AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT
3. Effective Date

2. Amendment/Modification No.
P00004

4. Requisition/Purchase Req No.

2021JUL26

6. Issued By

Code

W58P05

1. Contract ID CodePage

1 Of 6

Firm Fixed Price

5. Project No. (If applicable)

SEE SCHEDULE

7. Administered By (If other than Item 6)

Code

U.S. ACC, APG , NCD(b) (6)
10 GENERAL GREEN AVE, BLDG 1
NATICK, MA 01760-5011

EMAIL:(b) (6)

8. Name And Address Of Contractor (No., Street, City, County, State and Zip Code)

9A. Amendment Of Solicitation No.

REGENERON PHARMACEUTICALS, INC.
777 OLD SAW MILL RIVER RDTARRYTOWN, NY 10591-6717

9B. Dated (See Item 11)
X

10A. Modification Of Contract/Order No.
W15QKN-21-C-0014

10B. Dated (See Item 13)
Code 544P9

Facility Code2021JAN12

11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS
The above numbered solicitation is amended as set forth in item 14. The hour and date specified for receipt of Offers
is extended,
is not extended.
Offers must acknowledge receipt of this amendment prior to the hour and date specified in the solicitation or as amended by one of the following methods:(a) By completing items 8 and 15, and returning ____________ copies of the amendments: (b) By acknowledging receipt of this amendment on each copy of theoffer submitted; or (c) By separate letter or telegram which includes a reference to the solicitation and amendment numbers. FAILURE OF YOURACKNOWLEDGMENT TO BE RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATESPECIFIED MAY RESULT IN REJECTION OF YOUR OFFER. If by virtue of this amendment you desire to change an offer already submitted, such change
may be made by telegram or letter, provided each telegram or letter makes reference to the solicitation and this amendment, and is received prior to the opening
hour and date specified.
12. Accounting And Appropriation Data (If required)NO CHANGE TO OBLIGATION DATA

13. THIS ITEM ONLY APPLIES TO MODIFICATIONS OF CONTRACTS/ORDERS
It Modifies The Contract/Order No. As Described In Item 14.
A. This Change Order is Issued Pursuant To:
The Changes Set Forth In Item 14 Are Made In
The Contract/Order No. In Item 10A.
B. The Above Numbered Contract/Order Is Modified To Reflect The Administrative Changes (such as changes in paying office, appropriation data, etc.) Set
Forth In Item 14, Pursuant To The Authority of FAR 43.103(b).
X

C. This Supplemental Agreement Is Entered Into Pursuant To Authority Of:

FAR 52.243-1

D. Other (Specify type of modification and authority)
E. IMPORTANT: Contractor
is not,
X is required to sign this document and return _______________ copies to the Issuing Office.
14. Description Of Amendment/Modification (Organized by UCF section headings, including solicitation/contract subject matter where feasible.)
SEE SECOND PAGE FOR DESCRIPTION

Except as provided herein, all terms and conditions of the document referenced in item 9A or 10A, as heretofore changed, remains unchanged and in full force andeffect.
16A. Name And Title Of Contracting Officer (Type or print)
15A. Name And Title Of Signer (Type or print)(b) (6)

15B. Contractor/Offeror

15C. Date Signed

16B. United States Of America
By(Signature of person authorized to sign)
NSN 7540-01-152-8070
PREVIOUS EDITIONS UNUSABLE

30-105-02/SIGNED/

16C. Date Signed
2021JUL26(Signature of Contracting Officer)
STANDARD FORM 30 (REV. 10-83)
Prescribed by GSA FAR (48 CFR) 53.243

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Name of Offeror or Contractor: REGENERON PHARMACEUTICALS, INC.
SECTION A - SUPPLEMENTAL INFORMATION

Buyer Name:(b) (6)
Buyer Office Symbol/Telephone Number: CCAP/(b) (6)
Type of Contract 1: Firm Fixed Price
Kind of Contract: Other
Kind of Modification: G
Type of Business: Large Business Performing in U.S.
Surveillance Criticality Designator: A
Weapon System: No Identified Army Weapons Systems
Contract Expiration Date: 2022JAN11
Paying Office: HQ0490
DFAS-INDY VP GFEBS
8899 E. 56TH STREETINDIANAPOLIS IN 46249-3800*** End of Narrative A0000 ***The purpose of this modification is to:1) Revise CLIN 0001AC delivery date fromcomplete on or before.
(b) (4)(b) (4)to(b) (4). This change is for administrative purposes only as delivery was2) Add the following sentences to paragraph C.3.1: "The Government will make every effort to ensure appropriate utilization ofGovernment purchased product based on clinical need. Prior to the anticipated time of FDA approval of a Biologics License Application(BLA) for REGEN-COV, the parties will plan and coordinate to ensure efficient and effective distribution of commercial and noncommercial product."3) Revise paragraph C.8 to state, "Authorized or Approved Uses: Product sold to the Government may be distributed for use in any
indication approved or authorized by the FDA."
All other terms and conditions of this contract remain in full force and effect.

*** END OF NARRATIVE A0005 ***CONTINUATION SHEET

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Name of Offeror or Contractor: REGENERON PHARMACEUTICALS, INC.
ITEM NO

SUPPLIES/SERVICESQUANTITY

UNIT

UNIT PRICE(b) (4)

EA$______________
2,100.00000

AMOUNTSECTION B - SUPPLIES OR SERVICES AND PRICES/COSTS

0001ACCOVID-19 THERAPEUTIC (REGN10987 AND REGN1093____________________________________________COMMODITY NAME: COVID THERAPEUTIC
CLIN CONTRACT TYPE:
Firm Fixed Price
PRON: CB1RD41544
PRON AMD: 04
PSC: 6505

ACRN: AC

Packaging and Marking______________________________________________
Inspection
and Acceptance
INSPECTION: Destination

ACCEPTANCE: Destination_________________________
Deliveries
or Performance
DOC
SUPPL
REL CD______MILSTRIP________ADDR______SIG CD ______________MARK FOR
001 W56XNH10011003 W90ZQ2J
DEL REL CD________________________QUANTITY___________DEL DATE
001(b) (4)(b) (4)

FOB POINT: Destination
SHIP TO:(W90ZQ2)

XR JOINT PROGRAM EX OFC FOR CHEM, B
HQ JPEO
5101 HOADLEY ROAD
ABERDEEN PROVING GROUND,MD,21010-54

_____
TP
CD
3

$____

(b) (4)

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Name of Offeror or Contractor: REGENERON PHARMACEUTICALS, INC.
SECTION C - DESCRIPTION/SPECIFICATIONS/WORK STATEMENTSTATEMENT OF WORK
Production of Regeneron Therapeutic in Support of National Emergency Response to Coronavirus 2019 (COVID-19)
C.1 Scope: The Department of Defense (DoD) and Department of Health and Human Services (DHHS), in support of Operation Warp Speed (OWS)
and national emergency response to the Coronavirus Disease 2019 (COVID-19), requires the production of Regeneron therapeutic cocktail
REGN10987 and REGN10933 (casirivimab and imdevimab) on a commercial item basis, up to 1,250,000 doses to treat members of the DoD andthe general population infected with the SARS CoV-2 Virus.
C.1.1 Background: The DHHS continuously monitors emerging infectious disease risk and prepares to respond to the threat of novel
emerging infectious disease outbreaks in the United States. DHHS is responding to an outbreak of respiratory disease caused by a novel
coronavirus that was first detected in China, and which has now spread worldwide, including in the United States. The virus has been
named SARS-CoV-2 and the disease it causes has been named Coronavirus Disease 2019 (abbreviated COVID-19).
On January 30, 2020, the International Health Regulations Emergency Committee of the World Health Organization (WHO) declared theoutbreak a Public Health Emergency of International Concern (PHEIC). On January 31, Health and Human Services Secretary Alex M. Azar II
declared a Public Health Emergency (PHE) for the United States to aid the nations healthcare community in responding to COVID-19. On
March 11, WHO publicly characterized COVID-19 as a pandemic. On March 13, the President of the United States declared the COVID-19
outbreak a national emergency.
In July 2020, the DoD awarded an Other Transaction Agreement under the authority of 10 USC 2371b to Regeneron to manufacture and selldrug product to the Government, and to distribute such drug product for the Government in the U.S. These manufacturing production
activities included manufacturing at-scale, filling and finishing, and storage and shipping of REGN10987 and REGN10933 as a therapeutic
cocktail to treat COVID-19 infected patients. On November 21, 2020, Regeneron announced that the antibody cocktail casirivimab andimdevimab administered together, has received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA).
As part of DHHS preparedness and response activities, DHHS seeks to purchase up to 1,250,000 doses of the EUA authorized (or Biologics
License Application (BLA) approved) casirivimab and imdevimab therapeutic, enough to treat much of the targeted US population currently
or projected to be infected over the coming months.
C.2 Objectives and Quantity: The contractor shall produce up to 1,250,000 doses of therapeutic, and the Government will purchase allsuch doses available in Vendor-Managed Inventory (VMI) by the applicable date set forth below:
No Later Than (NLT) June 30, 2021. The Government will consider extending the time for delivery to NLT September 30, 2021, if thecontractor is unable to complete delivery to VMI by June 30, 2021, after making a good faith effort to do so. However, prior to any
extension to the delivery schedule, the contractor shall coordinate with the Government to determine an appropriate path forward,aligning with Government needs. The contractor shall comply with the procedures of FAR 52.212-4(f), Excusable Delays.
C.3 Requirements:
C.3.1 Therapeutic: The contractor shall distribute the product to Government designated sites as directed by the Government, EUA
authorized finished drug product in vials in accordance with the products storage and handling requirements in the EUA, including
temperature controls. This shall include storage and distribution activities. Regeneron will engage one or more third party service
providers (each a Distributor) to perform storage and distribution activities for drug product at the direction of the Government. The
Government will be solely responsible for all allocation determinations related to drug product, including allocation to end users andcommunication of such allocation determinations to the Distributor. Unless otherwise mutually agreed upon by the parties, drug productshall be shipped to the Government or distributed, as applicable, solely within the United States (including its territories andpossessions). The contractor shall, until the(b) (4)
product is distributed to the end user (e.g., the hospital, infusion center or other end-user). To the extent that Regeneron is
responsible for the correction, repair or replacement of Government property held in vendor-managed inventory or in distribution and in
the possession of the Distributor,, the Governmentof such(b) (4)(b) (4)
property. The parties will coordinate ordering through centralized distribution via the established Memorandum of Understanding between
Regeneron, Assistant Secretary for Preparedness and Response (ASPR), and AmerisourceBergen. Storage and distribution activities under
the EUA shall be supported under this agreement through the end of the period of performance. The Government will make every effort toensure appropriate utilization of Government purchased product based on clinical need. Prior to the anticipated time of FDA approval ofa Biologics License Application (BLA) for REGEN-COV, the parties will plan and coordinate to ensure efficient and effective distributionof commercial and non-commercial product.
C.3.2 Product Development Manufacturing Reports and Projections: Regeneron will provide manufacturing reports and manufacturing dosetracking projections/actuals, in the format and having the content mutually agreed upon by the Government and Regeneron. Regeneron will
update the reports (b) (4) during manufacturing campaigns and upon manufacturing deliverable submission during COVID-19 response
operations (where a Public Health Emergency has been declared), with the first deliverable submission withinof award.
(b) (4)For clarity, the reports described in this section apply to Formulated Drug Substance and Drug Product prior to delivery and acceptanceCONTINUATION SHEET

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Name of Offeror or Contractor: REGENERON PHARMACEUTICALS, INC.
by the Government. Tracking reports for product following delivery and acceptance, shall be set forth in the Memorandum of Understanding
between Regeneron, ASPR, and AmerisourceBergen.
C.4 Reporting: The contractor shall provide the following reports/deliverables in accordance with Exhibit A:______
CDRL
#
Title
_____
A001
Post Award Teleconference Minutes
A002
Kickoff Meeting Agenda and Minutes
A003
Teleconference Minutes
A004
Quarterly Meetings
A005
FDA Meeting Minutes
A006
Daily Check-in with Project Staff for COVID-19 Agreement
A007
Monthly Progress Reports
A008
Milestone Reports
A009
Draft Technical Progress Report
A010
Final Technical Progress Report
A011
Product Development Source Material and Manufacturing Report
A012
Contractor Locations
A013
Pandemic Management Plan
A014
Supply Chain and Distribution Tracking
A015
Distribution Plan
A016
Manufacturing Development Plan
A017
Quality Management Plan
A018
Quality Agreement
A019
Release Documentation for Doses to be Delivered
A020
Manufacturing and Distribution Records
A021
Security Plan
A022
Supply Chain Resiliency Plan
A023
Manufacturing Data Requirements
A024
BARDA Audit
A025
FDA Inspections
A026
QA Audits
A027
FDA Submissions
A028
EUA Filing
A029
Provision of Public Law 115-92 SPONSOR Authorization Letter
A030
Press Releases
C.5 Period of Performance: The period of performance for this contract is twelve (12) months.
C.6 Inspection/Acceptance:
C.6.1 Inspection: The Technical Point of Contact (TPOC) is a duly authorized representative of the Government, and is responsible forthe inspection and/or acceptance of all items/activities to be delivered and/or completed under this contract. The parties acknowledge
that acceptance may depend on the compliance with FDA regulations at 21 CFR 600-680 regarding the BLA, current Good Manufacturing
Practice (cGMP) regulations at 21 CFR 210, 211, and other FDA regulations.
C.6.2 Acceptance: Title to drug product will pass to the Government upon delivery of such drug product to VMI, and the Governments
corresponding written acceptance of such drug product. The Government shall accept product that conforms to contract requirements basedon a Certificate of Analysis (COA) and any other quality documentation required to be provided by Regeneron, as set forth in the Quality
Agreement ("Required Documents"), and the parties shall perform their obligations relating to product delivery set forth in theapplicable Quality Agreement for the product. The Government's acceptance of drug product will be(b) (4)
provide written notice of acceptance or rejection within(b) (4)(b) (4)
Any visibly damaged product will be rejected immediately. The contractor will transfer product from VMI to the(b) (4)
Distributor for distribution directed by the Government; provided that, product shall not be provided to the Distributor until it isaccepted by the Government. The contractor shall provide a shipment temperature tracking report withinof(b) (4)
contractors receipt of such report from its storage vendor, or otherwise in accordance with the applicable Quality Agreement. Any
product subject to a temperature excursion outside of acceptable tolerances, shall be rejected. Any rejected product shall be returnedto the contractor or otherwise disposed of according to contractor instructions. The Government will not be obligated to pay forrejected vials, nor will rejected vials count toward the delivery requirement. The contractor shall establish a notification mechanism
for delivery sites to contact the Government regarding rejected vials.
C.7 Packaging and Marking: The contractor shall label product according to FDA guidance/instructions.
containers according to the contractors standard commercial practice.

Packaging shall be in shipping

C.8 Authorized and Approved Uses: Product sold to the Government may be distributed for use in any indication approved or authorized by

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Name of Offeror or Contractor: REGENERON PHARMACEUTICALS, INC.
the FDA.
Public Disclosures: Notwithstanding any other provision in this contract, the contractor may publicly release any information related tothis contract without prior approval to the extent necessary to satisfy or address regulatory requirements, contractual obligations tothird parties, and the public interest in data about the safety or efficacy of the product.
Public Readiness and Emergency Preparedness (PREP) Act: The Government will ensure that no product purchased under this contract is usedoutside the United States (including its territories or possessions) or in a way that is not protected from liability by a declaration
issued under the PREP Act that is active at the time of use.
C.9 Government Technical Point of Contact:(b) (6)
HHS BARDA(b) (6)(b) (6)*** END OF NARRATIVE C0001 ***