VA797W-17-R-0003-144.docx

VA797W-17-R-0003

FedBizOpps Combined Synopsis/Solicitation Notice

CLASSIFICATION CODE

SUBJECT

CONTRACTING OFFICE'S

ZIP-CODE

SOLICITATION NUMBER

RESPONSE DATE (MM-DD-YYYY)

ARCHIVE

DAYS AFTER THE RESPONSE DATE

RECOVERY ACT FUNDS

SET-ASIDE

NAICS CODE

CONTRACTING OFFICE

ADDRESS

POINT OF CONTACT

(POC Information Automatically Filled from User Profile Unless Entered)

DESCRIPTION

See Attachment

AGENCY'S URL

URL DESCRIPTION

AGENCY CONTACT'S EMAIL

ADDRESS

EMAIL DESCRIPTION

ADDRESS

POSTAL CODE

COUNTRY

ADDITIONAL INFORMATION

GENERAL INFORMATION

PLACE OF PERFORMANCE

* = Required Field FedBizOpps Combined Synopsis/Solicitation Notice Rev. March 2010 R Solicitation for 2018 Reverse Distribution and Pharmaceutical Waste Disposal Contract 60141

VA797W-17-R-0003

01-11-2018 N 493110 Department of Veterans Affairs NAC, NCS, Prime Vendor Bldg 37 PO Box 76 60141 Karen E. Ade Senior Contract Specialist 708-786-5231 karen.ade@va.gov karen.ade@va.gov This action was previously synopsized under Notice VA797W-17-N-0002.

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

VA797W-17-R-0003

12-12 -2017 KAREN ADE (karen.ade@va.gov) 708-786-5231 01-11 -2018

1:30PM CT

003A4C Department of Veterans Affairs National Acquisition Center (003A4C4) Building 37 1st Avenue, One Block North of 22nd St.

Hines IL 60141 X X Y 493110 $27.5 Million X N/A X Government facilities per individual orders

003A4C Department of Veterans Affairs OA&L/National Acquisition Center Building 37 1st Avenue, One Block North of Cermak Hines IL 60141

Government facilities per individual orders

Pharmaceutical Reverse Distribution See Attached Schedule of Services Proposals shall be received at: karen.ade@va.gov or deliver to the address in block 9 by the solicitation due date $0.00 X X X Karen E. Ade Contracting Officer ADDENDUM TO STANDARD FORM 1449 (continued) Continuation of Blocks 19-24:

SCHEDULE OF SUPPLIES/SERVICES

Description of Service: Furnish all necessary labor, materials, and equipment to process pharmaceutical products in accordance with the requirements of the Statement of Work).

Please Note: All fees/prices must include the 0.5% Cost Recovery Fee and a fee/price must be submitted for every line item. The estimated quantities reflect the Government’s total for this procurement.

CUSTOMS TERRITORY OF THE UNITED STATES

Note: Customs Territory of the United States includes the 50 states, the District of Columbia, and the Commonwealth of Puerto Rico.

Line Item 0001: On-Site Processing at a Government Facility of Returnable Pharmaceuticals (Controlled and Non-Controlled Substances). Propose prices as a percentage of the actual credits to be received from pharmaceutical suppliers. Invoices must be submitted, payments will not be made through “credits”.

TOTAL AMOUNT

Line Item 0002: Off-Site Processing at the Contractor’s Facility of Returnable Pharmaceuticals (Controlled and Non-Controlled Substances). Propose prices as a percentage of the actual credits to be received from pharmaceutical suppliers.

TOTAL AMOUNT

Line Item 0003: Disposable of Non-returnable Non-Hazardous Pharmaceuticals. Propose as a firm fixed price per pound.

Line Item 0004: Disposal of Non-Returnable Hazardous Pharmaceuticals. Propose prices as a firm fixed price per pound.

OUTSIDE THE CUSTOMS TERRITORY OF THE UNITED STATES

Note: The areas outside the Customs Territory of the United States include the Virgin Islands, American Samoa, the island of Guam, and the Philippines.

Line Item 0005: On-Site Processing at a Government Facility of Returnable Pharmaceuticals (Controlled and Non-Controlled Substances). Propose prices as a percentage of the actual credits to be received from pharmaceutical suppliers.

TOTAL AMOUNT

Line Item 0006: Off-Site Processing at the contractor’s Facility of Returnable Pharmaceuticals

TOTAL AMOUNT

Line Item 0007: Disposal of Non-Returnable Non-Hazardous Pharmaceuticals. Propose prices as a firm fixed price per pound.

Line Item 0008: Disposal of Non-Returnable Hazardous Pharmaceuticals. Propose prices as a firm fixed price per pound.

The Government anticipates estimated annual returns valued at $61,126,635.00 and estimated annual disposal of 2,292,553 pounds based on historical returns data provided under the reporting requirements of current reverse distribution contracts. Estimated annual returns and disposal separated by agency and line item are included as Attachment A. The estimated annual returns processed provided in the schedule of supplies/services reflects total uses of the Department of Veterans Affairs (VA), Indian Health Service s(IHS), Bureau of Prisons (BOP), and U.S. Immigration and Customs Enforcement (ICE). Past volume does not guarantee future volume. There is no express or implied guarantee that the estimated volume of returns and/or disposal will occur under the contract awarded under this solicitation. Actual returns and/or disposal may exceed or be less than those represented.

Cost Recovery Fee and Submission of Quarterly Sales Report

(a) Quarterly Reports. The Contractor shall report all actual credits received and total dollar value of disposal services under this contract as separate line items and submit collected 0.5% Cost Recovery Fees on dollar amount of credits received and value of disposal services 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 credits received and total dollar value of disposal services must include all credits received and total dollar value of disposal services made to all authorized contract users. The report shall reflect actual credits received and total dollar value of disposal services by separate line item and shall be segmented by the Department of Veterans Affairs (VA) and Other Government Agencies (OGA). A Cost Recovery Fee equivalent to 0.5% of the total actual credits received and total dollar value of disposal services shall be collected from all contract users. The 0.5% Cost Recovery Fee shall be imbedded in the awarded contract fees/prices, and offers submitted in response to this solicitation shall include the Cost Recovery Fee in every line item fee/price offered. The reported contract totals shall include the cost recovery fee and each quarterly report shall show the total cost recovery fee amount collected on the reported actual credits received and total dollar value of disposal services. The Contractor shall maintain a consistent accounting method of reporting, based on the Contractor’s established commercial accounting practice.

(2) Contract 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 credits or disposal services are performed during the contract period.

(3) The report signed by an authorized representative of the contractor shall be sent by mail or facsimile to the contracting officer. Mailed reports shall be sent to the address listed below. Facsimile transmissions may be made to: (708) 786-5221.

(4) In addition to the submission of quarterly reports due to the contracting officer within 60 days after the end of each reporting quarter, contractors shall provide copies of reports simultaneously with contractor’s cost recovery fee payment submissions via facsimile, to the attention of C.R. Agent Cashier, fax: (708) 786-7525.

(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 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.

(1) Cost recovery fee payments made electronically shall include the following information:

(2) 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:

(c) The Government reserves the right to inspect without further notice, such records of the Contractor as pertain to actual credits received or total dollar value of disposal services 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 Federal Acquisition Regulation (FAR) Subpart 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 clause, all other rights and remedies permitted by Federal law and statutes.

Guaranteed Contract Minimum The Government guarantees that the selected contract awardee will be able to generate a minimum of $2,500 in revenue for their performance of reverse distribution and disposal services under the contract resulting from this solicitation. Revenues are generated from the percentage fees for processing returns and price per pound for disposal services. Total revenues earned by the contractor will be monitored through the Corporate Dashboard requirement of the Statement of Work.

Evaluation of Offers Evaluation of offers will consist of price and non-price factors in accordance with 52.212-2 Evaluation – Commercial Items. To be considered for award, an offeror shall submit a Technical proposal and past performance information (See Instructions to Offerors, page 53). To be considered for award, offerors are required to submit a proposal for all line items inside and outside the Customs Territory of the United States for the base year and each of the four option years. Proposals the fail to submit a proposal for the base year and each of the four option years for all line items will be rejected and will receive no further consideration. Proposed fees/prices should take into consideration all contractor costs including, but not limited to: packaging, shipping, processing and any other applicable costs in the performance of reverse distribution and disposal.

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA

(continuation from Standard Form 1449, block 18A.)

1. Contract Administration: All contract administration matters will be handled by the following individuals:

a. CONTRACTOR:

b. GOVERNMENT: Contracting Officer 36C797 Department of Veterans Affairs National Acquisition Center (003A4C4) Building 37 1st Avenue, One Block North of 22nd St.

Hines IL 60141

2. CONTRACTOR REMITTANCE ADDRESS: All payments by the Government to the contractor will be made in accordance with:

3. INVOICES: Invoices shall be submitted in arrears:

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.

Government facilities per individual orders

ACKNOWLEDGMENT OF AMENDMENTS: The offeror acknowledges receipt of amendments to the Solicitation numbered and dated as follows:

B.2 MANDATORY WRITTEN DISCLOSURES

Mandatory written disclosures required by FAR clause 52.203-13 to the Department of Veterans Affairs, Office of Inspector General (OIG) must be made electronically through the VA OIG Hotline at http://www.va.gov/oig/contacts/hotline.asp and clicking on "FAR clause 52.203-13 Reporting." If you experience difficulty accessing the website, call the Hotline at 1-800-488-8244 for further instructions.

B.3 LIMITATIONS ON SUBCONTRACTING-- MONITORING AND COMPLIANCE (JUN 2011)

This solicitation includes FAR 52.219-14 Limitations on Subcontracting. Accordingly, any contract resulting from this solicitation will include this clause. The contractor is advised in performing contract administration functions, the CO may use the services of a support contractor(s) retained by VA to assist in assessing the contractor's compliance with the limitations on subcontracting or percentage of work performance requirements specified in the clause. To that end, the support contractor(s) may require access to contractor's offices where the contractor's business records or other proprietary data are retained and to review such business records regarding the contractor's compliance with this requirement. All support contractors conducting this review on behalf of VA will be required to sign an “Information Protection and Non-Disclosure and Disclosure of Conflicts of Interest Agreement” to ensure the contractor's business records or other proprietary data reviewed or obtained in the course of assisting the CO in assessing the contractor for compliance are protected to ensure information or data is not improperly disclosed or other impropriety occurs. Furthermore, if VA determines any services the support contractor(s) will perform in assessing compliance are advisory and assistance services as defined in FAR 2.101, Definitions, the support contractor(s) must also enter into an agreement with the contractor to protect proprietary information as required by FAR 9.505-4, obtaining access to proprietary information, paragraph (b). The contractor is required to cooperate fully and make available any records as may be required to enable the CO to assess the contractor's compliance with the limitations on subcontracting or percentage of work performance requirement.

B.4 SUBCONTRACTING COMMITMENTS--MONITORING AND COMPLIANCE (JUN 2011)

This solicitation includes VAAR 852.215-70, Service-Disabled Veteran-Owned and Veteran-Owned Small Business Evaluation Factors, and VAAR 852.215-71, Evaluation Factor Commitments. Accordingly, any contract resulting from this solicitation will include these clauses. The contractor is advised in performing contract administration functions, the CO may use the services of a support contractor(s) to assist in assessing contractor compliance with the subcontracting commitments incorporated into the contract. To that end, the support contractor(s) may require access to the contractor's business records or other proprietary data to review such business records regarding contract compliance with this requirement. All support contractors conducting this review on behalf of VA will be required to sign an “Information Protection and Non-Disclosure and Disclosure of Conflicts of Interest Agreement” to ensure the contractor's business records or other proprietary data reviewed or obtained in the course of assisting the CO in assessing the contractor for compliance are protected to ensure information or data is not improperly disclosed or other impropriety occurs. Furthermore, if VA determines any services the support contractor(s) will perform in assessing compliance are advisory and assistance services as defined in FAR 2.101, Definitions, the support contractor(s) must also enter into an agreement with the contractor to protect proprietary information as required by FAR 9.505-4, obtaining access to proprietary information, paragraph (b). The contractor is required to cooperate fully and make available any records as may be required to enable the CO to assess the contractor compliance with the subcontracting commitments.

VA797W-17-R-0003

Page 1 of Page 1 of Page 1 of Page 1 of Table of Contents

1. GENERAL

The purpose of this solicitation is to establish one contract with a reverse distributor with destruction capability, hereafter referred to as the Contractor, capable of assisting the Department of Veterans Affairs (VA), Indian Health Service (IHS), Bureau of Prisons (BOP), ICE Health Services Corps (IHSC), and other approved federal agencies as may be authorized in the future to participate in VA’s Pharmaceutical Prime Vendor (PPV) Program, in achieving maximum credit return and in processing any related pharmaceutical waste that may arise out of non-returnable pharmaceuticals. The contract will include two regions: Customs Territory of the United States which include the 50 states, the District of Columbia and the Commonwealth of Puerto Rico and outside Customs Territory of the United States which include the Virgin Islands, American Samoa, the island of Guam and the Philippines. The vast majority of service will be provided to Customs Territory of the United States; however there will also be nominal service required for American Samoa, the Virgin Islands, the island of Guam, and the Philippines. The Government's need for on-site and off-site processing function is imperative to assure optimum inventory control and to minimize the violation of laws and regulations, especially in the area of pharmaceutical waste disposal. The contractor shall be compliant with all applicable regulations related to hazardous waste handling.

It is the intent that an efficient returns processing method where expired pharmaceuticals shipped to a centralized reverse distributor will reduce total costs in the health care system Returns to be processed will cover expired pharmaceuticals and pharmaceuticals due to be expire within 120 days from authorized agencies approved to participate in the VA’s Pharmaceutical Prime Vendor (PPV) program. Contractor shall only accept OTCs and pharmaceutical products including unit dose and partial bottles any other products will be returned to the facility by the Contractor at the expense of the facility.

2. AWARDS

The Government intends to award one (1) Indefinite Delivery, Indefinite Quantity, Firm-Fixed Price contract, resulting from this solicitation for a potential five-year period of performance. The Government will make this award based on Technical Capability, Past Performance and Price. Service fees shall consist of a percentage of the estimated return value for expired or near expired pharmaceuticals and the costs associated with destruction of non-returnable pharmaceuticals. Estimated return value is the amount that is expected to be credited based on the pricing file and order of precedence outlined in paragraph 9 of the Statement of Work, on the date the material arrives at the Contractor’s processing facility. The proposed reverse distribution processing fee shall be a firm fixed fee of the percentage of estimated return value and should cover all the contractor’s costs including, but not limited to, packaging, shipping, processing and any other applicable costs or fees incurred in performance of reverse distribution services. Payments shall be based on the actual credits, not estimated or anticipated credits, thereby increasing the contractor’s incentive to obtain maximum credit amounts. The proposed waste disposal fee shall be a firm fixed fee based on the number of pounds of product destroyed. Award will be made in the aggregate for all line items inside and outside the Customs Territory of the United States including the base year and option year one through four. To be considered for award, offerors are required to submit a proposal for all line items inside and outside the Customs Territory of the United States for the base year and each of the four option years. Proposals that fail to include fees for the base year and each of the four option years for all line items will be rejected and will receive no further consideration.

3. ESTIMATED ANNUAL REQUIREMENTS

VA estimated pharmaceutical returns for 2016 were $27,498,329.43 and Other Government Agencies (OGA) estimated annual pharmaceutical returns were $3,668,022.15. VA estimated pounds of pharmaceutical disposal for 2016 were 656,193 pounds and OGA estimated annual pounds of pharmaceutical disposal were 31,959 pounds. OGA’s include Indian Health Service (IHS) facilities, Bureau of Prison facilities and the ICE Health Services Corps (ICE). Requirements from other federally approved agencies authorized to participate in VA’s PPV Program will be identified by the individual facilities requesting this service. The estimated volume for each facility listed in Attachment “A “ represents the Government’s best estimate of annual returns in dollars and pounds of disposal that will be made through resultant contracts. The Government guarantees that it will order a minimum of $2,500 from the contract awardee for the performance of reverse distribution services under any contract resulting from this solicitation. The total ceiling for all VA and OGA sales generated from the performance of reverse distribution service shall not exceed $760,000,000 for the entire performance period, inclusive of the base year all four option years and the 6 month option to extend.

4. REGULATORY COMPLIANCE

The Contractor shall be required to provide all plant, equipment, materials, and labor needed to process credit return and/or arrange for proper disposal of designated pharmaceuticals, including Schedule II-V controlled substances for the Customs Territory of the United States. Schedule II-V returns are not permitted from outside the Customs Territory of the United States. Contractor shall be responsible for complying with all applicable federal regulations such as the Code of Federal Regulation (CFR) Title 21 Food & Drugs, Title 29 Hazardous Materials, Title 40 Protection of the Environment, Title 49 Department of Transportation; U.S. Environmental Protection Agency (EPA), Occupational Safety and Health Administration (OSHA), Food and Drug Administration (FDA), Drug Enforcement Administration (DEA), 41 U.S.C. chapter 67, Service Contract Labor Standards and VA regulations. The Contractor shall also comply with applicable state/local regulations, and consult with regional offices of the federal regulatory agencies that have jurisdiction over their operations to ensure compliance with laws and regulations of host countries. Accordingly, the Contractor shall arrange for, recommend, and/or advise the returning drug distribution point of the proper means of transporting the returned products to the Contractor's central processing facility.

5. LICENSES, PERMITS, REGISTRATION, INSURANCE

All necessary permits and licenses required by Federal, state, and local authorities shall be acquired and maintained by the Contractor for the life of the contract. This includes required licenses, certifications, etc. for individual contractor staff as well as any required permits and licenses for interstate transport, and storage/disposal of hazardous and non-hazardous unserviceable and non-returnable items or returns. This includes but is not limited to DEA, DOT, EPA, FDA, OSHA and individual State regulations.

The Contractor shall be a licensed DEA registrant to handle Schedule II - V controlled substances. A copy of all renewals shall be forwarded to the NAC contracting officer for retention in the contract file. The Contractor shall have proper insurance coverage, including environmental remediation and be prepared to list the VA, IHS, BOP, IHSC and other approved federal agencies as additional insured if awarded a contract. A copy of such insurance coverage shall be provided to the Contracting Officer, upon request.

6. CONTRACTOR AND SUBCONTRACTOR LICENSE QUALIFICATIONS REQUIREMENTS

The Contractor and any respective subcontractors shall maintain all necessary licenses, permits and certifications required by the Resource Conservation and Recovery Act, Clean Air Act, Clean Water Act, Occupational Safety and Health Administration, and all licenses and permits required by local agencies for reverse distribution operations. All vehicles shall have proper State and Federal Department of Transportation (DOT) licenses required for the transportation of hazardous wastes for each jurisdiction in which they will be operating under this contract.

7. SHIPPING/PROCESSING ARRANGEMENTS

The VA, IHS, BOP, IHSC, and other approved federal agencies will contact the Contractor directly to arrange for a return shipping date. The Contractor shall provide all instructions, forms, labels and DEA approved tamper-proof pouches needed to ship the designated items to a Contractor's central processing facility. Facilities will make the determination whether to have a Contractor work on-site to list all pharmaceuticals and prepare their outdated products for shipment to the reverse distribution facility for processing or have the Contractor provide off-site service. Whether the returns are processed using the Contractor’s on-site representative or via off-site processing, the Contractor is responsible for the shipment and associated costs from the facility to the Contractor’s reverse distribution facility. For areas outside the Customs Territory of the United States, the Government is responsible for the shipment and associated costs of transport to a stateside port of entry and the Contractor shall be responsible for the carrier’s shipment costs from the stateside port of entry to the Contractor’s reverse distribution facility for both onsite and offsite processing. Facilities will notify the reverse distributor of the port of entry location and the reverse distributor will make arrangements for pickup of product. For both on-site and off-site service, disposition shall be provided to each facility via the web-based service request ordering system within three (3) days after processing is complete.

If on-site service is desired, the Contractor shall provide on-site servicing within ten (10) business days from the date of the facility request. When proposing fees in response to this solicitation, the Contractor shall anticipate, at a minimum, 12 on-site visits within a calendar year per facility. Facilities requiring more than 12 on-site visits within a calendar year may be subject to additional fees per additional visits, such fees shall be negotiated at the order level by the cognizant Contracting Officer. The Contractor shall not separate returnable from non-returnable pharmaceuticals on-site, instead the Contractor shall package the designated returns and transport them to the Contractor’s facility where the determination will be made concerning product that is returnable and product that is waste. The Contractor shall prepare a list of pharmaceuticals removed from the pharmacy and the facility must validate the contents of the list for accuracy. Any discrepancies shall be resolved prior to the removal of the pharmaceuticals from the facility by the Contractor. The Contractor shall remove or pick up controlled substance returns from the facility by close of business the same day as service is completed and boxed for return. Large or special pickups requiring separate removal shall be scheduled within 48 hours of service, and daily updates will be provided to the facility until pickup is complete. Chain of custody paperwork shall be prepared for controlled substances and given to the returning facility by the Contractor at the time the package(s) are prepared for shipment. Within thirty (30) days of receiving the returned goods, the Contractor shall process all designated items by sorting, listing, and processing items through either a manufacturer's credit program or through the disposal process in accordance with all applicable federal, state and local regulations. The Contractor shall comply with any participating customers’ additional security requirements and procedures for access to facilities. All costs associated with gaining access to any customer facility shall be the responsibility of the Contractor.

8. BUREAU OF PRISONS (BOP) AND ICE HEALTH SERVICES CORPS (IHSC) SPECIFIC CUSTOMER SERVICE REQUIREMENTS Prospective contractors are advised that due to certain restrictions within the Bureau of Prisons and ICE Health Services Corps, contractor representatives that enter the secure confines of BOP or IHSC facilities/institutions will be subject to the following investigational procedures. (NOTE: These investigative procedures will not be required in situations where routine visits do not require entry into the secured BOP/IHSC facility).

a. National Crime Information Center (NCIC) Check

b. Completion of the Contractor Pre-Employment Form

c. Daily possession of a valid picture identification and daily entry into secured facility via metal detector Employees such as Customer Service representatives that need ongoing entry into secured BOP/IHSC institutions will also need to provide a fingerprint check and a name check at the discretion of the BOP/IHSC facility.

9. PHARMACEUTICALS QUALIFYING FOR MANUFACTURER'S RETURN

Products qualifying for manufacturer’s return are pharmaceuticals, including partials pharmaceuticals, in the original manufacturer containers. Everything else is considered waste and facilities must follow applicable federal, state, and local laws and ordinance for waste disposal. For pharmaceuticals that qualify for manufacturer’s return, the Contractor shall provide the returning facility a report stating the Estimated Return Value (ERV) of those items. The ERV will be used by the customer and the Contractor as an estimate for the amount that is expected to be credited. To obtain the manufacturer's ERV the Contractor shall use the file at http://www.pbm.va.gov/DrugPharmaceuticalPrices.aspx. Because there are daily price changes, the date to be used for the pricing file is the date the material arrives at the reverse distributor’s processing facility. The file is a dBase III compatible database (.DBF) file.

To determine the appropriate price to establish the ERV, the contractor shall use the following order of precedence, and as eligibility for these prices dictates:

1. National Contract Price (NC_Price)

1. VA Federal Supply Schedule Price Restricted (VA_FSS)

1. BIG 4 Price (Big4_Price)

1. Federal Supply Schedule Price (FSSPrice) If an item does not appear in the database, then the contractor shall use the Wholesale Acquisition Cost (WAC) as the basis for establishing the ERV for that item. The contractor shall use the prices published by First Data Bank as the source for obtaining the WAC prices.

Single Order Processing: Single order processing is required for each visit/pickup/package sent. No batch processing.

10. PHARMACEUTICALS INELIGIBLE FOR CREDIT FROM MANUFACTURER

The Contractor shall list all items (including non-controlled and controlled substances and non-hazardous and hazardous substances) designated for disposal on a disposal manifest. This list will include at a minimum product name, National Drug Code (NDC) or catalog number, quantity, total estimated return value, and reason for non-eligibility for credit. Separate manifests shall be provided for the disposal of Schedule II – V controlled substances and when disposing of hazardous waste products as defined by the EPA Resource Conservation and Recovery Act (RCRA) regulations. A Certificate of Destruction including the disposal date, destruction method, destruction location, weight, disposal company name and proof of destruction affidavit shall be provided to the returning facility and maintained on the reporting website upon completion of destruction. All Manifests shall be provided to the returning facility within 30 calendar days of Contractor's item receipt, with the exception of the Certificate of Destruction/Affidavit which shall be provided within 30 days of the completion of destruction. Shipments to the Contractor that require transport to the disposal location shall be done via approved and licensed vehicles in accordance with federal, state, and local laws and regulations where the processing will be completed. Contractor spills or releases of toxic/hazardous substances into the environment shall be reported to the returning facility immediately.

11. PAYMENTS

This contract is issued under Exchange/Sale Authority, allowing the government to retain reverse distributed pharmaceutical proceeds for the sole purpose of procuring additional pharmaceuticals. Such proceeds are referred to as “credits” throughout this contract to align with commercial practice. The payment of return fees and disposal services to the Contractor based on the Estimated Return Value (ERV) obtained from the pricing file in paragraph 9 of the Statement of Work will be paid by the Government and NOT out of facilities’ credits after actual credits are obtained from the manufacturer through the VA Pharmaceutical Prime Vendor (PPV). When actual credits are received, the Contractor shall update its database reflecting the actual credits received from the manufacturer and reconcile the difference between the estimated return value and the actual credits received based on the manufacturers’ credit memos. Credit memos must be requested by the Contractor from the manufacturers for all credits issued. Credit memos will be provided by the Contractor to each facility receiving credits and used by each facility for comparison of records/transactions of credits pending, credits received. On a quarterly basis, the Contractor and each agency/facility will work together to reconcile any discrepancies between the facility records and the Contractor records. The exact payment amount to be made to the Contractor shall include only the awarded contracted fee for return and disposal services as defined under paragraph 2, Awards and shall be paid directly from the Government not through credits.

To ensure adequate tracking of credits from inception to disposition, the Contractor shall provide the PPV confirmation of itemized credit statements received from the manufacturers at least on a monthly basis. The contractor shall instruct manufacturers to issue all credits directly to the PPV since the PPV has credit accounts established for each authorized user of the PPV Program for purposes including reverse distribution. Any credits received by the Contractor from the manufacturer shall be forwarded to the PPV within ten (10) business days from date of receipt. In addition, each agency/facility that receives credits directly from the manufacturers as a result of reverse distribution processing will be instructed to notify the Contractor of receipt of such credits so that the Contractor can update their electronic reporting system. Credits will be deposited into the individual facility accounts by the PPV upon receipt of itemized credit statements for each individual facility provided by the Contractor. The credit statements provided by the Contractor to the PPV shall include the customer account number and appropriate invoice number to facilitate this process and for tracking purposes. Based on the above, any arrangements to facilitate the processing of credits through the PPV must be made solely between the Reverse Distributor and the PPV. Any fees associated with this arrangement shall not be removed from the facility credits due. Credits may NOT be used by VA PPV customers for additional value added services from the Contractor, such as report customization or additional site visits, for VA facilities.

Within 15 days from receipt of award, the VA National Acquisition Center Contracting Officer shall be notified by the contractor awarded a contract under this solicitation if any business-to-business-agreements cannot be reached with the VA PPV. Failure or refusal to reach agreement with the VA 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 unless such failure is unintentional and for valid and justifiable reasons despite good faith discussions.

The Contractor is encouraged to establish a working relationship with each manufacturer and comply with each manufacturer’s return goods policy to ensure maximum credit receipt and reduce the cost of returning non-returnable items. The Contractor is responsible for contacting the manufacturer to ensure that credits are received in accordance with the negotiated timeframe stated in each return goods policy and to assist in resolving issues of inadequate or non-payment of outstanding credits. If manufacturers have an established reverse distributor that handles their credit and return process, the awarded Contractor shall make every effort to work with these reverse distributors that have current agreements directly with the manufacturers.

NOTE: There may be instances where more favorable return good policies have been negotiated on Federal Government contracts. In order to take advantage of more favorable return policies, the Government Contracting Officer will assist in providing a copy of the negotiated agreement(s) to the Contractor. There may be manufacturers that will only accept returns directly from the facility and will only provide credits through their own reverse distributor. If known, the Contractor shall identify in its proposal, those manufacturers that will not accept products through this Reverse Distribution Program.

12. WEB-BASED SERVICE REQUEST ORDERING SYSTEM

The contractor shall provide an 800 number and a web-based service request ordering system for work order placement by customers. At a minimum, the system shall include entry fields for Facility Name, Address, City, State, Zip Code, Contact Name, Phone Number, E-mail, DEA Number, Desired Pickup Date, Description of Returns and Estimated Quantity. In addition, the web-based service request ordering system shall allow for electronic order confirmation, inventory status of credits, credit reconciliation, and reporting capabilities to allow facilities to track from inception of product to credit disbursement and/or disposal.

13. AREAS OUTSIDE THE CUSTOMS TERRITORY OF THE UNITED STATES

Please note: Currently, no Schedule II-V controlled substances are allowed to be returned from any area outside the Customs Territory of the United States.

The Contractor shall provide on-site or off-site service to facilities as requested. The Contractor shall be responsible for all transportation, lodging, telecommunications requirements or any costs incurred to support their overseas service representatives. The Contractor shall provide all equipment, materials, and labor needed to process material to be returned.

For on-site service, the Contractor’s overseas representatives shall travel to any area outside the Customs Territory of the United States. The Contractor shall prepare all material for shipping. Each box shall have a copy of the list of pharmaceuticals inside the box. The Contractor shall prepare a list of pharmaceuticals removed from the pharmacy and the facility must validate the contents of the list for accuracy. Any discrepancies shall be resolved prior to the removal of the pharmaceuticals from the facility by the Contractor. The Contractor shall provide all instructions, applicable forms, and labels needed to ship designated items to the Contractor’s processing facility. Chain of custody paperwork shall be prepared for controlled substances and given to the returning facility by the contractor at the time the package(s) are prepared for shipment. Coordination with local transportation assets remains the responsibility of the activity involved. The Government is responsible for the shipment and associated costs of transport to a port of entry location and the Contractor shall be responsible for the carrier’s shipment costs from the port of entry location to the Contractor’s reverse distribution facility. The Contractor may assist the facility with any questions concerning transportation but shall not ship any material for them.

14. REVERSE DISTRIBUTION PROGRAM ELIGIBLE FACILITIES

Government Participants. The contractor shall provide reverse distribution services at the…