RFI - AncillaryKit VMI Attachment 1 Draft SOW.pdf

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

Statement of Work (SOW) for the Department of Health and Human Services/

H-CORE

DRAFT

1.0 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.

HHS Coordination Operations Response Element (H-CORE) is responsible for maintaining and deploying the vaccines, ancillary kits, testing supplies and personal protective equipment (PPE) needed during a public health response. During a public health emergency, federal supplies of ancillary kits, testing supplies and PPE may need to be distributed and dispensed to vaccine administration sites throughout the country. Currently, distribution and dispensing/administration of, ancillary kits, testing supplies and PPE from H-CORE relies on the public health system (state and local health departments) along with partnerships to store and distribute the ancillary goods.

2.0 SCOPE OF WORK

1. In response to the COVID-19 pandemic, H-CORE has a requirement for Vendor Managed Inventory (VMI) and distribution services of Government furnished product (GFP) consisting of ancillary kits and materials for the successful administration of the COVID-19 vaccine. The vendor shall provide VMI (logistical and supply chain support) for up to 119,000 pallet positions of GFP.

The Vendor shall be responsible to provide all VMI & distribution capabilities and services (such as, but not limited to, expertise, record & inventory management, labor, material, equipment, inspection, order picking, repackaging/palletizing, transportation assets, and properly licensed and secure facilities).

2. The vendor shall maintain the capability organically, or by subcontract, for medical waste disposal services for material that is still in manufacturers packaging or kits but has been damaged, is expired, or is no longer required to support an ASPR response.

3. The Vendor shall maintain the capability to process material requests and distribute pallets of kits or materials to locations as directed by the USG.

4. Vendor must be willing to enter into supporting contracts with other federal entities and commercial manufacturers to meet unique mission requirements.

3.0 TECHNICAL REQUIREMENTS

The Government is seeking to utilize the services of medical supply distributors to store and distribute ancillary kits and or supplies in the event of a pandemic or similar event during an infectious disease emergency across the United States. Vendor must have in place and maintain all medical licensing and facilities required to store and deliver medical supplies in accordance with FDA regulatory requirements at the time of award.

CLIN Item Description Quantity UOM Unit Price Total Price

(FFP)

Vendor Managed Inventory

(VMI)

Services

Includes all services as necessary to receive, inventory, store, manage and prepare Government Furnished Property (GFP) for distribution.

Includes all services to perform product management, documentation, reporting and distribution tasks as necessary to store and maintain product kits in deployable status in accordance with Section C, Task 1.

Includes all services as necessary for the initial receipt and continuous management invoiced by 50,000 pallets at fixed cost.

50,000 Fixed

Pallets

Each Year

(T&M)

Distribution (Bulk)

Vendor must be capable of shipping all items under appropriate conditions for the length of the contract.

Section 3.0. Task 2

Up to 25,000

Pallets DRAFT

(T&M)

Freight Small Parcel

Vendor must be capable of shipping all items under appropriate conditions for the length of the contract.

Section 3.0. Task 3

Up to 100,000

Each

(T&M)

Pick Pack Prepare

Vendors pick kits or materials per order and prepare for shipping.

Up to 100,000

Each

(T&M)

Disposal The vendor shall maintain the capability organically or by subcontract with a disposal vendor for medical material waste disposal services.

Up to 30,000,000

Pounds Non-hazardous Hazardous

(T&M)

Surge VMI Capacity (Optional)

Vendor shall provide services described in Task 6 for up to an additional 69,000 pallets billed at peak quantity monthly at 59-89°F

Up to 69,000

Each / Year

(FFP)

Setup All costs associated with the setup of IT solutions, licensing and additional costs associated with establishing customer accounts for ordering and distribution

1 LOT

(FFP)

Transition Vendor shall take possession of all GFE as described in Task 8

1 LOT

CONTRACT LINE ITEM NUMBER (CLIN) DESCRIPTION (OPTION YEAR 1)

CLIN Item Description Quantity UOM Unit Price Total Price

(FFP)

Vendor Managed Inventory

(VMI)

Services

Includes all services as necessary to receive, inventory, store, manage and prepare Government Furnished Property (GFP) for distribution.

Includes all services to perform product management, documentation, reporting and distribution tasks as necessary to store and maintain product kits in deployable status in accordance with Section C, Task 1.

Includes all services as necessary for the initial receipt and continuous management invoiced by 50,000 pallets at fixed cost.

25,000 Fixed

Pallets

Each Year

(T&M)

Distribution (Bulk)

Vendor must be capable of shipping all items under appropriate conditions for the length of the contract.

Section 3.0. Task 2

Up to 25,000

Pallets

(T&M)

Freight Small Parcel

Vendor must be capable of shipping all items under appropriate conditions for the length of the contract.

Section 3.0. Task 3

Up to 100,000

Each

(T&M)

Pick Pack Prepare

Vendors pick kits or materials per order and prepare for shipping.

Up to 100,000

Each

(T&M)

Disposal The vendor shall maintain the capability organically or by subcontract with a disposal vendor for medical material waste disposal services.

Up to 5,000,000

Pounds Non-hazardous Hazardous

(T&M)

Surge VMI Capacity (Optional)

Vendor shall provide services described in Task 6 for up to an additional 69,000 pallets billed at peak quantity monthly at 59-89°F

Up to 69,000

Each / Year

Task 1: Vendor Managed Inventory (VMI) Services

1. The vendor shall have capacity to coordinate receipt of 10,000 pallets per week up to a total of

119,000 pallets of USG product into its warehouses at time of award. At a minimum, the vendor shall have location/locations capable of warehousing the quantities referenced above under proper conditions and with the proper licensing for the storage and handling of the GFP medical countermeasures. The Government anticipates there could be many suitable locations and would like solutions presented based on the vendor’s expertise considering population centers, historical distribution patterns for these types of products, and other relevant factors. The vendor shall possess and populate upon receipt of GFP, an inventory system capable of providing up to date information on all Government owned inventory including quantity by lot, location, and expiration date, if applicable. Vendor shall conform to industry FIFO (first in first out) practices.

2. 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 40 per day. There may be domestic, international, and shipments to US Territories. 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.

3. The USG anticipates the initial load-in consisting of 3,000,000 number of kits on 77,000 number of pallets in addition to 42,000 number of pallets of un-kitted product.

4. 50,000 pallet spaces will be billed as a fixed cost monthly and may be a mixture of kits and un-kitted supplies.

5. The Vendor shall coordinate receipt of product (GFP shipped directly from USG or from manufacturers) into its designated warehouses across the United States. The products to be provided as GFP will be medical supplies such as but not limited to gloves, gowns, coveralls, goggles, face shields, masks, N-95, boot covers, test kits, swabs, media, ancillary vaccine kits, needles, medical equipment, and pharmaceuticals. At a minimum, Vendor shall have locations that are geographically disperse and able to service the entire United States while being capable of warehousing the quantities proposed. The Government anticipates there could be many suitable locations and would like solutions presented based on Vendor’s expertise considering population centers, historical distribution patterns for these types of products and other factors deemed relevant. 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:

a. Manufacturer and Model Number / Part Number

b. SKU Description

c. Unit of Measure

d. Quantity transported

e. Quantity on hand by facility

f. Warehouse location/multiple warehouse/storage points

g. Lot number

h. Expiration date

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

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

k. Bill of Lading

l. Packing Slip

6. Vendor shall inventory and validate receiving documentation of the product by annotating the incoming documentation with the name of the person receiving the product, date and time of the receipt. Any discrepancies between the incoming (packing list) documentation and the actual product shall be so annotated on the inbound documentation. Vendor shall ensure that quantities received are accurate and lot numbers match. Upon 100% visual inspection of the inbound shipment, any damage, shelf-life issues, or discrepancies in quantities shall be reported to the Contracting Officer’s Representative (COR) within 24 hours and material shall be sequestered and suspended by Vendor, pending resolution within 48 hours from the instruction of the COR.

Vendor shall acknowledge receipt and forward copies of all inbound documentation to the COR within 24 hours after receipt of material.

7. Vendor shall ensure that accurate records and accountability of both inbound and outbound shipment records are auditable and reconcilable to the Government. Vendor shall maintain an inventory record and location system for the GFP products throughout the terms of the contract.

All documentation related to the inventory quantities of product shall be retained by Vendor and made available to the USG upon request.

8. Vendor shall maintain inventory detail for kitted and un-kitted materials to the level required to implement any manufacturers recalls for items by description and Lot number.

9. Vendor shall have data feeds that supply H-CORE’s logistics management system with inventory data to maintain a robust accounting of product.

10. Additional pallets up to the projected 119,000 will be billed individually with the monthly invoice calculated by peak quantity of pallets above 50,000.

11. Any additional pallets stored utilizing the surge option of 69,000 pallets (see Task 6) will be added to the calculation of pallets above 50,000 for peak quantity monthly.

12. Normal operating hours for H-CORE and Vendors are, at a minimum, Monday-Friday 8 a.m. - 5 p.m. Eastern Standard time, and full mission capability is required during these hours. For all deliveries to the Vendor, appointments will be scheduled in advance.

13. Vendor receiving hours must be at a minimum, between 7 a.m. – 2 p.m. local time. Offerors shall provide their proposed receiving hours. Vendor shall keep a log of unscheduled deliveries and provide to the HHS Representative upon request.

14. Vendor shall provide after-hours operations as needed for emergency shipments or shipments that arrive later than the scheduled time on an as needed basis and is not anticipated to exceed more than two occurrences per month. All vendor support shall be provided at the vendor-provided facilities.

15. Vendor shall maintain an existing customer service toll-free number and email address will be required to address inquiries from shipping locations and administration sites re: ancillary kits about shipping status and product damage.

16. Vendor shall inventory and validate receiving documentation for GFP. Any discrepancies between the incoming (packing list) documentation and the actual product shall be annotated on the inbound documentation. At a minimum, the vendor shall ensure that quantities received are accurate and lot numbers match. Upon inspection of the inbound shipment, any damage, shelf-life issues, or missing quantities shall be reported to the HHS Representative immediately and material suspended by the vendor pending resolution of the problem. Ship all items under appropriate conditions (i.e. temperature, weight limitations, etc.). Confirmation of delivery will be provided to H-CORE by email in a format mutually agreed upon on each business day by 10:00 am EST.

17. Vendor shall acknowledge receipt and forward copies of all inbound documentation to the H- CORE representative within 24 hours after receipt of material.

18. The Vendor may receive pallets with mixed lots. Lot and expiry tracking is required by the USG, the Vendor shall maintain accountability by lot number and expiry in accordance with their SOP and may require pallets to be broken down and stored accordingly.

19. Receiving requirements:

a. 60” pallets

b. Only one packing list per truck

c. Packing list needs to be taped to the last pallet loaded onto the trailer

d. Single SKU pallets

e. Each pallet should be labeled with the lot #(s) (marker on shrink wrap, paper attached, etc.)

f. Delivery appointments are required

20. The Vendor shall provide up to 119,000 pallet spaces in an ambient warehouse for storage with the ability to maintain temperature ranges from 59-89 degrees Fahrenheit for all GFP if required by manufacturer specifications. The vendor shall adhere to all manufacturer specifications for the storage of GFP. Products and kits that do not require temperature controls may be stored in non-temperature-controlled warehouse, such as gloves and gowns or other ancillary products.

21. At the warehouse location(s), 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.

22. The vendor shall ensure that accurate records and accountability of both inbound and outbound shipment records are auditable and reconcilable to the Government. All documentation that is related to the inventory quantities of product shall be retained by the vendor and made available to the USG upon request.

23. Below is an example but not limited products that will be serviced under this VMI contract.

a. Ancillary kits

b. Un-kitted ancillary supplies

c. Other related vaccine administration supplies and medical countermeasures

d. PPE

e. Pharmaceuticals (not currently planned; any pharmaceutical storage and distribution requirements will be negotiated between the Vendor and USG at the time of requirement and adjustments to cost and capability will be agreed upon prior to execution)

24. 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 H-CORE 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 H-CORE for the lost or damaged GFP at the USG’s acquisition cost.

Task 2: Bulk Product Distribution (LTL/FTL)

The Vendor shall:

1. Deliver GFP within 96 hours of notification to CONUS; 120 hours to US Territories.

2. Maintain a readiness level to receive and respond to a notice to distribute from H-CORE

24/7/365 and distribute product as directed.

3. Have an emergency email established that will notify customer service 24/7/365 of a notice to distribute product as directed within specified timeframes. Customer service will coordinate with the distribution center to bring staff on site to prepare for distribution.

4. Within 24 hours of receipt of appropriate authorizations during normal hours of operation, the vendor must be able to load and begin transporting product to desired locations throughout the United States.

5. Be capable of making final delivery of product to the local site within the continental United States within four (4) business days of receipt of authorization.

6. Ship all items under appropriate conditions (i.e., temperature, weight limitations, etc.). The vendor shall provide confirmation of delivery to H-CORE by 10:00 am EST each business day via the daily report.

7. Invoice monthly based on distribution completed between first day and last day of the month if utilizing.

8. The vendor shall provide transportation tracking information from their facility to agreed destinations when requested by the USG (ASPR) and lot, track, and trace is required for all product shipping.

Table. Proposed Cost 40” x 48” x 800lbs: Bulk Distribution to freight forward sites

Task 3: (OPTION) Freight & Transportation (Small Parcel) shall be exercised in conjunction with the pick and pack option

1. The Vendor shall, at the direction of H-CORE, distribute products to all points of care as directed by the USG. Deliver GFP within 72 hours of notification to CONUS; 96 hours to US Territories.

Shipment of parcels will require lot, track, and trace for shipping.

Table 1: Distribution Fee Schedule

Method Unit of Measure

Zone 1 Zones 2-4 Zones 5-6 Zones 7-8

LTL Pallet FTL Pallet

Expedited Pallet

Distribution Fee Schedule Method Unit of

Measure Zones 2-4 Zones 5-6 Zones 7-8 Alaska, Hawaii, Puerto

Outside the Continental

U.S.

Task 4: (OPTION) Pick and Prepare shall be exercised in conjunction with the freight small parcel option

1. Following receipt and confirmation of items listed above, the Vendor shall pick and prepare specified quantities of GFP identified by H-CORE for shipment to any such delivery location(s) located within the US and Territories using the process outlined in Task 3 Freight & Transportation. For each shipment, the Vendor shall provide the following information to the H- CORE Designee within 48 hours after delivery:

a) Delivery/order number

b) NDC/Product #

c) Product Name

d) Quantity Shipped

e) Number of Containers/Pallets

f) Date Shipped

g) Estimated Arrival date/time

h) Carrier Name

i) Tracking Number(s)

j) Proof of Delivery

2. 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.”

g) FDA Discretion Notification Sticker

3. 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

Rico

Ground Case NDA Case LTL Pallet

TL Pallet Expedited Pallet

f) Quantity Shipped

g) Delivery/Order number

h) Transportation Control Number or Customer Requisition Number

Task 5: Product Disposal

1. The vendor shall maintain the capability organically, or by subcontract, for medical waste disposal services for; material that is still in manufacturers packaging or kits but has been damaged, is expired, or is no longer required to support an ASPR response.

2. The material disposal process begins with a representative from H-CORE initiating the directive for waste disposal by product/lot/quantity.

3. Vendor shall dispose of GFP upon direction from the USG.

4. Pricing is to be on a fixed per pound (lbs.) cost basis and include the cost of freight from vendor warehouse to disposal facility and shall be billed at that rate multiplied by poundage disposed of required. Pricing is to include both a rate for hazardous and non-hazardous materials.

5. The Vendor shall maintain record of disposal for each occurrence that provides quantity, lot, disposal vendor, disposal method and certification that materials were disposed of in accordance with federal, state and local regulations to include but not limited to the Occupational Safety and Health Administration (OSHA), National Institute for Occupational Safety and Health (NIOSH), U.S. Drug Enforcement Administration (DEA), U.S. Environmental Protection Agency (EPA) hazardous waste regulations, and Department of Transportation (DOT).

Task 6: (OPTION) Surge VMI Vendor shall provide services described in Task 1 above for up to an additional 69,000 pallets . Any additional pallets stored utilizing the surge option of 69,000 pallets will be added to the calculation of pallets above 50,000 for peak quantity monthly.

Task 7: Setup 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 8: Transition Vendor shall take possession of all GFE (117,000 pallets weighing a total of approximately 30M Lbs.)

from current vendor location and transport all materials to proposed new locations. Vendor will provide transition plan and cost with proposal.

4.0 DELIVERABLES

Item Deliverable Quantity Due Date 1 Receiving Report – Excel

Spreadsheet Original – H-CORE One electronic copy – H-CORE Text file submission to H-CORE

Within 24 hours of receipt of GFP

2 Inventory Report Original – H-CORE One electronic copy – H-CORE Text file submission to H-CORE

Next business day following direction of H-CORE with lot, track, and trace required for inventory reporting

3 Semiannual Physical Inventory Report

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

180 – 200 days within acceptance of award and 6 months thereafter

4 GFP Handling Issue Report Original – H-CORE One electronic copy – H-CORE

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

5 Bills of Lading and packing slips

Original – H-CORE One electronic copy – H-CORE

Within 48 hours upon receipt of inventory

6 Disposal Report Original – H-CORE One electronic copy – H-CORE Text file submission to H-CORE

Weekly containing: quantity, lot, certificate of destruction containing vendor, and destruction method

7 Shipping Report Documentation

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

Within 24 hours following each delivery and/or at the request of H- CORE. All products require delivery confirmation

8 Final Report Original – H-CORE One electronic Copy – H-CORE

Draft Final Report due in both hard copy and an electronic copy on/before the completion date of the contract.

Final Report due 30 business days after closeout.

5.0 SECURITY CRITERIA

The vendor’s facility shall meet the following security criteria.

1. Exterior camera coverage:

• Cameras to be day and night capable, DVR must store a minimum of 30 days motion activated images

• Provide 360-degree coverage of the exterior building

• Exterior personnel entrances

• Dock area

2. Interior camera coverage

• Each personnel door

• All roll-up doors (can be grouped)

• Load and unload areas.

3. Intrusion Detection System

• Reports to Underwriter Laboratories (UL)-certified Central Alarm Station (Contract for monitoring required)

• All doors and roof hatches with alarms and monitors.

• Motion detectors covering dock doors and external doors.

4. Access Control System

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

• Access control will be a stand-alone system with storage capacity for entrance/egress logs to be a minimum of 6 months.

• Access cards will be provided to permanent, on-site, vendor personnel. Temporary employees, USG personnel and visitors will be required to check-in with the Security Guard for access to the building.

• Security Guards shall be provided a daily list of approved personnel and must confirm each individual’s name and badge before allowing entry to the building.

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

5.1 Subtask – Site Criteria

The vendor’s site shall conform to the following criteria:

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

2. Have property terrain that is flat and level.

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

4. 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 to this requirement on a case-by- case basis. Current exceptions include hazardous material dedicated to airport operations and gasoline stations.

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

6. 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.

7. 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 jurisdiction within which the vendor facility is located. Such information shall be made available to the Government if requested.

5.2 Subtask – Grounds Criteria

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

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

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

3. 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.

4. Landscaping and vegetation shall comply with local jurisdiction requirements.

5. Be able to support a minimum height of six feet (unless preempted by local code and ordinance) fencing of the entire perimeter.

6. 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.

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

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

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

10. Comply with all applicable local zoning requirements.

11. Provide the Government adequate space to store raw materials and finished goods for up to 119,000 pallets to be stored and all other site requirements.

12. Provide the following redundant systems:

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

b) Uninterruptible power supply (UPS) for all data capture and security systems.

c) Data back-up of electronic data capture.

d) Network backup is accomplished with redundant wired circuits from two different providers, 4 circuits in total.

13. Ensure that all outside communications services are provided with conduit diversity and that multiple providers are available for redundancy.

14. Conduit diversity is a building with an additional wire line conduit entry point.

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

16. Facilities constructed after 2000 shall have been constructed utilizing International Building Code

(IBC) seismic design parameters.

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

5.3 Sub-task Reporting Requirements and Site Visits

The Vendor shall provide daily reports to USG in a mutually agreed upon format.

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.

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. Five business day notification is required to schedule Vendor Distribution Center site visits to allow for proper coordination of both the USG and Vendor.

The Vendor shall provide primary and secondary points of contact that will be available 24/7.

6.0 GOVERNMENT FURNISHED MATERIAL / INFORMATION

The USG may provide the following items as government furnished materials:

1. Needles of various gauges and lengths and syringes of various sizes, alcohol pads, masks, face shields, bandages, shipping containers, dry ice supplies, document templates (i.e., Vaccination card, Needle Information Card, and other templates as appropriate)

2. Up to 3,000,000 ancillary kits already produced.

3. Additional ancillary supplies required for a national response.

7.0 ONSITE GOVERNMENT PERSONNEL

When USG personnel are on-site for the inspection and acceptance of GFP at the Vendor facilities, USG personnel shall comply at all times with all facility security, access, safety, and other policies provided in writing to the USG personnel. USG personnel shall conduct their work at Vendor facilities in such a manner as to avoid endangering the safety or interfering with the job responsibilities of Vendor employees, representatives, suppliers, or other personnel.

8.0 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 with a modern stack, uses current code, and is housed in a USG approved Environment.

Annually, the Government may assess the Vendor’s facility and Quality Systems within six (6) months into the Period of Performance and decide regarding the site’s on-going acceptability and compliance to properly and safely store and handle 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 the 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 H- CORE’s logistics management system. 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 H-CORE’s 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

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 (If provided)

(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 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 DMS is not a requirement for your proposal, but you acknowledge that you will need to consent to working 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 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 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 contract 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 contract 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 information shall be made available in WMS within 12 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 Medical Countermeasures will arrive 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 Medical Countermeasures or other product 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.

Closeout

60 calendar days prior to contract completion, the HHS Representative will provide guidance for remaining products in vendor facilities. ASPR will direct vendor regarding final distribution of all USG products received from the Government and any products not yet moved. The vendor shall provide a complete accounting of all products received from the Government, delivered to customers, and final distribution of remaining product.

Upon expiration or termination (including partial termination) of this contract, the USG will direct final distribution of any products or kits on this contract and remaining in storage 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 offer products still in their original packaging for sale to the vendor.

• The USG may request distribution or provide disposal instructions of unshipped Kit products.

• Any costs resulting from final distribution of any products or kits remaining in storage at the expiration of termination of this contract will be at the expense of the USG.

• USG will bear any costs resulting from continued storage of kits or products by Vendor after the expiration or termination of this contract.

Vendor shall be provided final distribution instructions 60 days prior to the end of the contract Period of Performance.