36E79722R0003_1.docx
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- Attached to
- 6505-- Pharmaceutical Repackaging and Distribution Services Federal contract opportunity
- Solicitation number
- 36E79722R0003
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Other files for this federal contract opportunity
| File | Type | Posted |
|---|---|---|
| 36E79722R0003 0001.docx | DOCX document | |
| Attachment C - VA Crisis cap.pdf | ||
| Attachment B - Myhealthevet - URL.pdf | ||
| Attachment F - Small Business Subcontracting Plan.docx | DOCX document | |
| Attachment E - Wage Determination 2015-5017.pdf | ||
| Attachment A - Experience - Past Performance.doc | DOC document | |
| Attachment D - Product List.xls | XLS spreadsheet |
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36E79722R0003 See attached document: Attachment A - Experience - Past Performance.
See attached document: Attachment B - Myhealthevet - URL.
See attached document: Attachment C - VA Crisis cap.
See attached document: Attachment D - Product List.
See attached document: Attachment E - Wage Determination 2015-5017.
See attached document: Attachment F – Small Business Subcontracting Plan / 64
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
36E79722R0003 01-19-2022 Bonita Smith (bonita.Smith@va.gov) 708-786-5175 02-08-2022
10:00AM
CST
Department of Veterans Affairs OA&L / National Acquisition Center Building 37 1st Avenue, One Block North of Cermak Hines IL 60141 X 493110 $30 Million N/A X VA facilities per individual orders This includes nationwide locations, Gua Puerto Rico, American Samoa, Virgin Islands and the Philippines
Department of Veterans Affairs OA&L / National Acquisition Center Building 37 1st Avenue, One Block North of Cermak Hines IL 60141
Department of Veterans Affairs
CHIEF, FISCAL DIVISION (901A)
HINES SERVICE AND DISTRIBUTION CENTER
PO BOX 7005
HINES IL 60141-7005
Pharmaceutical Repackaging Program See the following pages X X Table of Contents
| SECTION A | 2 |
| A.1 SF 1449 SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL ITEMS | 2 |
| SECTION B - CONTINUATION OF SF 1449 BLOCKS | 4 |
| B.1 CONTRACT ADMINISTRATION DATA | 4 |
| B.2 SCHEDULE OF SUPPLIES | 5 |
| SECTION C - CONTRACT CLAUSES | 17 |
| C.1 52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL ITEMS (OCT 2018) | 17 |
| C.2 52.216-18 ORDERING (AUG 2020) | 23 |
| C.3 52.216-19 ORDER LIMITATIONS (OCT 1995) | 23 |
| C.4 52.216-21 REQUIREMENTS (OCT 1995) | 24 |
| C.5 MANDATORY WRITTEN DISCLOSURES | 25 |
| C.6 52.217-8 OPTION TO EXTEND SERVICES (NOV 1999) | 25 |
| C.7 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998) | 25 |
| C.8 SUPPLEMENTAL INSURANCE REQUIREMENTS | 25 |
| C.9 VAAR 852.212-70 PROVISIONS AND CLAUSES APPLICABLE TO VA ACQUISITION OF COMMERCIAL ITEMS (APR 2020) | 26 |
| C.10 VAAR 852.219-74 LIMITATIONS ON SUBCONTRACTING—MONITORING AND COMPLIANCE (JUL 2018) | 28 |
| C.11 VAAR 852.219-75 SUBCONTRACTING COMMITMENTS MONITORING AND COMPLIANCE (JUL 2018) | 28 |
| C.12 52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT STATUTES OR EXECUTIVE ORDERS—COMMERCIAL ITEMS (JAN 2021) (JUL 2020) (DEVIATION) | 29 |
| SECTION D - CONTRACT DOCUMENTS, EXHIBITS, OR ATTACHMENTS | 37 |
| SECTION E - SOLICITATION PROVISIONS | 38 |
| E.1 52.212-1 INSTRUCTIONS TO OFFERORS—COMMERCIAL ITEMS (SEP 2021) | 38 |
| E.2 52.212-2 EVALUATION—COMMERCIAL ITEMS (OCT 2014) | 45 |
| E.3 52.204-24 REPRESENTATION REGARDING CERTAIN TELECOMMUNICATIONS AND VIDEO SURVEILLANCE SERVICES OR EQUIPMENT (OCT 2020) | 49 |
| E.4 52.209-7 INFORMATION REGARDING RESPONSIBILITY MATTERS (OCT 2018) | 51 |
| E.5 52.216-1 TYPE OF CONTRACT (APR 1984) | 53 |
| E.6 52.233-2 SERVICE OF PROTEST (SEP 2006) | 53 |
| E.7 52.252-1 SOLICITATION PROVISIONS INCORPORATED BY REFERENCE (FEB 1998) | 54 |
| E.8 52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS—COMMERCIAL ITEMS (FEB 2021) (JUL 2020) (DEVIATION) | 54 |
SECTION B - CONTINUATION OF SF 1449 BLOCKS
B.1 CONTRACT ADMINISTRATION DATA
1. Contract Administration: All contract administration matters will be handled by the following individuals:
a. CONTRACTOR:
b. GOVERNMENT: Contracting Officer 36E797 Department of Veterans Affairs OA&L / National Acquisition Center Building 37 1st Avenue, One Block North of Cermak Hines IL 60141
2. CONTRACTOR REMITTANCE ADDRESS: All payments by the Government to the contractor will be made in accordance with:
| [X] |
| 52.232-33, Payment by Electronic Funds Transfer—System for Award Management, or |
| [] |
| 52.232-36, Payment by Third Party |
3. INVOICES: Invoices shall be submitted in arrears:
| a. Quarterly | [] |
| b. Semi-Annually | [] |
| c. Other | [X] The contractor shall provide an itemized invoice on a monthly basis that reflects the quantity of each product, by strength and package size, shipped to VA facilities during the month. Fees (prices) are based on the date of order placement by the facility. |
4. GOVERNMENT INVOICE ADDRESS: All Invoices from the contractor shall be submitted electronically in accordance with VAAR Clause 852.232-72 Electronic Submission of Payment Requests.
Department of Veterans Affairs
CHIEF, FISCAL DIVISION (003A1B3)
HINES SERVICE AND DISTRIBUTION CENTER
PO BOX 7005
HINES IL 60141-7005
ACKNOWLEDGMENT OF AMENDMENTS: The offeror acknowledges receipt of amendments to the Solicitation numbered and dated as follows:
| AMENDMENT NO |
| DATE |
B.2 SCHEDULE OF SUPPLIES
This contract, and the Schedule prices below, currently apply to the pharmaceuticals and sizes listed in Attachment D.
Fees (prices) are based on the date of order placement by the facility.
Fees:
1 Repackaging and Distribution Fee –The repackaging fee is a firm fixed price per bottle and should cover all the contractor’s costs including, but not limited to, bottles, caps, overhead, and the packaging, warehousing and shipping of the product to VA facilities.
2 Distribution Fee – The contractor should base its firm fixed price per bottle distribution fee on their ordering processing, warehousing, and shipping of products that will require no repackaging or relabeling.
| BASE YEAR- |
| Est. Qty |
| Unit |
| Unit Price |
| Total Price Unit Price X Est. Qty |
| 0001 |
| Repackaging & Distribution Fee – 120cc |
| 2,000,000 |
| BT |
| 0002 |
| Repackaging & Distribution Fee – 200cc |
| 1,300,000 |
| BT |
| 0003 |
| Repackaging & Distribution Fee - 300cc |
| 75,000 |
| BT |
| 0004 |
| Repackaging & Distribution Fee - 400cc |
| 750,000 |
| BT |
| 0005 |
| Repackaging & Distribution Fee - 625cc |
| 45,000 |
| BT |
| 0006 |
| Repackaging & Distribution Fee - 750cc |
| 5,000 |
| BT |
| 0007 |
| Repackaging & Distribution Fee - 950cc |
| 10,000 |
| BT |
| 0008 |
| Repackaging & Distribution Fee - 2500cc |
| 5,000 |
| BT |
| 0009 |
| Repackaging & Distribution Fee - 3000cc |
| 5,000 |
| BT |
| 0010 |
| Repackaging & Distribution Fee - 4000cc |
| 5,000 |
| BT |
| 0011 |
| Distribution Fee – 125cc |
| 10,000 |
| BT |
| 0012 |
| Distribution Fee– 200cc |
| 25,000 |
| BT |
| 0013 |
| Distribution Fee – 250cc |
| 10,000 |
| BT |
| 0014 |
| Distribution Fee– 400cc |
| 5,000 |
| BT |
| 0015 |
| Distribution Fee – 1250cc |
| 5,000 |
| BT |
| OPTION YEAR 1 |
| Est. Qty |
| Unit |
| Unit Price |
| Total Price Unit Price X Est. Qty |
| 1001 |
| Repackaging & Distribution Fee – 120cc |
| 2,000,000 |
| BT |
| 1002 |
| Repackaging & Distribution Fee – 200cc |
| 1,300,000 |
| BT |
| 1003 |
| Repackaging & Distribution Fee - 300cc |
| 75,000 |
| BT |
| 1004 |
| Repackaging & Distribution Fee - 400cc |
| 750,000 |
| BT |
| 1005 |
| Repackaging & Distribution Fee - 625cc |
| 45,000 |
| BT |
| 1006 |
| Repackaging & Distribution Fee - 750cc |
| 5,000 |
| BT |
| 1007 |
| Repackaging & Distribution Fee - 950cc |
| 10,000 |
| BT |
| 1008 |
| Repackaging & Distribution Fee - 2500cc |
| 5,000 |
| BT |
| 1009 |
| Repackaging & Distribution Fee - 3000cc |
| 5,000 |
| BT |
| 1010 |
| Repackaging & Distribution Fee - 4000cc |
| 5,000 |
| BT |
| 1011 |
| Distribution Fee – 125cc |
| 10,000 |
| BT |
| 1012 |
| Distribution Fee– 200cc |
| 25,000 |
| BT |
| 1013 |
| Distribution Fee – 250cc |
| 10,000 |
| BT |
| 1014 |
| Distribution Fee– 400cc |
| 5,000 |
| BT |
| 1015 |
| Distribution Fee – 1250cc |
| 5,000 |
| BT |
| OPTION YEAR 2 |
| Est. Qty |
| Unit |
| Unit Price |
| Total Price Unit Price X Est. Qty |
| 2001 |
| Repackaging & Distribution Fee – 120cc |
| 2,000,000 |
| BT |
| 2002 |
| Repackaging & Distribution Fee – 200cc |
| 1,300,000 |
| BT |
| 2003 |
| Repackaging & Distribution Fee - 300cc |
| 75,000 |
| BT |
| 2004 |
| Repackaging & Distribution Fee - 400cc |
| 750,000 |
| BT |
| 2005 |
| Repackaging & Distribution Fee - 625cc |
| 45,000 |
| BT |
| 2006 |
| Repackaging & Distribution Fee - 750cc |
| 5,000 |
| BT |
| 2007 |
| Repackaging & Distribution Fee - 950cc |
| 10,000 |
| BT |
| 2008 |
| Repackaging & Distribution Fee - 2500cc |
| 5,000 |
| BT |
| 2009 |
| Repackaging & Distribution Fee - 3000cc |
| 5,000 |
| BT |
| 2010 |
| Repackaging & Distribution Fee - 4000cc |
| 5,000 |
| BT |
| 2011 |
| Distribution Fee – 125cc |
| 10,000 |
| BT |
| 2012 |
| Distribution Fee– 200cc |
| 25,000 |
| BT |
| 2013 |
| Distribution Fee – 250cc |
| 10,000 |
| BT |
| 2014 |
| Distribution Fee– 400cc |
| 5,000 |
| BT |
| 2015 |
| Distribution Fee – 1250cc |
| 5,000 |
| BT |
| OPTION YEAR 3 |
| Est. Qty |
| Unit |
| Unit Price |
| Total Price Unit Price X Est. Qty |
| 3001 |
| Repackaging & Distribution Fee – 120cc |
| 2,000,000 |
| BT |
| 3002 |
| Repackaging & Distribution Fee – 200cc |
| 1,300,000 |
| BT |
| 3003 |
| Repackaging & Distribution Fee - 300cc |
| 75,000 |
| BT |
| 3004 |
| Repackaging & Distribution Fee - 400cc |
| 750,000 |
| BT |
| 3005 |
| Repackaging & Distribution Fee - 625cc |
| 45,000 |
| BT |
| 3006 |
| Repackaging & Distribution Fee - 750cc |
| 5,000 |
| BT |
| 3007 |
| Repackaging & Distribution Fee - 950cc |
| 10,000 |
| BT |
| 3008 |
| Repackaging & Distribution Fee - 2500cc |
| 5,000 |
| BT |
| 3009 |
| Repackaging & Distribution Fee - 3000cc |
| 5,000 |
| BT |
| 3010 |
| Repackaging & Distribution Fee - 4000cc |
| 5,000 |
| BT |
| 3011 |
| Distribution Fee – 125cc |
| 10,000 |
| BT |
| 3012 |
| Distribution Fee– 200cc |
| 25,000 |
| BT |
| 3013 |
| Distribution Fee – 250cc |
| 10,000 |
| BT |
| 3014 |
| Distribution Fee– 400cc |
| 5,000 |
| BT |
| 3015 |
| Distribution Fee – 1250cc |
| 5,000 |
| BT |
| OPTION YEAR 4 |
| Est. Qty |
| Unit |
| Unit Price |
| Total Price Unit Price X Est. Qty |
| 4001 |
| Repackaging & Distribution Fee – 120cc |
| 2,000,000 |
| BT |
| 4002 |
| Repackaging & Distribution Fee – 200cc |
| 1,300,000 |
| BT |
| 4003 |
| Repackaging & Distribution Fee - 300cc |
| 75,000 |
| BT |
| 4004 |
| Repackaging & Distribution Fee - 400cc |
| 750,000 |
| BT |
| 4005 |
| Repackaging & Distribution Fee - 625cc |
| 45,000 |
| BT |
| 4006 |
| Repackaging & Distribution Fee - 750cc |
| 5,000 |
| BT |
| 4007 |
| Repackaging & Distribution Fee - 950cc |
| 10,000 |
| BT |
| 4008 |
| Repackaging & Distribution Fee - 2500cc |
| 5,000 |
| BT |
| 4009 |
| Repackaging & Distribution Fee - 3000cc |
| 5,000 |
| BT |
| 4010 |
| Repackaging & Distribution Fee - 4000cc |
| 5,000 |
| BT |
| 4011 |
| Distribution Fee – 125cc |
| 10,000 |
| BT |
| 4012 |
| Distribution Fee– 200cc |
| 25,000 |
| BT |
| 4013 |
| Distribution Fee – 250cc |
| 10,000 |
| BT |
| 4014 |
| Distribution Fee– 400cc |
| 5,000 |
| BT |
| 4015 |
| Distribution Fee – 1250cc |
| 5,000 |
| BT |
For Option years 1-4, only the 120cc bottles and corresponding caps listed in the schedule shall be obtained through the mandatory source of Alphapointe, in accordance with FAR clause 52.208-9 – Contractor Use of Mandatory Sources of Supply or Services. Alphapointe shall be responsible for ensuring that the bottle and cap requirements listed in this solicitation are met, and that the 120cc cap bottle assembly/unit is in compliance with the Consumer Product Safety Commissions (CPSC) current protocol and standards for child resistant effectiveness as per Code of Federal Regulations (C.F.R.) Title 16, Part 1700 prior to the start of the contract. The successful offeror shall remain responsible for ensuring that all other size bottles and corresponding caps meet these requirements for the duration of the contract.
Instructions for ordering 120cc bottles from Alphapointe (for Option years 1-4):
The successful offeror awarded the contract under this solicitation shall be responsible for obtaining 120cc bottles and corresponding caps through the mandatory source of Alphapointe. Pricing information can be obtained by contacting Alphapointe’s customer service department as listed below. Orders can be completed by phone, fax or email. The potential contract awardee shall reference the contract # and order item by name and NSN. Below is ordering information and additional information for Alphapointe:
By Phone (customer Service Dept): (866) 240-1352 By Fax: (816) 237-2017 By email: customerservice@alphapointe.org
Alphapointe Headquarters 7501 Prospect Avenue Kansas City, MO 64132-2103 007156409 (DUNS Number) 44-0552486 (Tax ID Number) 9Y443 (CAGE Code)
NSN: 6530-00-NIB-0120 (PN: BOT1060)
GENERAL INFORMATION
1. Title of Project: Pharmaceutical Repackaging Program
a. Background
i. The Department of Veterans Affairs (VA) Pharmacy Benefits Management (PBM) and Consolidated Mail Outpatient Pharmacy (CMOP) has identified the need to receive repackaging and warehouse support from a contracted repackager/distributor (contractor) for oral, solid pharmaceuticals. The Pharmaceutical Repackaging Program (PRP), which is administered by the Department of Veterans Affairs (VA), National Acquisition Center (NAC), requires a contractor to serve as a unit-of-use repackager and distributor for generic pharmaceuticals needed by VA healthcare facilities. Under the program, NAC will purchase the bulk pharmaceuticals, separately from this contract, and arrange for delivery of such products to the contractor for processing. The Contracting Officer will provide instructions to the contractor for repackaging of the bulk product into various bottle sizes. In addition to repackaging of pharmaceuticals, the contractor shall be required to warehouse government-owned pharmaceuticals until such time ordered by facilities. Contractor shall ship product Freight on Board (FOB) Destination to VA facilities. The vast majority of shipment will be sent to facilities within the 50 United States; however, there will also be nominal shipments to Puerto Rico, American Samoa, the Virgin Islands, Guam, and the Philippines. Currently there are two drugs covered by the repackaging program (see Attachment D). Some products will be provided in package sizes of 500 or 1000 and will require no repackaging but will be required to be warehoused and distributed by the contractor so that VA will be assured of availability and consistency of product for nationwide usage. The mix and variety of bottle sizes required to be repackaged or warehoused by the contractor may vary through the life of the contract as the Contracting Officer adds drugs and package sizes to the program.
ii. The Contracting Officer at VA NAC is the only one authorized to order repackaging services under this contract. There are seven CMOPs and approximately 140 other facilities that may order pharmaceuticals under this program for delivery to their locations, through the repackager.
iii. Pharmaceuticals delivered to the contractor for repackaging will typically be in package sizes of 500s or 1000s, but1000s but may come in larger sizes.
iv. Some pharmaceuticals will be resold in the quantity and packaging they are received in and will require no repackaging. (e.g., bought in 1000ct bottles and only warehoused and distributed by the repackager.)
b. Scope of Work
i. To provide pharmaceutical repackaging, warehousing, and distribution services for both controlled and non-controlled pharmaceuticals.
ii. Provide the bottles, caps and labels for the repackaged pharmaceuticals.
iii. Contractor is responsible for repackaging approximately 300,000 bottles of various pharmaceuticals each month.
iv. Contractor is responsible for warehousing approximately 300,000 bottles of various pharmaceuticals at all times.
v. Contractor is responsible for distributing approximately 300,000 bottles of various pharmaceuticals nationwide, also including Puerto Rico, American Samoa, the Virgin Islands, Guam, and the Philippines.
vi. The numbers above are not cumulative but are meant to illustrate how this Pharmaceutical Repackaging Program works. In any given month the contractor can be expected to distribute 300,000 bottles, warehouse 300,000 bottles, and repackage 300,000. There will be a constant inflow and outflow of product through the repackager’s facility(s) as product is received, orders are placed, and with VA maintaining a constant (approximate) 30–45-day supply of product on hand for all products at the repackager’s facility(s).
2. Specific Requirements
a. Applicable Credentialing / Certification / Regulations / Standards
i. Contractor shall be FDA approved to repackage oral, solid pharmaceuticals and certified with the Drug Enforcement Agency (DEA) for class III (narcotic and non-narcotic), Class IV, and Class V controlled substances.
ii. Contractor control, accounting and repackaging of pharmaceuticals shall be done using FDA and DEA guidance, regulations and approved procedures, and in accordance with Current Good Manufacturing Practices (cGMPs).
iii. Contractor shall warehouse pharmaceuticals in accordance with FDA and U.S. Pharmacopeial Convention (USP) standards for both security and environmental requirements.
iv. The contractor shall submit to First Databank (FDB) and Medi-span product information pertaining to the products repackaged under this contract, including the contractor’s unique National Drug Code(s), during the period of contract performance. A New Product Submission Form can be completed by contacting:
First Databank:
| Web address: | http://www.fdbhealth.com/solutions/manufacturer-relations/ | ||
| Editorial Department: | 1-650-872-4566 | ||
| Email: | Editorial_Services@fdbhealth.com; |
Medi-Span:
| Web address: | http://www.wolterskluwercdi.com/manufacturers-exchange/ | ||
| Data Acquisition Department: | 1-800-388-8884 | ||
| Email: | mfgdata@wolterskluwer.com |
vi. The contractor shall follow all appropriate requirements as implemented in Drug Supply Chain Security Act (DSCSA).
vii. Contractor shall have a minimum of two years past experience as a pharmaceutical repackager, for both controlled and non-controlled substances, in the volume that meets or exceeds an average of 4-5 million bottles per year.
b. Product Characteristic Requirements
i. The pharmaceutical bottles shall have the following characteristics:
· White pharmacy grade High-density polyethylene
· Round with no ridges, bowing or protrusions that would prevent them from being horizontally or vertically stacked. (Convex shaped bottles are unacceptable)
· Must have a flat surface with minimum dimensions of 2.5’’ W x 5.5’’ L sufficient for applying a label without overlap.
· Bottle sizes repackaged into are 120cc, 200cc, 300cc, 400cc, 625cc, 750cc 950cc, 2500cc, 3000cc and 4000cc.
· Bottles shall be identified with a number 1, 2, or 3 designation for recycling.
· A tamper evident seal shall be applied to each bottle. This seal must not be above/over the cap.
· Must be capable of being dispensed from the automated labeling and automated dispensing systems installed at each CMOP facility, including but not limited to: Knapp A-Frames, SI Handling A-Frames, Flex-Pick systems, Automated Dispensing Unit (ADU) systems, automated labeling systems, and Package Dispensing and Labeling Automation (PDLA).
· The prospective contractor must supply testing data / certification showing that the cap bottle assembly / unit is in compliance with the Consumer Product Safety Commissions (CPSC) current protocol and standards for child resistant effectiveness as per Code of Federal Regulations (C.F.R.) Title 16, Part 1700. This does not apply to the bulk up sized bottles; bulk size is 500 or more tablet/capsule count.
ii. The bottle caps shall have the follow characteristics:
· Shall not exceed the diameter of the bottle
· Shall be of convertible design to allow user to convert it from child-resistant to non-child resistant with hand applied pressure to the center of the cap. This child-resistant cap requirement currently only applies to unit-of-use package sizes, which have a tablet/capsule count of 15s, 30s, 45s, 60s, 90s, 120s, 135s, 180s, 270s, 360s and 450s.
· Shall be imprinted with the “MyHealthE Vet” or the “VA Crisis hotline” logo in accordance with the attached logo specifications. See Attachments B and C.
· Must have the ability to imprint up to 4 different logos (at the VA’s discretion).
iii. All bottle and cap combinations shall meet or exceed the USP standards for moisture permeability and light resistance.
iv. The product labels shall have the following characteristics:
· Shall not exceed 3.5 mils thickness (for affixed labels).
· Directly printed labels may be used but shall be machine readable and non-smudging.
· Labels must not peel off or be damaged in automated machinery.
v. The product labels shall include the following information:
· The product label must be of a material that will allow a patient label to adhere to it.
· Fill size and strength for quick recognition. The generic name shall be bold font and larger font than other printed matter.
· Drug name positioned such that after applying the patient label a pharmacist can still identify the product. The product name, strength and package size shall be printed twice on the label: once on the face of the label in the middle and once on the extreme left-hand side vertically.
· Bar coded for contents. At the time of solicitation Bar Code 128 is required. The Government requirement for bar code may change during the performance of this contract to require a 2D (Q/R) type automated information data carrier. Bar codes shall be clear and defined with no break in the bar code graphics. A sufficient amount of clear white space needs to be around the bar code so numbers and/or letters do not interfere with the bar code. The Government requires identical vertical bar codes to appear on the left and right sides of the label. The bar code for Manufacturer Lot Number, Repackaged Batch Number, Expiration Date, and NDC number shall be printed vertically oriented, and also appear as human readable language adjacent to the bar code.
· State storage conditions
· Indicate the “Manufactured By” name and “Packaged By” name and address
· The statement "Warning: May be habit forming" where applicable, the controlled drug substances symbol required by Drug Enforcement Administration (DEA), and the name and quantity or proportion of any substance as required.
· Boxes or cases shall be clearly marked with a product label as described in 2.b.iv above. Bottle count shall be stamped on the outside of each case if it contains less than the standard container capacity (e.g.: 40 bottles in a box or case that holds 100) than would be expected.
vi. The repackager is not required to repackage the pharmaceuticals or apply the Product Characteristics described in paragraphs i – v to product that the NAC CO has designated as “distribution only” at the time repackaging instructions are provided. This currently applies to line items (e.g., The repackager receives two cases, with six 1000ct bottles each, and VA wants one case repackaged and one case kept for distribution as a case of six 1000ct bottles)
c. Product Handling
i. Pharmaceuticals shall be received by the contractor directly from the pharmaceutical supplier. This product is Government-owned property and will be ordered from the pharmaceutical supplier by the VA NAC Contracting Officer (CO). Immediately, upon receipt of Government-owned property, the contractor shall log and reconcile all Government-owned property with the shipment purchase order and DSCSA transaction information if applicable. The contractor is responsible for any product damage caused while the product is in the contractor’s care. These pharmaceuticals will be repackaged into unit of use sizes by direction of the Contracting Officer.
ii. The contractor shall segregate Government stock from contractor’s other products.
iii. Pharmaceutical product retention shall be handled as defined in Code of Federal Regulation Title 21, Section 211.
iv. Excess and/or damaged pharmaceuticals not repackaged will be added to the retention samples.
v. Product shall be processed and repackaged into unit of use sizes in accordance with the instructions provided by the Contracting Officer no later than 14 calendar days after receipt of product from the pharmaceutical suppliers, unless another arrangement is agreed upon between the repackager and the Contracting Officer.
vi. Destruction of retained samples, excess and/or damaged product shall be done in accordance with applicable regulations, including but not limited to any required by the DEA, FDA, and EPA. Within ten (10) days after destruction the contractor shall provide the Government with a Certificate of Destruction.
vii. Finished product that is shipped on pallets shall be shrink-wrapped. Pallets shall contain a packing slip identifying contents line by line, as well as an itemized invoice. Controlled substances shall be wrapped separately from other portions of a shipment. All pallets shall be wrapped using black shrink wrap to encapsulate the pallet and containers. Repackaged product shall not exceed 25lbs per case or box.
viii. Shipping of product will be completed FOB Destination within seven (7) days after receipt of order, by the ordering facility, in the fifty (50) states, and within fourteen (14) days after receipt of order, by the ordering facility, to Puerto Rico, American Samoa, the Virgin Islands, Guam, and the Philippines.
d. Ordering
i. The contractor shall provide VA facilities with a secure web-based ordering system. Pricing for the pharmaceutical products will be provided by the Contracting Officer to the repackager to be placed in the ordering system, but at no time will the repackager be responsible for or authorized to collect payment from the VA facilities.
ii. The ordering system shall be able to provide real-time confirmation within the system when an order is placed. The system shall process orders on a “fill or kill” basis, cancelling from the order any items that cannot be filled. The confirmation should indicate the cancelled items.
iii. After an order has been placed, an email confirmation shall be sent to the person placing the order. Concurrently a copy of the order shall also be emailed to the NAC Contracting Officer or their designated point of contact.
iv. When the order has shipped, a digitally signed email shall be sent to the ordering facility identifying the complete shipment, projected delivery date, and tracking number. This email shall also include a comma separated variable (CSV) file as an attachment, which will include the following minimum data fields:
| PO | (this is the VA facility purchase order number) | ||
| NDC | (this is the product National Drug Code) | ||
| Lotnumber | (this is the product lot number) | ||
| ExpirationDate | (this is the expiration date of the product) | ||
| Bottlesize | (this is the repackage bottle size) | ||
| Packsize | (this is the repackage pack size) | ||
| Quantity Shipped | (this is the quantity shipped by the repackager) | ||
| Drugcost | (this is the NAC assigned drug price, paid by VA facility) | ||
| DrugName | (this is the drug name, and is an optional field) | ||
| OrigManufacturer | (this is the Original Manufacturers name) | ||
| OrigLotNumber | (this is the Original Manufacturers Lot Number) |
v. The contractor shall make available contingency ordering methods for use when the web-based system is not functioning. These methods may include fax, email, or standard delivery methods (i.e., USPS, UPS, etc.). If one of these alternate methods are used the contractor shall promptly notify the ordering facility by telephone or e-mail whose order is received in such a way as to render it garbled or unclear. Each ordering facility using alternative ordering processes shall be notified of the cancellation of any items from an order that cannot be filled, or delivery will be delayed beyond the 7 or 14 (as appropriate for shipping destination) calendar days after receipt of order (ARO). At no time will oral orders be accepted.
vi. Access to the ordering system shall be limited to authorized VA ordering officials, as identified by the NAC Contracting Officer.
e. Reporting
i. The NAC CO will notify the contractor when a pharmaceutical order has been placed with a supplier, identifying the specific pharmaceutical(s) and quantities and estimated delivery date. Repackaging instructions will be provided by the NAC CO when the contractor has accepted the pharmaceuticals and confirmed receipt. Confirmed receipt of government property shall be in a report format agreed to by the NAC CO and shall include, at minimum, reconciliation to shipment purchase order and transaction information in accordance with DSCSA. Any discrepancies discovered during reconciliation of shipment shall result in the affected product being quarantined by the contractor until a subsequent investigation by the trading partners (the NAC CO, the shipper of product, and the repackager) into the product discrepancy determines the product status, whether usable or illegitimate.
ii. Yield Report – The contractor shall provide a weekly actual yield report (Microsoft Excel preferred). This report shall be provided by product and lot number reflecting at a minimum: the date received, quantity received, lot numbers, repackaging start and completion date, total yield (including samples and partials), quantity turned in for sale, samples not turned in, and process status (if in process, finished, etc.) Standard acceptance criteria for total unit doses packaged shall be + 1% variation; however reasonable variations may be permitted based on historic data by individual drug product. This report shall include distribution-only product as well to reflect shipment receipt. The Contracting Officer shall be consulted to establish any variation other than the 1% stated. For purposes of reporting, the week will begin on Thursday and end at close of business Wednesday with reports due by close of business the following day.
iii. Stock Status Report – The contractor shall provide a weekly and monthly stock status report (Microsoft Excel preferred) for the of all items by strength and package size, in bottle quantities, to reflect finished stock available and stock still in process. For purposes of reporting, the week will begin on Thursday and end at close of business Wednesday with reports due by close of business the following day.
f. Insurance
i. The Contractor shall maintain property damage liability insurance in the amount of at least $5 million (this is the current monthly average value of VA product on hand) to cover Government-owned stock in the event of loss, theft, or damage.
ii. The Contractor shall maintain liability insurance issued by a responsible insurance carrier in the amount of no less than $1 million per occurrence/$3 million aggregate, in the event of packaging, labeling, or misbranding errors.
iii. The policies evidencing required insurance shall also contain an endorsement to the effect that any cancellation or material change adversely affecting the Government’s interest shall not be effective until 30 days after the Contractor gives written notice to the Contracting Officer. If during the performance of the contract, the Contractor changes insurance providers, the Contractor must provide evidence that the Government will be indemnified to the limits specified in paragraphs (a) and (b) above, for the entire period of the contract, either under the new policy, or a combination of old and new policies.
iv. The Contractor shall, prior to commencement of services under this contract, provide to the Contracting Officer copies of Certificates of Insurance or insurance policies evidencing the required insurance coverage stated in paragraphs (a) and (b) above. The Contracting Officer or his/her designated representative reserves the right to examine the original copy of this certificate at any time.
3. General Information
i. The period of performance shall begin ninety days (or sooner upon mutual agreement) from the date of award and will be in effect for one year. The contract allows for four one-year option periods.
ii. There may be additional transition time required to completely deplete the stock warehoused at the current contractor’s facility.
iii. Additional products and package sizes may be added to the contract by mutual agreement of the contractor and the Government.
iv. Due to the materiality of the inventory’s total dollar amount, an annual inventory will be conducted on-site at the contractor’s facility by VA representatives and an independent audit firm, paid for by the Government. This inventory will take place in the month of September for each year of the contract.
v. Pharmaceuticals received by the contractor will typically be in package sizes of 500s or 1000s but may come in larger sizes; to be repackaged into smaller unit of use sizes typically 15s, 30s, 45s, 60s, 90s, 120s, 135s, 180s, 270s,360s and 450s.
vi. Pharmaceuticals received by the contractor will typically be in package sizes of 500s or 1000s but may come in larger sizes; to be repackaged into bulk sizes of 2500cc, 3000cc and 4000cc bottles.
vii. Historical data for the past year shows that there was an average of approximately 100 shipments per month, from the repackager to VA facilities.
viii. The Government attempts to place pharmaceutical orders once a month, to minimize the number of repackaging runs required. Historical data shows that this is done in an average of 20 production runs a week. The current list of pharmaceuticals (subject to change) and their sizes and strengths are shown in Attachment D.
ix. Quantities are based on estimates and past use, this does not guarantee future volume. There is no expressed or implied guarantee that the estimated quantities will be purchased under this contract. Actual quantities may exceed or be less than those represented.
x. The Government may place up to two employees in the contractor’s facility to observe contractor’s accountability and repackaging practices on behalf of the VA. The contractor shall provide office space for the employee(s), along with desks and chairs. Other office needs for this employee(s), e.g., IT equipment, file cabinets, telephone, office supplies, etc.), will be the responsibility of the Government.
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SECTION C - CONTRACT CLAUSES
C.1 52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL PRODUCTS AND SERVICES (NOV 2021)
(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 Federal Acquisition Regulation (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 FAR 32.608-2 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.
C.2 52.216-18 ORDERING (AUG 2020)
(a) Any supplies and services to be furnished under this contract shall be ordered by issuance of delivery orders or task orders by the individuals or activities designated in the Schedule. Such orders may be issued from date of contract award through the last date to order on the last option year.
(b) All delivery orders or task orders are subject to the terms and conditions of this contract. In the event of conflict between a delivery order or task order and this contract, the contract shall control.
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