36E79720R0009-005.docx
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- Sterile Bandage Rolls Federal contract opportunity
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- 36E79720R0009
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36E79720R0009 Page
1 OF
1. REQUISITION NO.
2. CONTRACT NO.
3. AWARD/EFFECTIVE DATE
4. ORDER NO.
5. SOLICITATION NUMBER
6. SOLICITATION ISSUE DATE
a. NAME
b. TELEPHONE NO. (No Collect Calls)
8. OFFER DUE DATE/LOCAL
TIME
9. ISSUED BY
CODE
10. THIS ACQUISITION IS
UNRESTRICTED OR
SET ASIDE:
% FOR:
SMALL BUSINESS
HUBZONE SMALL
BUSINESS
SERVICE-DISABLED
VETERAN-OWNED
SMALL BUSINESS
WOMEN-OWNED SMALL BUSINESS
(WOSB) ELIGIBLE UNDER THE WOMEN-OWNED
SMALL BUSINESS PROGRAM
EDWOSB
8(A)
NAICS:
SIZE STANDARD:
11. DELIVERY FOR FOB DESTINA-
TION UNLESS BLOCK IS
MARKED
SEE SCHEDULE
12. DISCOUNT TERMS
13a. THIS CONTRACT IS A
RATED ORDER UNDER
DPAS (15 CFR 700)
13b. RATING
14. METHOD OF SOLICITATION
RFQ
IFB
RFP
15. DELIVER TO
CODE
16. ADMINISTERED BY
CODE
17a. CONTRACTOR/OFFEROR
CODE
FACILITY CODE
18a. PAYMENT WILL BE MADE BY
CODE
TELEPHONE NO.
DUNS:
DUNS+4:
PHONE:
FAX:
17b. CHECK IF REMITTANCE IS DIFFERENT AND PUT SUCH ADDRESS IN OFFER 18b. SUBMIT INVOICES TO ADDRESS SHOWN IN BLOCK 18a UNLESS BLOCK BELOW IS CHECKED
SEE ADDENDUM
19.
20.
21.
22.
23.
24.
ITEM NO.
SCHEDULE OF SUPPLIES/SERVICES
QUANTITY
UNIT
UNIT PRICE
AMOUNT
(Use Reverse and/or Attach Additional Sheets as Necessary)
25. ACCOUNTING AND APPROPRIATION DATA
26. TOTAL AWARD AMOUNT (For Govt. Use Only) 27a. SOLICITATION INCORPORATES BY REFERENCE FAR 52.212-1, 52.212-4. FAR 52.212-3 AND 52.212-5 ARE ATTACHED. ADDENDA
ARE
ARE NOT ATTACHED.
27b. CONTRACT/PURCHASE ORDER INCORPORATES BY REFERENCE FAR 52.212-4. FAR 52.212-5 IS ATTACHED. ADDENDA
ARE
ARE NOT ATTACHED
28. CONTRACTOR IS REQUIRED TO SIGN THIS DOCUMENT AND RETURN _______________
29. AWARD OF CONTRACT: REF. ___________________________________ OFFER
COPIES TO ISSUING OFFICE. CONTRACTOR AGREES TO FURNISH AND
DATED ________________________________. YOUR OFFER ON SOLICITATION
DELIVER ALL ITEMS SET FORTH OR OTHERWISE IDENTIFIED ABOVE AND ON ANY
(BLOCK 5), INCLUDING ANY ADDITIONS OR CHANGES WHICH ARE
ADDITIONAL SHEETS SUBJECT TO THE TERMS AND CONDITIONS SPECIFIED
SET FORTH HEREIN IS ACCEPTED AS TO ITEMS:
30a. SIGNATURE OF OFFEROR/CONTRACTOR 31a. UNITED STATES OF AMERICA (SIGNATURE OF CONTRACTING OFFICER) 30b. NAME AND TITLE OF SIGNER (TYPE OR PRINT) 30c. DATE SIGNED 31b. NAME OF CONTRACTING OFFICER (TYPE OR PRINT) 31c. DATE SIGNED
AUTHORIZED FOR LOCAL REPRODUCTION
(REV. 2/2012)
PREVIOUS EDITION IS NOT USABLE
Prescribed by GSA - FAR (48 CFR) 53.212
7. FOR SOLICITATION
INFORMATION CALL:
STANDARD FORM 1449
OFFEROR TO COMPLETE BLOCKS 12, 17, 23, 24, & 30
SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL ITEMS
36E79720R0009 01/15/2020 Teresa Hussain teresa.hussain@va.gov 708-786-5852 01/28/2020
2:30 PM CT
Department of Veterans Affairs OPAL / National Acquisition Center Building 37, NCS (003B6C3) 1st Avenue, One Block North of Cermak Hines IL 60141 X Y 339113 750 Employees N/A N/A X VA Pharmaceutical Prime Vendor Refer to Attachment A, located in Section D.
Department of Veterans Affairs OPAL / National Acquisition Center Building 37, NCS (003B6C3) 1st Avenue, One Block North of Cermak Hines IL 60141
VA Pharmaceutical Prime Vendor Refer to Attachment A, located in Section D.
See CONTINUATION Page Sterile Bandage Roll One award will be made for line item 1:
Bandage Roll: sterile, single-use, 4.5in x 144-149 inches 100% woven cotton, prewashed, fluff dried gauze roll. 6-ply, latex free, hypoallergenic. Individually wrapped soft packaging.
To be considered for award, offerors must submit a price for the base year and all four one-year options.
Prices offered shall not exceed two decimal places.
Offered prices must include the Cost Recovery Fee of 0.5%, as outlined in Scope of Contract. Offerors must list a 12-digit GTIN or UPC number for offered item that is unique to the offeror or manufacturer as outlined in the scope of contract.
See CONTINUATION Page X X 1 scan
To be considered for award, offerors must submit a price for line item 1 for the base year and all four option years. One award will be made for the base years and all four options. Offered prices shall not exceed two decimal places. Preference will be given to VetBiz certified SDVOSB/VOSB firms if the price offered by the qualified SDVOSB/VOSB firm is not more than 5/3% higher than the otherwise lowest, responsive and responsible offeror. Note that the preference is based upon the offeror’s socioeconomic status; the business size of the manufacturer (if offeror is not manufacturer) will not be relevant for this preference.
Line Item 1
Bandage Roll: sterile, single-use, 100% woven cotton prewashed, fluff dried gauze roll. 6-ply, latex free, hypoallergenic. Individually wrapped soft packaging;
Size: 4.5in x 144-149in
GTIN # __________________
UPC#_________________
Contract Period Est. Qty. Unit Unit Price Total Price
Base Year 163,166 Rolls $_________ $__________ Option Year One 163,166 Rolls $_________ $__________ Option Year Two 163,166 Rolls $_________ $__________ Option Year Three 163,166 Rolls $_________ $__________ Option Year Four 163,166 Rolls $_________ $__________
Product Sample. Offerors shall provide one sample (one roll) for line item proposed, of the sterile bandage rolls that would be used to fulfill the requirements of this solicitation. Samples will be used to evaluate compliance with the salient characteristics listed above in Line Item 1 and in Attachment B and will not be returned. (See FAR Clause 52.212-1(d)) The samples must be submitted by the due date for offers. Any offer whose proposed sample fails to meet the minimum requirements shall be rejected and shall receive no further consideration. Any sample arriving after solicitation close deadline or sample not meeting specifications will result in rejection of offer.
Table of Contents
| SECTION A | 1 |
| A.1 SF 1449 SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL ITEMS | 1 |
| SECTION B - CONTINUATION OF SF 1449 BLOCKS | 5 |
| CONTINUATION OF STANDARD FORM 1449: SCHEDULE OF SUPPLIES/SERVICES | 5 |
| SCOPE OF CONTRACT | 6 |
| SECTION C - CONTRACT CLAUSES | 14 |
| C.1 52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL ITEMS (OCT 2018) | 14 |
| ADDENDUM to FAR 52.212-4 CONTRACT TERMS AND CONDITIONS--COMMERCIAL ITEMS | 19 |
| C.2 52.216-21 REQUIREMENTS (OCT 1995) | 20 |
| ADDENDUM to FAR 52.216-21 REQUIREMENTS | 21 |
| C.3 52.217-9 OPTION TO EXTEND THE TERM OF THE CONTRACT (MAR 2000) | 21 |
| C.4 52.204-13 SYSTEM FOR AWARD MANAGEMENT MAINTENANCE (OCT 2018) | 22 |
| C.5 VAAR 852.219-76 SUBCONTRACTING COMMITMENTS MONITORING AND COMPLIANCE (JUL 2018) | 24 |
| C.6 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998) | 24 |
| C.7 VAAR 852.219-9 VA SMALL BUSINESS SUBCONTRACTING PLAN MINIMUM REQUIREMENTS (JUL 2018) | 25 |
| C.8 VAAR 852.203-70 COMMERCIAL ADVERTISING (MAY 2018) | 25 |
| C.9 52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT STATUTES OR EXECUTIVE ORDERS--COMMERCIAL ITEMS (OCT 2019) | 25 |
| C.10 MANDATORY WRITTEN DISCLOSURES | 33 |
| SECTION D - CONTRACT DOCUMENTS, EXHIBITS, OR ATTACHMENTS | 34 |
| D.1 ATTACHMENT “A” | 34 |
| D.2 ATTACHMENT “B” | 35 |
| D.2 ATTACHMENT “C” | 36 |
| SECTION E - SOLICITATION PROVISIONS | 44 |
| E.1 52.212-1 INSTRUCTIONS TO OFFERORS--COMMERCIAL ITEMS (AUG 2018) | 44 |
| ADDENDUM to FAR 52.212-1 INSTRUCTIONS TO OFFERORS --COMMERCIAL ITEMS | 47 |
| E.2 52.204-7 SYSTEM FOR AWARD MANAGEMENT (OCT 2018) | 50 |
| E.3 52.209-7 INFORMATION REGARDING RESPONSIBILITY MATTERS (JUL 2013) | 51 |
| E.4 52.214-34 SUBMISSION OF OFFERS IN THE ENGLISH LANGUAGE (APR 1991) | 52 |
| E.5 52.214-35 SUBMISSION OF OFFERS IN U.S. CURRENCY (APR 1991) | 52 |
| E.6 52.216-1 TYPE OF CONTRACT (APR 1984) | 52 |
| E.7 52.233-2 SERVICE OF PROTEST (SEP 2006) | 53 |
| E.8 VAAR 852.233-70 PROTEST CONTENT/ALTERNATIVE DISPUTE RESOLUTION (JAN 2008) | 53 |
| E.9 VAAR 852.233-71 ALTERNATE PROTEST PROCEDURE (JAN 1998) | 53 |
| E.10 52.212-2 EVALUATION—COMMERCIAL ITEMS (OCT 2014) | 54 |
| E.11 52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS--COMMERCIAL ITEMS (DEC 2019) | 55 |
SECTION B - CONTINUATION OF SF 1449 BLOCKS
CONTINUATION OF STANDARD FORM 1449: SCHEDULE OF SUPPLIES/SERVICES
Please be advised the following are included in the solicitation and are highlighted here.
Proposals may be delivered to Department of Veterans Affairs, National Acquisition Center, National Contract Service (003B6C3), 1st Avenue, 1 Block North of Cermak Road, Building 37, Hines, IL 60141. Proposals will also be accepted in Microsoft Word or PDF form via e-mail at TeresaHussain@va.gov with a scanned (pdf) copy of the signed SF1449. Offerors are not required to submit an original proposal if an electronic proposal was received. Please note that faxed proposals are not acceptable and will be rejected. Reference FAR 52.212-1(f) regarding timeliness of submission of offers.
If the offeror is not the manufacturer of the offered items, the offeror shall submit a letter of commitment from the manufacturer to the offeror which will assure the offeror of a source of supply sufficient to satisfy the Government's requirements for the contract period. “Manufacturer” is defined as the entity that produces the product. This requirement shall be met before contract award. Offers that fail to submit a letter of commitment before contract award shall be rejected and shall receive no further consideration. (See Addendum 52.212-1 – Instruction to Offerors).
One award will be made for line item one for the base year, and all four option years. To be considered for award, offerors must propose a price for the base year and each option year. Proposals that fail to include a price for the base year and each of the four option years for line item one may be rejected and receive no further consideration.
(Refer to Schedule of Supplies for package size details and estimates)
Offered prices shall include a 0.50% Cost Recovery Fee (Scope of Contract, paragraph 12).
The Government will evaluate offers in accordance with the policies and procedures of the Federal Acquisition Regulation (FAR) Part 25. The Government will only consider offers of U.S.-made end products or designated country end-products, unless no offers for such products are received or are insufficient to fulfill the requirements.
Acknowledgement of Amendments. The following amendments are acknowledged as part of this solicitation. (Please complete if applicable)
| Amendment Number |
| Date Acknowledged by Offeror |
The System for Award Management (SAM) is an online system that replaces CCR/FedReg, ORCA, and EPLS. Contractors should now go to www.sam.gov to find their information. Training tools are available on the SAM website at www.sam.gov for familiarization with the SAM system. Prospective contractors shall maintain a current and accurate record in the SAM database. SAM updates are required, as necessary, but at least annually.
Subcontracting Plan Requirements: Pursuant to the requirements of 15U.S.C.644, all large business concerns are required to have an approved subcontracting plan for contracts valued over $700,000 before the Government can award a contract (see FAR 52.219-9 for details). Offerors must submit a currently approved commercial plan or a new plan for review and approval. Attachment “D” includes all of the elements required to be addressed and is included to facilitate the submission of a subcontracting plan. Note: The dollar value of $150,000 provided in paragraph (d)(11)(iii) of 52.219-9 which is incorporated by reference at 52.212-5(b)(17)(iii)] is revised to $250,000 in accordance with VA Class Deviation dated March 22, 2018.
As prescribed in FAR Part 42.15, VA evaluates contractor performance on all contracts that exceed the Simplified Acquisition Threshold, which was raised to $250,000, by a VA Class Deviation dated March 22, 2018, and shares those evaluations with other federal government agencies. The FAR requires that the contractor be provided an opportunity to comment on past performance evaluations prior to each report closing. To fulfill this requirement, VA will be using an online database, the Contractor Performance Assessment Reporting System (CPARS). Annual reporting of past performance will be completed at http://www.cpars.gov and uploaded to PPIRS (Past Performance Information Retrieval System).
SCOPE OF CONTRACT
1. INTRODUCTION
1.1 Background. All Ordering Activities under the VA acquire their pharmaceutical requirements through the Pharmaceutical Prime Vendor Program (PPV). The PPV Program is a separate contract which establish the fees for the distribution of pharmaceutical and some medical surgical products that are distributed through the PPV Program on Federal Government (i.e., Federal Supply Schedules, National Standardization) contracts. A contract resulting from this solicitation establishes the VA National Contract prices for the products listed in the schedule of supplies that will be distributed through the PPV Program for VA Pharmacy Personnel to order Medical/Surgical (Med/Surg) items through the PPV. Section 2.1, “Government Participants” lists the PPV Program participants that will be authorized users of the contract resulting from this solicitation.
1.2 Purpose and Objectives. The purpose of this solicitation is to establish a supply source that will provide the items listed in the schedule for purchase through the PPV Program. The total annual estimated usage for VA Pharmacy Personnel appears on the Schedule of Supplies section of this Solicitation. The objective of such a contract is to ensure availability and consistency of product for nationwide usage and to obtain volume-based, committed use pricing.
1.3 Government Purchase Compliance. VA Pharmacy Personnel will purchase their requirements for the medical item listed in the schedule through the PPV Program except when: (1) the contracted items are unavailable to meet the needs of the Government, or (2) an alternate is requested by the prescribing healthcare provider. If 1 or 2 applies, these instances will be considered exceptions to section C.3 – 52.216-21, Requirements. VA’s PPV contract has ordering lock-out procedures in place to support VA contract compliance and to prevent purchases of non-contract products.
1.4 Contract Effective Date. The contract will be effective on the date the Contracting Officer signs the SF1449 and notifies the contractor of award. The first 60 days of the contract period (or a shorter time period, if mutually agreed between the contractor and Government) will be an implementation period when the PPVs begin placing orders with the contractor for delivery to multiple PPV distribution centers. Orders placed with the PPV by Government participants will begin shipping under this contract upon the expiration of the 60-day implementation period. There are approximately 31 VA PPV Distribution Centers located nationwide. The contractor shall ensure that sufficient inventory of contract items awarded under this solicitation is available, and that chargeback agreements with the PPV have been executed with sufficient time to permit the PPV to begin timely distribution of Government orders by the expiration of the contract implementation period. The current PPV is listed as attachment “A” of this solicitation. The current PPV may change and the contractor will be notified of any changes to the PPV contractor during the term of the contract resulting from this solicitation. Payment terms, time and place of delivery to PPV distribution centers and other business-to-business agreement terms shall be agreed upon between the PPV contractor and the contractor awarded a contract from this solicitation. Within 15 days from receipt of award, the Contracting Officer shall be notified by the contractor if any business-to-business-agreements cannot be reached with the PPV. Failure or refusal to reach agreement with the PPV shall constitute sufficient cause for terminating the contract under Federal Acquisition Regulation Part 52.212-4(m), Contract Terms and Conditions-Commercial Items, Termination for Cause.
1.5 Contract Duration. The contract(s) resulting hereunder will be in effect for one (1) year with four (4) one-year pre-priced option periods that may be exercised unilaterally by the Government in accordance with FAR 17.207 and FAR 52.217-9.
1.6 Special Contract Considerations. As discussed in Section 1.2, this solicitation establishes a supply source to provide the products listed in the schedule for purchase through the PPV program. Additionally, as outlined in Section 1.4, the awarded contractor under this solicitation must reach a business-to-business agreement with the PPV. Because the PPV distributes the supplies sourced from this solicitation, special contract considerations apply. Under this resulting contract, the contractor will be receiving payments from the PPV instead of directly from the Government. Due to this unique payment structure, contractors are not permitted to assign their rights to receive payment under this contract. Additionally, disputes arising between a Contractor and any authorized Government Prime Vendor does not give rise to a “claim” under the Disputes Clause. Finally, no invoices will be provided from the Contractor to the Government ordering facilities. Instead, the contractor shall submit invoices in accordance with the business-to-business agreements reached with the PPV.
2. EXTENT OF OBLIGATION
2.1 Government Participants. The contractor shall provide the products specified in the schedule at the prices awarded herein for all VA Pharmacy Personnel at all VA facilities.
A database of all facilities authorized to use the VA PPV Program may be downloaded from the National Acquisition Center’s web site at http://www.va.gov/oal/business/nc/ppv.asp.
2.2 Product Samples. Offerors shall provide one sample (individual roll) for line item proposed, that is a true representation of the sterile bandages that would be used to fulfill the requirements of this solicitation. Samples will be used to evaluate compliance with the salient characteristics listed on pages 1 & 2 of the Schedule of Supplies of this RFP and in Attachment B and will not be returned. (See FAR Clause 52.212-1(d)) The samples must be submitted by the due date for offers. The samples shall be delivered to National Acquisition Center, National Contract Service (003B6C3), 1st Avenue, 1 Block North of Cermak Road, Building 37, Hines, IL 60141. Any offer whose proposed samples fail to meet the minimum requirements shall be rejected and shall receive no further consideration.
2.3 Estimated Quantities. The quantities in the schedule reflect the usage of all VA Pharmacy Personnel currently participating in the PPV Program. These estimated annual requirements do not include those of any other Government agency, including those currently participating in the VA PPV Program (e.g. Indian Health Service, Bureau of Prisons, Immigration and Customs Enforcement, Option 1 & 2 State Veteran’s Homes). The estimated usage cited in the Schedule is the Government’s total estimated usage for the sizes listed. There is no expressed or implied guarantee that the estimated quantity will be purchased under this contract. Actual quantities purchased may exceed or be less than those represented.
3. Product Requirements/Product Registration: The offeror must certify that it has on file (if any of the following are required by FDA for the offered products) an FDA 501k registration.
4. NATIONAL CONTRACT ITEM BACKORDERS
A contract awarded under this solicitation will be the primary source of supply for the Pharmacy Department of the VA (see FAR 52.216-21 Requirements). The Government’s ability to provide quality healthcare to its patient population is severely impaired when a national contract product is not available due to backorders. The purpose of this paragraph is to provide guidance to the awarded contractor regarding a temporary solution to national contract item backorders that may be implemented in lieu of the Government terminating the contract for cause. However, consideration of this paragraph shall not waive any of the Government’s rights to terminate the contract for cause in accordance with FAR 52.212-4(m).
For purposes of this contract, a backorder occurs when the PPV issues an order with the contractor awarded a contract for the products in this solicitation, and the complete order quantity is not delivered to the PPVs within 15 days after receipt of order. If a national contract item is backordered by the PPVs, the VA National Acquisition Center (VANAC) contracting officer will investigate the backorder to determine if the national contract contractor bears responsibility for the backorder. The awarded contractor shall inform the VANAC contracting officer within 4 calendar days after a backorder occurs. In addition to informing the contracting officer of the backorder, the contractor shall provide an estimated date when the backorder will be shipped and may propose a solution to satisfy the Government’s needs for the contract items until the backorder is resolved. The Government reserves the right to accept or reject any possible solutions that the contractor may propose to alleviate a national contract backorder situation. If the contracting officer determines that the contractor bears responsibility for the backorder, and the contractor is not able to provide a solution that is acceptable to the Government, (i.e., acceptable solution to the backorder, in lieu of Termination for Cause), the parties agree that the Government may buy against the contractor by acquiring the same or similar items from another source and billing the contractor for any excess procurement costs. In other words, if the government must purchase product from another vendor because of a national contract backorder, the contractor will issue credit or reimburse the Government for the difference between the purchase price and the contract price within 30 calendar days after receipt of notification. The contractor shall also provide written verification to the Contracting Officer when credits or reimbursement have been made within 30 calendar days from date of reimbursement. After a backorder incident occurs for which the Contractor is responsible, the Government’s decision to enter into a buy-against agreement described above will not deprive the Government of its right under Clause 52.212-4 (m) to terminate the contract for a breach of the buy-against agreement, for a subsequent contractor-caused backorder, or for any other sufficient cause.
5. PACKAGING REQUIREMENTS
Offerors must state the exact name of the product being supplied as it will appear on the label. Offerors shall also provide a unique 12-digit GTIN or UPC number for all items offered; the GTIN number must be specific to the offering company or the manufacturer for the item being supplied. Items are identified in the Schedule of Supplies and in Attachment B.
6. BAR CODING
All pharmaceutical products provided under this contract shall include bar code labeling at the unit-of-use package level. The bar code labeling must be in a linear format that conforms to all GS1-128 (formerly EAN.UCC) or Health Industry Business Communication Council (HIBCC) Health Industry Bar Code (HIBC) supplier labeling standards. The bar code symbology must comply with all GSI or HIBCC parameters including, but not limited to: symbology type or encoded pattern, bar and space dimensions and tolerances, and allowable ratio of wide to narrow elements.
The bar code may be any linear bar code symbology such as GS1-128 (formerly EAN.UCC), GS1 DataBar (formerly RSS), or Universal Product Code (if the UPC contains the National Drug Code or NDC). The bar code must encode the NDC, either alone or within the GS1 data structure (Global Trade Item Number (GTIN)).
The bar code printing must be American National Standards Institute (ANSI)/International Organization for Standardization (ISO)/IEC Quality Grade C or better. Manufacturers and packagers must ensure that production runs include an initial verification check, as well as routine audits to ensure the bar code is printed clearly and consistently to meet the quality standard of Grade C or better. Contractors shall be responsible for ensuring that bar code labels meet the quality requirements specified in this paragraph prior to shipping pharmaceutical products to any Government Prime Vendor under this contract.
The bar code must be on the outside container or wrapper of the medication as well as on the immediate container, unless the bar code is readily visible and machine-readable through the outside container or wrapper. When the bar code is not easily machine-readable through the over wrap, the over wrap must contain the bar code.
If applicable, the bar code must go on each cell of a blister pack. Furthermore, the bar code must remain intact under normal conditions of use; thus it should not be printed across the perforations of a blister pack.
When applicable to the symbology used, bar codes shall be surrounded by sufficient quiet zone so that the bar code can be scanned correctly. Bar code placement shall minimize curvature of the bar code. For example, bar codes should be placed in “ladder orientation” on vials or bottles to minimize curvature of the bar code. Bar code labeling shall not be placed solely on outer packaging. A human readable number must be placed adjacent (preferably below) the encoded bar code to ensure product is usable with VA Bar Code medication Administration (BCMA) in the event the bar code is in some way damaged.
It is recommended that bar code labeling also include the lot number and expiration date. If two separate distinctive bar codes are used, one for NDC and the other for lot number/expiration date; the lot number and expiration date bar code must not be in close proximity to the NDC barcode or in a format that may be confused with the NDC bar code. When applicable, all Healthcare Distribution Management Association (HDMA) guidelines shall be followed.
7. GLOBAL TRADE ITEM NUMBER / UNIVERSAL PRODUCT CODES
Offerors shall provide a unique 12-digit GTIN or UPC number for all items offered; the GTIN number must be specific to the offering company or the manufacturer for the item being supplied for each product proposed, in the space provided following each item in block 20 of the SF1449, “Schedule of Supplies and Prices” of the solicitation. Offers that fail to provide the information required by this paragraph by the solicitation closing date may be rejected and receive no further consideration.
8. FDA APPROVAL
All offerors shall submit their FDA 501K approval letter for the product proposed https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm. The offeror must certify that it has on file (if any of the following are required by FDA for the offered products) an FDA 501k registration.
9. RECALLS
If a product recall is initiated for any product provided under this contract, regardless of whether it is a voluntary recall by the manufacturer or a recall required by the U.S. Food and Drug Administration (FDA); the contractor shall immediately forward two copies of the recall notification along with any pertinent information to:
Chief, Pharmaceutical Division (003B6C3) VA National Acquisition Center National Contract Service 1st Ave., 1 Block North of Cermak Rd., Bldg. 37 P.O. Box 76, Hines, IL 60141 Fax Number (708) 786-5256
Deputy Chief Consultant (M/S119D) VHA Pharmacy Benefits Management Services 1st Ave., 1 Block North of Cermak Rd., Bldg. 37, Rm 139 Hines, IL 60141 Fax Number (708) 786-7894
Manager, Product Recall Office National Center for Patient Safety Veterans Health Administration 24 Frank Lloyd Wright Drive, Lobby M Ann Arbor, MI 48106 VHANCPSRecallsNotification@va.gov Phone Number: (734) 930-5865
All Government Prime Vendors that were sent shipments of the affected product(s).
10. COST RECOVERY FEE AND SUBMISSION OF QUARTERLY SALES REPORTS
(a) Quarterly Sales Reports. The Contractor shall report all contract sales under this contract and submit collected Cost Recovery Fees as follows:
(1) The Contractor shall accurately report the dollar value, in U.S. dollars and rounded to the nearest whole dollar, of all sales made under this contract by calendar quarter (January 1–March 31, April 1–June 30, July 1–September 30, and October 1–December 31). Reported sales must include all sales made to all authorized contract users, whether shipped directly to the users or through Prime Vendor contractors. The report shall reflect sales by contract line item and shall segment sales by the Department of Veterans Affairs (VA) and Other Government Agencies (OGA). A Cost Recovery Fee equivalent to 0.5 % of the current contract price shall be collected from all contract users. The 0.5 % Cost Recovery Fee shall be imbedded in the awarded contract prices and offers submitted in response to this solicitation shall include the Cost Recovery Fee in every line item price offered. The reported contract sales shall include the cost recovery fee and each quarterly report shall show the total cost recovery fee amount collected on the reported sales. The Contractor shall maintain a consistent accounting method of sales reporting, based on the Contractor’s established commercial accounting practice.
(2) Contract sales reports are due to the VA contracting officer within 60 calendar days following the completion of each reporting quarter or completion of the contract, whichever occurs first. A report is required even when no billings or invoices are issued or no orders are received during the contract period.
(3) The sales report signed by an authorized representative of the contractor shall be sent by mail to the address listed below, to the Contracting Officer’s email, or facsimile to the contracting officer. Facsimile transmissions may be made to: (708) 786-5256.
Department of Veterans Affairs National Acquisition Center (003B6C3) P.O. Box 76 First Avenue, 1 Block North of Cermak, Bldg. 37 Hines, IL 60141
(4) In addition to the submission of quarterly sales reports due to the contracting officer within 60 days after the end of each reporting quarter, contractors shall provide copies of sales reports simultaneously with contractor’s cost recovery fee payment submissions via facsimile, to the attention of C.R. Agent Cashier, fax: (708) 786-7525 or email: AMMHINBOCFISCAL@VA.GOV
(b) Cost Recovery Fee. The 0.5 % Cost Recovery Fee amount collected and due shall be paid either electronically or by check and shall be addressed to the “Department of Veterans Affairs”. When the Contractor has multiple national contracts, the fee may be consolidated into one check. Consolidated payments for multiple contracts shall identify each contract number included, dollar amount remitted for each contract number, and reporting quarter.
To ensure that the payment is credited properly, the contractor shall identify the check or electronic transmission as a “Cost Recovery Fee” and include a copy of the applicable Sales Report. The Cost Recovery Fee payment is due to the Fiscal Division at the same time the sales report is due to the contracting officer, i.e., within 60 calendar days following the completion of each reporting quarter or completion of the contract.
Cost Recovery Fee payments shall not be combined with any Industrial Fund Fee payments. Contractors shall remit separately any Industrial Fund Fee payments in support of any of the Contractor’s Federal Supply Schedule contracts.
Cost recovery fee payments made electronically shall include the following information:
| Receiving Bank Name: Department of Treasury |
| Receiving Bank Contact: Cash Link ACH Receiver |
| Contact Phone: 301/887-6600 |
| Receiving Bank City, State: Richmond, Virginia |
| Receiving Bank Routing/Transit Number: 051036706 |
| Receiving Bank Capability: CCD+ |
| Receiving Account Number: 220020 |
| 820 ACH Format used by Receiving Bank: Standard |
Contract Number(s): (Contractor shall insert the contract number, which will be assigned by the VA contracting officer at time of award.)
Cost recovery fee payments made in check form shall be made to the attention of “Department of Veterans Affairs” and mailed to the following address:
| Fiscal Division (901A) |
| Attn: C.R. Agent Cashier |
| P.O. Box 7005 |
| Hines, IL 60141 |
(c) The Government reserves the right to inspect without further notice, such records of the Contractor as pertain to sales under any contract resulting from this solicitation. Willful failure or refusal to furnish the required reports, or falsification thereof, shall constitute sufficient cause for terminating the contract under FAR 52.212-4(m), Contract Terms and Conditions - Commercial Items, Termination for Cause.
(d) Failure to remit the full amount of the Cost Recovery Fee within 60 calendar days after the end of the applicable reporting period constitutes a contract debt to the United States Government under the terms of (FAR) 32.6. The Government may exercise all rights under the Debt Collection Improvement Act of 1996, including withholding or setting off payments and interest on the debt (see FAR clause 52.232-17, Interest). Should the Contractor fail to submit the required sales reports, falsify them, or fail to timely pay the Cost Recovery Fee, the Government shall have, in addition to the rights and remedies described in this paragraph, all other rights and remedies permitted by Federal law and statutes.
11. MANUFACTURING FACILITIES/PLACE OF PERFORMANCE
1. If the products are to be manufactured at more than one location, each manufacturing facility and each facility address shall be listed along with the products manufactured at the facility.
2. Offeror shall identify below or by attachment (if additional space is needed), the products offered on this solicitation (products shall be identified by product name and by solicitation item number); whether the offeror manufactures the products; and/or whether the offeror is a distributor of the products offered. “Manufacturer” is defined as the entity that designs, manufactures, packages, and labels the product before it is available for sale/distribution.
3. The offeror is required to indicate below the complete name and address(es) of the manufacturer. The offeror is also required to check the box below that is applicable to its offer. Please note that the information required below must be the name and address of the manufacturing facility, rather than the address of the foreign headquarters, distributor or agent.
( ) OFFEROR IS THE MANUFACTURER (AT THE FOLLOWING LOCATIONS) OF THE PRODUCTS OFFERED ON THIS SOLICITATION.
( ) OFFEROR IS A DISTRIBUTOR OF THE PRODUCTS OFFERED ON THIS SOLICITATION.
The offeror must maintain the same manufacturer for the duration of the contract period, unless the Contracting Officer makes a determination that a change in the manufacturer is acceptable. This determination may take place before or after contract award.
THE PRODUCTS WILL BE MANUFACTURED BY THE FOLLOWING COMPANY AT THE FOLLOWING LOCATIONS:
(Name of Manufacturing Company)
(Street Address) (Post Office Address Not Acceptable)
(U.S.A. Point of Contact, e-Mail Address and U.S.A Telephone Number)
SECTION C - CONTRACT CLAUSES
C.1 52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL ITEMS (OCT 2018)
(a) Inspection/Acceptance. The Contractor shall only tender for acceptance those items that conform to the requirements of this contract. The Government reserves the right to inspect or test any supplies or services that have been tendered for acceptance. The Government may require repair or replacement of nonconforming supplies or reperformance of nonconforming services at no increase in contract price. If repair/replacement or reperformance will not correct the defects or is not possible, the Government may seek an equitable price reduction or adequate consideration for acceptance of nonconforming supplies or services. The Government must exercise its post-acceptance rights—
(1) Within a reasonable time after the defect was discovered or should have been discovered; and
(2) Before any substantial change occurs in the condition of the item, unless the change is due to the defect in the item.
(b) Assignment. The Contractor or its assignee may assign its rights to receive payment due as a result of performance of this contract to a bank, trust company, or other financing institution, including any Federal lending agency in accordance with the Assignment of Claims Act (31 U.S.C. 3727). However, when a third party makes payment (e.g., use of the Governmentwide commercial purchase card), the Contractor may not assign its rights to receive payment under this contract.
(c) Changes. Changes in the terms and conditions of this contract may be made only by written agreement of the parties.
(d) Disputes. This contract is subject to 41 U.S.C. chapter 71, Contract Disputes. Failure of the parties to this contract to reach agreement on any request for equitable adjustment, claim, appeal or action arising under or relating to this contract shall be a dispute to be resolved in accordance with the clause at FAR 52.233-1, Disputes, which is incorporated herein by reference. The Contractor shall proceed diligently with performance of this contract, pending final resolution of any dispute arising under the contract.
(e) Definitions. The clause at FAR 52.202-1, Definitions, is incorporated herein by reference.
(f) Excusable delays. The Contractor shall be liable for default unless nonperformance is caused by an occurrence beyond the reasonable control of the Contractor and without its fault or negligence such as, acts of God or the public enemy, acts of the Government in either its sovereign or contractual capacity, fires, floods, epidemics, quarantine restrictions, strikes, unusually severe weather, and delays of common carriers. The Contractor shall notify the Contracting Officer in writing as soon as it is reasonably possible after the commencement of any excusable delay, setting forth the full particulars in connection therewith, shall remedy such occurrence with all reasonable dispatch, and shall promptly give written notice to the Contracting Officer of the cessation of such occurrence.
(g) Invoice.
(1) The Contractor shall submit an original invoice and three copies (or electronic invoice, if authorized) to the address designated in the contract to receive invoices. An invoice must include—
(i) Name and address of the Contractor;
(ii) Invoice date and number;
(iii) Contract number, line item number and, if applicable, the order number;
(iv) Description, quantity, unit of measure, unit price and extended price of the items delivered;
(v) Shipping number and date of shipment, including the bill of lading number and weight of shipment if shipped on Government bill of lading;
(vi) Terms of any discount for prompt payment offered;
(vii) Name and address of official to whom payment is to be sent;
(viii) Name, title, and phone number of person to notify in event of defective invoice; and
(ix) Taxpayer Identification Number (TIN). The Contractor shall include its TIN on the invoice only if required elsewhere in this contract.
(x) Electronic funds transfer (EFT) banking information.
(A) The Contractor shall include EFT banking information on the invoice only if required elsewhere in this contract.
(B) If EFT banking information is not required to be on the invoice, in order for the invoice to be a proper invoice, the Contractor shall have submitted correct EFT banking information in accordance with the applicable solicitation provision, contract clause (e.g., 52.232-33, Payment by Electronic Funds Transfer—System for Award Management, or 52.232-34, Payment by Electronic Funds Transfer—Other Than System for Award Management), or applicable agency procedures.
(C) EFT banking information is not required if the Government waived the requirement to pay by EFT.
(2) Invoices will be handled in accordance with the Prompt Payment Act (31 U.S.C. 3903) and Office of Management and Budget (OMB) prompt payment regulations at 5 CFR part 1315.
(h) Patent indemnity. The Contractor shall indemnify the Government and its officers, employees and agents against liability, including costs, for actual or alleged direct or contributory infringement of, or inducement to infringe, any United States or foreign patent, trademark or copyright, arising out of the performance of this contract, provided the Contractor is reasonably notified of such claims and proceedings.
(i) Payment. —
(1) Items accepted. Payment shall be made for items accepted by the Government that have been delivered to the delivery destinations set forth in this contract.
(2) Prompt payment. The Government will make payment in accordance with the Prompt Payment Act (31 U.S.C. 3903) and prompt payment regulations at 5 CFR part 1315.
(3) Electronic Funds Transfer (EFT). If the Government makes payment by EFT, see 52.212-5(b) for the appropriate EFT clause.
(4) Discount. In connection with any discount offered for early payment, time shall be computed from the date of the invoice. For the purpose of computing the discount earned, payment shall be considered to have been made on the date which appears on the payment check or the specified payment date if an electronic funds transfer payment is made.
(5) Overpayments. If the Contractor becomes aware of a duplicate contract financing or invoice payment or that the Government has otherwise overpaid on a contract financing or invoice payment, the Contractor shall—
(i) Remit the overpayment amount to the payment office cited in the contract along with a description of the overpayment including the—
(A) Circumstances of the overpayment (e.g., duplicate payment, erroneous payment, liquidation errors, date(s) of overpayment);
(B) Affected contract number and delivery order number, if applicable;
(C) Affected line item or subline item, if applicable; and
(D) Contractor point of contact.
(ii) Provide a copy of the remittance and supporting documentation to the Contracting Officer.
(6) Interest.
(i) All amounts that become payable by the Contractor to the Government under this contract shall bear simple interest from the date due until paid unless paid within 30 days of becoming due. The interest rate shall be the interest rate established by the Secretary of the Treasury as provided in 41 U.S.C. 7109, which is applicable to the period in which the amount becomes due, as provided in (i)(6)(v) of this clause, and then at the rate applicable for each six-month period as fixed by the Secretary until the amount is paid.
(ii) The Government may issue a demand for payment to the Contractor upon finding a debt is due under the contract.
(iii) Final decisions. The Contracting Officer will issue a final decision as required by 33.211 if—
(A) The Contracting Officer and the Contractor are unable to reach agreement on the existence or amount of a debt within 30 days;
(B) The Contractor fails to liquidate a debt previously demanded by the Contracting Officer within the timeline specified in the demand for payment unless the amounts were not repaid because the Contractor has requested an installment payment agreement; or
(C) The Contractor requests a deferment of collection on a debt previously demanded by the Contracting Officer (see 32.607-2).
(iv) If a demand for payment was previously issued for the debt, the demand for payment included in the final decision shall identify the same due date as the original demand for payment.
(v) Amounts shall be due at the earliest of the following dates:
(A) The date fixed under this contract.
(B) The date of the first written demand for payment, including any demand for payment resulting from a default termination.
(vi) The interest charge shall be computed for the actual number of calendar days involved beginning on the due date and ending on—
(A) The date on which the designated office receives payment from the Contractor;
(B) The date of issuance of a Government check to the Contractor from which an amount otherwise payable has been withheld as a credit against the contract debt; or
(C) The date on which an amount withheld and applied to the contract debt would otherwise have become payable to the Contractor.
(vii) The interest charge made under this clause may be reduced under the procedures prescribed in 32.608-2 of the Federal Acquisition Regulation in effect on the date of this contract.
(j) Risk of loss. Unless the contract specifically provides otherwise, risk of loss or damage to the supplies provided under this contract shall remain with the Contractor until, and shall pass to the Government upon:
(1) Delivery of the supplies to a carrier, if transportation is f.o.b. origin; or
(2) Delivery of the supplies to the Government at the destination specified in the contract, if transportation is f.o.b. destination.
(k) Taxes. The contract price includes all applicable Federal, State, and local taxes and duties.
(l) Termination for the Government's convenience. The Government reserves the right to terminate this contract, or any part hereof, for its sole convenience. In the event of such termination, the Contractor shall immediately stop all work hereunder and shall immediately cause any and all of its suppliers and subcontractors to cease work. Subject to the terms of this contract, the Contractor shall be paid a percentage of the contract price reflecting the percentage of the work performed prior to the notice of termination, plus reasonable charges the Contractor can demonstrate to the satisfaction of the Government using its standard record keeping system, have resulted from the termination. The Contractor shall not be required to comply with the cost accounting standards or contract cost principles for this purpose. This paragraph does not give the Government any right to audit the Contractor's records. The Contractor shall not be paid for any work performed or costs incurred which reasonably could have been avoided.
(m) Termination for cause. The Government may terminate this contract, or any part hereof, for cause in the event of any default by the Contractor, or if the Contractor fails to comply with any contract terms and conditions, or fails to provide the Government, upon request, with adequate assurances of future performance. In the event of termination for cause, the Government shall not be liable to the Contractor for any amount for supplies or services not accepted, and the Contractor shall be liable to the Government for any and all rights and remedies provided by law. If it is determined that the Government improperly terminated this contract for default, such termination shall be deemed a termination for convenience.
(n) Title. Unless specified elsewhere in this contract, title to items furnished under this contract shall pass to the Government upon acceptance, regardless of when or where the Government takes physical possession.
(o) Warranty. The Contractor warrants and implies that the items delivered hereunder are merchantable and fit for use for the particular purpose described in this contract.
(p) Limitation of liability. Except as otherwise provided by an express warranty, the Contractor will not be liable to the Government for consequential damages resulting from any defect or deficiencies in accepted items.
(q) Other compliances. The Contractor shall comply with all applicable Federal, State and local laws, executive orders, rules and regulations applicable to its performance under this contract.
(r) Compliance with laws unique to Government contracts. The Contractor agrees to comply with 31 U.S.C. 1352 relating to limitations on the use of appropriated funds to influence certain Federal contracts; 18 U.S.C. 431 relating to officials not to benefit; 40 U.S.C. chapter 37, Contract Work Hours and Safety Standards; 41 U.S.C. chapter 87, Kickbacks; 41 U.S.C. 4712 and 10 U.S.C. 2409 relating to whistleblower protections; 49 U.S.C. 40118, Fly American; and 41 U.S.C. chapter 21 relating to procurement integrity.
(s) Order of precedence. Any inconsistencies in this solicitation or contract shall be resolved by giving precedence in the following order:
(1) The schedule of supplies/services.
(2) The Assignments, Disputes, Payments, Invoice, Other Compliances, Compliance with Laws Unique to Government Contracts, and Unauthorized Obligations paragraphs of this clause;
(3) The clause at 52.212-5.
(4) Addenda to this solicitation or contract, including any license agreements for computer software.
(5) Solicitation provisions if this is a solicitation.
(6) Other paragraphs of this clause.
(7) The Standard Form 1449.
(8) Other documents, exhibits, and attachments
(9) The specification.
(t) [Reserved]
(u) Unauthorized Obligations.
(1) Except as stated in paragraph (u)(2) of this clause, when any supply or service acquired under this contract is subject to any End User License Agreement (EULA), Terms of Service (TOS), or similar legal instrument or agreement, that includes any clause requiring the Government to indemnify the Contractor or any person or entity for damages, costs, fees, or any other loss or liability that would create an Anti-Deficiency Act violation (31 U.S.C. 1341), the following shall govern:
(i) Any such clause is unenforceable against the Government.
(ii) Neither the Government nor any Government authorized end user shall be deemed to have agreed to such clause by virtue of it appearing in the EULA, TOS, or similar legal instrument or agreement. If the EULA, TOS, or similar legal instrument or agreement is invoked through an “I agree” click box or other comparable mechanism (e.g., “click-wrap” or “browse-wrap” agreements), execution does not bind the Government or any Government authorized end user to such clause.
(iii) Any such clause is deemed to be stricken from the EULA, TOS, or similar legal instrument or agreement.
(2) Paragraph (u)(1) of this clause does not apply to indemnification by the Government that is expressly authorized by statute and specifically authorized under applicable agency regulations and procedures.
(v) Incorporation by reference. The Contractor’s representations and certifications, including those completed electronically via the System for Award Management (SAM), are incorporated by reference into the contract.
ADDENDUM to FAR 52.212-4 CONTRACT TERMS AND CONDITIONS--COMMERCIAL ITEMS
1. Ordering. This solicitation provides for award(s) of contract(s) in support of VA’s standardization program.
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