start of a vaccination campaign.
Provide the following information in order to coordinate the movement and delivery of vaccine product frommanufacturing locations to USG distribution centers:• Provide Points of Contact information (name, title, phone, email) for manufacturing / supply chain
personnel for each manufacturing, CMO, storage and distribution locations:• Head of Manufacturing• Production Planning• Logistics• Distribution• Labeling• Provide vaccine labeling, packaging and distribution information as soon as it becomes available. At aminimum, include the following:• Primary Container Information• Number of doses per primary container• Unit of Sale (carton, box, package, other)• Quantity per Unit of Sale
• National Drug Code (NDC) or NDC-like code under EUA• Unit of Sale dimensions (H,W, L)• Unit of Sale weight• Intermediate Package• Intermediate Package dimensions• Intermediate Package weight• Quantity Unit of Sale per pallet• Storage Requirements• Stability Information• Obtain concurrence on planned shipment protocols prior to transport• If vaccine will require ultra-cold storage temperatures at the designated distribution centers, products shouldbe packaged in 100-dose units to facilitate pick/pack process and reduce exposure of workers to ultra-coldtemperatures.
• Include the following DSCSA data elements, TI, TH and TS in packing lists.
• Include the contract number and CDC’s PO number (which BARDA will provide at the time the bulk orderis submitted) on the packing list for all shipments• Include a copy of the MSDS (with QR code) in the packing list envelope with each shipment.
• Send EDI 856 Advanced Shipment Notice for all products shipped to a USG directed location. CDC will
provide EDI mapping specifications that include the CDC generated PO number.

Sanofi Pasteur - Proprietary and Company Confidential

38Statement of WorkFor Adjuvanted Recombinant COVID-19
Vaccine Development
Send electronic/scanned copies of all bulk shipment related documents to the COR for three-way matchingon the day shipment occurs.
Packing List
Manufacturers should include the following information on the packing lists they send with bulk shipments tothe centralized depots•

Rationale: Required for receiving at centralized distributor.
• Transaction Information (TI), Transaction History (TH), Transaction Statement (TS)• CDC Purchase Order (PO) number
Advance Shipment Notices (ASNs)
Manufacturers should plan to transmit bulk shipment ASNs to CDC via Electronic Data Interchange (EDI)
Rationale: Required for receiving at centralized distributor.
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• Stability information of bulk substance and/or finished product• Shipment of bulk substance of final product• Disposal 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” or similar, on any contract/agreement that is manufacturing product,
including product for clinical trial use.
• 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 6th month contract anniversary.
• Contractor will update the Dose Tracking Template weekly during manufacturing campaigns and daily
during response operations (where a Public Health Emergency has been declared) and COVID 19
response, with the first deliverable submission within 15 days of award/modification. Updates to beprovided weekly in advance of commercial-scale manufacturing and daily once material for use in
response operations begins manufacture.
• 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

Sanofi Pasteur - Proprietary and Company Confidential

39Statement of WorkFor Adjuvanted Recombinant COVID-19
Vaccine Development•

Product Development and Source Material report to be submitted via spreadsheet, Dose Tracking canbe completed via spreadsheet or other format (e.g. XML or JSON) as agreed to by USG and Company

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.
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

•
•
•
•
•
•

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

Sanofi Pasteur - Proprietary and Company Confidential

40Statement of WorkFor Adjuvanted Recombinant COVID-19
Vaccine Development
Personnel Security

Physical Security Policies
and Procedures

Information Security

Information
Technology/Cyber Security
Policies and Procedures

2.

Site Security Master Plan

•
•
•
•
•
•
•
•

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
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
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

Sanofi Pasteur - Proprietary and Company Confidential

41Statement of WorkFor Adjuvanted Recombinant COVID-19
Vaccine Development
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)
c)

Shipping and Receiving

a)
b)
c)

Access Control

a)
b)
c)

d)
e)
f)

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.
Lighting must be sufficient for the effective operation of the CCTV
surveillance system during hours of darkness.
Must have CCTV coverage and an electronic access control system.
Must have procedures in place to control access and movement ofdrivers picking up or delivering shipments.
Must identify drivers picking up Government products by government
issued photo identification.
Must have an electronic intrusion detection system with centralized
monitoring.
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.).
The electronic access control should signal an alarm notification ofunauthorized attempts to access restricted areas.
Must have a system that provides a historical log of all key accesstransactions 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.

Sanofi Pasteur - Proprietary and Company Confidential

42Statement of WorkFor Adjuvanted Recombinant COVID-19
Vaccine Developmentg)

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 criticalassets within the facility.
a) Should issue company photo identification to all employees.
b) 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 beescorted by an employee while on the premises at all times.
Requirements for security fencing will be determined by the criticality of the
program, review of the security plan, threat assessment, and onsite security
assessment.

Employee/Visitor
Identification

Security Fencing

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

5. Security Operations
Description:
Information Sharing

Training
Security Management

6. Personnel Security
Description:a) Must have in-service training program.
b) Must have Use of Force Continuum.
c) 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.

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.

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

Sanofi Pasteur - Proprietary and Company Confidential

43Statement of WorkFor Adjuvanted Recombinant COVID-19
Vaccine Development
within the company; motor vehicle records check as appropriate; andlocal/national criminal history search.
Hiring and Retention
Standardsa)7. Information Security
Description:
Physical Document Control

Document Destruction

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.

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).

8. Information Technology & Cybersecurity
Description:
Identity Management

a)
b)
c)
d)
e)
f)
g)

Access Control

a)
b)
c)

Trainingd)a)Audit and Accountability

a)

b)
c)

Physical devices and systems within the organization are inventoried
and accounted for annually.
Organizational cybersecurity policy is established and communicated.
Asset vulnerabilities are identified and documented.
Cyber threat intelligence is received from information sharing forums
and sources.
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.

Sanofi Pasteur - Proprietary and Company Confidential

44Statement of WorkFor Adjuvanted Recombinant COVID-19
Vaccine Development

Configuration Management
Contingency Planning
Incident Response

Media and Information
Protection

Physical and Environmental
Protection

Network Protectiond) Perform periodic scans of the information system and real time scans offiles from external sources as files are downloaded, opened, or
executed.
a) Establish and enforce security configuration settings.
b) Implement sub networks for publically accessible system componentsthat are physically or logically separated from internal networks.
a) 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.
a) Establish an operational incident handling capability for information
systems that includes adequate preparation, detection, analysis,containment, and recovery of cybersecurity incidents. Exercise thiscapability annually.
a) Protect information system media, both paper and digital.
b) Limit access to information on information systems media to authorizedusers.
c) Sanitize and destroy media no longer in use.
d) Control the use of removable media through technology or policy.
a) Limit access to information systems, equipment, and the respective
operating environments to authorized individuals.
b) Intrusion detection and prevention system employed on IT networks.
c) Protect the physical and support infrastructure for all information
systems.
d) Protect information systems against environmental hazards.
e) 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.

Sanofi Pasteur - Proprietary and Company Confidential

45Statement of WorkFor Adjuvanted Recombinant COVID-19
Vaccine Developmentb) 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 facility 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.

Sanofi Pasteur - Proprietary and Company Confidential

46this Article F of this contract, and in the Statement of Work, attached to this contract as
Attachment 1 (SECTION J-List of Attachments).
i.

Monthly Progress Report
This report shall include a description of the activities during the reporting period,
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 ofthe initial month. Thereafter, the reporting period shall consist of each calendar
month.
The Contractor shall submit a Monthly Progress Report according to the dates
set forth in the summary table (“Summary of Contract Deliverables”) under thisarticle. The progress report shall conform to the requirements set forth in the
DELIVERIES Article in SECTION F of this contract.
The format should include:•

A cover page that includes the contract number and title; the typeof report and period that it covers; the Contractor’s name,address, telephone number, fax number, and e-mail address; andthe date of submission;•••

SECTION I – EXECUTIVE SUMMARYSECTION II - PROGRESSSECTION II Part A: OVERALL PROGRESS - A description of overall
progress.
SECTION II Part B: MANAGEMENT AND ADMINISTRATIVE UPDATE A description of all meetings, conference calls, etc. that have taken place
during the reporting period. Include progress on administration andmanagement issues (e.g., evaluating, and managing subcontractor
performance, and personnel changes).
SECTION II Part C: TECHNICAL PROGRESS - For each activity related
to Gantt chart, document the results of work completed and cost incurred
during the period covered in relation to proposed progress, effort andbudget. The report shall be in sufficient detail to explain comprehensively
the results achieved. The description shall include pertinent data and/orgraphs in sufficient detail to explain any significant results achieved andpreliminary conclusions resulting from analysis and scientific evaluationof data accumulated to date under the contract. The report shall include
a description of problems encountered and proposed corrective action;differences between planned and actual progress, why the differences
have occurred and what corrective actions are planned; preliminary
conclusions resulting from analysis and scientific evaluation of data
accumulated to date under the project.
SECTION II Part D: PROPOSED WORK - A summary of work proposed
related to Gantt chart for the next reporting period and preprints/reprintsof papers and abstracts.
SECTION III: Estimated and Actual Expenses.
a. This section of the report shall contain a narrative or table detailingwhether there is a significant discrepancy (>10%) at this time between

•

•

•

•

14

the % of work completed and the cumulative costs incurred to date.
Monthly and actual expenses should be broken down to the appropriate
WBS level.
b. This section of the report should also contain estimates for the
Subcontractors’ expenses from the previous month if the Subcontractor
did not submit a bill in the previous month. If the subcontractor(s) was
not working or did not incur any costs in the previous month, then astatement to this effect should be included in this report for those
respective subcontractors.
A Monthly Progress Report will not be required in the same month that theAnnual Progress Report is submitted.
ii.

Annual Progress Report
This report shall include a summation of the results of the entire contract work forthe period covered. Monthly Progress Reports shall not be submitted in the samemonth when an Annual Progress Report is due. Furthermore, an Annual
Progress Report will not be required for the period when the Final Report is due.
The first Annual Progress Report shall be submitted in accordance with the dateset forth in the table (“Summary of Contract Deliverables”) under ARTICLE F.2.
of this contract. The progress report shall conform to the requirements set forth in
the DELIVERIES Article in SECTION F of this contract.
Each Annual Progress Report shall include:

•

•

•
•
•

•

•

A Cover page that includes the contract number and title; the type ofreport and period that it covers; the Contractor's name, address,
telephone number, fax number, and email address; and the date ofsubmission;
SECTION I: EXECUTIVE SUMMARY - A brief overview of the work
completed, and the major accomplishments achieved during thereporting period.
SECTION II: PROGRESSSECTION II Part A: OVERALL PROGRESS - A description of overall
progress.
SECTION II Part B: MANAGEMENT AND ADMINISTRATIVE UPDATE A high level summary of critical meetings, etc. that have taken place
during the reporting period. Include progress on administration andmanagement to critical factors of the project (e.g. regulatory compliance
audits and key personnel changes).
SECTION II Part C: TECHNICAL PROGRESS - A detailed description of
the work performed structured to follow the activities and decision gatesoutlined at the Integrated Baseline Review and as described in the
Integrated Master Plan. The Report should include a description of any
problems (technical or financial) that occurred or were identified during
the reporting period, and how these problems were resolved.
SECTION II Part D: PROPOSED WORK - A summary of work proposed
for the next year period to include an updated Gantt Chart.
15

•

SECTION III: Estimated and Actual Expenses.
a. This section of the report shall contain a narrative or table detailingwhether there were discrepancies between estimated and actual
expenses over the past year. Actual expenses should be broken down tothe appropriate WBS level. This section of the report should also containestimates for outstanding costs for the previous year which may havebeen incurred, but not yet billed.

Contractor also should include the following in the Annual Progress Report:
1. Copies of manuscripts (published and unpublished), abstracts, andany protocols or methods developed specifically under the contract
during the reporting period; and2. A summary of any Subject Inventions per the requirements under FAR
Clause 52.227-11.
iii. Draft Final Report and Final Report
These reports are to include a summation of the work performed and results
obtained for the entire contract period of performance. This report shall be insufficient detail to describe comprehensively the results achieved. The Draft Final
Report and Final Report shall be submitted in accordance with the DELIVERIES
Article in SECTION F of the contract. An Annual Progress Report will not be
required for the period when the Final Report is due. The Draft Final Report andthe Final Report shall be submitted in accordance with the dates set forth in thetable (“Summary of Contract Deliverables”) under ARTICLE F.2. of this contract.
The report shall conform to the following format:
1. Cover page to include the contract number, contract title, performance
period covered, Contractor's name and address, telephone number,
fax number, email address and submission date.
2. SECTION I: EXECUTIVE SUMMARY - Summarize the purpose andscope of the contract effort including a summary of the major
accomplishments relative to the specific activities set forth in theStatement of Work.
3. SECTION II: RESULTS - A detailed description of the work performed
related to WBS and Gantt chart, the results obtained, and the impact of
the results on the scientific and/or public health community including alisting of all manuscripts (published and in preparation) and abstracts
presented during the entire period of performance and a summary of
all inventions.
Draft Final Report: The Contractor is required to submit the Draft Final Report to
the Contracting Officer’s Representative and Contracting Officer. The Contracting
Officer’s Representative and Contracting Officer will review the Draft Final Reportand provide the Contractor with comments in accordance with the dates set forthin ARTICLE F.2. of this contract.
Final Report: The Contractor will deliver the final version of the Final Report on or
before the completion date of the contract. The final version shall include or16address the COR’s and CO’s written comments on the draft report. Final Reportshall be submitted on or before the completion date of the contract.
iv.

Summary of Salient Results
The Contractor shall submit, with the Final Report, a summary (not to exceed
200 words) of salient results achieved during the performance of the contract.

v.

Audit Reports
Within thirty (30) calendar days of an audit related to conformance to FDA
regulations and guidance, including adherence to GLP, GMP, GCP guidelines,
the Contractor shall provide copies of the audit report (so long as received fromthe FDA) and a plan for addressing areas of nonconformance to FDA
regulations and guidelines for GLP, GMP, or GCP guidelines as identified in the
final audit report.

vi.

Other Technical Reports
1. Draft Report for Clinical and Non-Clinical Studies and Final Report for
Clinical and Non-Clinical Studies
•
•

•

•
•

The clinical trial reports shall follow the format of International
Conference on Harmonization document ICH E3 “Guideline for Industry
on Structure and Content of Clinical Study Reports”
Draft Final Report for Clinical and Non-Clinical Studies funded by thiscontract will be submitted to the Contracting Officer’s Representative andContracting Officer (CO) for review and comment within the time frames
set forth in the table (“Summary of Contract Deliverables”) under
ARTICLE F.2.
Subcontractor prepared reports received by the Contractor shall be
submitted to the Contracting Officer’s Representative and Contracting
Officer (CO) for review and comment as set forth by the table in this
Article. Contractor shall consider revising reports to address BARDA’s
recommendations prior to FDA submission.
The Government shall provide written comments to the Draft Final
Report for Clinical and Non-Clinical Studies in accordance with the dates
set forth by the table in this Article.
The comprehensive Final Report for Clinical and Non-Clinical Studies will
be submitted to the Contracting Officer and the Contracting Officer’s
Representative set forth by the table in this Article.

2. Supplemental Technical Documents
Upon request, Contractor shall provide CO and COR with the following
contract funded documents as specified below but not limited to: Process
Development Reports; Assay Qualification Plan/Report, Assay Validation
Plan/Report, Assay Technology Transfer Report, Batch Records,
Contractor/Subcontractor Standard Operating Procedures (SOP’s),
Master Production Records, Certificate of Analysis, Clinical Studies Data
or Reports. The CO and COR reserve the right to request within the
Period of Performance a non-proprietary technical document for
distribution within the USG. Contractor shall provide technical document
17

within 10 business days of CO or COR request. Contractor can request
additional time on an as needed basis. If edits are recommended, theContractor must address, in writing, concerns raised by BARDA.
B. Deliverables Arising from FDA Correspondence
i. FDA Meetings
The Contractor shall forward the dates and times of any meeting with the FDA to BARDA
and make arrangements for appropriate BARDA staff to attend the FDA meetings.
BARDA staff shall include up to a maximum of four people.
••

Contractor shall notify BARDA of upcoming FDA meeting within 24 hours ofscheduling Type A, B or C meetings OR within 24 hours of meeting occurrence
for ad hoc meetings.
The Contractor shall forward initial Contractor and FDA-issued draft minutes
and final minutes of any meeting with the FDA to BARDA within 5 business daysof receipt. All documents shall be duly marked as either “Draft” or “Final.”

ii. FDA Submissions
The Contractor shall provide BARDA all documents submitted to the FDA.
Contractor shall provide BARDA with an electronic copy of the final FDA submission. All
documents shall be duly marked as either “Draft” or “Final.”•••

When draft documents are submitted for BARDA review, BARDA will provide
feedback to Contractor within 10 business days of receipt.
When BARDA reviews draft documents, the Contractor shall revise their
documents to address BARDA’s written concerns and/or recommendations priorto FDA submission.
Final FDA submissions shall be submitted to BARDA concurrently or no later
than 1 calendar day of their submission to FDA.

iii. FDA Audits
In the event of an FDA inspection which occurs as a result of this contract and for the
product, or for any other FDA inspection that has the reasonable potential to impact theperformance of this contract, the Contractor shall provide the USG with an exact copy
(non-redacted) of the FDA Form 483 and the Establishment Inspection Report (EIR)
within five (5) business days after the Contractors receipt of those documents. The
Contractor shall provide the COR and CO with copies of the plan for addressing areas ofnon-conformance to FDA regulations for GLP, GMP, or GCP guidelines as identified in
the audit report, status updates during the plans execution and a copy of all final
responses to the FDA. The Contractor shall also provide redacted copies of any FDA
audits received from subcontractors that occur as a result of this contract or for thisproduct. The Contractor shall make arrangements for BARDA representative(s) to bepresent during the final debrief by the regulatory inspector.
•

Contractor shall notify CO and COR within 10 business days of a scheduled
FDA audit or within 24 hours of an ad hoc site visit/audit if the FDA does notprovide advanced notice.

18

Contractor shall provide copies of any FDA audit report received fromsubcontractors that occur as a result of this contract or for this product within 5business days of receiving correspondence from the FDA, Subcontractor, or
third party.
Within 10 business days of audit report, Contractor shall provide CO with aplan for addressing areas of nonconformance, if any are identified.

•

•

iv.

Manufacturing Campaign Reports
Contractor shall provide Manufacturing Campaign Reports to BARDA for review andcomment prior to submission to FDA.
The COR and CO reserve the right to request within the Period of Performance (PoP) a
non-proprietary Manufacturing Campaign Report for distribution within the USG.
••••

Contractor will submit Manufacturing Campaign Reports at least 15 businessdays prior to FDA submission.
If corrective action is recommended, Contractor must address, in writing, allconcerns raised by BARDA.
Contractor shall revise the reports to address BARDA’s concerns and/or
recommendations prior to FDA submission.
Final FDA submission shall be submitted to BARDA concurrently or no later
than 1 business day after submission to the FDA.

v. Other FDA Correspondence
The Contractor shall memorialize any correspondence between Contractor and FDA
and submit to BARDA. All documents shall be duly marked as either “Draft” or “Final.”
Contractor shall provide written summary of any FDA correspondence within 5 businessdays of correspondence.
i. Risk Management Plan
The Contractor shall provide a Risk Management Plan that outlines the impacts of eachrisk in relation to the cost, schedule, and performance objectives. The plan shall include
risk mitigation strategies. Each risk mitigation strategy will capture how the corrective
action will reduce impacts on cost, schedule and performance.
••••

Due within 90 days of contract award
Contractor provides updated Risk Management Plan in Monthly Progress
ReportBARDA shall provide Contractor with a written list of concerns in response
plan submitted
Contractor must address, in writing, all concerns raised by BARDA within 20
business days of Contractor’s receipt of BARDA’s concerns.

19

20

3. Contract WBS Milestones/Deliverables and Technical Deliverables(This section is completed by individual project teams and below are a few examples)
GONOGONo Milestone
.
*

1.

2.

A1

A

Milestone
Definition

Success
Criteria

FailureCriteria

Deliverabl
eWBS
Element

Feasibility of
XXX####:
effective
clinical dose
regimenStudiesdemonstra
te aneffective
dose of
XXX####:
with apotentiallyacceptablesafetymargin, in
combinatio
n with a(drug) be
defined

Draft
Study
Reports

1.3.3.5
and1.3.7.4

1

Pre IND
meeting

FDA
generalacceptanceof
proposeddata
package tosupport an
IND

Studies failtodemonstrat
e aneffective
dose of
XXX####:
with apotentiallyacceptablesafetymargin, in
combinatio
n with a(drug) canbe defined

CLIN
Initiated
CLI
by
N MilestoneSuccess

FDA nonacceptanceof data
package tosupport an
IND

Meeting
Minutes

1.5.1.1

1

3.

4.

A

Phase 1 Firstin Humanstudy

XXX####
is welltoleratedwith nosignificant
safetysignalobserved

Study
Report1.4.1.3

1Phase 1 renal
impairment
study

Definitionof doseadjustmen
t factor for
XXX####+/-durg inenrolled
subgroups

Doseadjustment
in enrolled
patient
subgroups
cannot bepredicted

Availabili
ty of topline data

1.4.1.2

2

5.

6.

C

2

Any safetyor PKinteraction
which
necessitatesterminatio
n of clinicaldevelopme
nt

21

3

GONOGONo Milestone
.
*

7.

D

8.

9.

E

10.

Milestone
Definition

Success
Criteria

FailureCriteria

Deliverabl
eWBS
Element

Manufacturi
ng of cGMP
batch Phase
3 Campaign#1

CLIN
Initiated
CLI
by
N MilestoneSuccess

Material
released

Material
notreleased

Releasecertificate

1.6.3.3.2.
1

3

End of phase
2 meeting

FDA
considerPhase 3strategy
acceptable

FDA
considerphase 3strategy
unacceptableMeeting
minutes

1.5.1.4

3

4

6

Appendix: BARDA SOP for Product Acceptance and Model Contract
Language•

Acceptance: BARDA’s standard operating procedure (SOP) for productacceptance will be followed for any product accepted regardless of the method ofdelivery; stockpile (SNS), distribution location, held in vendor managed inventory(VMI), or others as defined at a future date.
• 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 theGovernment’s corresponding written acceptance of the delivery of eachsuch lot of drug substance and/or drug product.
• Any deviations, out of specification (OOS) results, or other product issues
shall be reported to the USG within 3 calendar days.
• These materials should be maintained in the contractor’s quality andinventory 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.
• Notification must be made to the Agreements Officer (AO) andgovernment representative for product acceptance at least 10 calendar
days prior to delivery. Exceptions are permitted if approved by the AO.
• The Government shall accept product that conforms to contract
requirements based on Certificates of Analysis and Certificate(s) of
Current Good Manufacturing Practices (cGMP) Conformity provided byContractor.

22

Any product produced or stored under this contract is subject toinspection by a duly authorized US Government representative, and withreasonable notice (i.e., not less than 24 hours).
• Upon receipt of Final Report and inspection (physical or representative,i.e., pictures), the AOR will review and recommend acceptance orrejection; the AO will correspondingly notify the Contractor of acceptanceor rejection. HHS reserves the right to audit, either by HHS and/or HHS
designee(s), the facilities used under this contract and all records related
to the manufacture, testing, and storage of the product.
• 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).
• Unless otherwise mutually agreed upon by the parties, drug product shallbe shipped, trackable by GPS, to the Government-designated sites within
the continental United States.
• Contractor will retain physical risk of loss for all product stored as vendormanaged inventory until delivery and accepted by Government atgovernment-designated site.
• 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 days
• To the extent that Contractor is responsible for the correction, repair or
replacement of Government property held in vendor-managed inventory
and replacement upon loss or damage is feasible, the Government will
accept replacement of such property.
• Vendor-managed storage of product manufactured under this agreement
is supported through [Date], and, as such, the Government must either(a) take possession on or before this date and provide Contractor withdisposition instructions in sufficient time to transfer physical material fromContractor by this date or (b) bilaterally modify this agreement to extend
the period of vendor management of storage prior to this date.
• The Government understands that prices identified in this contract include
insurance costs applicable to material that will become Government
property, including product stored as vendor-managed inventory.
USG right to inspect product: The AO and/or the AOR may perform inspection ofmaterials and services. Inspections of material created under this contract may
be made by a duly authorized US Government representative, and withreasonable notice (i.e., not less than 24 hours). HHS reserves the right toconduct an audit, either by HHS and/or HHS designee(s), of the facilities used
under this contract and all records related to the manufacture, testing, andstorage of the product.
• The manufacturer will make the necessary efforts to arrange and hold
Final Drug Product (FDP) at a facility under their control. In this case, themanufacturer will:
•

•

23

Provide temperature controlled storage at the manufacturer’s site
approved by HHS, according to cGMP and the Contractor’s
product specifications.
• Store bulk lots and final containers physically segregated fromother products• Ensure proper labeling of stored materials as USG property.
• Execute stability testing of stored material in a manner consistent
with the stability testing plan approved by HHS. Report interim
data and results to HHS on a monthly basis.
• Appropriately identify reserve samples that are representative ofeach lot of drug substance and drug product shall be retained.
The reserve samples consist of at least twice the quantity
necessary for all tests required to determine whether the drug
substance and drug product meets its established specifications
including a minimum of 60 months of stability testing.
• Ensure stored materials are compliant with the Contractor’sinternal quality control system and are ready for use in further
cGMP governed manufacturing of clinical material or licensed
doses as directed by HHS.
• Provide the government access to review the security systems inplace and request 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 quantity changes, current quantity, storage
facility/location, manufacturing date, latest stability result forpotency, date of next expected stability result and the current
expiration date (if applicable).
• Ensure that material being relocated for the contractors’
convenience is adequately insured at no cost to the government
and with AO approval.
• Conduct testing necessary to ensure continued use of the stored
material for pre-pandemic preparation, pandemic response and,
where appropriate, manufacture of licensed doses.
• Make appropriate updates to the regulatory documentation
supporting the continued use of the stored material for prepandemic preparation, pandemic response and, whereappropriate, 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 HHS.
The contractor may request to arrange and hold FDP at a USG government
contracted facility (e.g., SNS facility). 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 to move FDP to the USG
•

•

24

•

•

•

contracted facility remain with the manufacturer. Title remains with the
manufacturer.
The manufacturer may invoice for costs incurred while in VMI and prior todelivery and acceptance 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:• If product does not meet any criterion outlined in this contract.
• 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 and Human Services, Food and Drug
Administration, Office of Regulatory Affairs; or based 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 outline in FAR Clause 52.246-16 (below)
apply.
The Contractor cannot reclaim title to product upon acceptance by theGovernment. Prior to expiration or termination of this contract, the Government
may affect final distribution of any vaccines remaining in storage by any one or
combination of the following methods:• The Government may elect to require shipment of the vaccine to US
Government facilities or to state and local health agencies and/or otherproviders.
• The Government 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 upondelivery of drug product to VMI and the Government’s corresponding written acceptance of thedelivery 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 withtransportation to final destination and cost to replace product for losses en route to finaldestination.
52.246-16 – Responsibility for Supplies (Apr 1984)(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; or25

(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. Contractor is liable for risk of loss or damage productuntil receipt at the final destination.
(d) Under paragraph (b) of this section, the Contractor shall not be liable for loss of or damage
to supplies caused by the negligence of officers, agents, or employees of the Government acting
within the scope of their employment.

Appendix II: BARDA Deliverables for RQA Product AcceptanceAcceptance Documents

The following pre-delivery documents are a requirement of eachmanufacturer:
SDS, Sample Label, CoC and COA

Document Delivery

Documents will be shared to a mutually specified sharing
platform, such as Box

Lot Release Timeline

An EUA release means the product is ready for shipment
immediately or <4 hours later

Document Timeline

Pre-delivery documents are to be provided to BARDA and the
FDA for each and every lot no later than manufacturer lot release

Invoicing Timeline

Invoicing timeline should be specified under one of the following
conditions:a) Upon receiving CoC or CoAb) Upon successful hand off to CDC or Designee

26