BPA SOW Storage and Distribution Draft V1 RFI.docx

Statement of Work (SOW) for the Department of Health and Human Services Rapid Response Storage, Handling, and Distribution of Government Furnish Pharmaceutical and Ancillary Medical Supplies

SECTION B - SUPPLIES OR SERVICES AND PRICES/COSTS

B.1. PRICE

Period of Performance: 10/01/2024 through 09/30/2029

Includes all services to perform all product management, documentation, reporting, and distribution management tasks as necessary to store and maintain pharmaceutical products in deployable status in accordance with the SOW.

Up to 20,000 pallets of cold-chain products stored at temperatures recommended by the manufacturer (Cold Chain Storage) in ranges 2°C to -80°C and ambient storage at 15⁰ - 25⁰C.

Includes all services to perform all product management, documentation, reporting, and distribution management tasks as necessary to store and maintain ancillary kits and materials in deployable status in accordance with the SOW.

Up to 20,000 pallets of medical grade sterile products stored at ambient temperatures recommended by the manufacturer (15⁰-25⁰C)

(T&M)

Includes freight & transportation of GFP from Vendors storage/distribution centers to USG provided destinations at time of need. All Transportation to and from the 3rd Party Logistics (3PL) warehouse locations must use the appropriate cold chain protocols as needed.

Requires delivery of GFP within 72 hours of notification to CONUS, Alaska, Hawaii, and 96 hours to US Territories.

Includes: Vendors pick and pack of GFP per order and prepare for shipping, including materials, as described in 3.1.1.a

B.2 Breakdown of Costs for CLIN 0003 – Product Receipt/Inventory Services:

Due to Government Furnished Product (GFP) under this agreement being pharmaceutical products for responding to current and future public health emergencies, the USG is not able to provide the exact quantity of pallets and cases needing to be broken down and inventoried. The vendor shall provide and breakdown any separate costs associated with performing such services for up to 40,000 pallets of product.

B.3 Breakdown of Costs for CLIN 0004 - Freight & Transportation of products:

Due to Government Furnished Product (GFP) under this agreement being pharmaceutical products for responding to current and future public health emergencies, it is not possible to identify the locations of delivery in advance. Freight & Transportation of GFP from Vendors distribution centers to Government provided destinations will be determined at time of need. All Transportation to and from the 3PL warehouse locations shall use appropriate cold chain packaging and shipping methods to maintain manufacturer’s recommended temperature range. All packages shall be appropriately marked and contain temperature monitoring devices. Deliver GFP within 72 hours of notification to CONUS, Alaska, Hawaii and 96 hours to US Territories.

B.4 Breakdown of Costs for CLIN 0005 – Pick, Pack & prepare for shipping Labor and Materials for shipping cold chain products:

Due to Government Furnished Product (GFP) under this agreement being pharmaceutical products and ancillary supplies for responding to current and future public health emergencies, the USG is not able to provide the exact quantity of packages to be picked, packed, and prepared. Vendors shall pick and pack treatment courses (full cases/kits only) per order and prepare/coordinate for shipping. Vendors shall prepare all cold chain shipments in shipping containers and must be prepared to maintain the product at manufacturer’s recommended temperature range for between 48-120 hours depending on time and distance of shipping requirements and contain the appropriate temperature monitor for the transit hours. Monitors will be utilized to provide validation of cold chain. The box will be labeled and sealed with tamper evident tape for closure. Vendors shall ship cold chain packages and provide confirmation of delivery and validation of cold chain.

B.8 Breakdown of Costs for CLIN 0006: Disposal Option Contractor shall dispose of GFP upon direction from the USG. The Contractor shall be responsible for complying with all applicable local, state, and federal regulations. Pricing is anticipated to be on a fixed per pound (lb) cost basis and shall be billed at that rate x poundage disposed of.

Statement of Work Rapid Response Storage, Handling, and Distribution of Government Furnish Pharmaceutical and Ancillary Medical Supplies C.1 Background

The Office of the Assistant Secretary for 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 vaccines, therapeutics, medical and testing supplies needed during a public health response. During a public health emergency, federal stockpiles of medical products and material may need to be distributed and dispensed to people throughout the country. Currently, distribution and dispensing/administration of vaccines and therapeutics relies heavily on the manufacturers and the public health system (state and local health departments).

C.2 Scope of Work

In response to potential public health emergencies, the United States Government (USG) has a requirement for Rapid Response Storage, Handling, and Distribution of pharmaceutical and ancillary medical Supplies. The contractor shall have a cloud-based warehouse management system with a modern stack, uses current code, is housed in a USG approved Environment, is FedRamp approved or in the process of approval, and has an existing Federal ERA or ATO. Distribution services of Government furnished product (GFP) vaccines, therapeutics, and ancillary supplies will use best commercial practices to ensure cold chain is maintained during shipment and products/Supplies arrive at the Government provided destinations on time. The storage requirement consists of 20,000 pallets of cold-chain product stored at 2°C to -80°C, at up to three geographically diverse warehouse locations. The GFP to be provided will be pharmaceutical products and ancillary kits or supplies needed to administer the pharmaceutical products that the USG has or will procure in response to potential public health emergencies.

This Blanket Purchase Agreement establishes the framework for a rapid response capability to receive and distribute needed pharmaceutical products and ancillary Supplies in response to a public health emergency. The product/Supplies will be furnished by the Government to the contractor. Quantities and Containerization (cases/pallets) will be provided at the time an order is issued to the contractor. The Government will give the contractor at least 30 days’ notice through issuance of an order that products are being shipped. All pertinent information such as temperature range requirements, quantities, handling instructions, etc. regarding the shipment will be provided with the order for CIN 0001 and/or CLIN 0002 and CLIN 0003. Separate orders for Freight and Handling (CLIN 0004), Pick and Pack (CLIN 0005) and Disposal (CLIN 0006) will be issued, as necessary. During the first 30 days following issuance of the order exercising CLIN 0001 and/or CLIN 0002 and CLIN 0003, the contractor shall provide to the Government the warehouse location where the shipment will be sent, prepare the location for receipt of shipment including but not limited to establishing sufficient storage space that can maintain cold chain storage temperatures, personnel to receive and inventory the GFP, load the product information in the inventory system and establish the link to the HHS ordering system, and prepare for a subsequent pick and pack, distribution order. The Government will issue Freight and Handling (Distribution) (CLIN 0004) and Pick and Pack (CLIN 0005) orders as needed for distribution of the products received under CLIN 0001 and/or 0002. Product may remain in contractor storage for up to one year pending a distribution order. Leftover (after one year in storage), expired products, or excess non-returnable product will be destroyed under CLIN 0006. The contractor’s inventory system shall provide the Government with accurate pertinent information to allow issuance of an order for disposal (CLIN 0006).

The Vendor(s) shall have capabilities to rapidly deliver and distribute products to anywhere in the United States (US) within 72 hours and all the US Territories within 96 hours via approved transportation providers.

C.3 Technical Requirements

Task 1: Temporary Storage (CLIN 0001 and CLIN 0002)

The Vendor shall provide (logistical and supply chain support) for up to 40,000 pallets of GFP within 30 days of receiving an order, with this quantity decreasing as the stock is distributed or destroyed under subsequent orders. There are currently no plans to backfill any of these products as they are distributed or destroyed.

The Vendor shall provide 20,000 pallet space for cold-chain product 2°C to -80°C and 20,000 pallet spaces for ambient temperature products 15⁰ - 25⁰C. The Vendor shall ensure that all material is warehoused in accordance with manufacturer and FDA specifications and that the facility is an approved storage facility to perform pharmaceutical warehousing compliant 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’s Representative (COR) that the facility being used to perform this agreement does indeed meet all Federal and State Regulatory requirements for the storage of pharmaceutical products.

The following product may be provided as GFP. However, this is not an exhaustive list:

Vaccines including

COVID19

Influenza Avian Influenza Therapeutics Including

Paxlovid (15°C-25°C) 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) Ancillary Kits and Materials including:

Masks Face Shields Bandages Document templates (Vaccination cards, etc.)

At the warehouse location(s), the Vendor shall have adequate space for storage, staging, receiving, and shipping of the products while maintaining manufacturer’s recommended storage and handling temperature requirements. 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 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) and that no pharmaceutical product is shipped that will expire before the anticipated administration date. 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. The vendor shall ensure cold chain shipping is maintained and monitored and provide to the ASPR upon request the record of temperature fluctuations while in shipment. At no time shall products exceeding the manufacturer’s recommended temperature range be administered, therefore temperature monitoring while in transit shall be reported within 24 hours after delivery.

If GFP is damaged while under possession of the vendor, the vendor is responsible for all disposal and replacement costs. GFP is not considered under the vendor’s possession upon transfer to a designated receiver. The Vendor shall provide loss prevention and insurance on stored products in the event of loss/damage/destruction/temperature variance exceeding manufacturers recommended range equal to the replacement cost and payable to the US Federal 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 1.1: CLIN 0006 Disposal

Contractor shall dispose of GFP upon direction from the USG. 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; 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 Contractor 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 2: Product Receiving/Inventory (CLIN 0003)

The Vendor will coordinate receipt of up to 40,000 pallets of GFP shipped to its warehouse(s) in the US. At a minimum, the Vendor shall be able to distribute products 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 align with the HHS system for reporting and ordering purposes.

For planning purposes, upon issuance of an order for CLIN 0001 and/or 0002 and 0003, 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 potential emergency response conditions, the Vendor shall expect to manage multiple shipments during standard business hours until the emergency condition 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 30 days 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 annotated on the inbound documentation. All GFP shall be shipped/stored in accordance with manufacturers requirements. All GFP shall 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 COR 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 0003)

The Vendor shall, at the direction of the COR, distribute products to all points of care utilizing best commercial practices. All shipments shall be made using traceable means.

For each shipment, the Vendor shall provide the following information to the COR 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 SNS 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 damage 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 COR, 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.

1.1 Sub-Task 1: Product Distribution (CLIN 0004/0005)

1.1.1 Standard Disbursement – Pick and Pack

The Vendor shall pick and package pharmaceutical and ancillary supplies according to Government instruction under BPA orders for CLIN 0005. The Vendor shall be responsible for packing only full case quantities and not be responsible for Kitting or re-Kitting any ancillary supplies. The Vendor shall prepare pick and packed materials for shipping according to manufacturer’s recommended packaging and handling instructions including cold chain requirements as well as safety and security requirements of federal, state, and local laws, regulations and guidelines.

For GFP that is provided under a disbursement strategy in response to a stated public health emergency, 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 a range of 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, 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. 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 Agreement and/or orders shall be communicated to the Vendor only by the Contracting Officer or COR.

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

a) ASPR will provide sufficient and timely information to the Vendor regarding the disbursed quantities of GFP to be shipped to the 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, Alaska, and Hawaii within three (3) business days. The Vendor shall not be required to deliver within the specified time frame 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 four (4) business days. Shipments to a delivery location(s) in a US Territory will be subject to the applicable OCONUS Outbound Fees. 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 approved shipping containers and must be prepared to maintain the product at manufacturer’s recommended temperature range 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.

c) Cold chain shipping containers shall be sufficiently sturdy, adequately insulated, and able to maintain stable temperatures using dry ice or any other means to minimize any temperature variations during the entire shipping period.

1.1.2 Final (Winddown) Disbursement

At 90 days prior to conclusion of this agreement, the Vendor will be responsible for coordinating and beginning to deliver all undistributed Government-owned property to ASPR identified locations. The Vendor shall provide a complete accounting of all products received from the Government, products distributed, and products delivered back to ASPR. ASPR will direct final distribution of any GFP at the Vendor’s facility by any one or combination 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 request distribution or provide disposal instructions of unshipped products.

· USG will bear any costs resulting from continued storage of GFP after the expiration or termination of this agreement.

At the completion of this agreement, there will be a wind-down period of 45 days to transfer all products to the next contractor or storage facility if applicable.

C.4 Period of Performance

The Period of Performance is: Comment by Colon-Serna, Rachelle (ASPR/ADMIN): Add PoP based on an 11/04/2024 anticipated award date.

Initial Period:

This Blanket Purchase Agreement shall be reviewed annually and continue for a period not to exceed five (5) years. Any changes to the terms and conditions or pricing shall be incorporated by formal modification. The contractor may submit requested revisions to terms and conditions or pricing within 60 days prior to the anniversary date of this agreement. Submission of requested revisions does not constitute automatic acceptance of the revisions by the Government. The Agreements Officer may a) accept the revisions and incorporate by formal modification, b) open discussions with the contractor and negotiate a mutually agreed upon revision which will be incorporated by formal modification, or c) reject the revisions and terminate the agreement by formal modification. If the Agreements Officer chooses (B) opening discussions, the current terms and conditions and pricing shall remain in effect until discussions are concluded and a mutually agreed upon revision is reached. Revisions may be retroactively applied to the anniversary date of the agreement.

C.5 Returns & Recalls

Once the Vendor has delivered the product to the ASPR provided delivery location(s), product shall not be eligible for returns to the Vendor.

If the applicable manufacturer of certain GFP conducts a recall or market withdrawal involving GFP distributed by the Vendor on behalf of ASPR or warehoused by the Vendor on behalf of ASPR under this agreement and/or orders, the Vendor will coordinate the recall of any distributed GFP per the applicable manufacturer direction. Any shipment of recalled GFP back to the applicable manufacturer or Government shall be subject to the End of Tender of Service Redistribution Fee set forth in Section B.3.

C.6 Deliverables

One electronic copy – SNS Text file submission to the SNS Tracking Tool

Within 24 hours of receipt of GFP

One electronic copy – SNS Text file submission to the SNS Tracking Tool

Next business day following direction of SNS

One electronic copy – SNS Text file submission to the SNS Tracking Tool Within 24 hours following each delivery and/or at the request of SNS. All therapeutic products require delivery confirmation and cold chain validation.

One electronic copy – SNS

Within 24 hours days of becoming aware GFP was not properly handled, maintained, stored, transported, delivered and/or otherwise managed by Vendor.

One electronic copy – SNS Within 48 hours upon receipt of inventory

One electronic Copy – SNS One electronic copy – SNS Draft Final Report due in both hard copy and an electronic copy on/before the completion date of the Tender of Service. Final Report due 30 business days after closeout.

C.7 Security Criteria

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 (Agreement 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 responsible for continuous maintenance and repair or replacement of security equipment for the life of the Agreement.

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 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 enough parking space for staging trucks during an actual event.

b.

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 Agreement is separated and secured from other tenants, including external points of egress.

f. Have limited glass frontages and skylights. If present, the Vendor shall demonstrate how glass frontages and skylights will be physically secured and not detrimental to GFP temperature requirements

g. Comply with all applicable local zoning requirements.

h. Provide the Government adequate space to store up to 40,000 pallets of pharmaceuticals and ancillary supplies, , including 20,000 pallets in cold storage.

i. 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.

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

k. 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.

C.8 Place and Method of Delivery

The delivery locations will be provided by the USG to the Vendor no less than 96 hours prior to requested delivery. All deliveries will be billed in accordance with Section B.3.

C.9 Reporting Requirements and Site Visits

C.9.1 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.

C.9.2. Site Visits

The USG reserves the right to conduct site visits and collect samples 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.

C.9.3. POCs

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

C.10 Vendor Qualifications

The Vendor shall be responsible to adhere to all applicable current good manufacturing practice (cGMP) requirements and Government quality assurance requirements regarding receiving, storing, and distribution of pharmaceutical products.

The Vendor shall be responsible to maintain comprehensive Quality System programs, which shall comply with all applicable federal, state, and local regulations, for storage, handling, and transportation of pharmaceutical products, including controlled substances, and the Government performance requirements cited throughout this agreement for the warehousing (receiving, holding, and shipping preparation) of product.

Vendor shall utilize an Inventory system to provide full accountability for all GFP sent to and shipped from the vendor’s facilities, preferably one that has a cloud-based warehouse management system with a modern stack, uses current code, is housed in a USG approved Environment, is FedRamp approved or in the process of approval, and has an existing Federal ERA or ATO.

The Government may conduct an audit of the vendor’s operations, including storage, handling, pick and pack, shipping and disposal of GFP to ensure compliance with all applicable regulations and this agreement. 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 continued Government use of this agreement. 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 the Government in accordance with their standard procedures. The The Government is responsible for product impact evaluation and contacting appropriate manufacturers, when required. The completed deviation report including product disposition, if 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 COR.

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 with 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 sub vendor Qualification - The Vendor shall be responsible to ensure that all sub vendors 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 Agreement. All sub vendors shall be regularly evaluated by the primary vendor to ensure performance and quality compliance. Records identifying acceptable sub vendors, 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 and cold chain storage

2. Data back-up of electronic data capture

j. Change Control - The Vendor shall be responsible for documenting 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, which is not a “like for like” change, which 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 people to observe the inspection.

l. Inventory and Maintenance Management System- The Vendor shall provide an inventory and maintenance management system that is transparent and as a minimum provide CSV files to the Government. If available and can meet Government requirements for interface between Government and non-Government systems a directly accessible Inventory and Maintenance Management System that provides a real time dashboard for all warehouses for this program on one dashboard with the ability to expand the Warehouse Management System to other existing warehouses is preferrable. The Vendor shall have an internal "real time” on-line electronic data interchange (EDI) that captures all transactions pertaining to the government-owned property and provide the data to HHS/ASPR or others as directed that provides near real-time readiness status.

1. The inventory management system should be able to provide status and location confirmation for all material. Inventory systems shall be maintained in accordance with the 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 in a CSV file. These reports will include notations of any material damaged, lost, or theft. These reports shall be sent to the assigned ASPR/DASPR Project Officer and SNS Representative by close of business on 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 to manage all GFP in vendor warehouses. WMS must provide inventory management control – by manufacturer, lot number, expiration date of the COVID-19 Tx and other products, 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 WMS is not a requirement for the proposal, but the Vendor acknowledges they will need to consent to collaborating with a provider for this added capability in the future.

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 tender 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 tender award winner. More specifically, no information shall be shared with anyone outside of the US Federal Government and the tender 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 must have one dashboard portal set up that will provide visibility for all warehouse locations. The US Government will have access to the dashboard within 15 days of award and within 90 days at any other locations that may not include the warehouse awarded location/s as directed by HHS – additional cost set up of the cloud-based WMS is to be submitted as a one-time fee with required ongoing maintenance of the WMS for the life of the Agreement for each facility.

c. The WMS shall provide all the above functions in near real time. 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…