Modification P00006 to Supply Agreement, dated as of February 24, 2022, by and between the Registrant and the U.S. Army Contracting Command, New Jersey

Contract Categories: Business Operations - Supply Agreements
EX-10.6 4 regn-ex_106x3312022x10q.htm MOD. P00006 TO SUPPLY AGREEMENT - REGENERON AND US ARMY CONTRACTING COMMAND Document
Exhibit 10.6

1. Contract ID Code
Firm Fixed Price
Page 1 Of 6
2. Amendment/Modification No.
3. Effective Date
4. Requisition/Purchase Req. No.

5. Project No. (If applicable)
6. Issued By
7. Administered By (If other than Item 6)

NATICK, MA ###-###-####

8. Name and Address of Contractor (No., Street, City, Country, State and Zip Code)

TARRYTOWN, NY 10591-6717
9A. Amendment Of Solicitation No.
9B. Dated (See Item 11)
10A. Modification Of Contract/Order No.

10B. Dated (See Item 13)
Code 544P9
Facility Code
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 the offer submitted; or (c) By separate letter or telegram which includes a reference to the solicitation and amendment numbers. FAILURE OF YOUR ACKNOWLEDGMENT TO BE RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATE SPECIFIED 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)

It Modifies The Contract/Order No. As Described In Item 14.
A. This Change Order is Issued Pursuant To:
       The Contract/Order No. In Item OA.
The Changes Set Forth in Item 14 Are Made In
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).
C. This Supplemental Agreement Is Entered Into Pursuant To Authority Of:
FAR 43.103(a)
D. Other (Specify type of modification and authority)
E. IMPORTANT: Contractor £ is not, S 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.)


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 and effect.
15A. Name And Title Of Signer (Type of print)

Robert Landry - Executive Vice President
16A. Name And Title Of Contracting Officer (Type or print)
15B. Contractor/Offeror
______/s/ Robert Landry________________________
(Signature of person authorized to sign)
15C. Date Signed

16B. United States Of America
By _/s/ ___________________________
(Signature of Contracting Officer)
16C. Date Signed

NSN 7540-01-152-8070
Prescribed by GSA FAR (48 CFR) 53.243

Reference No. of Document Being Continued
Page 2 of 6
Name of Offeror or Contractor: REGENERON PHARMACEUTICALS, INC.

Buyer Name:
Buyer Office Symbol/Telephone Number: CCAP-CR/
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: 2022JUL31
Paying Office: HQ0490
8899 E. 56TH STREET
INDIANAPOLIS IN ###-###-####
*** End of Narrative A0000 ***
The purpose of this modification is to rescind the Health Resource Priority and Allocations Systems (HRPAS) Rating of DO-HR from Section
*** END OF NARRATIVE A0007 ***

Reference No. of Document Being Continued
Page 3 of 6
Name of Offeror or Contractor: REGENERON PHARMACEUTICALS, INC.

As this is a commercial contract, any special requirements contained in this section and throughout the contract, are incorporated by addendum.
I.Key Personnel
Any key personnel specified in this contract are considered to be essential to work performance. At least [* * *] prior to the Contractor voluntarily diverting any of the specified individuals to other programs or contracts, the Contractor shall notify the CO and shall submit a justification for the diversion or replacement and a request to replace the individual. The request must identify the proposed replacement and provide an explanation of how the replacement's skills, experience, and credentials meet or exceed the requirements of the contract (including, when applicable, Human Subjects Testing requirements). If the employee of the Contractor is terminated for cause or separates from the Contractor voluntarily with less than [* * *], the Contractor shall provide the maximum notice practicable under the circumstances. The Contractor shall not divert, replace, or announce any such change to key personnel without the written consent of the CO. The contract will be modified to add or delete key personnel as necessary to reflect the agreement of the parties. The following individuals are determined to be key personnel:
Reference Regeneron's Technical Proposal dated 29 December 2020, Section, Program Management, for a listing of key personnel
II.Substitution of Key Personnel
The Contractor agrees to assign to the contract those persons whose resumes/CVs were submitted with the proposal who are necessary to fill the requirements of the contract. No substitutions shall be made, except in accordance with this clause.
All requests for substitution must provide a detailed explanation of the circumstance necessitating the proposed substitution, a complete resume for the proposed substitute and any other information requested by the CO to approve or disapprove the proposed substitution. All proposed substitutes must have qualifications that are equal to or higher than the qualifications of the person to be replaced. The CO or authorized representative (TPOC) will evaluate such requests and promptly notify the Contractor of his approval or disapproval thereof.
The Contractor further agrees to include the substance of this clause in any subcontract, which may be awarded under this contract.
III.Disclosure of Information
Performance under this contract may require the Contractor to access non-public data and information proprietary to a Government agency, another Government Contractor or of such nature that its dissemination or use other than as specified in the work statement would be adverse to the interests of the Government or others. Neither the Contractor, nor Contractor personnel, shall divulge nor release data nor information obtained under performance of this contract, except authorized by Government personnel or upon written approval of the CO in accordance with OWS or other Government policies and/or guidance. The Contractor shall not use, disclose, or reproduce proprietary data that bears a restrictive legend, other than as specified in this contract, or any information at all regarding this agency.
The Contractor shall comply with all Government requirements for protection of non-public information. Unauthorized disclosure of nonpublic information is prohibited by the Governments rules. Unauthorized disclosure may result in termination of the contract, replacement of a Contractor employee, or other appropriate redress. Neither the Contractor nor the Contractors employees shall disclose or cause to be disseminated, any information concerning the operations of the activity, which could result in, or increase the likelihood of, the possibility of a breach of the activitys security or interrupt the continuity of its operations.
No information related to data obtained from the Government under this contract shall be released or publicized without the prior written consent of the TPOC, whose approval shall not be unreasonably withheld, conditioned, or delayed, provided that no such consent is required to comply with any law, rule, regulation, court ruling or similar order; for submission to any Government entity for submission to any securities exchange on which the Contractors (or its parent corporations) securities may be listed for trading; or to third parties relating to securing, seeking, establishing or maintaining regulatory or other legal approvals or compliance, financing and capital raising activities, or mergers, acquisitions, or other business transactions.
IV.Publications and Publicity
The Contractor shall not release any reports, manuscripts, press releases, or abstracts about the work being performed under this contract without written notice in advance to the Government.
(a) Unless otherwise specified in this contract, the Contractor may publish the results of its work under this contract. The Contractor shall promptly send a copy of each submission to the TPOC for security review prior to submission. The Contractor shall also inform the TPOC when the abstract article or other publication is published, and furnish a copy of it as finally published.

Reference No. of Document Being Continued
Page 4 of 6
Name of Offeror or Contractor: REGENERON PHARMACEUTICALS, INC.

(b)Unless authorized in writing by the CO, the Contractor shall not display Government logos, including Operating Division or Staff Division logos on any publications.
(c)The Contractor shall not reference the products(s) or services(s) awarded under this contract in commercial advertising, as defined in FAR 31.205-1, in any manner which states or implies Government approval or endorsement of the product(s) or service(s) provided.
(d)The contractor shall include this clause, including this section (d) in all subcontracts where the subcontractor may propose publishing the results of its work under the subcontract. The Contractor shall acknowledge the support of the Government whenever publicizing the work under this contract in any media by including an acknowledgement substantially as follows:
"This project has been funded in whole or in part by the U.S. Government under Contract No. W15QKN-21-C-0014. The US Government is authorized to reproduce and distribute reprints for Governmental purposes notwithstanding any copyright notation thereon."
V. Confidentiality of Information
a.Confidential information, as used in this article, means information or data of a personal nature about an individual, or proprietary information or data submitted by or pertaining to an institution or organization.
b.The CO and the Contractor may, by mutual consent, identify elsewhere in this contract specific information and/or categories of information which the Government will furnish to the Contractor or that the Contractor is expected to generate which is confidential. Similarly, the CO and the Contractor may, by mutual consent, identify such confidential information from time to time during the performance of the contract. Failure to agree will be settled pursuant to the "Disputes" clause.
c.If it is established elsewhere in this contract that information to be utilized under this contract, or a portion thereof, is subject to the Privacy Act, the Contractor will follow the rules and procedures of disclosure set forth in the Privacy Act of 1974, 5 U.S.C. 552a, and implementing regulations and policies, with respect to systems of records determined to be subject to the Privacy Act.
d.Confidential information, as defined in paragraph (a) of this article, shall not be disclosed without the prior written consent of the individual, institution, or organization.
e.Whenever the Contractor is uncertain with regard to the proper handling of material under the contract, or if the material in question is subject to the Privacy Act or is confidential information subject to the provisions of this article, the Contractor shall obtain a written determination from the CO prior to any release, disclosure, dissemination, or publication.
f.Contracting Officer Determinations will reflect the result of internal coordination with appropriate program and legal officials.
g.The provisions of paragraph (d) of this article shall not apply to conflicting or overlapping provisions in other Federal, State or local laws.
All above requirements MUST be passed to all sub-contractors.
VI. Organizational Conflicts of Interest
Performance under this contract may create an actual or potential organizational conflict of interest such as are contemplated by FAR Part 9.505-General Rules. The Contractor shall not engage in any other contractual or other activities which could create an Organizational Conflict of Interest (OCI). This provision shall apply to the prime Contractor and all sub-contractors. This provision shall have effect throughout the period of performance of this contract, any extensions thereto by change order or supplemental agreement, and for two (2) years thereafter. The Government may pursue such remedies as may be permitted by law or this contract, upon determination that an OCI has occurred.
The work performed under this contract may create a significant potential for certain conflicts of interest, as set forth in FAR Parts 9.505-1, 9.505-2, 9.505-3, and 9.505-4. It is the intention of the parties hereto to prevent both the potential for bias in connection with the Contractors performance of this contract, as well as the creation of any unfair competitive advantage as a result of knowledge gained through access to any non-public data or third party proprietary information.
The Contractor shall notify the CO immediately whenever it becomes aware that such access or participation may result in any actual or potential OCI. Furthermore, the Contractor shall promptly submit a plan to the CO to either avoid or mitigate any such OCI. The CO will have sole discretion in accepting the Contractors mitigation plan. In the event the CO unilaterally determines that any such OCI cannot be satisfactorily avoided or mitigated, other remedies may be taken to prohibit the Contractor from participating in contract requirements related to OCI.
Whenever performance of this contract provides access to another Contractors proprietary information, the Contractor shall enter into a written agreement with the other entities involved, as appropriate, in order to protect such proprietary information from unauthorized use or disclosure for as long as it remains proprietary; and refrain from using such proprietary information other than as agreed to,

Reference No. of Document Being Continued
Page 5 of 6
Name of Offeror or Contractor: REGENERON PHARMACEUTICALS, INC.

for example to provide assistance during technical evaluation of other Contractors offers or products under this contract. An executed copy of all proprietary information agreements by individual personnel or on a corporate basis shall be furnished to the CO within [* * *] of execution.
1. In recognition of the Governments need to provide sufficient quantities of a COVID-19 therapeutic to protect the United States population, the Government shall have the remedy described in this section to ensure sufficient supply of the product to meet the needs of the public health or national security. This remedy is not available to the Government unless and until both of the following conditions ((a) and (b)) are met:
(a) Regeneron gives written notice, required to be submitted to the Government no later than [* * *], of:
i.any formal management decision to terminate manufacturing of this product therapeutic prior to delivery of the minimum required doses to the U.S. Government under this contract, as well as all additional orders accepted by the Contractor, other than as a result of clinical failure, or serious technical or safety reasons
ii.any formal management decision to discontinue sale of this product therapeutic to the Government prior to delivery of the minimum required doses to the U.S. Government under this contract, as well as all additional orders accepted by the Contractor, other than as a result of clinical failure, or serious technical or safety reasons; or any filing that anticipates Federal bankruptcy protection; and
(b) Regeneron has submitted an Emergency Use Authorization application under Section 564 of the Food, Drug, and Cosmetic (FD&C) Act or a biologics license application under the provisions of Section 351(a) of the Public Health Service Act (PHSA).
2. If both conditions listed in section 1 occur, Regeneron, upon the request of the Government, shall provide the following items necessary for the Government to pursue manufacturing of this therapeutic product with a third party for exclusive sale to the U.S. Government:
(a)a writing, evidencing a non-exclusive, non-transferable, irrevocable (except for cause), royalty-free paid- up license to practice or have practiced for on behalf of the U.S. Government, any Regeneron Background Patent, Copyright, other Regeneron Intellectual Property, Regeneron Know-How, and Regeneron Technical Data rights necessary to manufacture doses of the SARS-CoV2 medical countermeasure neutralizing monoclonal antibodies, designated as casirivimab and imdevimab; necessary FDA regulatory filings or authorizations owned or controlled by Regeneron related to this therapeutic product, and any confirmatory instrument pertaining thereto; and
(b)any outstanding Deliverables contemplated or materials purchased under this contract.
3. This remedy will remain available until the end of the contract, and the license rights and items may only be used by the Government and its contractors to the extent needed to manufacture the number of doses that are not received under this contract, including with respect to any additional orders that are accepted by the Contractor.
A. In the event the Government determines that does of REGN10987 and REGN10933 (casirivmab and imdevimab) funded under the contract are no longer needed by the Government, the Government may donate remaining doses to any foreign government to the extent mutually agreed to by the Government and Contractor; provided that:
(x)the Contractor secures any necessary approvals that are contractually required under existing licensing agreements for REGN10987 and REGN10933 (casirivimab and imdevimab);
(y)the foreign nation has an active commercial marketing approval or active regulatory authorization in place for use of REGN10987 and REGN10933 (casirivimab and imdevimab) combined (and not individually) at the time of donation; and
(z)         the Contractor has the option to establish an indemnification agreement with the applicable recipient foreign government.

Reference No. of Document Being Continued
Page 6 of 6
Name of Offeror or Contractor: REGENERON PHARMACEUTICALS, INC.

B.The Government shall notify the Contractor in writing prior to any planned donation to a foreign nation. The Contractor (itself or through its collaborators) agrees to work with the Government in good faith with respect to applicable regulatory submissions, import/export permits, and other reasonable requirements for donation to the extent that donation is authorized under paragraph A above. For clarity, the Contractor's obligations under this paragraph shall not include any requirment to grant licenses to intellectual property or to provide sensitive manufacturing information to any such foreign government nor any obligation to ship product outside the United States.
C.The Government will be responsible for shipment of REGN10987 and REGN 10933 (casirivimab and imdevimab) to the receiving foreign nation in accordance with applicable shipping specifications, and the Contractor's obligations regarding distribution and risk of loss in Section C.3.1 shall not apply.
D.The parties acknowledge that PREP Act coverage may not apply to the provision of any doses under this Section to a foreign nation. The USG makes no representations as to PREP Act coverage thereto. Any immunity or indemnity arrangements in a foreign jurisdiction are the responsibility of the Contractor.
E.The Government agrees that the Contractor's collaborators may perform the Contractor's activities described in this Section, and that the Government shall cooperate with any such collaborators.
*** END OF NARRATIVE H0001 ***