W911SR23R0009_Amendment 0001.pdf

USA CONTRACTING CMD-APG. - W911SR

110 THOMAS JOHNSON DR

FREDERICK MD 21702

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT

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)

30-105-04EXCEPTION TO SF 30

APPROVED BY OIRM 11-84

STANDARD FORM 30 (Rev. 10-83) Prescribed by GSA

FAR (48 CFR) 53.243

Posting responses to Contractor questions and amending Past Performance Evaluation Criteria in provision FAR 52.212-2, Evaluation of Offerors.

1. CONTRACT ID CODE PAGE OF PAGES

J 1 3

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

16C. DATE SIGNED

BY 23-Aug-2023

16B. UNITED STATES OF AMERICA15C. DATE SIGNED15B. CONTRACTOR/OFFEROR

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

8. NAME AND ADDRESS OF CONTRACTOR (No., Street, County, State and Zip Code) X W911SR23R0009

X 9B. DATED (SEE ITEM 11)

16-Aug-2023

10B. DATED (SEE ITEM 13)

9A. AMENDMENT OF SOLICITATION NO.

11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS

X The above numbered solicitation is amended as set forth in Item 14. The hour and date specified for receipt of Offer is extended, X is not extended.

Offer 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 amendment; (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)

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

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

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:

D. OTHER (Specify type of modification and authority)

E. IMPORTANT: Contractor is not, 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.)

10A. MOD. OF CONTRACT/ORDER NO.

2. AMENDMENT/MODIFICATION NO. 5. PROJECT NO.(If applicable)

6. ISSUED BY

3. EFFECTIVE DATE

23-Aug-2023

CODE

USA CONTRACTING CMD-APG. - W911SR

EDGEWOOD CONTRACTING DIVISION

8456 BRIGADE STREET

BLDG E4215

ABERDEEN PROVING GROUND MD 21010-5401

W911SR 7. ADMINISTERED BY (If other than item 6)

4. REQUISITION/PURCHASE REQ. NO.

CODE W911SR

FACILITY CODECODE

EMAIL:TEL:

W911SR23R0009

SECTION SF 30 BLOCK 14 CONTINUATION PAGE

SUMMARY OF CHANGES

SECTION SF 1449 - CONTINUATION SHEET

The following have been modified:

52.212-2 EVALUATION--COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (NOV 2021)

(a) The Government will award a contract resulting from this solicitation to the responsible offeror whose offer conforming to the solicitation is the lowest price technically acceptable offer. The following factors shall be used to evaluate offers:

Storage Facility Product Distribution Process Disposal Process Program Management Past Performance

The following outlines the technically acceptable criteriafor each of the factors listed above. Offerors must be evaluated as technically acceptable in each factor to be eligible for award.

Storage Facility The Government will evaluate the Offeror’s storage facility. To receive an acceptable rating the offeror must demonstrate all of the below items.

a. Storage facility is capable of storing products under the conditions specified in appendix C.

b. Storage facility is capable of storing a minumum of six (6) cubic feet of product at a controlled room temperature (+20ºC to +25ºC).

c. Storage facility is capable of storing 203 cubic feet of product at refrigerated temperatures (+2ºC to +8ºC).

d. Storage facility is capable of storing a minimum of three (3) cubic feet of product at freezer temperatures

((-20ºC to -10ºC (±10ºC)).

e. Storage facility is capable of storing a minimum of one (1) cubic foot of product at ultra-low temperatures

Ultra-Low (-80ºC (±10ºC)).

f. Storage facility has temperature and humidity monitoring systems that provide notice within 24 hours of a failure incident.

g. Offeror has defined a process to rectify temperature and humidity failures within 72 hours of failure incident.

Product Distribution Process The Government will evaluate the Offeror’s product distribution process. To receive an acceptable rating the offeror must demonstrate all of the below items.

a. Packaging and shipping processes describe methods and products used for shipping products under each of the temperature conditions referenced in Appendix C.

b. The offerors shipping labeling system and process is FDA compliant with Carton and Container Labeling regulations for Vaccine products.

c. Offeror demonstrates ability to track all vaccine products from shipping to delivery location and outlines a process for mitigating late or missing shipments.

d. Offeror Describes temperature monitoring devices/system(s) used for the shipment of products in accordance with FDA guidance and regulations, and a process for mitigating temperature monitoring device failures or temperature exceedances recorded during shipment.

W911SR23R0009

Disposal process The Government will evaluate the Offeror’s Disposal process. To receive an acceptable rating the offeror must demonstrate all of the below items.

a. Offeror describes procedures for disposing of expired or excess products that align with applicable federal, state, or local disposal regulations.

b. Offeror's disposal service, whether in-house or sub-contracted, is compliant with all Federal, State, and local disposal regulations.

Program Management The Government will evaluate the Offeror’s Program management process. To receive an acceptable rating the offeror must demonstrate all of the below items.

a. Offeror provides an organization structure identifying personnel (by title or by function) and their responsibilities in performing work required under task orders executed under this ID/IQ.

b. Offeror’s project management plan describes a process of managing task orders issued under this ID/IQ from reciept of executed order to execution of storage, distribution and disposal services.

Past performance The Government will evaluate past performance. To receive an acceptable rating the offeror must demonstrate all of the below items.

a. Past Performance shows experience in storing, distributing and disposing of drug, pharmaceutical, or similar materials in each of the conditions specified in Appendix C.

b. Past Performance evaluations show no assessments evaluated lower than “Satisfactory”.

Price The Government will use the Total Evaluated Price proposed on the Price Evaluation Sheet in the determination of the lowest priced technically acceptable offerors. The ID/IQ Price Sheet will be reviewed and incorporated into the contract to establish baseline pricing for storage, distribution and disposal services performed under orders issued through the resulting ID/IQ contract. The Government will review the ID/IQ Price Sheet for balanced pricing.

Offerors demonstrating unbalanced pricing, or “buying in” with unreasonably low initial pricing may be deemed ineligible for award. The TPOXX Task Order Price Sheet shall be reviewed for alignment to the proposed ID/IQ Price Sheet. Neither the ID/IQ Price Sheet or the TPOXX Task Order Price Sheet shall be used in calculating the lowest price for the evaluation of offerors.

(b) Options. The Government will evaluate offers for award purposes by adding the total price for all options to the total price for the basic requirement. The Government may determine that an offer is unacceptable if the option prices are significantly unbalanced. Evaluation of options shall not obligate the Government to exercise the option(s).

(c) A written notice of award or acceptance of an offer, mailed or otherwise furnished to the successful offeror within the time for acceptance specified in the offer, shall result in a binding contract without further action by either party. Before the offer's specified expiration time, the Government may accept an offer (or part of an offer), whether or not there are negotiations after its receipt, unless a written notice of withdrawal is received before award.

(End of provision)

(End of Summary of Changes)