US Army Contracting Command (via ATI) – Regeneron, COVID-19 Antibodies Large-Scale Manufacturing Agreement

Provision Language

1.5 Follow–on Activityb>span>p>
In accordance with 10.U.S.C. 2371b(f), and upon successful demonstration of the prototype, or at the accomplishment of particularly favorable or unexpected results achieved outside of this Agreement that would justify transitioning to production (e.g., <a href=”#kt“>EUAa> or <a href=”#kt“>BLAa>), additional at–scale manufacturing of [* * *], supported by a mutually agreed upon follow–on 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 and effective COVID–19 therapeutic or prophylactic treatment courses to ensure nationwidespan> 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 be obligated to negotiate or enter into such a separate agreement for follow–on production.span>p>
During the performance of the prototype project, the Government and contractor may negotiate the scope and price of follow–on production.span>p>
4.0 Deliverablesb>span>p>
Offeror assumed [* * *]. Regeneron shall have the right to provide deliverables directly to the Government and not to the Consortium Management Firm (CMF).span>p>
Deliverable Table (June 2020 – June 2021)span>p>
<table>
<tbody>
<tr>
<td>Deliverableb>td>
<td>Due Dateb>td>
<td>Total Program Fundsb>td>
<td>Data Rightsb>td>
tr>
<tr>
<td>Project Kick–Off; Deliverablespan>td>
<td>[* * *]span>td>
<td>[* * *]span>td>
<td>[* * *]span>td>
tr>
<tr>
<td>DS/FDS Bulk GMP Lot [* * *]span>td>
<td>[* * *]span>td>
<td>[* * *]span>td>
<td>[* * *]span>td>
tr>
<tr>
<td>DS/FDS Bulk GMP Lot [* * *]span>td>
<td>[* * *]span>td>
<td>[* * *]span>td>
<td>[* * *]span>td>
tr>
<tr>
<td>DS/FDS Bulk GMP Lot [* * *]span>td>
<td>[* * *]span>td>
<td>[* * *]span>td>
<td>[* * *]span>td>
tr>
<tr>
<td>Fill Product [* * *]span>td>
<td>[* * *]span>td>
<td>[* * *]span>td>
<td>[* * *]span>td>
tr>
<tr>
<td>Fill Product [* * *]span>td>
<td>[* * *]span>td>
<td>[* * *]span>td>
<td>[* * *]span>td>
tr>
<tr>
<td>Fill Product [* * *]span>td>
<td>[* * *]span>td>
<td>[* * *]span>td>
<td>[* * *]span>td>
tr>
<tr>
<td>Package/Label Productspan>td>
<td>[* * *]span>td>
<td>[* * *]span>td>
<td>[* * *]span>td>
tr>
<tr>
<td>Storage of Drug Product [* * *]span>td>
<td>[* * *]span>td>
<td>[* * *]span>td>
<td>[* * *]span>td>
tr>
<tr>
<td>Storage of Drug Product [* * *]span>td>
<td>[* * *]span>td>
<td>[* * *]span>td>
<td>[* * *]span>td>
tr>
<tr>
<td>Storage of Drug Product [* * *]span>td>
<td>[* * *]span>td>
<td>[* * *]span>td>
<td>[* * *]span>td>
tr>
<tr>
<td>Storage of Drug Product [* * *]span>td>
<td>[* * *]span>td>
<td>[* * *]span>td>
<td>[* * *]span>td>
tr>
<tr>
<td>[* * *]span>td>
<td>[* * *]span>td>
<td>[* * *]span>td>
<td>[* * *]span>td>
tr>
<tr>
<td>[* * *]span>td>
<td>[* * *]span>td>
<td>[* * *]span>td>
<td>[* * *]span>td>
tr>
<tr>
<td>[* * *]span>td>
<td>[* * *]span>td>
<td>[* * *]span>td>
<td>[* * *]span>td>
tr>
<tr>
<td>[* * *]span>td>
<td>[* * *]span>td>
<td>[* * *]span>td>
<td>[* * *]span>td>
tr>
tbody>
table>
*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 <a href=”https://ghiaa.org/provision_document/regeneron–ati–agreement–for–large–scale–manufacturing–of–antibodies–directed–to–sars–cov–2–2/” target=”_blank” rel=”noopener“>Section 7.3a>span> to technical data disclosed under this Statement of Work.span>p>
** 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).span>p>
5.0 Milestone Payment Schedule; Termination Costsb>span>p>
<table>
<tbody>
<tr>
<td>Milestone #b>td>
<td>Milestone Descriptionb>p>
(Deliverable Reference)b>td>
<td>Due Dateb>td>
<td>Total Program Fundsb>td>
tr>
<tr>
<td>5.1span>td>
<td>[* * *]span>td>
<td>[* * *]span>td>
<td>[* * *]span>td>
tr>
<tr>
<td>5.2span>td>
<td>[* * *]span>td>
<td>[* * *]span>td>
<td>[* * *]span>td>
tr>
<tr>
<td>5.3span>td>
<td>[* * *]span>td>
<td>[* * *]span>td>
<td>[* * *]span>td>
tr>
<tr>
<td>5.4span>td>
<td>[* * *]span>td>
<td>[* * *]span>td>
<td>[* * *]span>td>
tr>
<tr>
<td>5.5span>td>
<td>[* * *]span>td>
<td>[* * *]span>td>
<td>[* * *]span>td>
tr>
<tr>
<td>5.6span>td>
<td>[* * *]span>td>
<td>[* * *]span>td>
<td>[* * *]span>td>
tr>
<tr>
<td>5.7span>td>
<td>[* * *]span>td>
<td>[* * *]span>td>
<td>[* * *]span>td>
tr>
<tr>
<td>5.8span>td>
<td>[* * *]span>td>
<td>[* * *]span>td>
<td>[* * *]span>td>
tr>
<tr>
<td>5.9span>td>
<td>[* * *]span>td>
<td>[* * *]span>td>
<td>[* * *]span>td>
tr>
<tr>
<td>5.10span>td>
<td>[* * *]span>td>
<td>[* * *]span>td>
<td>[* * *]span>td>
tr>
<tr>
<td>5.11span>td>
<td>[* * *]span>td>
<td>[* * *]span>td>
<td>[* * *]span>td>
tr>
<tr>
<td>Total (Include Payment Type; FFP):b>td>
<td>$450,262,000b>td>
<td>td>
<td>td>
tr>
<tr>
<td>Period of Performance:b>td>
<td>June 2020 – June 2021b>td>
<td>td>
<td>td>
tr>
tbody>
table>
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 3rd 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.span>p>
Total pricing is a firm fixed price per lot, [* * *]. Regeneron will deliver [* * *] of filled/finished drug product. Regeneron will be entitled to full payment for drug product upon 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 product at 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 co–formulated, 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 for therapeutic use. [* * *] Regeneron will provide the Government with the timeline for fill/finish activities, including the dates by which the parties must determinespan> the allocation of fill/finish activities. Notwithstanding the foregoing, as part of this Project Agreement, Regeneron will have the right to utilize material and capacity supported by this agreement to fill up to [* * *], as well as any additional drug product mutually agreed upon by Regeneron and the Government (with respect to which use the Government will not unreasonably withhold consent.span>p>
In the event this Statement of Work is terminated prior to completion, termination costs recoverable by Regeneron under Section 2.04 of the MCDC Base Agreement, shall include the following: the full contract price for any drug product manufactured and not yet paid for; a pro–rated portion of the contract price for drug substance or drug product that is in process, based on the stage of production; [* * *] and raw materials that Regeneron purchased (or is obligated to purchase) that cannot be allocated to other products.span>p>
7.0 Patent Rights; Data Rights; PREP Act and Transparencystrong>span>p>
7.2 Patent Rightsb>p>
[…]p>
h. Compulsory Licensing Rightsspan>p>
Regeneron agrees that, with respect to any <a href=”#kt“>Subject Inventiona> 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 that are reasonable under the circumstances, and if Regeneron, assignee, or exclusive licensee refuses such a request, the Government has the right to grant such a license within the Field itself span>onlyspan>i> if the Government determines that:span>p>
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:span>p>
a. Declaration for Public Health Emergency by the Secretary of HHS;span>p>
b. Determination that there is a significant potential for a public Health emergency that has a significant potential to affect a national or health security of U.S. citizens as determined by the Secretary of HHS; orspan>p>
c. Declaration by WHO Director General of a public health emergency of international concern.span>p>

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