Amendment 0004 Language -solicitation changes.pdf

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Pharmaceutical Prime Vendor Global GEN V Solicitation
Solicitation number
SPE2DX-24-R-0001_SOLICITATION
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About this file

This document is an amendment to the Pharmaceutical Prime Vendor Generation V (PPV-G GEN V) Solicitation SPE2DX-24-R-0001 issued by the Defense Logistics Agency Troop Support Medical. The amendment extends the solicitation closing date to May 24, 2024, updates various clauses and contract terms, makes changes to the Statement of Work, and provides additional instructions for offerors. Key changes include revisions to pricing terms, delivery requirements, data reporting, and past performance submission. The amendment also clarifies technical requirements for back-up suppliers, including mandatory minimum coverage levels for day-to-day items. Overall, the amendment provides updates to the solicitation requirements and evaluation criteria.

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Other files

File Type Posted
SPE2DX24R0001 revised by Amendment 0008.pdf PDF
SPE2DX24R0001 AMENDMENT 0008.pdf PDF
SPE2DX24R0001 AMENDMENT 0007.pdf PDF
SPE2DX24R0001 AMENDMENT 0006.pdf PDF
Attachment 9 - NIST SP 800-171 Assessment Summary updated Amendment 0006.xlsx XLSX spreadsheet
SPE2DX24R0001 AMENDMENT 0005.pdf PDF
SPE2DX24R0001 AMENDMENT 0004.pdf PDF
Attachment 6 - PPV-G PVR-WRM Requirements Spreadsheet Updated Amendment 0004.xlsx XLSX spreadsheet
Amendment 0004 Submitted Questions and Answers.pdf PDF
SPE2DX24R0001 Revised by Amendment 0004.pdf PDF
Attachment 2 - PPVG GEN V - Price Proposal Submission Spreadsheet updated Amendment 0004.xlsx XLSX spreadsheet
SPE2DX24R0001 AMENDMENT 0003.pdf PDF
Attachment 3 - PPV-G Specialty Drug List 3.27.24.xlsx XLSX spreadsheet
SPE2DX24R0001 AMENDMENT 0002.pdf PDF
SPE2DX24R0001 AMENDMENT 0001.pdf PDF
Attachment 2 - PPVG GEN V - Price Proposal Submission Spreadsheet.xlsx XLSX spreadsheet
Attachment 8 - NIST SP 800-171 System Security Plan Template.docx DOCX document
Attachment 11 - NIST.SP.800-171(r2) Publication.pdf PDF
Attachment 5 - Preservation Packaging Packing Labeling and Marking PPPLM.pdf PDF
Attachment 6 - PPV-G PVR-WRM Requirements Spreadsheet.xlsx XLSX spreadsheet
Attachment 9 - NIST SP 800-171 Assessment Summary.xlsx XLSX spreadsheet
SPE2DX24R0001 Final 3.13.24.pdf PDF
Attachment 7 - PPV-G Day-to-Day Requirements Spreadsheets.xlsx XLSX spreadsheet
Attachment 1 - PPVG GEN IV 2023 SALES BY NDC.xlsx XLSX spreadsheet
Attachment 10 - NIST SP 800-171 Assessment Methodology.pdf PDF
Attachment 3 - PPV-G Specialty Drug List.xlsx XLSX spreadsheet
Attachment 4 - Discrepancy Report Template.XLSX XLSX spreadsheet
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Below are all changes made to the solicitation as per Amendment 0004. The remaining vendor submitted questions have been addressed in another attachment.

1. The solicitation closing date has been extended to May 24, 2024 03:00PM EST.

2. All page numbers have been revised.

3. Changes from Amendment 0003 have been incorporated into the attached revised solicitation.

4. Page 2 – Table of Contents

FAR 52.229-12 Tax on Certain Foreign Procurements was removed from the table of contents as it is checked on page 212.

5. Page 6 – Product Pricing

The following language was included:

All Prime Vendors (both Primary and Back-up) are expected to negotiate in good faith when engaging in negotiations to establish agreements with national contract holders. The Government is not obligated to become involved in or assume any responsibility for financial or other disputes involving these agreements. Since it is required to have an agreement in place with national contract holders, failure to do so may result in negative information in CPARS, filing of a claim and even termination.

6. Page 11 to 16 – FAR 52.212-5 Contract Terms and Conditions Required to Implement Statutes or Executive Orders – Commercial Items

FAR 52.212-5 Contract Terms and Conditions Required to Implement Statutes or Executive Orders – Commercial Items was revised to FEB 2024 along with the following clause changes:

FAR 52.204-30, Federal Acquisition Supply Chain Act Orders – Prohibition (DEC 2023) (Pub. L. 115-390, title II) with its Alternate I (DEC 2023) of 52.204-30 has been incorporated by reference.

52.219-8, Utilization of Small Business Concerns (FEB 2024) (15 U.S.C. 637 (d)(2) and (3)).

52.222-19, Child Labor—Cooperation with Authorities and Remedies (FEB 2024) (E.O.

13126).

(vii) 52.219-8, Utilization of Small Business Concerns (FEB 2024) (15 U.S.C. 637(d)(2) and (3)), in all subcontracts that offer further subcontracting opportunities. If the subcontract

(except subcontracts to small business concerns) exceeds the applicable threshold specified in FAR 19.702(a) on the date of subcontract award, the subcontractor must include 52.219-8 in lower tier subcontracts that offer subcontracting opportunities.

7. Page 19 - DFARS 252.225-7967 - PROHIBITION REGARDING RUSSIAN FOSSIL FUEL

OPERATIONS

DFARS 252.225-7967 - PROHIBITION REGARDING RUSSIAN FOSSIL FUEL

OPERATIONS was updated to (DEVIATION 2024 O0006, Revision 1) (FEB 2024)

8. Page 20 – FAR 52.216-18 Ordering

Language was revised to reflect 30-month periods rather than 24-month periods.

9. Page 22 – FAR 52.222-19 Child Labor – Cooperation with Authorities and Remedies

FAR 52.222-19 Child Labor – Cooperation with Authorities and Remedies was updated to FEB 2024 with the following revisions:

(2) Mexico, and the anticipated value of the acquisition is $102,280 or more; or

(3) Armenia, Aruba, Australia, Austria, Belgium, Bulgaria, Canada, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hong Kong, Hungary, Iceland, Ireland, Italy, Japan, Korea, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Moldova, Montenegro, Netherlands, New Zealand, North Macedonia, Norway, Poland, Portugal, Romania, Singapore, Slovak Republic, Slovenia, Spain, Sweden, Switzerland, Taiwan, Ukraine, or the United Kingdom and the anticipated value of the acquisition is $174,000 or more.

10. Page 28 – SOW Section 1.A.2. Global Region West and PACOM

Included the following language – Note: The distribution center for servicing OCONUS must be within the CONUS United States (excluding Hawaii and Alaska) within the awarded region.

11. Page 29 – SOW Section 1.A.4. Fleet (CONUS and OCONUS)

Language was revised to the following:

If a ship places a PV order and that ship is not at the home port, and if the Fleet PV delivers product, which is then returned to the PV, the PV can charge the ship a re-stocking fee from the ship’s credit account which must be approved by the Contracting Officer.

12. Page 29 – SOW Section 1.A. Program Overview

Language was revised to the following:

NOTE: All Primary Suppliers must provide a dedicated customer service line staffed 24 hours per day, 7 days a week for all sites, CONUS and OCONUS.

13. Page 38 to 39 – Specialty Items

Changed language to - The PPV is expected to be able to support the NDC’s and the estimated utilization on the Attachment #3 – PPV-G Specialty Drug List.

Changed language to – The PS and BS may also submit items for consideration to the Contracting Officer, with appropriate documentation that the item meets at least four of the specialty characteristics identified above.

Changed language to - The PPV (both PS and BS) may offer a separate distribution fee to account for the ordering of specialty pharmaceuticals on the Government provided list. Each delivery site could have multiple fees for the ordering and delivery of items. The PPV awardee is responsible to maintain the separate catalogues and ensure that the customer orders are filled under the correct fee (Brand/Generic or Specialty).

14. Page 48 – SOW Section 2.G.9. Delivery of Routine Orders

The following language has been added:

The customer shall notify the Prime Vendor if there is a planned based closure (e.g. training event, planned construction, etc.). If the prime vendor attempts delivery during a planned closure without receiving notice 24 hours prior from the customer, the PV may submit a re-delivery fee of $50 from the customer credit account, subject to KO approval.

15. Page 69 – SOW Section 3.E.2.

Language has been amended to: At a minimum the confirmation shall include item identification number (National Drug Code (NDC)/Prime Vendor Order Number (PVON)), quantity to be delivered, unit of issue, price, shelf-life status and delivery order number.”

16. Page 83 – SOW Section 10.C. Quarterly Usage Report

Language has been changed to the following:

Usage Report In order to establish a military readiness posture for all NDCs under this contract, the PPV shall provide, upon request, the average individual monthly usage (based on the quantity of units sold) for both commercial and Government sales. An excel file containing the NDC and quantity shall be provided to the DLA Troop Support PPV Contracting Officer within thirty days of the initial request.

17. Page 85 - SOW Section 11.B.6. Unique Entity ID (UEI)/Dun & Bradstreet (DUNS) Number

Unique Entity ID (UEI)/Dun & Bradstreet (DUNS) Number: The UEI/DUNS number will be used as the Sender and Receiver ID for EDI transactions that are sent between the Prime Vendor and DMLSS/TEWLS/other EDI retail systems. At some point in time during this contract, the GLN may replace the UEI/DUNS for identification of Sender and Receiver IDs. Any changes to the use of UEI/DUNS number will be communicated via modification in the future.

18. Page 108 to 109 - SOW Section 11.C.4. PV Master Catalog Item File (aka File #1)

“Values: Y/Yes, N/No, U/Unknown” has been added to the comments for SOW data element descriptions Product ORIGIN_COUNTRY_CD, API_ORIGIN_COUNTRY_CD, and

FINAL_MFG_COUNTRY_CD.

The following language has been included:

Note: #141 Country of Origin is where the production began. #143 Final-Mfg-Country is where production is finished. These could be the same location. #141, #142, and #143 are all mandatory fields but the option to input Y/Yes, N/No, and/or U/Unknown is included. If data is available, it should be transmitted. Having a product on a government pricing vehicle (FSS, DAPA, etc.) does not change the need for the most current data.

19. Pages 116 through 119 - SOW Section 11.C.9. Distribution Center File (aka File #6)

Velocity Code, DMD_FORECAST_30_DAY, DMD_FORECAST_60_DAY, and CLASS_CODE requirement has been changed from “Mandatory” to “Optional.”

Additional language has been added as follows:

Note: DMD_FORECAST_30_DAY, DMD_FORECAST_60_DAY, Class, and Velocity are all optional fields. At least one of the three fields (1. Velocity code, 2. Class code, or 3.

DMD_FORECAST_30_DAY or DMD_FORECAST_60_DAY) should be included by both the primary and backup suppliers. This field should encompass ALL demand for the item (commercial and government). The intent is to allow the customers to make sourcing decisions based on the overall demand for an item.

20. Page 125 – SOW Section 11.C.12. Product Sourcing Request

Language has been removed.

21. Page 142 – SOW Section 12.A.1. Packing List

Language in fourth paragraph updated to NSN/Part Number/NDC/PVON.

22. Page 143 – SOW Section 12.A.B. Perishable Medical Material

The below language has been added in addition to the PPPL&M attachment:

Vendors utilizing dedicated pharmaceutical tote container systems to move refrigerated and frozen materials via ground courier services (i.e. in-house and/or contracted trucks) in support of locations within the Continental United States (CONUS). The vendor will use one of the following temperature monitoring devices within each container or submit an alternative industry acceptable temperature monitoring device to DLA for approval:

Sensitech:

TagAlert Enhanced: Government Pre-Programmed Part# TBD

Berlinger:

Q-tag Quad: Government Pre-Programmed Part# TBD

Vendors utilizing parcel commercial carriers (i.e. FedEx or UPS) in support of CONUS and/or Domestic locations Outside the Continental United States (i.e. Hawaii and Alaska), will prepare refrigerated and frozen materials utilizing the same stringent cold chain management packaging supplies and protocols that are specified within for the International OCONUS Pharmaceutical Prime Vendor requirements; to include, TempTale®4 Bio (TT4) Temperature Monitors.

23. Page 143 – SOW Section 12.A.B. Perishable Medical Material

Note - Temperature monitors are required for all cold chain shipments CONUS and OCONUS. The Government will allow the PV to phase in the temperature monitors for the first three (3) months after the effective date of the contract. The PV must contact the Contracting Officer and Cold Chain Manager once the temperature monitors are fully implemented.

No other exception was taken to the attachment.

24. Page 152 – SOW Section 13.I.9. Electronic System Requirements

The following language has been removed in paragraph 9:

“…however, the Government reserves the right to require EDI testing to be successfully completed within 30 calendar days after contract award.”

25. Page 155 – SOW Section 15. Drug Supply Chain Security Act

The following language has been updated:

The data shall be made continuously electronically accessible to all ordering facilities within the Pharmaceutical Prime Vendor- Global program and DLA Troop Support Representatives in accordance with DSCSA timeframes both during the duration of the contract and post-contract completion remain accessible to the customers (i.e. via website portal) for six (6) years after completion of the contract.

The following language has been included:

The PV (PS and BS) will maintain DSCSA in a searchable format (“pull method”) for DLA customers for a minimum of six years. DLA customers will have the ability to query the database at any time during the contract terms and at least six years after the contract ends.

The PV (PS and BS) will be able to transmit DSCSA data (“push method”) electronically via the DLA provided portal. Establishing the connections will be completed during implementation.

Note: Global Locator Numbers (GLN) will be assigned by the Government via 838 transaction.

26. Page 165 – FAR 52.212-1 Addendum #2 Solicitation Provisions Preparation and Organization of Proposals

The following language has been changed to:

For an offeror to be considered for an award (for both the Primary Supplier(s) and/or Back- Up Supplier unless otherwise stated) the contractor shall submit ONE (1) electronic copy via DIBBS of the following volumes of documentation at or before the solicitation closing date and time:

Each offeror is required to submit one (1) electronic copy of its technical proposal, which must include Tabs 1(A) through 1(I) as stated below:

27. Page 165 to 166 - Tab 1(E): Proposal Requirements Table

The following language has been removed in paragraph 5:

“… (Note – It is not required for a vendor to provide any additional past performance information).”

Changed Past Performance Requirement #1 to “Offeror provided past performance information.”

28. Page 167 – Past Performance

Changed to - Tab 1(I): The offeror shall provide past performance information for consideration in evaluating past performance in Tab 1(I) of their proposal. (see Addendum #4).

29. Page 168 - FAR 52-212-1 Addendum #3

Under DEMONSTRATION OF CAPABILITY TO MEET PPV-G (GEN V) DAY-TO-DAY REQUIREMENTS FOR BRAND, GENERIC, AND SPECIALTY ITEMS (Applies to Primary Supplier and Back-Up Supplier Line Items)

Changed to - If an offeror is bidding on only the Back-Up Supplier line items, the offeror must certify that it has the capability to successfully or unsuccessfully meet the minimum 80% breadth (number of items) and 10% depth coverage (quantity of each item) for normal day to day PPV-G requirements for each tab/region listed in the spreadsheet provided as attachment #7.

30. Page 172 - FAR 52.212-1 Addendum #4

The offeror shall provide past performance information, as follows, for consideration in evaluating past performance: A list of three (3) government and/or commercial contracts for the same or similar items contracts, performed within the past twenty-four (24) months preceding the closing date of the solicitation.

31. Page 174 – Technical Requirements, Back-Up Supplier Line Items (0009AA through

0010AD)

If a vendor is bidding on ONLY the Back-Up region (line items 0009AA through 00010AD), the offeror must meet a minimum of 80% breadth (number of items) and 10% depth coverage (quantity of each item) for each of the Primary Supplier regions (North/EUCOM, West/PACOM, South/SOUTHCOM, and Fleet) normal day to day PPV- G requirements as indicated in the spreadsheet provided as Attachment #7.

The Government may conduct site visits at the offerors’ distribution centers to verify the offerors capability to meet the 80% breadth and 10% depth for technical requirement #1. If the Government determines that a site visit is required, the offeror will be contacted no earlier than 30 days after the solicitation closing. DLA Troop Support may utilize the E-Z Quant Software Program with a 98% confidence level and 5% error rate to randomly select the number of NDCs to be verified during the site visits for the PPV-G Day-to-Day requirement. A random sampling will be used for the number of unique day-to-day items.

The offeror must meet the 80% breadth and 10% depth requirement to be considered technically acceptable if award is made on initial offers without discussions. If discussions occur, an offeror can become technically acceptable by demonstrating its ability to meet technical requirement #1 during a site visit at its distribution center prior to the request for final proposal revisions.

32. Page 176 – Past Performance

Changed to:

Sources of Past Performance Information for Evaluation are as follows:

• Past performance information shall be provided by the offeror, as solicited.

33. Page 184 - FAR 52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS—

COMMERCIAL ITEMS ALTERNATE I

FAR 52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS—

COMMERCIAL ITEMS ALTERNATE I was revised to FEB 2024 along with the following updates:

On page 186, the language was updated to the following:

Service-disabled veteran-owned small business (SDVOSB) concern mean a small business concern—

(1) (i) Not less than 51 percent of which is owned and controlled by one or more service-disabled veterans or, in the case of any publicly owned business, not less than 51 percent of the stock of which is owned by one or more service-disabled veterans; and

(ii) The management and daily business operations of which are controlled by one or more service-disabled veterans or, in the case of a service-disabled veteran with permanent and severe disability, the spouse or permanent caregiver of such veteran; or

(2) A small business concern eligible under the SDVOSB Program in accordance with 13 CFR part 128 (see subpart 19.14).

(3) Service-disabled veteran, as used in this definition, means a veteran, as defined in 38 U.S.C. 101(2), with a disability that is service-connected, as defined in 38 U.S.C. 101(16), and who is registered in the Beneficiary Identification and Records Locator Subsystem, or successor system that is maintained by the Department of Veterans Affairs’ Veterans Benefits Administration, as a service-disabled veteran.

Service-disabled veteran-owned small business (SDVOSB) concern eligible under the SDVOSB Program means an SDVOSB that–

(1) Effective January 1, 2024, is designated in the System for Award Management (SAM) as certified by the Small Business Administration (SBA) in accordance with 13 CFR 128.300;

or

(2) Has represented that it is a SDVOSB concern in SAM and has submitted a complete application for certification to SBA on or before December 31, 2023.

Service-Disabled Veteran-Owned Small Business (SDVOSB) Program means a program that authorizes contracting officers to limit competition, including award on a sole source basis, to SDVOSB concerns eligible under the SDVOSB Program.

On page 188-189, the language was updated to the following:

(3) SDVOSB concern. [Complete only if the offeror represented itself as a veteran-owned small business concern in paragraph (c)(2) of this provision.] The offeror represents as part of its offer that it □ is, □ is not an SDVOSB concern.

(4) SDVOSB concern joint venture eligible under the SDVOSB Program. The offeror represents that it □ is, □ is not an SDVOSB joint venture eligible under the SDVOSB Program that complies with the requirements of 13 CFR 128.402. Complete only if the offeror represented itself as a veteran-owned small business concern in paragraph (c)(2) of this provision.} [The offer shall enter the name unique entity identifier of each party to the joint venture:___________.]

34. Page 203 - DFARS 252.225-7966 - PROHIBITION REGARDING RUSSIAN FOSSIL

FUEL BUSINESS OPERATIONS – REPRESENTATION

DFARS 252.225-7966 - PROHIBITION REGARDING RUSSIAN FOSSIL FUEL

BUSINESS OPERATIONS – REPRESENTATION was updated to DFARS 252.225-7966 -

PROHIBITION REGARDING RUSSIAN FOSSIL FUEL BUSINESS OPERATIONS –

REPRESENTATION (DEVIATION 2024-O0006, Revision 1) (MAR 2024)

(a) Definitions. The terms business operations and fossil fuel company have the meanings given in the 252.225-7967 clause of this solicitation.

35. Page 207 - Incorporate FAR 52.204-29 Federal Acquisition Supply Chain Security Act Orders—Representation and Disclosures as follows:

Federal Acquisition Supply Chain Security Act Orders—Representation and Disclosures (Dec 2023)

(a) Definitions. As used in this provision, Covered article, FASCSA order, Intelligence community, National security system, Reasonable inquiry, Sensitive compartmented information, Sensitive compartmented information system, and Source have the meaning provided in the clause 52.204-30, Federal Acquisition Supply Chain Security Act Orders— Prohibition.

(b) Prohibition. Contractors are prohibited from providing or using as part of the performance of the contract any covered article, or any products or services produced or provided by a source, if the prohibition is set out in an applicable Federal Acquisition Supply Chain

Security Act (FASCSA) order, as described in paragraph (b)(1) of FAR 52.204-30, Federal Acquisition Supply Chain Security Act Orders—Prohibition.

(c) Procedures. (1) The Offeror shall search for the phrase “FASCSA order” in the System for Award Management (SAM)( https://www.sam.gov) for any covered article, or any products or services produced or provided by a source, if there is an applicable FASCSA order described in paragraph (b)(1) of FAR 52.204-30, Federal Acquisition Supply Chain Security Act Orders—Prohibition.

(2) The Offeror shall review the solicitation for any FASCSA orders that are not in SAM, but are effective and do apply to the solicitation and resultant contract (see FAR 4.2303(c)(2)).

(3) FASCSA orders issued after the date of solicitation do not apply unless added by an amendment to the solicitation.

(d) Representation. By submission of this offer, the offeror represents that it has conducted a reasonable inquiry, and that the offeror does not propose to provide or use in response to this solicitation any covered article, or any products or services produced or provided by a source, if the covered article or the source is prohibited by an applicable FASCSA order in effect on the date the solicitation was issued, except as waived by the solicitation, or as disclosed in paragraph (e).

(e) Disclosures. The purpose for this disclosure is so the Government may decide whether to issue a waiver. For any covered article, or any products or services produced or provided by a source, if the covered article or the source is subject to an applicable FASCSA order, and the Offeror is unable to represent compliance, then the Offeror shall provide the following information as part of the offer:

(1) Name of the product or service provided to the Government;

(2) Name of the covered article or source subject to a FASCSA order;

(3) If applicable, name of the vendor, including the Commercial and Government Entity code and unique entity identifier (if known), that supplied the covered article or the product or service to the Offeror;

(4) Brand;

(5) Model number (original equipment manufacturer number, manufacturer part number, or wholesaler number);

(6) Item description;

(7) Reason why the applicable covered article or the product or service is being provided or used;

(f) Executive agency review of disclosures. The contracting officer will review disclosures provided in paragraph (e) to determine if any waiver may be sought. A contracting officer may choose not to pursue a waiver for covered articles or sources otherwise subject to a FASCSA order and may instead make an award to an offeror that does not require a waiver.

36. Page 209 – FAR 52.233-2 Service of Protest

The contracting officer’s email has been corrected to lorinda.ferraiolo@dla.mil.

37. Page 213 to 214, the language was updated to the following:

DFARS 252.225-7021, Trade Agreements (FEB 2024) _____Alternate II (FEB 2024) of 252.225-7021 _____Alternate III (FEB 2024) of 252.225-7021 _____Alternate IV (FEB 2024) of 252.225-7021

38. Page 216 – Attachments

Attachment 2 – PPV-G GEN V – Price Proposal Submission Spreadsheet has been corrected and attached.

Attachment 6 – PPV-G PVR/WRM Requirements Spreadsheet has been updated and attached.

mailto:lorinda.ferraiolo@dla.mil

Language was revised to the following:
If a ship places a PV order and that ship is not at the home port, and if the Fleet PV delivers product, which is then returned to the PV, the PV can charge the ship a re-stocking fee from the ship’s credit account which must be approved by the Contra...
Language has been changed to the following: Usage Report
Unique Entity ID (UEI)/Dun & Bradstreet (DUNS) Number: The UEI/DUNS number will be used as the Sender and Receiver ID for EDI transactions that are sent between the Prime Vendor and DMLSS/TEWLS/other EDI retail systems. At some point in time during t...
Changed to - Tab 1(I): The offeror shall provide past performance information for consideration in evaluating past performance in Tab 1(I) of their proposal. (see Addendum #4).
Past performance information shall be provided by the offeror, as solicited.

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