SPE2D224R00050005_Amendment 0005 for Budesonide.pdf

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT

1. CONTRACT ID CODE

2. AMENDMENT/MODIFICATION NO.

See Block 14

4. REQUISITION/PURCHASE REQ. NO. 5. PROJECT NO. (If applicable)

6. ISSUED BY CODE SPE2D2 7. ADMINISTERED BY (If other than Item 6) CODE

8. NAME AND ADDRESS OF CONTRACTOR (No., street, county, State and ZIP Code)

CODE FACILITY CODE

SPE2D224R0005

X

2024 MAR 12

10A. MODIFICATION OF CONTRACT/ORDER NO.

10B. DATED (SEE ITEM 13)

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 OffersX is extended, X is not extended.

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.

1 copies of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted;

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:

12. ACCOUNTING AND APPROPRIATION DATA (If required)

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.

B. THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES (such as changes in paying office, appropriation date, 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:

E. IMPORTANT: Contractor is not, X is required to sign this document and return 1 copies to 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 or print)

NSN 7540-01-152-8070

Previous edition unusable

STANDARD FORM 30 (REV. 10-83)

Prescribed by GSA FAR (48 CFR) 53.243

16B. UNITED STATES OF AMERICA15B. CONTRACTOR/OFFEROR

(Signature of Contracting Officer)(Signature of person authorized to sign)

16A. NAME AND TITLE OF CONTRACTING OFFICER (Type or print)

(a) By completing Items 8 and 15, and returning

DLA TROOP SUPPORT

MEDICAL SUPPLY CHAIN FSGB

700 ROBBINS AVENUE

PHILADELPHIA PA 19111

15C. DATE SIGNED 16C. DATE SIGNED

D. OTHER (Specify type of modification and authority)

3. EFFECTIVE DATE

See Attached Continuation Sheet(s).

(X)

CHECK ONE

9A. AMENDMENT OF SOLICITATION NO.

9B. DATED (SEE ITEM 11)

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

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

CONTINUATION SHEET REFERENCE NO. OF DOCUMENT BEING CONTINUED: PAGE 2 OF 2 PAGES

SPE2D224R0005 - 0005

The purpose of this amendment is to update the language of the solicitation.

The following changes have been made to the solicitation as shown below:

1. On page 50 of the solicitation, under FAR 52.212-2 (Evaluation Commercial Products and Commercial Services (Nov.

2021)), the sentence is changed from, Vendor must meet minimum requirements of Technical Requirements (a) through (h) and Past Performance (a) through (c), under 52.212-1.

To:

Vendor’s technical acceptability will be determined based upon the contracting officer’s discretion and review of the information submitted in response to Technical Requirements (a) through (h) and Past Performance (a) through (c), under 52.212-1.

2. On page 75, the following sentence is changed from:

The contracting officer may in their discretion consider offers from companies with open and unresolved cGMP compliance issues in an FDA warning letter. Before a contract can be awarded, the potential offeror shall submit evidence of current cGMP compliance status with the FDA, including applicable warning letters, corrective action plans, and any FDA close-out letters.

To:

The contracting officer may in their discretion consider offers from, and award the contract to, any company with open and unresolved cGMP compliance issues in an FDA warning letter based upon the contracting officer’s review of the information submitted in response to Technical Requirements (a) through (h) and Past Performance (a) through (c), under 52.212-1.

3. All other terms and conditions have remain unchanged.