Modification P00005 to Supply Agreement, dated as of September 14, 2021, by and between the Registrant and the U.S. Army Contracting Command, New Jersey

☐    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

SEE SECOND PAGE FOR DESCRIPTION

EUA Wind-Down. If a BLA is issued during the term of this Contract for REGEN-COV, contractor shall ensure that any doses subsequently provided to the Government under this Contract are appropriately labeled under the terms of the EUA (before expiration)or the BLA and are otherwise suitable for use in the United States under the terms of the EUA (before expiration) or the BLA.

C.3    Requirements:

C.3.1    Distribution: The contractor shall distribute the product to Government designated sites as directed by the Government, EUA authorized or BLA approved finished drug product in vials in accordance with the products storage and handling requirements in the EUA (and, if granted, the BLA as applicable), 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 and on behalf of the Government. The Government will be solely responsible for all allocation determinations related to drug product sold hereunder, including allocation to end users and communication of such allocation determinations to the Distributor. Unless otherwise mutually agreed upon by the parties, drug product shall be shipped to the Government or distributed, as applicable, solely within the United States (including its territories and possessions) .The contractor [* * *], until the 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 Government [* * *] of such 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 (or any other ordering process mutually agreed by such entities). Storage and distribution activities shall be supported under this agreement through the end of the period of performance. The Government will make every effort to ensure appropriate delivery and utilization of Government 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.

C.3.2 Product Development Manufacturing Reports and Projections: Regeneron will provide manufacturing reports and manufacturing dose tracking projections/actuals, in the format and having the content mutually agreed upon by the Government and Regeneron. Regeneron will update the reports [* * *] 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 within [* * *] of award. For clarity, the reports described in this section apply to Formulated Drug Substance and Drug Product prior to delivery and acceptance 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:

C.5    Period of Performance: The period of performance for this contract is from date of award through [* * *].

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 for the 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 Vendor-Managed Inventory

(VMI), and the Governments corresponding acceptance of such drug product, as described in this paragraph. The Government shall accept product that conforms to contract requirements based on 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 the applicable Quality Agreement for the product. The Governments acceptance of drug product [* * *] the Governments written acceptance of such drug product or, [* * *] provide written notice of acceptance or rejection of such drug product, within [* * *]. Any visibly damaged product will be rejected immediately. The contractor will transfer product from VMI to the Distributor for distribution directed by the Government; provided that, product shall not be provided to the Distributor until it is accepted by the Government. The contractor shall provide a shipment temperature tracking report within [* * *] of 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 returned to the contractor or otherwise disposed of according to contractor instructions. The Government will not be obligated to pay for rejected 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. Packaging shall be in shipping containers according to the contractors standard commercial practice.

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

Public Disclosures: Notwithstanding any other provision in this contract, the contractor may publicly release any information related to this contract without prior approval to the extent necessary to satisfy or address regulatory requirements, contractual obligations to third 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 used outside 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, except as provided in Special Contract Requirements Paragraph 4., Donation of Excess Product, which remains in effect.

C.9    Government Technical Point of Contact:

HHS BARDA

Contingencies and Operational Requirements Goal Delivery Schedule*

    Approximately [* * *] doses delivered in [* * *]

    Approximately [* * *] doses delivered in [* * *]

    Approximately [* * *] doses delivered in [* * *]

    Approximately [* * *] doses delivered in [* * *]

* The delivery schedule is non-binding and for illustrative purposes only and it is subject to the following contingencies and operational requirements:

A.    FDA action on submissions currently under review:

[* * *]

B.    Additional Regulatory Actions[* * *]:

[* * *]

C.    Operational Requirements:

[* * *]