SOW July_8_2024.docx

Request for Logistics Requirements for Warehousing, Warehousing Operations, Distribution, and Disposal.

Statement of Work (SOW) for the Department of Health and Human Services HHS-Coordination Operations and Responsive Element (H-CORE)

Statement of Work H-CORE Therapeutic & Vaccine VMI, Distribution and Destruction

Background

The Administration for Strategic Preparedness and Response (ASPR) leads the nation in preventing, preparing for, responding to, and recovering from the adverse health effects of emergencies and disasters by supporting our communities’ ability to withstand adversity, strengthening our health and response systems, and enhancing national health security. ASPR is responsible for stockpiling and deploying therapeutics, vaccines, medical and testing supplies needed during a public health response. During a public health emergency, federal stockpiles of therapeutics and vaccines may need to be distributed and dispensed to people throughout the country. Currently, distribution and dispensing/administration of therapeutics and vaccines relies heavily on Vendor Managed Inventory (VMI) distributing to federal, state and local health departments.

Objective

The goal of this contract is to provide Vendor Managed Inventory (VMI) services, storage, distribution, and destruction, for United States Government (USG) procured therapeutics and/or vaccines.

Scope of Work

Due to the continued efforts to provide a ready response to COVID-19, the USG has a requirement for VMI for storage of up to 2,800 pallets spaces at up to two geographically diverse warehouse locations, specifically: up to 800 pallets of cold-chain product stored at 2°C to 8°C, as well as adequate space for up to 2,000 pallets of ambient product stored at 15°C to 25°C, and distribution and destruction for up to 2,000 pallets of ambient and/or up to 800 pallets of cold-chain product. The Government Furnished Property (GFP) to be provided will be therapeutics and/or vaccines the USG has or will procure in response to COVID-19 or another public health event, including the potential for Schedule II drugs. VMI will use a cloud-based warehouse management system or backup to a third-party vendor for data storage with a modern stack, uses current code, is housed in a USG approved environment, and will utilize a proven inventory model designed to streamline inventory management and order fulfillment. The vendor will need to receive order data feeds from HHS's Health Partner Ordering Portal (HPOP) to fulfill requests for therapeutics and/or vaccines from H-CORE partners and will need to have interoperable data feeds with Tiberius, H-CORE’s system of record and accountability for all inventory.

Technical Requirements

Task 1: Vendor Managed Inventory (VMI) (CLIN 0001/0002)

The Vendor shall provide VMI (logistical and supply chain support) for 400 fixed pallet spaces for cold-chain product 2°C to 8°C. Additionally, with 30 days of notice the Vendor shall provide VMI for up to 400 additional cold-chain pallet spaces for surge capacity. The Vendor shall ensure that all material is warehoused in accordance with manufacturer and/or FDA specifications and that the facility is an approved storage facility to perform pharmaceutical warehousing in accordance with Current Good Manufacturing Practices (cGMP) and meets all Federal and State Government regulatory requirements. The Vendor shall be responsible to ensure that all products are stored in compliance with all applicable regulations as administered by the Department of Health and Human Services (HHS), Food and Drug Administration (FDA), Drug Enforcement Agency (DEA), and other Federal, State, or local laws and regulations that may apply. All material shall be warehoused and distributed by a Vendor that has a Drug Distribution Accreditation. In addition, the Vendor shall provide certification and proof upon request from the Contracting Officer that the facility being used to perform this contract does indeed meet all Federal and State Regulatory requirements for the storage of pharmaceutical products, including Schedule II drugs.

The following products may be provided as GFP; however, this is not an exhaustive list:

· Bebtelovimab (2°C to 8°C)

· Sotrovimab (2°C to 8°C)

· Regen-Cov (2°C to 8°C)

· Evusheld (2°C to 8°C)

· Molnupiravir/Lagevrio (15°C to 25°C)

· Bamlanibimab (2°C to 8°C)

· Etesevimab (2°C to 8°C)

At the warehouse location(s), the Vendor shall have adequate space for storage, staging, receiving, and shipping product. The facility must have dock doors to adequately support receiving and shipping simultaneously. The Vendor shall use commercially reasonable efforts to segregate GFP stored in its Distribution Facilities from any commercial inventories of products owned by the Vendor. The VMI includes all services as necessary for the management of up to 800 cold-chain pallet spaces 2°C to 8°C until the pallets are depleted through distribution or disposal orders. Vendor must have the capability to distribute product from up to three (3) separate locations.

The Vendor shall ensure that accurate records and accountability of both inbound and outbound shipment records are auditable and reconcilable to the Government. The Vendor shall maintain an inventory record and location system for the pharmaceutical products to ensure that products are shipped First Expire, First Out (FEFO). All documentation related to the inventory quantities of product shall be retained by the Vendor and made available to the USG upon request. The Vendor shall provide ASPR access to its inventory system which will specify quantities of GFP held in each Distribution Facility.

If GFP is damaged while under possession of the vendor, the vendor is responsible for all disposal and replacement costs. The Vendor shall provide loss prevention and insurance on stored product in the event of loss/damage/destruction equal to the replacement cost and payable to the United State (US) Federal Government (Government). The Vendor shall report damaged material within 24 hours of finding. Upon the Government’s approval, the Vendor shall dispose of the material in compliance with applicable local, state, and federal regulatory requirements. The Government shall be reimbursed for the USG cost of the damaged product.

Task 2: Product Receiving/Inventory (CLIN 0003)

The Vendor will coordinate receipt of the up to 2,800 pallets with up to 100,000 cases of GFP shipped to its warehouse(s) in the US. At a minimum, the Vendor shall be able to distribute product to the continental US and all US Territories while being capable of warehousing the quantities referenced above under proper conditions. The Vendor must possess an inventory system capable of providing up-to-date information on all Government-owned inventory including quantity, expiry date, and location, if applicable. This inventory system must be compatible with HHS’s system for reporting and ordering purposes, an Oracle-based system, either via a direct data feed to be established during system set-up or a comma-separated values (csv) file generated from the vendor’s inventory management system, as described in C.5 Deliverables.

For planning purposes, and notwithstanding initial load-in and surge requirements, the number of trucks delivering and/or removing products from the facility may average 15 per day per warehouse until all product is delivered. The Government anticipates that approximately 95 percent of the product received by the Vendor will be on standard pallets weighing no more than 2,500 pounds per pallet. Pallets will not exceed 60 inches in height and not be double stacked.

Normal hours of operation are Monday-Friday, 7 a.m. - 5 p.m. local time. Full mission capability is required during these hours. Given the current response conditions, the Vendor shall expect to manage multiple shipments during standard business hours until the COVID-19 conditions and inventory has stabilized. The Vendor shall provide weekend and after-hours operations as needed for emergency shipments or shipments that arrive later than the scheduled time. All Vendor support shall be provided at the Vendor -provided facilities. The USG will notify the Vendor no less than 72 hours in advance of its intent to ship GFP to the Vendor and provide a listing of the initial GFP and their quantities intended to be shipped to the Vendor (“Shipment Notice”). Upon receipt of the Shipment Notice, the Vendor shall coordinate with ASPR to determine the quantities of GFP to be shipped into each Distribution Facility.

The Vendor shall possess an inventory system capable of providing up to date information on all Government owned inventory, and capture this information at time of receipt to include:

0. Manufacturer and Model Number / Part Number

0. SKU Description

0. Unit of Measure

0. Quantity transported

0. Quantity on hand by facility

0. Warehouse location/multiple warehouse/storage points

0. Lot number

0. Expiration date

0. Condition Code (used to account for product recall, materiel complaints, etc.)

0. Note Codes (materiel subject to damage by freezing, hazardous material, etc.)

0. Bill of Lading

0. Packing Slip

Any discrepancies between the incoming (packing list) documentation and the actual product shall be so annotated on the inbound documentation. All ambient and cold storage products shall be shipped/stored in accordance with manufacturers requirements. All GFP will be tracked through shipping process including storage facilities to their destination. Upon inspection of the inbound shipment, any damage, shelf-life issues, or missing quantities shall be reported to the designated H-CORE official within 24 hours of identification and material suspended by the Vendor pending resolution of the problem. Upon direction from the USG, Vendor shall quarantine damaged GFP.

Task 3: Freight & Transportation (CLIN 0004/0005/0006/0007)

The Vendor shall, at the direction of the H-CORE, distribute products to all points of care. All shipments shall be made using traceable means.

For each shipment, the Vendor shall provide the following information to the H-CORE Designee within 48 hours after delivery:

Outside packing label for each shipping container pallet, case or box must contain the following minimum data elements:

a) Shipper’s address

b) Ship to address

c) Mark for data or Transportation Control Number (TCN)

d) Delivery/Order Number

e) Number of Boxes/Cases Shipped; 1 of 4, 2 of 4, 3 of 4, 4 of 4, etc.

f) Shipping Label Fixed to outer box(es) may contain additional wording as determined by the designated H-CORE Representative, such as “PANDEMIC COVID-19 PROGRAM.”

At a minimum the inside packing slip must contain the following information:

a) Customer name

b) Ship to address

c) NDC

d) Product Name

e) Unit of Issue

f) Quantity Shipped

g) Delivery/Order number

h) Transportation Control Number or Customer Requisition Number

Under Free on Board (FOB) Destination procedures any loss of material or damages of product while in storage at the Vendor facilities, are the responsibility of the Vendor. The Vendors shall always handle, maintain, transport, deliver and/or otherwise manage, and distribute the GFP in its possession in accordance with the applicable handling and storage requirements (as set forth in the special handling and storage requirements of the Product Information sheet provided by the manufacturers for any GFP). In the event the Vendor has not handled, maintained, stored, transported, and/or otherwise managed GFP in accordance with this paragraph, the Vendor shall notify ASPR within 24 hours of knowledge of such incident and provide a GFP Handling Issue Report and shall destroy such GFP in accordance with all applicable laws, ordinances, regulations, and rules at no cost to the Government within three (3) business days of becoming aware of such incident. Within 72 hours after providing such notice of loss or damage to the H-CORE official, the Vendor shall reimburse ASPR for the lost or damaged GFP at the USG’s acquisition cost. To the extent ASPR provides the Vendor GFP with the shortest dating first (“Short Dated GFP”), the Vendor shall ship Short Dated GFP to the delivery locations prior to all other GFP.

Sub-Task 3.1: Product Distribution (CLIN 0004/0005/0006/0007/0011)

3.1.1 Standard Disbursement

For GFP that is to be provided under a disbursement strategy, ASPR shall notify the Vendor in writing every other week of its intention to disburse GFP to locations (each such period, a “Disbursement Period”). The Vendor and ASPR shall determine the extent to which any specific disbursement request to the Vendor of GFP under the Program should be exercised by ASPR pursuant to its priorities and disbursements authority. The Vendor shall coordinate with ASPR to establish the pace of disbursement and distribution of GFP based on various factors to be determined by the parties (including disbursement and distribution forecasts that are communicated periodically from ASPR to the Vendor).

After ASPR identifies the delivery locations to receive GFP during any Disbursement Period, the Vendor will contact those locations to confirm shipment location, shipment dates, and other delivery requirements. To the extent a location declines/refuses any amount of GFP allotted to it by ASPR, the Vendor shall notify ASPR, which shall determine the disposition of such GFP for the next Disbursement Period. The Vendor shall have no responsibility or liability for any such declination decisions made by delivery locations. Any decisions, notifications, or instructions issued by ASPR under this contract shall be communicated to the Vendor only by those individuals designated by H-CORE. Shipments should be an average of two times a day but up to three times a day.

The Vendor will ship the designated amount of GFP to specific delivery locations identified by ASPR, subject to the following:

a) ASPR will provide sufficient and timely information to the Vendor within the Disbursement Period regarding the disbursed quantities of GFP to be shipped to delivery location as well as any additional information needed to fulfill this request.

b) Each disbursement of GFP to a delivery location shall be based on multiples of Minimum Order Quantities of each product of the applicable GFP and all products with cold chain requirements will require delivery confirmation and cold chain validation.

Following receipt and confirmation of items listed above, the Vendor shall pick, pack and prepare specified quantities of GFP for shipment to any such delivery location(s) located within the continental US within three (3) business days. The Vendor shall not be required to deliver within three (3) business days should the delivery location be unable or unwilling to accept the delivery within that time. For delivery location(s) located outside the continental US, the Vendor shall notify ASPR of the time frame for expected delivery, which the delivery schedule will be subject to any additional time required to clear Customs or other applicable import or export procedures. When possible, deliveries to US Territories should be made within five (5) business days. The Vendor shall notify ASPR of any governmental support needed to facilitate deliveries to delivery location(s) in US Territories. Delivery location(s) in US Territories may require the use of a customs broker and/or may have to pay import fees, taxes, or duties to deliver the GFP. The Vendor shall not be responsible for any such fees, taxes, duties, or related costs incurred by such delivery location(s) to deliver GFP. All products with cold chain requirements will require delivery confirmation and cold chain validation.

a) Vendor will provide all ambient shipments in a secure corrugated box. The box will be of sufficient strength and density of construction to withstand the rigors of handling and interstate shipment. The box will be labeled and sealed with tamper evident tape for closure.

b) Vendor shall prepare all cold chain shipments in shipping containers and must be prepared to maintain the product at 2°C- 8° C for the required transit time of 48-120 hours location dependent and contain a temperature monitor capability appropriate to the transit times that will be utilized to provide validation of cold chain.

3.1.2 Expedited (Emergency) Disbursement

For expedited needs to distribute GFP outside a Disbursement Period cycle (an “Emergency Disbursement”), the authorized representatives of ASPR shall notify the Vendor of the request, which shall consist of (i) the quantity of GFP requested by ASPR to be disbursed to the delivery location(s), and (ii) the Delivery location(s) designated to receive such GFP. Upon receipt of an Emergency Disbursement request, the Vendor shall notify ASPR of the time frame anticipated for delivery to the designated Delivery location(s). Deliveries of any GFP pursuant to an Emergency Disbursement shall be to bulk and small parcel freight identified in CLIN 0004 and CLIN 0006.

3.1.3 Final (Winddown) Disbursement

The Vendor shall be responsible for coordinating final disposition of all GFP remaining in VMI. At 120 calendar days prior to the end date of the contract period of performance (PoP), the Vendor shall provide to USG an inventory of all remaining GFP, including product name, Lot number, number of doses, and date of expiry. Subsequently, ASPR will direct final disbursement of any GFP at the Vendor’s facility by one or more of the following methods:

· The USG may elect to direct the Vendor to ship to a consignee or consignees designated by the USG, all products remaining in storage at the Vendor’s facilities.

· The USG may direct distribution of unshipped GFP, per Section C.4.3.1.1 and C.4.3.1.2 above.

· The USG may direct destruction of GFP, per Section C.4.5 below.

Within thirty (30) calendar days of the end date of the contract PoP, the Vendor shall provide a full accounting of all GFP received from the Government, GFP stored in VMI, GFP distributed, GFP transferred to ASPR-identified locations, and GFP destroyed. This account must include the product name, Lot number, number of doses, and dates of Vendor action (e.g., date received, and date distributed/transferred/sent for destruction) for dates spanning the entire contract PoP.

Table 1: Distribution Fee Schedule (CLIN 0004 - Freight & Transportation of Cold Chain Products Final Mile) Distribution Fee Schedule

Table 2: Distribution Fee Schedule (CLIN 0006 - Freight & Transportation of Ambient Products Final Mile) Distribution Fee Schedule

Table 3: Distribution Fee Schedule (CLIN 0011 – Bulk Distribution) Distribution Fee Schedule

Task 4: VMI Services Ambient Products (CLIN 0008/0009) The Vendor shall provide VMI for 500 fixed pallet spaces. Additionally, with 30 days of notice the Vendor shall provide VMI for up to 1500 additional pallets of ambient storage space. Includes all services and facilities, up to two geographically diverse warehouse locations, as necessary to receive Government Furnished Property, manage GFP, store GFP, and prepare GFP for distribution. Includes all services to perform all product management, documentation, reporting, and distribution management tasks as necessary to store and maintain GFP in deployable status in accordance with the SOW. Includes all services as necessary for the management of up to 2000 ambient pallet spaces 15°C to 25°C until the pallets are depleted through distribution or disposal orders. Vendor must have the capability to distribute product from up to three (3) separate locations.

Task 5: Disposal (CLIN 0010) Vendor shall dispose of GFP upon direction from the USG. The Vendor 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), Department of Natural Resources (DNR), and the Center for Disease Control and Prevention (CDC). The Vendor shall also consult applicable state/local regulations and the regional office of the federal regulatory agency that has jurisdiction over their operation to assure compliance.

A Certificate of Destruction and/or Certificate of Recycling for all products shall be submitted within thirty (30) days after destruction.

Task 6: Set Up (CLIN 0012) Vendor shall establish operations prior to first planned reception of materials to include IT solutions and distribution capability. All costs associated with the setup of IT solutions, licensing and additional costs associated with establishing customer accounts for ordering and distribution.

Task 7: Transition (CLIN X013) Vendor shall take possession of all GFP from the current vendor’s two locations in Ohio and Mississippi, and transport all viable materials (~160 cold storage pallets and 3 ambient pallets) to the proposed new locations and expired product (~700 pallets) for disposal. Vendor will provide transition plan and cost with proposal.

Deliverables

One electronic copy – H-CORE Text file submission to the H-CORE Tracking Tool

· Product Name

· Item #/NDC

· Lot #

· Expiration Date

· Quantity

· Location Received

· Received From

· Received Date

Additional fields as negotiated.

Original – H-CORE One electronic copy – H-CORE Text file submission to the H-CORE Tracking Tool

· Product Name

· Item #/NDC

· Lot #

· Expiration Date

· Quantity

· Location

Additional fields as negotiated.

One electronic copy – H-CORE Text file submission to the H-CORE Tracking Tool

· Product Name

· Item #/NDC

· Lot #

· Expiration Date

· Quantity

· Location

Additional fields as negotiated.

One electronic copy – H-CORE Text file submission to the H-CORE Tracking Tool

· Order Number

· Product Name

· Item #/NDC

· Lot #

· Expiration Date

· Quantity Shipped

· Quantity Delivered

· Customer Name

· Customer Address

· Date Shipped

· Date Delivered

· Delivery Status

· Tracking Number(s)

Additional fields as negotiated.

(contractor format) Original – H-CORE One electronic copy – H-CORE

· Product Name

· Item #/NDC

· Lot #

· Expiration Date

· Quantity

· Product Location

· Issue Date

· Issue Description

· Remediation Actions

Additional fields as negotiated.

(contractor format) Original – H-CORE One electronic copy – H-CORE

· Product Name

· Item #/NDC

· Lot #

· Expiration Date

· Quantity

· Shipper Name

· Shipper Address

· Consignee Name

· Consignee Address

· Date Shipped

Additional fields as negotiated.

(contractor format)

· Product Name

· Item #/NDC

· Lot #

· Expiration Date

· Quantity

· Disposal Date

· Destruction Method

Additional fields as negotiated.

(contractor format) Original – H-CORE One electronic Copy – H-CORE

Minimum data fields:

· Product Name

· Item #/NDC

· Lot #

· Expiration Date

· Quantity

Additional fields as negotiated.

(contractor format) Original – H-CORE One electronic Copy – H-CORE

Minimum data fields:

· Product Name

· Item #/NDC

· Lot #

· Expiration Date

· Quantity

· Dates of Vendor actions during the POP (e.g., dates received/ distributed/ transferred/ sent for destruction)

Additional fields as negotiated.

Government-Furnished Property, Material, or Information (GFP, GFM, GFE, or GFI) The USG may provide the following items as Government-furnished materials:

· Bebtelovimab

· Sotrovimab

· Regen-Cov

· Evusheld

· Molnupiravir/Lagevrio

· Bamlanibimab

· Etesevimab

Additional products may be provided as additional products become available; however, the total quantity of products will not exceed 2,800 pallet positions in total.

Security The Vendor’s facility shall meet the following security criteria:

a. Exterior camera coverage:

1. Cameras to be day and night capable, DVR will store a minimum of 30-days’ motion activated images

2. Provide 360-degree coverage of the exterior building

3. Exterior personnel entrances

4. Dock area

b. Interior camera coverage

1. Each personnel door

2. All roll-up doors (can be grouped)

3. Load and unload areas

c. Intrusion Detection System

1. Reports to UL certified Central Alarm Station (Contract for monitoring required)

2. All doors and roof hatches

3. Motion detectors covering dock doors and external doors

d. Access Control System

1. Card access for all exterior doors, interior doors to warehouse areas, and gates

2. Access control will be a stand-alone system with storage capacity for entrance/egress. Logs shall be maintained for a minimum of 6 months

e. The Vendor is responsible for quarterly maintenance and repair or replacement of security equipment for the life of the contract

SUBTASK – SITE CRITERIA

The Vendor’s site(s) shall conform to the following minimum criteria:

a. The site shall have access to multiple routes to the highway system and airport.

b. Have property terrain that is flat and level

c. Not be located over watersheds, wetlands, and/or floodplains

d. Any hazardous material capable of creating an explosive, biological, or hazardous event within a quarter mile radius (as measured from the nearest property line of the facility in question to the nearest property line of the proposed facility) shall be identified. The Government shall assess risk and provide waivers on a case-by-case basis. Current exceptions include hazardous material dedicated to airport operations and gasoline stations.

e. Be of an architectural make-up that does not cause undue attention to it within the context of an industrial park

f. Be positioned in an industrial park in such a way that it is readily identifiable from the industrial park’s main thoroughfare so it can be found during an emergency response

g. Not be in an area with high crime rates at the time of award (that is above the national average) or showing evidence of gang or other criminal activity as identified by police in the Government-designated cities (i.e., Site X). Such information shall be made available to the Government if requested.

SUBTASK – GROUNDS CRITERIA

The Vendor’s facility grounds shall conform to the following criteria:

a. Provide visitor and employee parking areas and follow all local codes regarding parking standards

b. Provide enough parking space for staging trucks during an actual event

c. Landscaping and vegetation shall not impede access/egress of trucks from the site and shall not obscure line of vision around the perimeter and fencing of the facility

d. Landscaping and vegetation shall comply with local jurisdiction requirements

e. Be standalone facilities; however, a multi-tenant facility may be considered if the Vendor can demonstrate to the satisfaction of the Government that the space for this Contract is separated and secured from other tenants, including external points of egress

f. Internal roof access is preferred for guards to gain access

g. Have a minimum of a 50’ setback from access site boundaries

h. Have limited glass frontages and skylights. If present, the Vendor shall demonstrate how glass frontages and skylights will be physically secured

i. Comply with all applicable local zoning requirements

j. Provide the Government adequate space to store up to 2,000 pallets of GFP, including 800 pallets in cold storage.

k. Provide the following redundant systems:

1) Back-up generator power to maintain all necessary life safety features as required by code

2) Uninterruptible Power Supply for all data capture and security systems

3) Data back-up of electronic data capture

4) Network backup is accomplished with redundant wired circuits from two different delivery location(s), 4 circuits in total

l. Ensure that all outside communications services are provided with conduit diversity and that multiple delivery location(s)s are available for redundancy. Conduit diversity is a building with an additional wire line conduit entry point

m. Ensure that all communications, water, fire, natural gas, power, and sewer service connections are each located within five feet of the building

n. Facilities constructed after 2000 shall have been constructed utilizing International Building Code (IBC) seismic design parameters

All designs, construction, renovation, and modifications will comply with the latest version of the IBC and National Fire Protection Association (NFPA) standards. The latest version of the IBC and NFPA are defined as the closest version year to the date of the RFP

Special Material Requirements and Considerations Reporting Requirements and Site Visits

Daily/Weekly/Monthly Teleconferences The Vendor, upon request, will participate in teleconferences with the USG to discuss progress and performance. The situation will dictate the frequency of meetings. The purpose of these meetings will be oriented on the coordination efforts necessary to ensure continuity of effort and uninterrupted flow of materials.

Site Visits The USG reserves the right to conduct site visits, collect samples, and conduct a joint physical inventory of up to 10% of products held and stored by the Vendor. The USG may ask to place a representative on-site during peak operations. The USG will provide the Vendor notice 24 hours in advance of requested site visit.

POCs The Vendor shall provide primary and secondary points of contact that will be available 24/7, seven days a week.

Other Unique Requirements Vendor Qualifications

The Vendor shall be responsible to adhere to all applicable current good manufacturing practice (cGMP) requirements and Government quality assurance requirements to ensure the contracted for VMI service is adhering appropriately to those standards regarding receiving, storing, and distribution of finished medical/surgical products.

The Vendor shall be responsible to maintain comprehensive Quality System programs, which shall comply with all applicable federal, state, and local regulations, and the Government performance requirements cited throughout this existing contract for the warehousing (receiving, holding, and shipping preparation) of product.

Vendor shall utilize a Vendor Managed Inventory (VMI) process that has a cloud-based warehouse management system or backup to a third-party vendor for data storage with a modern stack, uses current code, is housed in a USG approved environment, and will utilize a proven inventory model designed to streamline inventory management and order fulfillment.

After the first six (6) months of performance, the USG may annually assess the Vendor’s facility and Quality Systems and the site’s on-going acceptability and compliance to ensure proper and safe storage and handling of the Government-owned product. The assessment agenda will include, but not be limited to, a review of the following areas covering the receiving, holding, and shipping preparation of product:

1. Standard Operating Procedures

2. Deviation system

3. Corrective Action and Preventive Action system

4. Quality Assurance

5. Training management system

6. Facility maintenance

7. Equipment maintenance and calibration

8. Facility Sanitation program

9. Document control system

10. Organization and personnel qualifications and responsibilities

11. Regulatory inspection history (482, 483, warning letter, etc.)

Upon completion of a Government quality assessment site visit, the Vendor shall receive a written formal assessment report. Upon the Vendor’s receipt of the Government’s written formal assessment report, the Vendor shall have 30 calendar days to respond in writing to the Government’s required and/or suggested improvement recommendations with proposed corrective actions and target dates for completion. ASPR, based on the requirements of this agreement, shall determine when the Vendors completed/proposed corrective actions are sufficient to allow Government owned product(s) to remain being stored at the facility. The Government may conduct “for cause” audits to address product quality or safety concerns within ten (10) business days of notification to the Vendor.

a. Document Control Program - The Vendor shall be responsible for maintaining a formal document control program to manage the approval, distribution, archival, and change control of all documents. This program shall minimally include SOPs, manuals and protocols, and training records covering the receiving, holding, and shipping preparation of product, and shall be made available to the Government.

b. Standard Operating Procedures (SOP) - The Vendor’s performance responsibilities and activities shall be described and controlled in their SOPs covering the receiving, holding, and shipping preparation of product. All Vendor employees shall be trained on all approved SOPs applicable to assigned tasks prior to performing the tasks in areas that may affect Government-owned products or equipment. Current, approved, and controlled SOPs shall be readily available to Vendor employees at the managed service facility.

c. Training Program - The Vendor shall be responsible to implement a training program that defines the training requirements covering the receiving, holding, and shipping preparation of product. The Vendor -provided training shall be in the operations that the Vendor performs. All training shall be documented, and records properly maintained.

d. Deviation and Corrective Action Tracking - The Vendor shall maintain deviation and Corrective Action/Preventive Action (CAPA) systems and document nonconformances to approved procedures including root cause analysis and actions taken. All deviations that can potentially impact product(s) safety, identity, strength, quality, or purity shall be evaluated and fully documented by H-CORE in accordance with their standard procedures. H-CORE is responsible for product impact evaluation and contacting appropriate manufacturers, when required. The completed deviation report including product disposition, when applicable, may then be provided to the Vendor by the Government.

e. Incident Notification and Reporting - The Vendor shall be responsible to report to the Government, as applicable, of the following:

1. Any event that results in product being unavailable for deployment. A detailed incident report shall be provided to the Government at no later than two workdays after the incident. More critical deviations or incidents may require an immediate interim written report upon request by the Government. If the incident results in a deviation, the deviation report shall be submitted within 30 calendar days from the date of the incident. All associated CAPA reports shall be forwarded to the Government and Facility Manager upon completion. The vendor shall provide additional supporting information as requested by the Government.

2. For situational awareness, if any Government personnel are present on-Site X during an incident, the Vendor shall include them when making notification to the Government and H-CORE designated representative.

f. Facility Design and Maintenance/Sanitation Program - The Vendor shall be responsible to provide a maintenance program that shall document that all storage facilities are maintained in a good state of repair and cleanliness and that all facility documents associated with the maintenance program are retained in appropriate files. The Vendor shall institute appropriate measures concerning cleaning, maintenance, pest control, and the quality system governing these procedures to ensure that the storage specifications for Government-owned products are met.

g. 21CFR Part11 Compliance and Validation of Computerized System - The Vendor shall be responsible to ensure that all computerized systems that create, modify, maintain, archive, retrieve, or transmit data that directly or indirectly may affect the quality of the cGMP products are 21CFR Part11 compliant and are validated as per Software Development Life Cycle (SDLC) concept. A periodic performance review process shall also be in place to ensure that all such systems remain in the validated state throughout their lifecycle. The inventory tracking system must interface with the HHS ordering posture. The Vendor shall provide the Government a written statement confirming these processes upon request and be able to demonstrate the capability of their inventory system to align with the HHS system.

h. Vendor or subvendor Qualification - The Vendor shall be responsible to ensure that all subvendors utilized by the Vendor to perform functions that may have an impact on Government-owned products have the training and skills to perform under the existing contract. All subvendors shall be regularly evaluated by the primary vendor to ensure performance and quality compliance. Records identifying acceptable subvendor, their evaluation, and evaluation criteria used shall be documented and available for review by the Government upon its request.

i. Redundant Systems - The Vendor shall be responsible to provide and maintain the following redundant systems:

1. Uninterrupted Power Source (UPS) for all data capture

2. Data back-up of electronic data capture

3. A minimum of 2 Warehouses in geographically diverse locations of the US

j. Change Control - The Vendor shall be responsible to document changes to SOP’s and all validated systems utilized to monitor and hold Government-owned products. The Vendor shall notify the Government, in advance of implementation, for assessment and approval of any planned system changes that may impact Government-owned products. Notification of any unplanned change, such as a system repair, that is not a “like for like” change, that may affect the qualification of the system impacting Government-owned product processing shall be provided to the Government within two (2) workdays.

k. Facility Inspection Notifications - The Vendor shall be responsible to immediately notify the Government of any notice of inspection and unscheduled inspections or actions by regulatory agencies, other enforcement agencies (e.g., FDA, DEA, Occupational Safety and Health Administration (OSHA)), and third-party vendors that may involve and/or impact Government-owned products. If no advance notice is given, the Government should be notified immediately upon the arrival of the inspector(s). The Government shall be permitted to delegate at least two persons to observe the inspection.

l. Inventory and Maintenance Management System- The Vendor shall provide an inventory and maintenance management system that is transparent and directly accessible by the Government and provides a real time dashboard for all warehouses for this program on one dashboard with the ability to expand the WMS to other existing warehouses. The Vendor shall have a "real time” on-line electronic data interchange (EDI) that captures all transactions pertaining to the government-owned property and provide a digital dashboard to HHS/ASPR or others as directed that provides real-time readiness status.

1. Inventory management system should be able to provide status and location confirmation for all material. Inventory systems shall be maintained in accordance with National Institute for Standards and Technology (NIST) security standard NIST SP 800-171. In addition, API bridges will be established to drive demand management input with machine learning and predictability that your team will be required to work with.

2. At a minimum, the Vendor shall maintain an inventory record and provide a monthly inventory status report of all material received, shipped, and moved. These reports will include notations of any material damaged, lost, or theft. These reports shall be sent to assigned ASPR/DASPR Project Officer and H-CORE Representative by close of business the last day of the month. At a minimum, this report shall contain the following:

Store Keeping Unit (SKU) Information:

(1) Manufacturer and Model Number / Part Number

(2) SKU Description

(3) Unit of Measure

(4) Unit Cost

(5) Quantity transported

(6) Quantity on hand by facility

(7) Warehouse location/multiple warehouse/storage points

(8) Lot number

(9) Expiration date

(10) Condition Code (used to account for product recall, materiel complaints, etc.)

(11) Note Codes (materiel subject to damage by freezing, hazardous material, etc.)

Transactions:

(1) Receipts/partial and complete

(2) Report of item discrepancies

(3) Inventory transfers and value of inventory in transit

(4) Inventory count sheets (for physical inventories)

(5) Inventory valuation (and method such as latest acquisition cost)

(6) Deployment capacity (calculates number of units that can be rotated based on historical demand and SKU Shelf-Life/Expiration Date)

(7) Transportation time for the inventory transfers

m. Warehouse Management System (WMS) The Vendor shall provide a warehouse management system that is cloud-based and able to be used in warehouses that the provider may or may not be awarded, WMS must provide inventory management control – by manufacturer, lot number, expiration date of the GFP, warehouse location address segmentation required, ability to dynamically route parcel, LTL, FTL shipments from the warehouse that is closest to the final destination point, delivery coordination, onsite storage capabilities, and other logistics management of equipment and supplies needed.

HHS may decide to develop a Database Migration Service (DMS) connection that will connect to the WMS and will have the following features:

i. API and other input from feed provided by states, cities, medical centers, and other aggregators of caseload data. This data will be used by the system to predict demand.

ii. Machine learning platform to take input data and produce regular predictions for demand by region and state.

iii. Interface for State DOHs and others authorized to request tests from the system to display predicted demand signal and accept/modify request.

iv. Interface for HHS managers to link system to real time inventory feeds.

v. Interface for third-party logistics providers chosen by HHS to provide delivery and other services.

vi. The DMS will be cloud-based and hosted at a cloud provider chosen by HHS.

The DMS is not a requirement for your proposal, but within the proposal, acknowledge you will need to consent to working with a provider for this added capability in the event it is required.

WMS Minimum Requirements

a. Provide a secure cloud-based Warehouse Management System (WMS) existing and expandable System at the proposed warehouse location(s). HHS/ASPR will have access to the dashboard through an encrypted password protected portal. The IT Proposal must contain content on fire wall hardening to protect against a security breach. A Strict Non-Disclosure must be signed by all contract award winners and under no circumstance is any data, shipping addresses, final delivery names and any other details about the entire operation to be shared with anyone outside of the contract award winner. More specifically, no information shall be shared with anyone outside of the US Federal Government and the contract award winner/s unless authorized by the US Federal Government.

b. Furthermore, the WMS shall provide information reporting on product receiving, current inventory quantities by pallet, lot numbers, cartons, units, manufacturers, expiration dates of OTC or other products that is placed in inventory, planned-pending shipments, shipping schedules, overall property/product management reporting with all above information by warehouse addresses, product flow in and out, and the cloud based WMS will provide visibility for all warehouse locations. The US Government will have access to the WMS data in accordance with required deliverables.

c. The WMS shall provide all the above functions in the Daily Inventory Report. The WMS shall provide an order/request function allowing the US Government personnel to input orders and other requests for the vendor personnel to process.

d. Inventory data shall be made available in WMS within 24 hours of receipt.

e. Inventory information, to include barcode data, shall be made available in the WMS within two (2) business days of receipt.

f. Provide order picking, packing, and palletization - if required – please note that all GFP will arrive mostly palletized. Provide and maintain shipping equipment at the stated operational facilities to fulfill orders placed by US Federal Government.

g. Provide a detailed shipping manifest (per parcel, pallet) identifying each POC\group to which the GFP is being sent.

h. Provide shipping reporting in the WMS within 8 hours of departure from warehouse to include lot numbers, serial numbers, quantity, pallet/carton count, destination and receiving site, with confirmation that the site has authorized the release of this delivery. Proof of Delivery required for all shipments uploaded to the WMS dashboard is required within five (5) business days. Any exceptions must be communicated.

Government Program Points of Contact Contracting Officer Representative: (insert name) Office Title Cell: (insert number) Email: (insert email address)

CONTRACTING SPECIALIST:

SIDNIE MIRANDA

CENTER FOR HHS COORDINATION OPERATIONS AND RESPONSE ELEMENT (HCORE) CONTRACTING

OFFICE OF THE HEAD OF CONTRACTING ACTIVITY (OHCA)

CELL: 202-692-4679

EMAIL: SIDNIE.MIRANDA@HHS.GOV

CONTRACTING OFFICER:

KETWANA WRIGHT

CENTER FOR HHS COORDINATION OPERATIONS AND RESPONSE ELEMENT (HCORE) CONTRACTING

OFFICE OF THE HEAD OF CONTRACTING ACTIVITY (OHCA)

CELL: 202-579-8902

EMAIL: KETWANA.WRIGHT@HHS.GOV