DEPARTMENT OF THE ARMY
U.S. ARMY CONTRACTING COMMAND — NEW JERSEYPICATINNY ARSENAL, NEW JERSEY 07806-5000
REPLY TOATTENTION OF
06 July 2020
Army Contracting Command — New Jersey
ACC-NJ, Building 9
Picatinny Arsenal, NJ 07806
SUBJECT: Technical Direction Letter for Medical CRBN Defense Consortium (MCDC), Request
for Prototype Proposals (RPP) 20-08, Objective TRE-PRE-20-08 for "Large-Scale Manufacturing of
Antibodies Directed to SARS-CoV-2" (Regeneron Pharmaceuticals, Inc.)
REF: Regeneron Request for Technical Direction Letter, RPP 20-08 under OTA W15QKN-16-91002 for Objective TRE-PRE-20-08, dated 30 June 2020
Advanced Technology International
ATTN: (b) (6), Sr. Contracts Manager
315 Sigma Drive
Summerville, SC 29486
Dear (b) (6)9The Army Contracting Command — New Jersey (ACC-NJ), in supporting the Joint Project Manager— Medical Countermeasure Systems (JPM-MCS), issued MCDC RPP 20-08 on 17 May 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
Regeneron as the awardee. The Government requests that a Firm-Fixed-Price Project Agreement be
issued to Regeneron to award this proposal under Other Transaction Agreement W15QKN-16-91002, to be performed in accordance with the attached Government Statement of Work (SOW).
Based upon the acceptable update of Regeneron's proposal for "Large-Scale Manufacturing of
Antibodies Directed to SARS-CoV-2" and 1) The Project Agreement Recipient's concurrence withthe requirements included in the Government SOW; 2) An acceptable milestone schedule that meets
SOW requirements, and; 3) The cost proposal that has been analyzed and negotiated by theGovernment, you are hereby directed to issue a Project Agreement to Regeneron for the subject
project. The total project value has been determined fair and reasonable and Regeneron's proposal
has been selected IAW the above referenced Basis of Selection.
The total approved cost to the Government for this effort is not to exceed $450,392,000.00. The breakout of the costs is as follows: $450,262,000.00 to perform project efforts included in the SOW and$130,000.00 for the Consortium Management Firm (CMF) Administrative Cost. The CMF
Administrative Cost and Fee was approved as a "Special Allocation" for Operation Warp Speed(OWS) Prototype Projects executed under the MCDC OTA. The effort currently has $450,392,000.00
of available funding, comprised of $450,262,000.00 for the Project Agreement and $130,000.00 for
the CMF. PAH COVID-19 work shall be tracked separately using the funding obligated via

modification P00074. In alignment with the special allocation conditions, it is noted that this project
has a period of performance of twelve (12) months, with a projected completion date of 30 June 2021.
A customized clause for the special allocation, will be incorporated into the funding modification forthis prototype project.
The PAH is considered a small business, nontraditional defense contractor, or nonprofit research
institution and determined to be providing a significant contribution. The affirmation of businessstatus certifications submitted as part of the proposal are hereby incorporated into the agreement. The
contractor shall notify the MCDC CMF of any deviation from the final proposed affirmation ofbusiness status certifications that would affect the contributions of the small business, nontraditional
defense contractor, or nonprofit research institution as proposed.
In accordance with 10.U.S.C. 2371b(f), and upon a determination that the prototype project for thistransaction has been successfully completed, this competitively awarded prototype OTA may resultin the award of a follow-on production contract or transaction without the use of competitive
procedures.
The Government and Advanced Technology International ("ATI") hereby agree and confirm that (a)ATI, in its capacity as the Consortium Management Firm under the Medical CBRN Defense
Consortium (MCDC) Other Transaction Agreement No. W15QKN-16-9-1002 (the MCDC
Agreement), has the authorization to enter into the Medical CBRN Defense Consortium Base
Agreement No. 2020-504 and the Statement of Work (collectively, the "Regeneron Agreement") with
Regeneron on behalf of the Government, (b) the Government is and shall be bound by its obligations
set forth in the Regeneron Agreement, and the MCDC Agreement is hereby amended to incorporate
these obligations in the MCDC Agreement, as that Agreement relates to Regeneron, and (c)Regeneron is an intended third-party beneficiary of such obligations that can enforce them directlyagainst the Government, and (d) in the event of any conflict between the Regeneron Agreement, on
the one hand, and the MCDC Agreement, on the other hand, the Regeneron Agreement shall control
and take precedence.
Points of Contact:

Agreements Specialist:(b) (6)E-mail: (b) (6)Phone: (b) (6)Agreements Officer:(b) (6)E-mail: (b) (6)Phone: (b) (6)Regards,x (b) (6(b) (6)
Agreements Officer
Signed by: (b) (6)

Attachments:
Attachment 1: MCDC2008-005 - Regeneron - 7-3-2020
Attachment 2: OPSEC Language Addendum
Attachment 3: MCDC OTA Special Allocation Letter(b) (6)ATI Signatory

Page 1 of 24
Regeneron Pharmaceuticals, Inc.
July 6, 2020

Statement of WorkFor
Large-Scale Manufacturing of Antibodies Directed to SARS-CoV-2

RPP #: RPP-20-08
Project Identifier: MCDC OTA 2008-005, W15Q101-16-9-1002
Consortium Member: Regeneron Pharmaceuticals, Inc.
Title of Proposal: Large-Scale Manufacturing of Antibodies Directed to SARS-CoV-2
1.0

INTRODUCTION, SCOPE, AND OBJECTIVES

A. Preamble
Regeneron Pharmaceuticals, Inc. (referred to herein as "Regeneron", "Offeror", "Contractor" or"Recipient") has demonstrated experience with rapid scale-up of biopharmaceuticalprograms. Our excellent history of receiving development scale processes from Research andDevelopment (R&D) laboratories, and then expanding to clinical or commercial Good
Manufacturing Practice (GMP) scale production, is well documented. Greater than 65 processes
have been transferred since 2008 with a success rate of 100%. We have consistently demonstrated
our ability to expedite the delivery of high quality, safe and efficacious products (Ebola
therapeutic) in partnership with the Government (anti-MERS, anti-Ebola).
Fully human monoclonal antibodies (mAbs) are molecules with high potency, predictable
Pharmacokinetics (PK), and limited off-target toxicity, and thus provide attractive types oftherapeutics for emerging diseases. Importantly, we have repeatedly demonstrated that candidate
mAb-based drugs to prevent and/or treat emerging infections, can be rapidly obtained fromRegeneron's proprietary VelocIrnmune® mice. Further, our ability to concurrently generate
isogenic cell lines that are optimized for rapid antibody scale up and manufacturing using our
proprietary Chemistry, Manufacturing, and Controls (CMC) platform technologies, havefacilitated both testing of our mAbs in preclinical models and subsequent development of thesemAbs into drugs suitable for human testing. In the process of completing many of these activities
we have collaborated with other entities (including BARDA, Research Institutes, Government
Laboratories and Universities). Our manufacturing has been designed to be paired with ourproprietary VelocImmune® R&D technology, that is a proven process to rapidly take a researchconcept from the bench, into large scale production, with the ability to delivery medicines topatients.
The Government has advised Regeneron that it is appropriate for the project described in thisProject Agreement to be performed through the Medical CBRN Defense Consortium (MCDC),
under the authority of the MCDC Other Transaction Agreement No. W15QKN-16-91002. Regeneron is amenable to performing the project pursuant to such authority, based on theadvice of the Government, and due to the unprecedented circumstances of the Coronavirus Disease2019 (COVID-19) pandemic and, accordingly, the parties have entered into this Project
Agreement.
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Regeneron Pharmaceuticals, Inc.
July 6, 2020

B. Overall Objectives and Scope
This project is defined by discrete work segments for the continuous manufacture of drug
substance, formulated drug substance and filled, packaged and labeled drug product, in accordancewith a mutually agreed schedule.
Pursuant to this project, Regeneron will manufacture and sell drug product to the applicable UnitedStates (U.S.) Federal Government agency, for distribution in the U.S. All manufacturing describedherein will be compliant with Food and Drug Administration (FDA) current Good Manufacturing
Oractices (cGMP), as 21 CFR 210 and 211.
1.1

Introduction

The objective is to conduct the manufacturing production activities described in this proposal for
prototypes consisting of novel, proprietary mAb therapeutics and prophylactics, to reduce
pathology of COVID-19 disease and/or prevent development of disease when administeredprophylactically.
1.2

Scope

These manufacturing production activities will include manufacturing at-scale, filling andfinishing, and storage and shipping of Severe Acute Respiratory Syndrome Coronavirus 2 (SARSCoV-2)-specific monoclonal antibodies (referred to herein as the "prototype", the "prototype
product", the "product" or "drug product") for treatment and/or prophylaxis against COVID-19.
1.3

Definition of the Prototype Project

Consistent with USG objectives, Regeneron will employ its proprietary manufacturing technology
and processes, in a manner compliant with applicable laws and regulations, including 21 CFR 210
and 211 and the Drug Supply Chain Security Act, to manufacture the prototype product. This effort
constitutes a prototype project because it will be used to evaluate the technical feasibility of
manufacturing the prototype product during the ongoing COVID-19 pandemic. In addition, thisis a prototype project because Regeneron will demonstrate, and prove-out the at-scale, multi-lot
proprietary manufacturing activities of Regeneron in order to assess the feasibility of these
activities to support the necessary quantity of the prototype product to treat the U.S. population.
Successful completion of the prototype project will demonstrate Regeneron's capability to (i)rapidly manufacture product, which can be further scaled-up to meet mutually agreed to surge
requirements with little advance notification and (ii) facilitate the Government's ability tostockpile and distribute large quantities of the drug product to respond when needed, including foruse in clinical studies, under an Emergency Use Authorization (EUA), or pursuant to otherclearance from the U.S. FDA. For clarity, any manufacturing and supply of drug product in excessof the specific quantities set forth in Section 4.0 of this Statement of Work, shall be subject to a
separate mutual agreement between Regeneron and the Government.

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Regeneron Pharmaceuticals, Inc.
July 6, 2020

The scope of effort supported by this agreement is further clarified in Section 1.4. It is important
to note that nonclinical and clinical studies for the prototype are being conducted by Regeneronoutside of this agreement. The results of those studies may be used to develop use case scenarios
and, in turn, inform the USG's deployment strategy as it relates to product manufactured under
this agreement; however, such results (including the degree to which the data are "positive" or"negative") shall not be a factor in this prototype project.
Objective

1.4

1.5

•

Conduct its proprietary manufacturing production activities described in this proposal for
prototypes consisting of novel, proprietary mAb therapeutics and prophylactics, to reduce
pathology of COVID-19 disease and/or prevent development of disease when administeredprophylactically.

•

The prototypes will include one or more of the following, as mutually agreed between
Offeror and the Government:o the mAbs known as REGN10987 and REGN10933, as a cocktail;o Other mAbs (as monotherapies or a cocktail) as agreed to by bilateral modification
between Offeror and the Government.

•

The deliverables will be the products listed above (i.e., REGN10987 and REGN10933), in
the form of bulk formulated drug substance and/or filled and finished product in vials, as
mutually agreed between Offeror and the Government, packaged and labeled drug product,
results, reports and records associated with generation of data demonstrating quality andcontrol.

•

The products will be delivered in the form and quantity to be agreed between Offeror and
the Government. It is expected that the prototypes will be stored by Offeror until such timeas (a) they can be used for pre-clinical or clinical development purposes under an
Investigational New Drug application (IND), or (b) upon the FDA's grant of an EUA under
Section 564 of the Food, Drug and Cosmetic Act (FD&C Act), or full marketing approval
under a full Biologics License Application (BLA) under Section 351(a) of the Public
Health Service Act (PHSA).
Follow-on Activity

In accordance with 10.U.S.C. 237 lb(f), and upon successful demonstration of the prototype, or at
the accomplishment of particularly favorable or unexpected results achieved outside of thisAgreement that would justify transitioning to production (e.g., EUA or BLA), additional at-scale
manufacturing of up to 800,000 treatment courses, supported by a mutually agreed upon followon production contract or Other Transaction Agreement, may be awarded to Regeneron, without
further competition, to partially or completely meet the USG objective of supplying a safe andeffective COVID-19 therapeutic or prophylactic treatment courses to ensure nationwide access.
For clarity, any manufacturing and supply of drug product in excess of the specific quantities set
forth in Section 4.0 of this Statement of Work shall be subject to a mutually-agreed upon separate
agreement between Regeneron and the Government. For further clarity, neither party shall beobligated to negotiate or enter into such a separate agreement for follow-on production.
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Regeneron Pharmaceuticals, Inc.
July 6, 2020

During the performance of the prototype project, the Government and contractor may negotiate
the scope and price of follow-on production.
APPLICABLE REFERENCES

2.0

Current Good Manufacturing Practices, 21 CFR 210, 211
3.0

REQUIREMENTS

3.1

Technical•

The Offeror's technical approach is expected to be similar, but not duplicative, to its
manufacturing activities under its current agreements with the Biomedical Advanced
Research and Development Authority (BARDA), including contract #HHS0100201700016C, and will include the following:o Drug Substance, Formulated Drug Substance, Drug Product (DS/FDS/DP) quality
and control.
•

Regeneron will apply statistical process analysis to continuously qualify inprocess controls and release parameters.

•

The manufacturing process will be evaluated against parameters that are
correlated to process performance and product quality. Ranges for the
performance of each unit operation will be established through processdevelopment recommended ranges, the generation of statistical limits basedon small-scale studies, and/or continuous commercial-scale manufacturingexperience. These ranges will be monitored during the execution of quality
and control, and are designed to ensure that the process is in a state ofcontrol and to ensure that the manufacturing process operates in a consistentand reproducible manner. The quality and control runs will also confirm
that the process and product impurity profiles are within limits, demonstrate
the consistent removal of impurities, and demonstrate that the process iscapable of operating within acceptable microbiological control limits.
Additional sampling and testing beyond that needed to assess process
performance, may be completed to further process understanding.

•Intermediate Hold Time Validation: Intermediate hold time validation to be
performed via combination of at scale and small scale executions:•

Microbial Control: Where appropriate, microbial control data fromat scale hold time studies, will be leveraged from historicalvalidation runs with molecules which have similar equipment andsanitization procedures.

•

Chemical Stability: Chemical stability will be demonstrated using
data from laboratory scale hold time studies performed for each of
the prototypes, using material obtained from in-process pools fromthe 10,000 L manufacturing executions.
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Regeneron Pharmaceuticals, Inc.
July 6, 2020•

Media, Feed and Buffer Mixing Validation: Preparation of buffers andmedia will be validated at commercial-scale. These validation studies will
demonstrate that the preparation process consistently produces solutions
meeting predefined limits for parameters indicative of homogeneity, suchas pH, conductivity, osmolality, and turbidity. Where vessels of equivalentdesign and construction exist within the manufacturing facility, validationof media and buffer preparation will be performed on one representative
vessel on at least three consecutive and successful executions.

•

Medium Storage Validation: Medium storage validation will be separated
into preparation hold and post-filtration storage, and has two components:
microbial control and chemical stability. Pre-filtration microbial control is
specific to the raw materials and the environment, and post-filtration
microbial control is specific to each storage container and the ability of thestorage container to maintain a microbial free condition. Maximum storage
times for medium solutions with respect to microbial control will bevalidated as necessary at commercial scale, through preparation and storageof medium for extended storage times pre- and post-filtration. Validation
will be achieved by demonstrating microbial control for a number ofconsecutive attempts established in the relevant validation protocol.
Solutions will be prepared, stored for defined periods and tested forbioburden and endotoxin. Chemical stability of medium may be performed
at small-scale to demonstrate storage conditions maintain integrity ofchemical components. Bracketing approaches may be used to cover thedifferent feeds and medium used, provided the individual protocol justifies
the bracket.

•

Buffer Storage Validation: Buffer storage validation is separated into
preparation hold and post-filtration storage, and has two components:
microbial control and chemical stability. Preparation holds are dependent
on the solution composition. The worst- case solution for growth isdetermined using a risk-based approach, and post-filtration microbial
control is specific to each vessel and the ability of a vessel to maintain amicrobial free condition. Maximum storage times for buffer solutions will
be validated as necessary at commercial-scale for microbial control, throughpreparation and storage of a non-growth inhibiting buffer for extended
storage times pre- and post-filtration. Validation will be achieved bydemonstrating microbial control for a number of consecutive attempts
established by the protocol. Buffer hold validation in stainless steel vessels
will require ongoing evaluation and monitoring; however, buffer holdvalidation in disposable bioprocess containers may be shortened, if
appropriate, by a bracketing approach. Solutions will be prepared, held andmonitored over time for bioburden, endotoxin. Chemical stability of buffers
may be performed at small-scale to demonstrate that storage conditions
maintain integrity of chemical components. Bracketing approaches may be
used to cover the large number of buffers used, provided the individual
protocol justifies the bracket.
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Regeneron Pharmaceuticals, Inc.
July 6, 2020•

Chromatography Cohmm &mitt:7(7110n and Storage Validation: Any newly

required studies will be
Irocedures for (b) (4)donned to validate the cleaning and storage

chromatography columns
used in the manufacture of the prototypes. In addition, the maximum
allowable storage period following cleaning will be established for each of
the chromatography resins.
The efficacy of thesolutions used to clean the chromatography columns will be examined asnecessary over three consecutive executions during commercial scale
manufacturing of each of the prototypes. The effectiveness of the cleaning
procedures will be assessed by sampling the post cleaning lgost-usel Water
for Injection (WFI) flush effluent; at approximateir
into the flush for bioburden and endotoxin levels (the purpose ofwhich is to demonstrate microbial control). In addition, Total Organic
Carbon (TOC) will be measured to verify the absence of lot to lot protein
can-y over.

•

Chromatography Colunm Cleaning Validation:•

Chromatography Cohnim Storage Validation: The efficacy of the solutions

used to store the chromatography columns will be examined, as necessary,over three consecutive executions during commercial scale manufacturingof each of the prototypes. The effectiveness of the cleaning and storage
procedures will be assessed by sampling the post storage (pre-use) WFI
flush effluent for bioburden, eudotoxiu levels and TOC. The maximum
allowable storage period for each column will be established based on the
shortest of the three consecutive executions for which the column remainedin the storage solution.
•

Establishment of In-Process Control (IPC) Program: The IPC program will

utilize Statistical Process Control (SPC) to monitor critical and generalprocess parameters, and critical and general quality attributes for each lot
manufactured. On completion of quality and control activities, the IPC
development report will establish the set of parameters and attributes to bemonitored, and justify appropriate action limits for each. Upon approval ofthe development report, a Process Performance Monitoring (PPM) Plan will
be generated containing the list of IPCs, historical data, selection ofmonitoring tools and response to signal strategy, statistical summary, andvisualization of the IPCs. The IPC development report and PPM Plan will
be fluffier updated as laboratory and production scale characterization andvalidation data is gained, once defined production milestones are achieved,
and then annually afterward. The annual updates will assess the overall stateof process control and include process capability analysis and assessmentof evidence of special cause variation for all aulicable IPCs. Process datafor individual lots will be monitored through (b) (4)"M meetings,
where any trend signals are identified and responded to. These meetings
will be attended by subject matter experts from departments including, but
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Regeneron Pharmaceuticals, Inc.
July 6, 2020

not limited to,Tb) (4)oMaster Cell Bank (MCB1 Genetic Characterization: (b) (4)oWnrkincr Cell Rank (Well) Genetic Char1cteri79tinn•o DS/FDS/DP Registration Stability: Stability studies for DS/FDS/DP will be
initiated and executed according to stability protocols, International Council for
Harmonisation (ICH) guidelines and internal procedures. Quality and control lots
will be stored and monitored at the routine long term storage condition per theSpecification for (b) (4)Samples will also be stored and monitoredat Accelerated (b) (4)condition for 6 months, and Stress (b) (4)condition for (b) (4)for the evaluation and identification of degradation
pathways of the molecule. Stability studies performed on the quality and control
lots will support the shelf life of each prototype, and confirm that the manufacturing
process is suitable for commercial-scale manufacture. All testing will be conductedin a GMP Quality Control (QC) Laboratory. Any Out of Specification (00S) or
Out of Trend (00T) results will be investigated.
o DS/FDS/DP Shipping Validation: Shipping Validation by actual transport will be
performed on the DS/FDS/DP of each prototype to cover a distance and durationthat will exceed routine shipment to the intended fill site. Successful shipping
validation of intended shipping lanes is based on the ability of the container tomaintain the product at a specified temperature, to preserve product quality, andmeet specifications.
o DS/FDS/DP Photostability Studies: To determine overall photosensitivity of
DS/FDS/DP 2er ICH requirements, a stud will be performed at (b) (4) under 211
and (b) (4)light. Samples will be oriented for(b) (4)maximum light exposure using container closures designed for direct exposure,immediate pack/marketing pack, and a foil covered control. Testing will then be
perfornied on (b) (4)sample sets for stability indicating attributes.
o QC Reference Standard Production and Stability: Reference standards for theindividual DS/FDS/DP GMP lots will be generated according to internal standard
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Regeneron Pharmaceuticals, Inc.
July 6, 2020

operating procedures. The DS/FDS/DP for each prototype will be filled as a productreference standard. The first manufactured lot (leadbe sub-aliquoted into
single use vials, stored and routinely monitored at (b) (4) by Offeror's Quality
Control personnel. The reference standard will be qualified prior to use, according
to specifications. A Certificate of Qualification (CofQ) will be issued for eachindividual reference standard at the time of initial qualification and following
recertification testing. A stability study to monitor the critical quality attributes ofeach reference standard will also be conducted.
o Assay Validation: Will be performed as necessary to support any applicable EUA
or other regulatory requirements.
oManufacturing: Following the completion of the activities described above,
Offeror will manufacture prototypes at scale in order to achieve the intended scopeof the contract.

o Label/Pack: Labeling and packaging of investigational product for clinical studies
or for use under an EUA or approval, will be completed at a GMP contract
manufacturing organization managed by Offeror's External Manufacturing group.
o Storage: Packaged and labeled material storage will be managed by Offeror's
External Manufacturing group.
3.2

Management and Reporting

3.2.1

Program Management

Below are the individuals currently assigned to key roles on the project team. Regeneron reserves
the right to make personnel changes which will be communicated accordingly.
a. Regeneron will manage, integrate and coordinate all activities, including utilizing
Regeneron's state-of-the-art technical and administrative infrastructure to ensure
efficient planning, initiation, implementation and direction of contracted activities.
b. The (b) (4)approach and scope of this Program.
c.

, is responsible for guiding the project, will serveas Lead PI for this Program. The PI will be responsible for project management,
communication, tracking, monitoring and reporting on status and progress, andmodification to the project requirements and timelines, including any projects
undertaken by subcontractors.

(b) (4)d. A (b) (4), will be responsible for monitoring andtracking day-to-day progress and timelines, coordinating communication and project
activities, costs incurred, and program management for this Program. The contract
deliverables list identifies all contract deliverables and reporting requirements for thiscontract.
e.

, will provide
development of compliant subcontracts, consulting, and other legal agreements.
UNCLASSIFIED(b) (4)

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Regeneron Pharmaceuticals, Inc.
July 6, 2020f.

, will be responsible forfinancial management and reporting on all activities conducted by Regeneron and any
subcontractors.

(b) (4), will be responsible forg. A (b) (4)facilitating the development of integrated CMC plans and for monitoring and tracking
the progress of the CMC milestones.

h. A (b) (4), will be responsible formanagement of batch disposition, oversight of discrepancy investigations, and toensure all released product confonns to GMP standards.
will bei. A (b) (4)responsible for analytical method development, method transfer and specification
development.
, will beA
responsible for ensuring Regeneron quality, preclinical, and clinical drug development
programs are conducted in compliance with regulations governing pharmaceutical drug
development, and with project specific regulatory commitments/requirements ,and willserve as the liaison for communications with the US Food and Drug Administration.
k. Regeneron shall provide Quarterly Progress Reports, which shall include a descriptionof the activities during the reporting period and the activities planned for the ensuingreporting period.
1.

Regeneron shall provide Annual Progress Reports, which shall include a summation of
the activities during the reporting period, and the activities planned for the ensuingreporting period.

m. Regeneron shall provide Draft and Final Reports, which shall include a summation of
the work performed and results obtained for execution of various studies or technicalwork packages during the entire contract period of performance. This report shalldescribe the results achieved.
n. Regeneron shall participate in regular meetings to coordinate and oversee the contracteffort, as directed by a single point of contact established by the Government. Suchmeetings may include, but are not limited to, meetings of Regeneron and subcontractors
to discuss clinical manufacturing progress, product development, scale-up
manufacturing development, preclinical/clinical study designs and regulatory issues,meetings with individual contractors and other Health and Human Services (HHS)
officials to discuss the technical, regulatory, and ethical aspects of the prop-am, andmeetings with technical consultants to discuss technical data provided by Regeneron.
Regeneron shall also consult with the Government as required in connection withmeetings and submissions to regulatory agencies, including the FDA. The Government
will establish a single point of contact for regular meetings and coordinate all requests
for information through such point of contact, such that Regeneron shall not be required
to attend multiple meetings with different Government agencies for the same (orsimilar) subject matter, or respond to multiple requests for information or materials
concerning the same (or similar) subject matter.
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July 6, 2020

o. Regeneron shall participate in teleconferences at an agreed upon frequency between
Regeneron and -to review technical progress.
3.2.2

Integrated Master Schedule (IMS)Regeneron will provide an Integrated Master Schedule within (b) (4) of the award, andshall update such schedule to reflect any material changes. Within an agreed upon
timeframe of the effective date of the contract, Regeneron will make any agreed uponchanges between Regeneron and Agreements Officer and/or Project Officer at the theGovernment. The IMS shall be incorporated into the contract and will be used to monitor
perfonnance of the contract. Regeneron shall include the key milestones and Go/No-Go
decision gates. The IMS for the period of perfonnance will be accepted by the Governmentof the Government's receipt of such IMS.
(b) (4)

3.2.3

ReportingOn completion of a stage of the product development, as defined in the agreed upon IMS
and Integrated Master Plan, Regeneron shall prepare and submit to the Project Officer andthe Agreements Officer, reports from time to time that contain (i) reasonable detail,documentation and analysis to support successful completion of the stage according to thepredetermined qualitative and quantitative criteria, and (ii) a description of the next stageof product development to be initiated, and a request for approval to proceed to the nextstage of product development.

3.2.4

Data Management
Regeneron will utilize existing systems to implement data management and quality control
systems/procedures, including transmission, storage, confidentiality, and retrieval ofcontract data. Provide analysis of data generated with contract finding to the Project
Officer or Agreements Officer, upon request.

3.2.5

Technical and Financial Reporting

Technical Reports are described in Section 3.3.1 k., 1. and m. They are also listed in themilestone schedule and deliverables table in Section 5 of this Statement of Work.
For Financial Reporting, firm fixed price invoices will be submitted on a quarterly basis as
described in Section 5 below. Invoices will include data and technical reports sufficient tosupport the accomplishment of each milestone, as appropriate, during the invoicing period.
Regeneron will provide quarterly Financial Status Reports outlining billed vs. budgeted
activity for each period, and in aggregate for the contract.
4.0

DELIVERABLES; Filled/Finished Drug Product Deliveries
Regeneron shall have the right to provide deliverables directly to theGovernment and not to the Consortium Management Firm (CMF).
Offeror assumed .

(b) (4)

UNCLASSIFIED
CON-F-JDE-NTIAL/-PRO-PRI-E-TARY

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Regeneron Pharmaceuticals, Inc.
July 6, 2020

Deliverable Table (June 2020 - June 2021)

Deliverable
Project Kick-Off; Deliverable

Due Date(b) (4)

Total Program
Funds(b) (4)

DS/FDS Bulk GMP Loll!
DS/FDS Bulk GMP Lola'
DS/FDS Bulk GMP Lola
Fill Product (b) (4)Fill Product (b) (4)Fill Product (b) (4)Package/Label ProductStoraoe of Drug Product in• • (b 4
Storaoeof Drugt- Product inQ• •Storage of Drug Product in• • (b 4)
Storage of Drug Product in• • (b 4
Quarterly Technical andBusiness Status Report, seeabove for submission schedule
Annual Technical and Business
Status Report, see above forsubmission schedule
Quarterly Technical andBusiness Status Report, seeabove for submission schedule(6) (h4)I—1

Data Rights*Specially
Negotiated*Specially
Negotiated*Srecially
Negotiated*Srecially
Negotiated*Specially
NegotiatedSpecially
Negotiated*Specially
Negotiated*Specially
Negotiated*Specially
Negotiated*Specially
Negotiated*Specially
Negotiated*Specially
Negotiated*Specially
Negotiated*Specially
Negotiated*Specially
Negotiated
Limited Rights

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July 6, 2020

Total Program
Data Rights
Funds
S450,262,000(FFP)*Upon payment, delivery and acceptance in accordance with the terms of this Project Agreement,
the Government will have title to the product produced under this Statement of Work. The
Government will have the rights described below in Section 7.3 to technical data disclosed under
this Statement of Work.
** Packaging and labeling of product will be performed following the determination of the use of
the applicable drug product (e.g., for clinical trials or for distribution under an EUA or BLA).
Deliverable

5.0

MILESTONE PAYMENT SCHEDULE; TERMINATION COSTS

Milestone

Milestone Description(Deliverable Reference
Drug Substance Deliverable
Dnia Substance)
rug Substance Deliverablesof Drug Substance)
Millugjrcduct Deliverables (Fill/Finish
for b 4 of Drug Substance)(b) (4) Drug Substance Deliverables (b) (4) ofDrug Substance)
Drug Product Deliverables (Fill/Finishfor (. (4) of Drug Substance)
Quarterly Technical and Business Status
Report, Reference 3.3.1.kAnnual Technical and Business Status
Report; Rtftrtuct 3-3.1.1
Storage of Drug Product in VMI
Storage of Drug Product in VMI
Storage of Drug Product in VMI
Storage of Drug Product in VMI
Total (Include Payment Type; FFP):
Period of Performance: I
I

5.1

a

5.2

Zt

5.3
5.4
5.5
5.6
5.7
5.8
5.9
5.10
5.11

Due Date

Total Programsi

S450,262,000
June 2020 —June 2021

The overall price is fixed price at $450,262,000. Milestone payments will be made quarterly as
set forth in the table above, corresponding to the deliverables and any 31<1 party commitments
Regeneron needs to make. In the event the deliverables in a given quarter are less than or exceed
the projected quantity, the milestone payment for such quarter will be equitably adjusted based on
the shortfall or excess amount, as applicable, however the price will not exceed $450,262,000
Milestone payment terms will be net 30 days.
Total ricinz is a firm fixed price per lot, (b) (4). Regeneron will deliver b4
UNCLASSIFIEDCONFIDENTIAL/PROPRIETARYPage 13 of 24
Regeneron Pharmaceuticals, Inc.
July 6, 2020of filled/finished drug product. Regeneron will be entitled to full payment for drug productupon delivery/acceptance (as described herein) of filled/finished drug product, prior to packaging
and labeling. However, Regeneron shall be responsible for the packaging and labeling of productat no additional cost following the determination of the use of such drug product (e.g., for clinical
trials or for distribution under an EUA or BLA). Drug product will comply with the Drug Supply
Chain Security Act serialization and tracking requirements. Drug product will not be cofonnulated, except as otherwise mutually agreed by the parties. Unless and until otherwise
mutually agreed, the drug product produced under this Statement of Work will be filled forthera eutic use. In order to change this allocation, Regeneron will require at least (b) (4)(h(4prior written notice, in order to meet Regeueron's notification requirements to its
fill/finish subcontractor. Regeneron will provide the Government with the timeline for fill/finish
activities, including the dates by which the parties must determine the allocation of fill/finish
activities. Notwithstanding the foregoing, as part of this Project Agreement, Regeneron will havethe riLit to utilize material and caLaci, suuorted bz this agreement to fill up to b) (4), as well as any additional drug product(b) (4)mutually agreed upon by Regeneron and the Government (with respect to which use theGovernment will not unreasonably withhold consent.
lb) (9)In the event this Statement of Work is fel-ululated prior to completion, termination costs
recoverable by Regeneron under Section 2.04 of the MCDC Base Agreement, shall include thefollowing: the full contract price for any drug product manufactured and not yet paid for; a prorated portion of the contract mice for drug substance or dru roduct that is in Erocess, based on
the staoe of productifor7 iU
and raw materials that Regeneron purchased (or is obligated to purchase) that cannot beallocated to other products.
6.0

STORAGE AND SIIIPPING PROVISIONS

Upon acceptance by the Agreements Officer Representative of any lot of antibodies under thiscontract, title to such antibodies will transfer as follows: upon deliveiy of drug product to vendormanaged inventory and the Government's corresponding written acceptance of the delivery ofeach such lot of drug product. The Government shall accept product that confonns to contract
requirements based on a Certificate of Analysis i COA.2 Erovided by Releneron. The
Government's acceptance of product will be (b) (4)Lrovide written notice of acceLtance or rejection (b) (4)nless otherwise mutually agreed upon by the parties, drug(b) (4)eroduct shall be shiprd to the Government within the continental United States. Regeneron will
for all product stored as vendor-managed inventory. To the extent thatb) (4)
Regeneron is responsible for the correction, repair or reolacement of Government property held invendor-managed inventory DK
willIheof such proper. Vendor-managed storage of product manufactured under this(b) )t , such, the Government must either (a) takeagreement is supported thr• • I (0) (4)possession on or before this date and provide Regeneron with disposition instructions in sufficient
time to transfer physical material from Regeneron by this date or (b) bilaterally modify thisagreement to extend the period of vendor management of storage prior to this date.
UNCLASSIFIEDCONFIDENTIAL/PROPRIETARYPage 14 of 24
Regeneron Pharmaceuticals, Inc.
July 6, 2020

The Government understands that prices identified in this contract include
applicable to material that will become Government property, including product stored as vendormanaged inventoiy.
7.0

PATENT RIGHTS; DATA RIGHTS; PREP ACT AND TRANSPARENCY

Article X, ("PATENT RIGHTS") and Article XI. ("DATA RIGHTS") of Other Transaction
Agreement number W15QKN-16-9-1002 shall not apply to this Project Agreement and are hereby
replaced for the purpose of this Project Agreement, with this Section 7.0 (including Sections 7.17.4 and the Definitions Appendix).
Definitions:
Capitalized terms used in this Section 7.0 (including Sections 7.1-7.4) shall have the meanings
ascribed to such terms in the Definitions Appendix to this Project Agreement.
For purposes of this Project Agreement, all rights of the Government in and to Data or Subject
Inventions are granted solely to The United States of America, as represented by the Department
of Health & Human Services, Office of the Assistant Secretary for Preparedness & Response("ASPR"), Office of Biomedical Advanced Research and Development ("BARDA") (represented
by Office of Acquisition Management, Contracts and Grants (AMCG)) and to no other agency of
the United States of America (including JPEO) or representative of any such other agency(including the CMF). The parties acknowledge that Regeneron is permitted to communicate solely
with BARDA regarding the matters described in this Section 7.0 (including Sections 7.1-7.4) andis not obligated to communicate with any other Government agency or representative regarding
such matters.
7.1

BACKGROUND INTELLECTUAL PROPERTY

Each party acknowledges that it has no rights to the other party's inventions, discoveries, knowhow, Data, technology or intellectual property generated, discovered, conceived or reduced topractice prior to or otherwise outside of this Statement of Work (also referred to herein as, this
"Project Agreement" or this "Agreement"), and any improvements or modifications thereto,
including,
without
limitation,
thebackgroundintellectual
property(andimprovements/modifications) for the Government and Regeneron described below, as follows:
Government Background Intellectual Property. None.
Contractor Background Intellectual Property: Includes, but is not limited to, (b) (4)UNCLASSIFIED
CON-F-IDENTIAL/-PROMETARYPage 15 of 24
Regeneron Pharmaceuticals, Inc.
July 6, 2020

63/004,312, filed April 2, 2020 "Anti-SARS-CoV-2-Spike Glycoprotein Antibodies and AntigenBinding Fragments"(b) (4)63/014,687, filed April 23, 2020 "Anti-SARS-CoV-2-Spike Glycoprotein Antibodies andAntigen-Binding Fragments"b)

63/025,949, filed May 15, 2020 "Anti-SARS-CoV-2-Spike Glycoprotein Antibodies and AntigenBinding Fragments"(b) (4)b) (4)

63/034,865, filed June 4, 2020 "Anti-SARS-CoV-2-Spike Glycoprotein Antibodies and AntigenBinding Fragments"(b) (4)(b) (4)(b) (4)(b) (4)(b) (4)(b) (4)(b) (4)

No party relinquishes rights in any of its background intellectual property to any other party under
this contract.
Either Party may update its disclosure of background intellectual property under this Section 7.1
upon written notice to the other Party.
7.2

PATENT RIGHTS
a. Allocation of Principal Rights
UNCLASSIFIEDCONFIDENTIAL/PROPRIETARYPage 16 of 24
Regeneron Pharmaceuticals, Inc.
July 6, 2020

The parties agree that the Bayh-Dole statute does not apply to this Project Agreement.
Ownership of inventions Made in the performance of this Project Agreement shall follow
inventorship, and inventorship shall be determined in accordance with United States patent laws.
With respect to any Subject Invention Made (in whole or in part) by or on behalf of Regeneron,unless Regeneron shall have notified the Government (in accordance with Subparagraph b. below)that Regeneron does not intend to properly disclose and elect title to a Subject Invention,
Regeneron shall retain the entire right, title, and interest throughout the world to such Subject
Invention, and the Government shall have a nonexclusive, nontransferable, irrevocable, paid-up
license to practice or have practiced on behalf of the United States the Subject Invention
throughout the world. This license does not include the right to use or allow others to use the
Subject Invention for commercial purposes. If Regeneron does not properly disclose and elect title
to any such Subject Invention (in accordance with Subparagraph b. below), then the Government
may exercise its rights to seek ownership of such Subject Invention, pursuant to clause 7.2.c.
below.
b. Invention Disclosure, Election of Title, and Filing of Patent Application
i. Regeneron shall disclose in writing each Subject Invention to the OTTR within
12 months after the inventor discloses it in writing to Regeneron personnel
responsible for patent matters. The disclosure shall identify the inventor(s) andthis Project Agreement under which the Subject Invention was made. It shallbe sufficiently complete in technical detail to convey a clear understanding of
the Subject Invention. The disclosure shall also identify any publication, on sale(i.e., sale or offer for sale), or public use of the Subject Invention, or whether amanuscript describing the Subject Invention has been submitted for publication
and, if so, whether it has been accepted for publication. In addition, after
disclosure to the Government funding agency (HHS/BARDA), Regeneron shallpromptly notify the OTTR of the acceptance of any manuscript describing the
Subject Invention for publication and any on sale or public use.
Regeneron shall elect in writing whether or not to retain ownership of any
Subject Invention by notifying the OTTR within 2 years of disclosure to theGovernment funding agency. However, in any case where publication, on sale,or public use has initiated the 1-year statutory period during which valid patent
protection can be obtained in the United States, the period for election of title
may be shortened by the agency to a date that is no more than 60 calendar days
prior to the end of the statutory period.
Regeneron shall file either a provisional or a non-provisional patent application
for an elected Subject Invention within 1 year after election of title. However,in any case where a publication, on sale, or public use has initiated the 1-year
statutory period during which valid patent protection can be obtained in the
United States, Regeneron shall file the application prior to the end of thatstatutory period. If Regeneron files an initial provisional application, it shallfile a non-provisional application within 10 months of the filing of the initial
provisional application. Regeneron shall include a Government Support
Clause (GSC) within the specification of any United States patent applications
and any patent issuing thereon covering a subject invention.
UNCLASSIFIED

Page 17 of 24
Regeneron Pharmaceuticals, Inc.
July 6, 2020

iv. Regeneron may request extensions of time for disclosure, election, or filingunder subparagraphs (b)(i), (b)(ii) and (b)(iii) of this clause. An extension oftime for each deadline, may be granted at the discretion of the Government
funding agency.
v. If Regeneron determines that it does not intend to elect to retain title to any such
Subject Invention, Regeneron shall notify the Government, in writing, within
two (2) years of disclosure to the Government. However, in any case where
publication, sale, or public use has initiated the one (1)-year statutory period
wherein valid patent protection can still be obtained in the United States, theperiod for such notice may be shortened by the Government to a date that is no
more than sixty (60) calendar days prior to the end of the statutory period.
c. Conditions When the Government May Obtain Title
Upon the Government's written request, Regeneron shall convey title to any Subject
Invention to the Government funding agency if Regeneron fails to disclose the Subject Invention
or elects not to retain title to the Subject Invention within the times specified in Subparagraph b of
Section 7.2. The Government may request title after learning of the failure of Regeneron todisclose or elect within the specified times for an unlimited time. The Government funding agency
may request title upon Regeneron's omission to timely file patent applications in any country. The
Government funding agency may request title in any country in which Regeneron decides todiscontinue prosecution.
d. Rights to Regeneron and Protection of Regeneron's Right to File
Regeneron shall retain a fully paid up, sub-licensable, nonexclusive, royalty-free license
throughout the world in each Subject Invention to which the Government obtains title. Regeneron
license extends to Regeneron's subsidiaries and other affiliates (outside this Agreement), if any,
within the corporate structure of which Regeneron is a party and includes the right to grant licensesof the same scope to the extent that Regeneron was legally obligated or permitted to do so at thetime the Project Agreement was executed. The license is otherwise transferable only with theapproval of the Government, except when transferred to an Affiliate or successor of that part ofRegeneron's business to which the Subject Invention pertains. The Government approval forlicense transfer shall be provided on a timely basis (and in no event later than 90 calendar days
following Regeneron's request) and shall not be unreasonably withheld.
i. The Regeneron license may be revoked or modified by the Government to theextent necessary to achieve expeditious Practical Application of the Subject
Invention pursuant to an application for an exclusive or nonexclusive licensesubmitted consistent with appropriate provisions at 37 CFR Part 404.
Regeneron's license shall not be revoked in that field of use or the geographicalareas in which Regeneron has achieved Practical Application of the Subject
Invention and continues to make the benefits of the Subject Invention
accessible to the public.
ii. Before revocation or modification of Regeneron's license, the Government
shall furnish Regeneron with a written notice of its intention to revoke ormodify the license, which notice shall include a detailed explanation of the
UNCLASSIFIED

Page 18 of 24
Regeneron Pharmaceuticals, Inc.
July 6, 2020

reasons for such revocation or modification, and Regeneron shall be allowed
thirty (30) calendar days (or such other time as may be authorized for goodcause shown) after the notice to show cause why the license should not be
revoked or modified.
e. Action to Protect the Government's Interest
Regeneron agrees to execute or to have executed and promptly deliver to the Government
all instruments necessary to (i) establish or confirm the rights the Government has throughout theworld in those Subject Inventions to which Regeneron elects to retain title, and (ii) convey title to
the Government when requested under Subparagraph c of this Section 7.2 and to enable theGovernment to obtain patent protection throughout the world in that Subject Invention.
i. Regeneron agrees to require, by written agreement, its employees, other thanclerical and non-technical employees, to disclose promptly in writing topersonnel identified as responsible for the administration of patent matters andin a format suggested by Regeneron, each Subject Invention made under thisAgreement so Regeneron can comply with the disclosure provisions of thisSection 7.2. Regeneron shall use reasonable efforts to instruct employees,
through employee agreements or other suitable educational programs, on theimportance of reporting inventions in sufficient time to permit the filing ofpatent applications prior to U.S. or foreign statutory bars.
ii. Regeneron shall notify the Government of any decisions not to continue theprosecution of a patent application for a Subject Invention, pay maintenancefees, or defend in a reexamination or opposition proceedings on a patent of a
Subject Invention, in any country, not less than thirty (30) calendar days before
the expiration of the response period required by the relevant patent office.
Regeneron shall include, within the specification of any United States patent application
and any patent issuing thereon covering a Subject Invention, the following statement: "Thisinvention was made with Government support under Agreement MCDC2020-504, awarded by
the U.S. Department of Health and Human Services. The Government has certain rights in theinvention."f. Lower Tier Agreements
Regeneron shall ensure that its Affiliate agreements and Sub-Recipient Agreements
regardless of tier, for experimental, developmental, or research work entered into after the
Effective Date and submitted for reimbursement under this Agreement, contain invention reporting
and assignment requirements sufficient to permit Regeneron to comply with this Section 7.2.

g. Reporting on Utilization of Subject Inventions
i. Regeneron agrees to submit, during the term of this Project Agreement, anannual report on the utilization of a Subject Invention or on efforts at obtaining
such utilization that is being made by Regeneron or its licensees or assignees.
Such reports shall include information regarding the status of development,
date of first commercial sale or use, and such other data and information as the
UNCLASSIFIED

Page 19 of 24
Regeneron Pharmaceuticals, Inc.
July 6, 2020

agency may reasonably specify. Regeneron also agrees to provide additional
reports as may be requested by the Government in connection with any marchin proceedings undertaken by the Government in accordance with
Subparagraph h of this Section 7.2. Consistent with 35 U.S.C. § 202(c)(5), theGovernment agrees it shall not disclose such information to persons outside theGovernment without permission of Regeneron.
ii. All required reports shall be submitted to the e-room, OTAS, OTAO, andOTTR.
h. Compulsory Licensing Rights
Regeneron agrees that, with respect to any Subject Invention in which it has retained title,
the Government has the right to require Regeneron, an assignee, or exclusive licensee of a Subject
Invention to grant a non-exclusive license to a responsible applicant or applicants, upon terms thatare reasonable under the circumstances, and if Regeneron, assignee, or exclusive licensee refusessuch a request, the Government has the right to grant such a license within the Field itself only if
the Government determines that:i. Action is necessary to alleviate the following health or safety needs that may
affect the United States and Regeneron (itself or through its assignee,
subcontractor or licensee) is unwilling or unable to manufacture or supply the
Subject Invention to address such needs:
a. Declaration for Public Health Emergency by the Secretary of
HHS;
b. Determination that there is a significant potential for a public
Health emergency that has a significant potential to affect anational or health security of U.S. citizens as determined by the
Secretary of HHS; orc. Declaration by WHO Director General of a public healthemergency of international concern.
DATA RIGHTS

7.3
a.

Allocation of Principal Rights
i. For Data produced under this SOW including Computer Software, to theextent developed with Government funds provided under this SOW, except
as expressly provided elsewhere in this Project Agreement (including
Section 7.3.b.), Regeneron grants to the Government a paid-up,
nonexclusive, nontransferable, irrevocable, worldwide license in such Data(a) to exercise Government Purpose Rights for a period of ten (10) years
following the production of such Data, (b) to exercise Unlimited Rights
following the expiration of such ten (10)- year period. For Data produced
under this Project Agreement, excluding Computer Software, to the extent
developed with private funds and for other Data designated by Regeneronas "Limited Rights Data", Regeneron grants to the Government a paid-up,
UNCLASSIFIED

Page 20 of 24
Regeneron Pharmaceuticals, Inc.
July 6, 2020

nonexclusive, nontransferable, irrevocable, worldwide license in such Data
to exercise Limited Rights. The Government will not obtain any rights in
Computer Software produced under this Project Agreement to the extent
developed with private funds. For certificates of analysis and batch records
pertaining to drug product purchased under this Project Agreement, theGovernment shall have Unlimited Rights.
Regeneron agrees to retain and maintain in good condition all Data
produced under this Project Agreement and necessary to achieve Practical
Application of any Subject Invention in accordance with Regeneron's
established record retention practices. In the event of an exercise of theGovernment's compulsory licensing rights as set forth under Section 7.2.h.,Regeneron agrees, upon written request from the Government, to deliver at
no additional cost to the Government, all existing Data produced under thisProject Agreement necessary to achieve Practical Application of therelevant Subject Invention within sixty (60) calendar days from the date of
the written request.
Regeneron's right to use Data is not restricted and includes the right under
Regeneron's established business policies to make public research Data(especially human research Data) by publication in the scientific literature,by making trial protocols, trial results summaries, and clinical studies
reports publicly available, and by making trial patient-level data available
for third-party analysis.
b.

Proprietary Manufacturing Data

Notwithstanding anything to the contrary in this Project Agreement, Regeneron retains allrights in and to Data relating to or comprising Regeneron's proprietary manufacturing technology
and processes, including any trade secrets, Chemistry, Manufacturing and Controls information(CMC Data), and Data concerning or arising from test method development, device or delivery
system development, assay development, formulation, quality assurance/quality control
development, technology transfer, process development and scale-up and cell-line development,
and the Government shall have no rights to use such Data independently from this Agreement or
to disclose such Data to any third party. Regeneron may designate certain Data concerning its
manufacturing activities as Limited Rights Data, in which case the Government shall have Limited
Rights in and to such Data. Regeneron will use reasonable efforts to mark any Limited Rights Datadelivered under this Project Agreement with appropriate Limited Rights markings.
c.

Identification and Disposition of Data

Regeneron shall keep copies of all Data relevant to this Project Agreement as required by
the Food and Drug Administration (FDA) for the time specified by the FDA. The Government
reserves the right to review any other data determined by the Government to be relevant to thisAgreement. The Government further acknowledges that Regeneron holds the commercializationrights for all products developed under this Agreement in the U.S. and will be responsible for theirregistration with the FDA. This provision is subject to any applicable limitations on the
Government's rights under Article VIII.B.a-b of the BARDA OTA.
UNCLASSIFIEDCONFIDENTIAL/PROPRIETARYPage 21 of 24
Regeneron Pharmaceuticals, Inc.
July 6, 2020

7.4

REGULATORY RIGHTSThe Contractor agrees to the following:a. Regulatory Data. Regeneron shall provide to the OTTR and OTAS copies of formal FDA
submissions pertaining to the scope of the project, no later than 10 business days before submission
to the FDA. For clarity, CMC Data included in such submissions shall be subject to Section 7.3.b.
b. Rights of Reference. Upon mutual agreement, Regeneron will grant to the Government a rightof reference to any Regulatory Application submitted in support of this Project Agreement, solely
for the purpose of the Government conducting a clinical trial with the drug product supplied under
this Project Agreement under a protocol approved by Regeneron for performance by theGovernment. In such a case, Regeneron agrees to provide a letter of cross-reference to theGovernment and file such letter with the appropriate FDA office. Nothing in this paragraphreduces the Government's data rights as articulated in other provisions of this award.
c. Clause 7.4.b. will survive the acquisition or merger of the Contractor by or with a third party.
This clause will survive the expiration of this contract.
7.5 PREP Act Coverage. It is the intent of the Parties that the drug product provided pursuant tothis Agreement be covered by the March 10, 2020 declaration under the Public Readiness andEmergency Preparedness Act (PREP Act), 42 U.S.C. § 247d-6d, 85 Fed Reg. 15,198 (March 17,2020), or any amendments thereto that provides liability protection for such use. Based on an
independent review by each of the Parties of the PREP Act Declaration issued by DHHS on March
10, 2020, pursuant to section 319F-3 of the Public Health Service Act (42 U.S.C. 247d-6d), and a
related advisory opinion issued by the DHHS Office of General Counsel on April 14, 2020, theParties believe that Regeneron is a covered person eligible for immunity under the PREP Act for
activities related to medical countermeasures against COVID-19. To the extent DoD or BARDA
is authorized to do so as an Authority Having Jurisdiction, the Government designates Regeneron
as a covered person eligible for immunity under the PREP Act Declaration issued by DHHS on
March 10, 2020, pursuant to section 319F-3 of the Public Health Service Act (42 U.S.C. 247d-6d),
for activities related to medical countermeasures against COVID-19. The Government further
warrants that the drug product provided pursuant to this Project Agreement will not be (a) sold toany entity nor will it be returned after acceptance under the terms of this contract or (b) distributedor used, or authorized for distribution or use, outside the United States or to the extent suchactivities are not protected from liability under an active PREP Act declaration.
7.6 Transparency. To the extent permitted under applicable laws, the Government will provide
Regeneron in a timely manner copies of reports concerning this Project Agreement that areprovided to other Government agencies or legislative or executive branches of the government.
8.0

SECURITY

The security classification level for this effort is UNCLASSIFIED.
UNCLASSIFIEDCONFIDENTIAL/PROPRIETARYPage 22 of 24
Regeneron Pharmaceuticals, Inc.
July 6, 2020

9.0

MISCELLANEOUS REQUIREMENTS (SAFETY, ENVIRONMENTAL, ETC.)

N/A

10.0

GOVERNMENT FURNISHED PROPERTY/MATERIAL/INFORMATION

None
11.0

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

AOR
NAME: ozoni
i
EMAIL: (b) (6)
PHONE zuraf
AGENCY NAME/DIVISION/SECTION: HHS/ASPR/BARDA
Alternate AOR

NAME:
MAILING ADDRESS:EMAIL:
PHONE:
AGENCY NAME/DIVISION/SECTION:
Requiring Activity:
US Department of Health & Human Services (HITS), Assistant Secretary for Preparedness andResponse (ASPR), Biomedical Advanced Research and Development Authority (BARDA)

UNCLASSIFIEDCONFIDENTIAL/PROPRIETARYPage 23 of 24
Regeneron Pharmaceuticals, Inc.
July 6, 2020

Definitions Appendix
Computer Software:
To perform and further this Project Agreement:
Computer programs that comprise a series of instructions, rules, routines, or statements,
regardless of the media in which recorded, that allow or cause a computer to perform a specificoperation or series of operations; andRecorded information comprising source code listings, design details, algorithms, processes,
flow charts, formulas, and related material that would enable the computer program to be
produced, created, or compiled.
Does not include computer databases or computer software documentation.
Data: Means recorded information, regardless of form or the media on which it may berecorded. The term includes technical data and Computer Software. The term does not include
information incidental to contract administration, such as financial, administrative, cost or
pricing, or management information.
Field: The development of anti-pathogen assets to treat, diagnose or prevent emerging infectious
diseases.
Government: The United States of America, as represented by the Department of Health &Human Services ("Government"), Office of the Assistant Secretary for Preparedness & Response("ASPR"), Office of Biomedical Advanced Research and Development ("BARDA")(represented by Office of Acquisition Management, Contracts and Grants (AMCG)).
Government Purpose: Any activity in which the United States Government is a party, including
cooperative agreements with international or multi-national defense organizations, or sales ortransfers by the United States Government to foreign governments or international organizations.
Government purposes include competitive procurement, but do not include the rights to use,
modify, reproduce, release, perform, display, or disclose technical data for commercial purposes
or authorize others to do so.
Government Purpose Rights: The rights by Government to1.
Use, modify, reproduce, release, perform, display, or disclose technical data within the
Government without restriction; and2.
Release or disclose technical data outside the Government and authorize persons towhom release or disclosure has been made to use, modify, reproduce, release, perform, display,or disclose that data for United States Government Purpose.

Invention: Any invention or discovery that is or may be patentable or otherwise protectable
under Title 35 of the United States Code.
UNCLASSIFIEDCONFIDENTIAL/PROPRIETARYPage 24 of 24
Regeneron Pharmaceuticals, Inc.
July 6, 2020

Limited Rights: The rights to use, modify, reproduce, perform, display, or disclose Data, inwhole or in part, within the Government solely for research purposes for the Field. Government
will ensure that disclosed information is safeguarded in accordance with the restrictions of thisAgreement. The Government may not, without the prior written permission of Recipient, releaseor disclose the Data outside the Government, use the Data for competitive procurement or
manufacture, release or disclose the data for commercial purposes, or authorize the Data to be
used by another party. The Parties shall maintain the confidentiality of all Data subject to or
designated as falling within Limited Rights.
Limited Rights Data: Data, other than Computer Software, that embody trade secrets or arecommercial or financial and confidential or privileged, to the extent that such Data pertain to
items, components, or processes developed at private expense, including minor modifications.
Made: The conception or first actual reduction to practice of the invention as defined in thisAgreement.
Option: An option, entered into by bilateral agreement pursuant to a Statement of Work andbudget, by which, for a specified time, the Government may elect to purchase additional supplies
or services called for by the Agreement.
Other Transaction Agreement Officer ("OTAO"): Is the responsible Government official
authorized to bind the Government by signing this Agreement and bilateral modifications.
Other Transaction Agreement Specialist ("OTAS"): Is a supporting official that assists andrepresents the OTAO. The OTAO is the only official who can bind the Government.
Other Transaction Agreement Technical Representative ("OTTR"): Is the primary
Government official for all technical matters on the Agreement.
Practical Application: With respect to a Subject Invention, to manufacture, in the case of acomposition or product; to practice, in the case of a process or method; or to operate, in the caseof a machine or system; and, in each case, under such conditions as to establish that the Subject
Invention is capable of being utilized and that its benefits are, to the extent permitted by law orGovernment regulations, available to the public for a regulatory approved product.
Subject Invention: Any Invention Made in the performance of work under this Agreement
within the Field for which Recipient pursues a patent.
Sub-Recipient: Akin to a subcontractor. Any supplier, distributor, vendor, or firm that furnishes
supplies or services to or for the Recipient, an Affiliate, or a Sub-Recipient. A Sub-Recipient
differs from an Affiliate in that Sub-Recipients are not listed as an Affiliate in Attachment 3 andmay be used to execute tasks under the SOW by Recipient or Affiliate.
Sub-Recipient Agreement: Any contract entered into by a Sub-Recipient to furnish supplies orservices for performance of this Agreement. This term describes an agreement with a 1st-Tier
Sub-Recipient, except as expressly noted in this Agreement.

UNCLASSIFIEDCONFIDENTIAL/PROPRIETARYARTICLE XVII.

SECURITY & OPSEC

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