Reverse_Distribution_RFP_FINAL_Update_8.4.docx

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1. THIS CONTRACT IS A RATED ORDER

UNDER DPAS (15 CFR 700)

RATING

2. CONTRACT NO.

N/A

3. SOLICITATION NO.

RFP-17-100-SOL-00023

8/04/2017

6. REQUISITION/PURCHASE NO.

N/A

8. ADDRESS OFFER TO (If other than Item 7)

HHS/OS/ASPR/AMCG

200 C Street, S.W.

Washington, DC 20024

NOTE: In sealed bid solicitations “offer” and “Offeror” mean “bid” and “bidder.”

SOLICITATION

(Hour) (Date) (Hour)

CAUTION -- LATE Submissions, Modifications, and Withdrawals: See Section L, Provision No. 52.214-7 or 52.215-1.

All offers are subject to all terms and conditions contained in this solicitation.

10. FOR INFORMATION

CALL:

A. NAME

Minnie Wright

a. TELEPHONE (NO COLLECT CALLS)

(202) 260-1460

b. E-MAIL ADDRESS minnie.wright@hhs.gov

11. TABLE OF CONTENTS

((x)PAGE(S)

SEC.

SEC.

PAGE(S)

PAGE(S)

SEC.

SEC.

PAGE(S)

DESCRIPTION

(x)

DESCRIPTION

XK

REPRESENTATIONS, CERTIFICATIONS, AND

OFFER (Must be fully completed by Offeror)

NOTE: Item 12 does not apply if the solicitation includes the provisions at 52.214-16, Minimum Bid Acceptance Period.

12. In compliance with the above, the undersigned agrees, if this offer is accepted within ___150___calendar days (60 calendar days unless a differentCALENDAR DAYS

CALENDAR DAYS

14. ACKNOWLEDGMENT OF AMENDMENTS

(Type or Print)

(Type or Print)

CODE

FACILITY

16. NAME AND ADDRESS OF PERSON AUTHORIZED TO SIGN OFFER

15B. TELEPHONE NO.

AREA CODE NUMBER EXT.

18. OFFER DATE

AWARD (To be completed by Government)

19. ACCEPTED AS TO ITEMS NUMBERED 20. AMOUNT

22. AUTHORITY FOR USING OTHER THAN FULL AND OPEN COMPETITION:

21. ACCOUNTING AND APPROPRIATION

26. NAME OF CONTRACTING OFFICER (Type or print)

27. UNITED STATES OF AMERICA

(Signature of Contracting Officer)

28. AWARD DATE

IMPORTANT -- Award will be made on this form, or on Standard Form 26, or by other authorized official written notice.

FAR (48 CFR) 53.214

NOTE TO OFFERORS

The information in SECTION A - Solicitation/Contract Form, contains important information for any Offeror interested in responding to this solicitation. Any contract resulting from this solicitation will include in its SECTION A - Solicitation/Contract Form, accounting, appropriation, and general information applicable to the contract award.

The contract schedule, set forth in SECTIONS B through H, contains contractual information pertinent to this solicitation. It is not an exact representation of the contract document that will be awarded as a result of this solicitation. The contract price or price and other contractual provisions unique to the Offeror's proposal may be included in the resultant contract.

The contract schedule is intended to provide the Offeror with information to aid in understanding the likely terms and conditions of any resultant contract.

PART I – THE SCHEDULE

Section B – Supplies or Service and Cost/Price

ARTICLE B.1. BRIEF DESCRIPTION OF SUPPLIES OR SERVICES

This Request for Proposal (RFP) (RFP-17-100-SOL-00023) solicits offers for reverse distribution services for the disposal of medical supplies, pharmaceuticals, and biohazard items in accordance with existing regulations and laws on behalf of the Office of Emergency Management (OEM) within the office of the Assistant Secretary for Preparedness and Response (ASPR) at the U.S. Department of Health and Human Services (HHS) located in Washington, D.C.

The NAICS Code is 562112: Hazardous Waste Collection.

The small business size standard is $38.5 million.

ARTICLE B.2. CONTRACT TYPE

The Government intends to award a single-award Indefinite Delivery, Indefinite Quantity (IDIQ) contracts for the services identified in SECTION C, after evaluation of offers. During the period of performance of the contract, the Government may order, and the Contractor shall provide, services as identified in future Task Orders. At the discretion of the Government, Task Orders issued under this contract will primarily be Firm-Fixed Price, but may contain a cost reimbursable line item for disposal services.

ARTICLE B.3. SUPPLIES OR SERVICES

The contractors shall provide services set forth in SECTION C.

ARTICLE B.4. CONTRACT DEFINITION – INDEFINITE DELIVERY/INDEFINITE QUANTITY

This is a single-award indefinite-delivery, indefinite-quantity contract as defined in Subpart 16.5 of Federal Acquisition Regulation (FAR). Services provided by the successful contractor under the resulting contract shall be secured by the issuance of delivery (for supplies) or task (for services) orders placed in accordance with the following clauses: FAR 52.216-18 – Ordering, FAR 52.216-19 Order Limitations and the Ordering Procedures in FAR § 16.505.

ARTICLE B.5. ADVANCE UNDERSTANDINGS

The final contract may contain additional advance understandings between the Government and the Offeror.

B.5.1. Minimum and Maximum Ordering Amounts

The Government estimates that each selected contract awardee will be able to generate a minimum of $2,500 in revenue for their performance of reverse distribution services under any contract resulting from this Statement of Work. Total revenues earned by the contractor will be monitored through the Corporate Dashboard requirement of the Statement of Work. The maximum revenue to be generated from the performance of reverse distribution services by any selected contract awardee resulting from this solicitation shall not exceed $2.5 million for the entire performance period, inclusive of the base year and all four option years.

Revenues are generated from the percentage of fees for processing returns and price per pound fees for disposal services and transportation. Total revenues earned by the contractor will be monitored through the web-based reporting tool requirement of the Statement of Work.

See SECTION G.4. for further ordering information and procedures.

ARTICLE B.6. FUNDING

The Contractor will only be paid for effort that has been authorized by the Government and performed in accordance with the contract specifications, except for the minimum amount guaranteed (Section B.5.1).

ARTICLE B.7. CLIN STRUCTURE

All prices are firm-fixed price, with the exception of the processing of special waste disposal and hazardous waste disposal which will be done on a cost reimbursable basis with a Not To Exceed amount of $30,000. Any additional expenses beyond $30,000 resulting from the processing of special waste disposal and hazardous waste disposal are the responsibility of the contractor on a per pound basis. For the returnable products, please propose a percentage of the total returns processed that the Government will receive as a credit. For the non-returnable products, please propose a cost per pound for disposal.

Processing of Returnable Products On-Site

Period of Performance: TBD, 2017-2018

Processing of Returnable Products Off-Site

Period of Performance: TBD, 2017-2018

Processing of Special Waste Disposal and Hazardous Waste

Non-Returnable, Non-Hazardous Products and Non-Returnable Biohazard Products

Period of Performance: TBD, 2017- 2018

$30,000.00

Additional Processing of Special Waste Disposal and Hazardous Waste

Non-Returnable, Non-Hazardous Products and Non-Returnable Biohazard Products

Period of Performance: TBD, 2017- 2018

Processing of Returnable Products On-Site

Period of Performance: TBD, 2018-2019

Processing of Returnable Products Off-Site

Period of Performance: TBD, 2018-2019

Processing of Special Waste Disposal and Hazardous Waste Disposal

Non-Returnable, Non-Hazardous Products and Non-Returnable Biohazard Products

Period of Performance: TBD, 2018-2019

$30,000.00

Additional Processing of Special Waste Disposal and Hazardous Waste Disposal

Non-Returnable, Non-Hazardous Products and Non-Returnable Biohazard Products

Period of Performance: TBD, 2018 - 2019

Processing of Returnable Products On-Site

Period of Performance: TBD, 2019-2020

Option Year 2

Processing of Returnable Products Off-Site

Period of Performance: TBD, 2019-2020

% of Actual Credit Received

TBD

Processing of Special Waste Disposal and Hazardous Waste Disposal

Non-Returnable, Non-Hazardous Products and Nonreturnable, Biohazard Products

$30,000.00

Additional Processing of Special Waste Disposal and Hazardous Waste Disposal

Non-Returnable, Non-Hazardous Products and Nonreturnable, Biohazard Products

Processing of Returnable Products On-Site

Period of Performance: TBD, 2020-2021

Processing of Returnable Products Off-Site

Period of Performance: TBD, 2020-2021

Processing of Special Waste Disposal and Hazardous Waste Disposal

Non-Returnable, Non-Hazardous Products and Non-Returnable, Biohazard Products

Period of Performance: TBD, 2020-2021

$30,000.00

Option Year 3

Additional Processing of Special Waste Disposal and Hazardous Waste Disposal

Non-Returnable, Non-Hazardous Products and Non-Returnable, Biohazard Products

Period of Performance: TBD, 2020-2021

Processing of Returnable Products On-Site

Period of Performance: TBD, 2021-2022

Processing of Returnable Products Off-Site

Period of Performance: TBD, 2021-2022

Processing of Special Waste Disposal, and Hazardous Waste Disposal

Non-Returnable, Non-Hazardous Products and Non-Returnable, Biohazard Products

Period of Performance: TBD, 2021-2022

$30,000.00

Additional Processing of Special Waste Disposal, and Hazardous Waste Disposal

Non-Returnable, Non-Hazardous Products and Non-Returnable, Biohazard Products

Period of Performance: TBD, 2021-2022

Contract Total

TBD

Section C – STATEMENT OF WORK (SOW)

ASPR/OEM/Logistics Reverse Distribution

ARTICLE C.1. REQUIRING ORGANIZATION

Department of Health and Human Services OS/ASPR/OEM/Logistics 200 Independence Ave, SW C1J23 Washington DC 20201

ARTICLE C.2. OBJECTIVE

The purpose of this Statement of Work (SOW) is to establish a contract with a reverse distributor, hereafter referred to as the Contractor, capable of assisting the Department of Health and Human Service (HHS), the Office of the Assistant Secretary for Preparedness and Response (ASPR), Office of Emergency Management (OEM) in achieving maximum credit and proper disposal for the return of expired or soon to be expired pharmaceuticals, medical surgical consumables, and/or biohazards. The contract will include all 50 United States and U.S. territories.

ARTICLE C.3. BACKGROUND

ASPR provides emergency medical care to the victims of public health emergencies and catastrophic events that overwhelm the capacity of State and Local Emergency Medical Systems when responding to disasters. ASPR currently has teams located across the nation that are prepared to deploy within hours to respond to an all hazards environment. ASPR has positioned medical supplies caches/kits at various locations around the Continental United States, Alaska, Puerto Rico, and Hawaii. These caches/kits consist of medical surgical supplies and pharmaceuticals that must be in a constant state of readiness for immediate use to meet operational requirements. Maintaining these caches/kits creates a steady flow of expired biohazard, medical surgical supplies, and pharmaceuticals. Local, State, and Federal regulations prohibit simply discarding these items due to the potential for diversion and contamination of local water/land fill sites.

ARTICLE C.4. SCOPE

The purpose of this SOW is to establish contract terms between the DHHS/ASPR/OEM and the reverse distribution Contractor. ASPR requires proper disposal of medical supplies, pharmaceuticals, and biohazard items in accordance with existing regulations and laws.

During a disaster, ASPR will experience an increase in disposal needs to include biohazards. The exact amount of increase will be an unknown in advance and may vary considerably depending on the disaster response.

The resulting contract between Contractor and ASPR allows for pick-up, sorting, and accountability for biohazard, medical surgical and pharmaceutical expired and/or unusable product. At time of pick up product may not be expired but is deemed unusable due to exposure to extreme heat or cold, vermin contamination, or other factors affecting the quality of the products.

The resulting reverse distribution contract will be for both preparedness and disaster responses. The resulting contract for disposal services will allow for increased volume when indicated.

An Offeror must include price for destruction, service fees, anticipated profit percentage, and other value added services with their proposal, i.e., other services directly relating to reverse distribution such as additional report customization, additional site visits (more than 12 across all sites in a calendar year as required by the SOW), or any other services that exceed the minimum requirements stated in the SOW. The Offeror must propose reverse distribution of pharmaceuticals, medical surgical consumables and biohazards. Value added services will not be evaluated as part of the contract award process. Any value added service not directly related to reverse distribution and/or not derived from an element of the SOW will not be included under a contract awarded via this SOW.

The services involved under this SOW shall include, but are not limited to, the following requirements:

Nationwide Service:

· The Contractor shall provide pick up services at HHS Mission Support Centers in CA, MD and TX and Regional Facilities in GA, PR, HI, AK and all regions of the United States and its territories. The Contractor shall provide a list or map stating the locations of their processing centers and the areas they service.

· The Contractor must be able to pick up or ship expired/unusable product from all sites at least quarterly during steady state operations. The amount of product at pick up could be up to a truck load or more. The contractor must demonstrate the capacity to manage large volumes on a routine basis.

· The Contractor must demonstrate the ability to outsource their reverse distribution services provided they are unable to meet the volume needs when ASPR has a surge of activities and is generating higher volumes of expired/unusable product. The Contractor must have the capacity for pick up from other ASPR designated locations in addition to the Mission Support Centers located in CA, MD, and TX, and the Regional Facilities located in GA, PR, HI, and AK.

Customer Service:

· The Contractor shall provide a Customer Service Representative assigned to the account that shall assist with day-to-day requirements. Examples of Contractor support shall include: coordinating the transportation, accountability of prescription medications and controlled substances.

· Contractor operations must have a footprint sufficient to cover ASPR’s geographically wide needs. The Contractor must provide a map of their facility owned reverse distribution centers. This map must be updated and must be provided upon request at any given time.

· The Contractor shall maintain and identify key personnel to respond to Government requests on their behalf at various nationwide locations.

· The Contractor shall provide a single initial supervisory or alternate point of contact to ASPR for coordinating the overall processing of returns and disposal operations.

Contractor Availability and Quality of Service:

· The Contractor shall be willing to work with ASPR to provide disposal services in accordance with this SOW.

· The Contractor shall pick up, properly pack and label the medical surgical consumables, biohazards and pharmaceutical products on site to ensure safe transportation by ordinary handling.

Delivery of Service:

· The management of biohazard, medical surgical and pharmaceutical returns requires maximum coordination between ASPR and the Contractor; however the Contractor shall be responsible for total management of these items during the period of performance including pick up, sorting and disposal.

· The Contractor shall be responsible for the transportation of ASPR’s returns to locations specified by the Contractor for disposable and reverse distributing operations.

· The Contractor shall provide immediate telephonic notification to the Contracting Officer (CO) of any accident or incident involving the cargo which results in any delay, loss, or damage to the expired medical supplies.

· When requested by ASPR, the Contractor shall liaise with ASPR personnel to arrange for pickups at alternate destinations within an increased security perimeter. Arrangements may include a request for positive driver identification of those handling shipments which includes advance photos via email.

· Some materials for disposal may not be eligible for reverse distribution. The Contractor is still expected to pick up and dispose of those materials within the scope of its licenses.

Data Support Service:

· The Contractor shall provide a detailed returns report by manufacturer to each returning facility within 30 calendar days after processing for all returns.

· This report should include at a minimum, the contract number, applicable task order, Return Authorization Number, product name, NDC, lot or batch number, quantity, return value and fee’s associated with returns processing.

· Also, the report shall include a list of returnable pharmaceuticals and medical surgical consumables by manufacturer with actual credits clearly identified; a list of non-returnable pharmaceuticals, medical surgical consumables, and/or biohazards with the cost for disposal; credit reports showing both estimated credits and actual credits received; and cost reports identifying contractor fees for return.

· The contractor shall also provide separate reports for Schedule II-V controlled substances and destruction costs for hazardous items. For on-site service, chain of custody paperwork shall be prepared and given to the returning facility by the contractor at the time the package(s) are prepared for shipment.

· The Contractor shall provide a web-based reporting tool that at a minimum can generate the following reports for customer visibility:

· Monthly Status Reports of credit receipts listing the contract/order or invoice number, manufacturer, estimated return value, actual return value, and pending credits from the contractor to the facility.

· Monthly Reconciliation Reports for each individual account. Reconciliation data shall include but not be limited to NDC, quantity, product name, manufacturer, strength, package size, and form.

· Quarterly Roll-Up Reports which include, the Earned Return Value (ERV) for returnable items, disposal costs for non-returnable items, all line item charges associated with reverse distribution processing and disposal, credits received, and credits pending.

Pick up and disposition of inventory:

· The contractor shall provide a statement for services rendered listing all items processed and annotating returnable and non-returnable items to the Contracting Officer and the Contracting Officer Representative within 7 days of providing the credit.

Other:

· The Contractor shall provide a disaster operations plan to ensure continued operations if one or several reverse distribution sites are affected.

· This SOW represents the entire terms between the parties. Any modification of a resulting contract shall be invalid unless in writing and signed by an authorized representative of the Contractor, and an appropriate Officer of ASPR.

· A waiver of any defaults hereunder shall not be deemed a waiver of any other or subsequent default.

· This contract will be governed by and constructed in accordance with the federal laws of the United States of America without regard to or application of any conflict of law principles.

ARTICLE C.5. TECHNICAL REQUIREMENTS/TASKS

The Contractor shall be required to provide all facilities, equipment, materials, and labor needed to process credit returns and/or arrange for proper disposal of designated pharmaceuticals, medical surgical consumables and/or biohazards, including Schedule II-V controlled substances. The 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 (DOT); U.S. Environmental Protection Agency (EPA), Occupational Safety and Health Administration (OSHA), Food and Drug Administration (FDA), Drug Enforcement Administration (DEA), and Department of Defense (DoD) 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 Mission Support Centers and Regional Facilities of the proper means of transporting the returned products to the Contractor's central processing facility.

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, permits, and any other requirements 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 Contracting Officer for retention in the contract file.

HHS/ASPR will contact the Contractor directly to schedule an appointment to process returns; all appointments should be scheduled within 10 days. The frequency of these appointments may be monthly, bi-monthly, or quarterly at each Mission Support Center, Regional Facility and other locations as needed.

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. HHS/ASPR will make the determination whether to have a Contractor work on-site to inventory all pharmaceuticals, medical surgical consumables, and/or biohazards and prepare their outdated products for shipment to the reverse distribution facility for processing or have the Contractor provide off-site service, the exception is for schedule II-V controlled substances which will be inventoried and packaged on site for shipment. If on-site service is desired, the Contractor shall provide on-site servicing within a reasonable period of time, preferably within ten business days from the date of the facility request. The Contractor shall not separate returnable from non-returnable items 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 non-returnable. However, all controlled substance 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 substances from the facility by close of business the same day inventory is completed and boxed for return. In addition, the Contractor shall comply with any participating customers’ additional security requirements and procedures for access to facilities. Any and all costs associated with gaining access to a customer facility shall be the responsibility of the Contractor. Within 30 days of receiving the returned goods, the Contractor shall process all designated items by sorting, inventorying, 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. 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 pharmaceuticals that qualify for manufacturer’s return, the Contractor shall provide the returning facility and the COR 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 only. The payment of return fees to the Contractor will be based solely on the Actual Return Value (ARV) obtained from the manufacturer.

Contractor shall obtain and complete all manufacturers' return authorization forms. If it is the manufacturer's policy to send these forms directly to the returning facility (HHS), that facility will forward the forms to the Contractor.

Contractors can work with 3rd party reverse distributors that have current agreements with the manufacturers.

The Contractor is encouraged to establish a working relationship with each returning facility and the Contracting Officer Representative to ensure maximum credit receipt and reduce the cost of returning non-returnable items. The Contractor is responsible for contacting the manufacturer to assist in resolving issues of inadequate, or non-payment of, outstanding credits.

The Contractor shall list all items including: pharmaceuticals, controlled substances, non-hazardous, hazardous, and medical surgical items designated for disposal on a Certificate of Destruction. This list will include at a minimum, the contract number, product name, National Drug Code (NDC), quantity, total estimated return value, and reason for non-eligibility for credit. Separate reports 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. The Certificate of Destruction should also include the disposal date, destruction method, destruction location, and disposal company name. A proof of destruction affidavit shall also be provided to the returning facility upon completion of destruction as part of the Certificate. All reports 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 and Contracting Officer immediately. For on-site service, chain of custody paperwork shall be prepared and given to the returning facility by the contractor at the time the package(s) are prepared for shipment.

Payments to the Contractor for the return and disposal processes will be funded from the credits received by the Contractor on behalf of HHS from each manufacturer. The Contractor will take their fees from the credits received from the manufacturers and the remaining balance will be sent to accounts HHS/ASPR/OEM identifies. The Contractor shall exercise its discretion in allocating the credit amount that it is to receive and the amount that shall be returned to the Government.

The contractor shall provide the Government with itemized credit statements for each individual facility serviced by the Contractor. Credit statements shall include the customer account number and appropriate invoice number to facilitate this process and for tracking returns. Prior to processing any returns for the Government, the Contractor shall be notified by the Government POC as to where each Government credit shall be deposited as the Government’s needs may vary throughout the life of this contract. Credits will then be deposited into the HHS/ASPR/OEM account of the Government’s choosing.

The Contractor shall provide a return detail report by manufacturer to each returning facility within 30 calendar days after processing for all credit returns. This report should include at a minimum, the contract number and applicable task order number or return authorization, product name, NDC, lot or batch number, quantity, and actual return value. Also, the report shall include a list of returnable pharmaceuticals and medical surgical consumables by manufacturer with actual credits clearly identified; a list of non-returnable pharmaceuticals, medical surgical consumables, and/or biohazards with the cost for disposal; credit reports showing both estimated credits and actual credits received; and cost reports identifying contractor fees for each return. The contractor shall also provide separate reports for Schedule II-V controlled substances and for hazardous waste.

The Contractor shall provide, at no cost to the Government, orientation and training at the facility level on the various reports and functionality of reports to assist the facilities in monitoring and tracking potential credits. Training shall be provided on-site at each participating Government facility within thirty (30) calendar days after the Contractor receives notice that they have been requested to perform reverse distribution services at that facility. The contractor shall notify all sites within seven (7) calendar days before the date of their scheduled training. Training shall cover at a minimum the following:

· Full web access and reports training, including targeted data extrapolation.

· Reconciliation reports between estimated and actual credits.

· Potential inventory management strategies.

In addition, the Reverse Distributor shall provide updates and system changes, and training on these changes as they occur throughout the term of the contract in a format acceptable to the facility, e.g., on-site, on-line, written material, etc. A contact person and telephone number shall be provided to each facility in the event additional instruction is necessary or if there is a change in personnel.

The contractors shall provide a toll free phone number and a web-based service request ordering system for work order placement by the government. 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 Service 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.

The contractor shall provide reverse distribution services for the facilities listed below:

a. Mission Support Center MD (Frederick, MD)

b. Mission Support Center TX (Grand Prairie, TX)

c. Mission Support Center CA (Rancho Cordova, CA)

d. Regional Facility AK (Anchorage, AK)

e. Regional Facility HI (Aiea, HI)

f. Regional Facility GA (Atlanta, GA)

g. Regional Facility PR (San Juan, PR) The Government intends to issue task orders against an awarded Indefinite Delivery, Indefinite Quantity, Firm Fixed Price, no cost contract as a result of this solicitation. The exact number of Task Orders issued will be at the sole discretion of the Contracting Officer. However, the intent is to issue one task order per year for standard reverse distribution service at all of the above facilities, and to issue additional task orders in response to emergencies as needed. The Government will make this award based on the lowest-priced offers that are considered technically acceptable in accordance with the solicitation requirements and whose service fees are determined fair and reasonable. Awards will be made in the aggregate for all line items inside and outside the Territory of the United States including the base year and option year one through four. 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.

For returnable items, the proposed service fees shall be a firm fixed fee stated as a percentage of the actual credits to be received for expired or near expired medical product eligible for return to manufacturers or other vendors for credit.

The proposed disposal price shall be a firm fixed price per pound based on the non-returnable pharmaceuticals, medical surgical consumables and/or biohazard categories and the number of pounds associated with destruction as each. The contractor will receive a NTE amount of $30,000.00 in cost-reimbursable funding to aid in the cost of the destruction and disposal of non-returnable items.

Proposed fees/prices 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. Should costs for disposal exceed refunds the contract is receiving (through reverse distribution), the Contractor should contact the Government to negotiate a mutually beneficial solution.

ARTICLE C.6. GOVERNMENT FURNISHED RESOURCES AND INFORMATION

When accessing Federally-controlled facilities, the contractor shall provide valid ID and verification that they are part/and party to the contractor's organization such as credentials or a letter of intent. The Contractor shall comply with any participating customers’ additional security requirements and procedures for access to facilities. Any and all costs associated with gaining access to a customer facility shall be the responsibility of the Contractor.

ARTICLE C.7. PLACE OF PERFORMANCE

The Place of Performance will be designated Mission Support Centers in Rancho Cordova, CA, Grand Prairie, TX and Frederick, MD as well as Regional Facilities in Atlanta, GA, San Juan, PR, Aiea, HI and Anchorage, AK. Facility locations may change over the period of this contract.

ARTICLE C.8 SECURITY

The work will be considered Unclassified. However, the successful Offeror shall meet all Federal and Health and Human Services security requirements and standards. A list of applicable policies will be provided to the awardee post award.

Section D – Packaging, Marking and Shipping

ARTICLE D1. POSTAGE AND FEES

All postage and fees related to submitting information, including forms, reports, etc., to the Contracting Officer or the Contracting Officer Representative shall be the responsibility of the contractor.

ARTICLE D2. MARKING

All information submitted to the Contracting Officer of the Contracting Officer Representative under the resulting contract shall be clearly marked to show the following information on the cover:

· Name of the contractor

· Contract Number

· Consignee’s Name and Address

· The title of the deliverables

· Date of the Deliverables

ARTICLE D3. SHIPPING

Documents will be delivered electronically (via email) hard copy to the CO and in original hard copy to the Contracting Office (CO) and the COR to be specified in individual Task Orders. Unless otherwise specified by the CO and/or COR all hard copy deliverables and reports furnished to the Government under the resultant contract (including invoices) shall be addressed as follows:

Contracting Officer

HHS/ASPR/AMCG

200 C St. SW Washington, DC 20024 Email: TBD Contracting Officer

HHS/ASPR/AMCG

330 Independence Ave. SW, Room G640

Email: TBD

Contracting Officer Representative

HHS/ASPR/BARDA

200 C St. SW Washington, DC 20024 Email: TBD Contracting Officer Representative

HHS/ASPR/BARDA

330 Independence Ave. SW, Room G640

Email: TBD

In addition to those reports required by other terms of this contract, the contractor(s) shall submit to the COR monthly Task Order Reports as identified in the Task Order. These reports shall be subject to the technical inspection and requests for clarification by the COR. These reports shall be brief and factual and prepared in accordance with instructions specified in the contract SOW, with additions specified in each individual Task Order if applicable.

Section E – Inspection and Acceptance

ARTICLE E.1 FEDERAL ACQUISITION REGULATION CLAUSES INCORPORATED BY REFERENCE

This section or other parts of this solicitation may incorporate one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at this address: https://www.acquisition.gov/far

FAR 52.246-4 -- Inspection of Services - Fixed Price (August 1996) FAR 52.246-5 -- Inspection of Services – Cost Reimbursement (Apr 1984)

Inspection and acceptance of the product, services, and documentation called for herein shall be accomplished by the Government COR. The COR will review, examine, and verify that all services and deliverables fulfill and are in compliance with the requirements and standards as stated in the resulting contract. Technical inspection and acceptance will take place at:

Office of Emergency Management (OEM) Office of the Assistant Secretary for Preparedness and Response 200 C Street, S.W.

Washington, D.C. 20024

Additional inspection will be undertaken by government employees at government facilities as designated by the COR.

ARTICLE E.2 OFFEROR PERFORMANCE

At the COR’s discretion, he/she and the Offeror’s program manager will meet to evaluate the manner in which the Offeror is performing in accordance with the contract requirements and standards such as: good workmanship, the Offeror’s record of forecasting and controlling cost; the Offeror’s adherence to 508 compliance; the Offeror’s adherence to contract schedule, Offeror’s history of reasonable and cooperative behavior and commitment to customer satisfaction, and generally, the Offeror’s business like concern for the interest of the customer. The Contracting Officer may attend these meetings.

Formal performance reviews will be conducted at least annually on or about the anniversary date of the contract.

SECTION F – DELIVERIES/PERFORMANCE

ARTICLE F.1. FAR 52.252-2 – Clauses Incorporated by Reference (JUN 1998) The resulting contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Full text may be accessed electronically at https://www.acquisition.gov/far/index.html

FAR 52.242-15 STOP-WORK ORDER (AUG 1989)

ARTICLE F.2. REPORTS/DELIVERABLES

Successful performance of the final contract shall be deemed to occur upon performance of the work described in SECTION C of this contract, laid out in individual issued Task Orders, and upon delivery and acceptance of the items described above.

The contractor shall be responsible for submission of all reports and deliverables.

All reports should be delivered to the COR and CO in a .pdf format unless specified otherwise in the task order.

ARTICLE F.3. TIME OF PERFORMANCE

The Offeror shall work normal business hours Monday through Friday, with core hours being between 8:00AM to 5:00PM ET, or as specified by the COR. If a specific project requires an urgent and immediate response, the Offeror may be requested to work after normal duty hours, including evenings, nights, weekends, and federal holidays.

ARTICLE F.4. PERIOD OF PERFORMANCE

The Period of Performance is not expected to exceed twelve (12) months from the date of award with four (4) twelve (12) month option periods not to exceed forty-eight (48) months.

ARTICLE F.5. OBSERVANCE OF LEGAL HOLIDAYS AND GOVERNMENT CLOSURE

The Department of Health and Human Service observes the following days as holidays:

· New Year’s Day

· Martin Luther King’s Birthday

· Washington’s Birthday

· Memorial Day

· Independence Day

· Labor Day

· Columbus Day

· Veterans Day

· Thanksgiving Day

· Christmas Day

· Inauguration Day (Every 4 Years; Washington DC Only)

Any other day designated by Federal law, Executive Order, or Presidential Proclamation.

When any such day falls on a Saturday, Friday is taken as the observation day. When the holiday falls on a Sunday, then Monday is the observation day. Observance of such days by Government personnel shall not be cause for additional period of performance or entitlement to compensation except as set forth in the contract. If the Offeror’s personnel work on a holiday, no form of holiday or other premium compensation will be reimbursed either as a direct or indirect cost, unless authorized pursuant to an overtime clause elsewhere in this contract.

The Offeror agrees to continue to provide sufficient personnel to perform round-the-clock requirements of critical tasks, and shall be guided by the instructions issued by the Contracting Officer or his/her duly authorized representative.

SECTION G- CONTRACT ADMINISTRATION

ARTICLE G.1. CONTRACTING OFFICER (CO)

The Contracting Officer is the only individual who can legally commit the Government to the expenditure of public funds. No person other than the Contracting Officer can make any changes to the terms, conditions, general provisions or other stipulations of this contract. Any other commitment, either explicit or implied, is invalid.

The CO is the only person with authority to act as agent of the Government under this contract. Only the Contracting Officer has authority to: (1) direct or negotiate any changes in the statement of work; (2) modify or extend the period of performance; (3) change the delivery schedule; (4) authorize reimbursement to the Offeror for any prices incurred during the performance of this contract; (5) obligate or de-obligate funds into the contract; or (6) otherwise change any terms and conditions of this contract.

No information, other than that which may be contained in an authorized modification to this contract duly issued by the Contracting Officer, which may be received from any person employed by the United States Government, or otherwise, shall be considered grounds for deviation from any stipulation of this contract.

ARTICLE G.2. CONTRACTING OFFICER’S REPRESENTATIVE (COR)

The Contracting Officer’s Representative (COR) is:

To be identified at the time of award of contract.

As delegated by the CO, the COR is responsible for: (1) monitoring the Offeror's technical progress, including the surveillance and assessment of performance and recommending to the Contracting Officer changes in requirements; (2) assisting the CO in interpreting the statement of work and any other technical performance requirements; (3) performing technical evaluation as required; (4) performing technical inspections required by this contract; and (5) assisting in the resolution of technical problems encountered during performance.

ARTICLE G.3. CONTRACTOR’S POINTS OF CONTACT

The Contractor shall provide primary and secondary points of contact that will be available 24 hours per day, 7 days per week, to be notified in case of a public health emergency to receive continuity of operations directions.

ARTICLE G.4. ORDERING PROCEDURES

G.4.1. Ordering Official

The CO is the only designated Ordering Official for the contract. Only the CO may issue Task Orders to the Offeror, providing specific authorization or direction to perform work within the scope of the contract and as specified in the Statement of Work. Unless specifically authorized by the Contracting Officer, the Offeror shall not commence work until a fully executed Task Order has been awarded. The Offeror may incur prices under this contract in performance of Task Orders and Task Order modifications issued in accordance with this ARTICLE.

No other prices are authorized unless otherwise specified in the contract or expressly authorized by the Contracting Officer. This contract provides for the issuance of Task Orders which will be placed via electronic mail (e-mail).

G.4.2. Method of Ordering

When the Government elects to fill a requirement under this contract, the CO shall provide a RTOP to the contractor (s). Each RTOP shall, at a minimum include a Performance Work Statement or Statement of Work, an Independent Government Cost Estimate for the cost of the performance of the Task Order, deliverables and delivery schedule and any special instructions. Time allowed for proposal preparation and submission will vary depending on the task and will be designated in each RTOR.

In providing services under this contract, in addition to the procedures specified under FAR 16.505, the following procedures shall apply to the award of Task Orders. All work required under this contract shall be authorized through execution of an agreement, “Task Order,” signed by the contractor and CO. The Task Order may be awarded at any time within the period of performance.

The Government will evaluate the proposal based on the associated technical evaluation criteria and conduct negotiations as necessary. The CO is the only individual authorized to issue a Task Order under this contract. Unless specifically authorized by the CO, the contractor shall not commence work on a requirement until a fully executed Task Order has been awarded.

The Contracting Officer or a designated individual may solicit responses to RTOP requirements within a technical area covered by a Task Order requirement in writing. The will be prepared and issued for each Task Order requirement.

Generally, the RTOP package will include but is not limited to the following:

Statement of Work Evaluation Criteria, Reporting Requirements and Deliverables, Independent Government Cost Estimate, Period of performance; and Anticipated Contract type of the Task Order

If necessary, the CO will arrange a teleconference between the contractor and the CO to discuss the proposed Task Order prior to submitting Task Order proposals. Proposals shall include appropriate support of all costs proposed as necessary for performing the services identified in the Task Order.

The contractor shall submit a proposal in response to a RTOP, which shall include, but not necessarily be limited to the following information:

The Government will evaluate the proposal based on the associated technical evaluation criteria and conduct negotiations as necessary. The CO is the only individual authorized to issue a Task Order under this contract. Unless specifically authorized by the CO, the contractor shall not commence work on a requirement until a fully executed Task Order has been awarded.

ARTICLE G.5.