36E79725R0045 0002.docx

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6505--Ustekinumab or Biosimilar Syringes/Vials
Solicitation number
36E79725R0045
Issued by

About this file

This document is a Standard Form 30 Amendment of Solicitation/Modification of Contract for a Department of Veterans Affairs solicitation (36E79725R0045) for Ustekinumab or Biosimilar Syringes/Vials. The amendment updates the annual estimates for Line Item 3 (Ustekinumab 90MG/ML INJ, SYR, 1ML) from 38,028 to 45,763 units annually. The solicitation covers three line items of Ustekinumab products in different strengths and volumes, to be used by multiple federal agencies including VA, Department of Defense, Bureau of Prisons, and Indian Health Service.

The amendment requires offerors to provide both syringe and vial versions for each strength at the same price, with proposed biosimilar products mandated to be FDA-licensed biological products meeting specific criteria. The estimated annual usage varies across line items, with Line Item 3 showing the highest volume at 38,028 units (prior to this amendment). Offerors must complete pages 2 and 3 with updated estimates and return the signed amendment with their offer. The contract includes a base year and four option years, with consistent annual quantities across each line item and year.

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5. PROJECT NUMBER (if applicable)

CODE

7. ADMINISTERED BY

2. AMENDMENT/MODIFICATION NUMBER

CODE

6. ISSUED BY

8. NAME AND ADDRESS OF CONTRACTOR

4. REQUISITION/PURCHASE REQ. NUMBER

3. EFFECTIVE DATE

9A. AMENDMENT OF SOLICITATION NUMBER

9B. DATED

PAGE OF PAGES

10A. MODIFICATION OF CONTRACT/ORDER NUMBER

10B. DATED

BPA NO.

1. CONTRACT ID CODE

FACILITY CODE

CODE

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:

The above numbered solicitation is amended as set forth in Item 14. The hour and date specified for receipt of Offers

E. IMPORTANT:

is extended,

(a) By completing Items 8 and 15, and returning __________ copies of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted; or (c) By separate letter or electronic communication 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 is not extended.

12. ACCOUNTING AND APPROPRIATION DATA

(REV. 11/2016)

is required to sign this document and return ___________ copies to the issuing office.

is not, A. THIS CHANGE ORDER IS ISSUED PURSUANT TO: (Specify authority) THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE CONTRACT ORDER NO. IN ITEM 10A.

15C. DATE SIGNED

B. THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(b).

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 letter or electronic communication, provided each letter or electronic communication makes reference to the solicitation and this amendment, and is received prior to the opening hour and date specified.

C. THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF:

D. OTHER

Contractor

16C. DATE SIGNED

14. DESCRIPTION OF AMENDMENT/MODIFICATION

16B. UNITED STATES OF AMERICA

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

16A. NAME AND TITLE OF CONTRACTING OFFICER

15B. CONTRACTOR/OFFEROR

STANDARD FORM 30

PREVIOUS EDITION NOT USABLE

Prescribed by GSA - FAR (48 CFR) 53.243 (Type or print) (Type or print) (Organized by UCF section headings, including solicitation/contract subject matter where feasible.)

(Number, street, county, State and ZIP Code) (If other than Item 6) (Specify type of modification and authority) (such as changes in paying office, appropriation date, etc.)

(If required)

(SEE ITEM 11)

(SEE ITEM 13)

(X)

CHECK

ONE

13. THIS ITEM APPLIES ONLY TO MODIFICATIONS OF CONTRACTS/ORDERS,

IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14.

11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT

(Signature of person authorized to sign) (Signature of Contracting Officer) 07-16-2025 Department of Veterans Affairs OPAL / National Acquisition Center Building 37 1st Avenue, One Block North of Cermak Hines

IL

60141 Department of Veterans Affairs OPAL / National Acquisition Center Building 37 1st Avenue, One Block North of Cermak Hines

IL

60141 To all Offerors/Bidders

36E79725R0045

X X X X Update Anual Estimates for Line item 3 - Ustekinumab Syringes/Vials

This amendment is issued to update annual estimates for line item 3 from 38,028. to 45,763 annually.

Please complete pages 2 and 3 below with the updated estimates, and sign and return amendment 002 with your offer.

Chris Carthron Contract Officer

Line Item 2

USTEKINUMAB 45MG/0.5ML,0.5ML 1 Syringe/Vial

NDC # __________________

BLA#_________________

Alternative Presentation (Syringe or Vial version of NDC proposed above), if available

Syringe or Vial (indicate which) _________________

Schedule of Supplies
Quantity
Package Size (Syringe/Vial)
Unit Price
Amount (Unit Price x Quantity)
Base Year
8,925
1
Option Year One
8,925
1
Option Year Two
8,925
1
Option Year Three
8,925
1
Option Year Four
8,925
1

Line Item 3

USTEKINUMAB 90MG/ML INJ, SYR,1ML 1 Syringe/Vial

NDC # __________________

BLA#_________________

Alternative Presentation (Syringe or Vial version of NDC proposed above), if available

Syringe or Vial (indicate which) _________________

Schedule of Supplies
Quantity
Package Size (Syringe/Vial)
Unit Price
Amount (Unit Price x Quantity)
Base Year
38,028
1
Option Year One
38,028
1
Option Year Two
38,028
1
Option Year Three
38,028
1
Option Year Four
38,028
1

D.3 ATTACHMENT “C”

ESTIMATED ANNUAL REQUIREMENTS BY AGENCY

ITEM
DESCRIPTION
PACKAGE SIZE (SYRINGE/ VIAL)
VA EST. ANNUAL USAGE (SYRINGE/ VIAL)
DOD EST. ANNUAL USAGE (SYRINGE/ VIAL)
BOP EST. ANNUAL USAGE (SYRINGE/ VIAL)
IHS EST. ANNUAL USAGE (SYRINGE/ VIAL)
TOTAL EST. ANNUAL USAGE (SYRINGE/ VIAL)
1
USTEKINUMAB 5MG/ML INJ,SOLN,26ML
1
1,832
366
17
702
2,917
2
USTEKINUMAB 45MG/0.5ML,0.5ML
1
3,416
5,321
21
167
8,925
3
USTEKINUMAB 90MG/ML INJ,SYR,1ML
1
20,354
16,996
111
567
38,028

For any strength/line item in which the offeror has both syringe and vial available commercially, the offeror must offer both the syringe and vial version for that strength/line item; the syringe and vial must be offered at the same price.

Proposed biosimilar products must be biological products licensed by the FDA under 42 U.S.C § 262 and must meet all biosimilar criteria described in 42 U.S.C. § 262. Additionally, Biosimilars Products must be FDA approved as a biologic medication that is compared to the innovator (the original biologic) and listed as a biosimilar to the innovator in the FDA Purple Book (https://purplebooksearch.fda.gov/).

Updated estimates for line item 3

File details come from the government source that posted it. Updated .