W911SR23R0009_TPOXX Task Order_SOW_Draft.docx

Statement of Work(SOW)

Retrieval, Storage, Inventory, Distribution, and Disposal of Government Owned Ticovirimat (TPOXX®)

1.0 Background and Purpose

The Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear (JPEO-CBRN) Medical requires a vendor managed inventory (VMI) performer to support government needs in storing and distributing TPOXX® manufactured by SIGA Technologies, Inc., the oral antiviral therapeutic for smallpox.

The objective of this effort is to receive, store, inventory, distribute, and dispose of government owned TPOXX® subject to regulations administered by the US Food and Drug Administration (FDA), the United States Pharmacopeia (USP), and other federal agencies.

2.0 Applicable Documents

In performance of this contract, the Contractor must abide by all applicable regulations, publications, manuals, and local policies and procedures listed below.

2.1 United States Pharmacopeia, Chapter 1079, “Good Storage and Shipping Practices.”

2.2 Food and Drug Administration (FDA), Title 21 CFR, Parts 210 and 211.

2.3 Hazardous Material Regulations; 49 CFR, Parts 171-180.

3.0 Requirements

The Contractor shall store up to 30,000 bottles of TPOXX® under controlled room temperature conditions for a period of three years and process monthly distribution requests for shipment.

3.1 Receipt: The Contractor shall a receive single shipment of TPOXX® from the Government under this task order. The shipment will consist of up to 30,000 bottles of TPOXX® in multiple pallets (5 pallets) of the following dimensions: 14-11/16” x 11-5/16 x 11”. The Contractor shall be given 5 days notification in advance of receipt of in-shipments from the Government.

3.2 Storage: The Contractor shall store materiel under the controlled room temperature conditions specified below for a period of three years:

3.2.1 The Contractor shall provide room temperature storage services for the TPOXX vaccines in accordance with current Good Manufacturing Practices (cGMP) Title 21 CFR Parts 210 and 211 standards. Controlled Room Temperature is considered within the following range.

Controlled Room Temperature 20oC to 25oC (68oF to 77oF) Drugs (TPOXX®)

3.3 Inventory: The contractor shall conduct 100% annual inventory and provide CBRN Medical a copy of inventory records as the basis for maintaining accountability.

3.3.1 The Contractor shall conduct a formal 100% material inventory annually for products managed under this ID/IQ and 30 days prior to the conclusion of the period of performance of the ID/IQ. Additionally, the Contractor shall provide quarterly updates of the status of inventory documenting any changes that occurred during the quarter per task order.

3.3.2 The Contractor shall ensure that all material storage boxes have properly fitting lids, and all material storage boxes are properly and consistently labeled in accordance with FDA requirements.

3.4 Distribution: The Contractor shall distribute material in accordance with the following guidance.

Notification: The Contractor shall receive requests for distribution from the US Army Medical Materiel Agency (USAMMA) Distribution Operations Center (DOC) point of contact noted below:

USAMMA DOC POC:

Liz Andrews Deputy Director, US Army Medical Materiel Agency (USAMMA) Distribution Operations Center (DOC) 693 iman Street Fort Detrick, MD 21702 301-676-1184 571-588-9777 Olga.L.Andrews.civ@army.mil

The number of anticipated in-shipments and out-shipments for TPOXX® is captured on the following table:

It is anticipated that requests for TPOXX® distribution will be 25 shipments per week. It is anticipated that 16% of the annual shipments will be to OCONUS locations and the remaining shipments to CONUS addresses. The average anticipated shipment is expected to consist of two (2) bottles of the vaccine along with the SENSITECH TempTale 4 BIO (described below) and cold packs.

Government order requests from USAMMA DOC will identify the quantity of bottles, the shipping address, a primary contact, an alternate contact, and any pertinent information required and necessary for the Contractor to prepared product for shipment.

3.4.1 Within one (1) business day of Government notification to distribute material, the Contractor shall pack and ship material in accordance with applicable validated packing protocols, DoD and Department of the Army regulations, applicable FDA and Department of Transportation guidance and regulations, in addition to guidance provided in USP Chapter 1079, Good Storage and Shipping Practices. The Contractor shall ensure material is continuously maintained at room temperature, 20C to 25C (68F to 77F), until delivery is accepted at the destination.

3.4.2 Packing of product shall consist of using the thermal safe, Sonoco shipping boxes, with a TempTale to ensure validity of product and a minimum of two refrigerated gel packs, surrounding the inner box, dependent on weather to ensure temperature does not exceed 25oC/77oF. The Contractor shall use a SENSITECH TempTale 4 BIO (TT4 Bio) Monitor to ensure product temperature is maintained. A TT4 shall be inserted into each shipment box for all temperature sensitive shipments along with a return envelope for return of the TT4 to the Contractor for recording of shipment data.

3.4.3 The contractor shall provide package tracking information to the Government representative at USAMMA DOC, the day of shipment or upon creation tracking numbers.

3.4.4 After receipt of the TT4 BIO from the shipment recipient, the contractor shall record the data into the SENSITECH TempTale Manager Desktop Software and provide a report of the data to the USAMMA DOC POC within 2 business days.

4.0 Deliverables

4.1 Project data and deliverables for this task order are identified in appendix D of the overarching Performance Work Statement (PWS) Contract Data Requirements List (CDRLs exhibit A001-A005) . The delivery of data and physical deliverables shall be coordinated with the Contracting Officer (KO), Contracting Officer Representative (COR) and USAMMA DOC POC. A copy of all data deliverables shall be sent to: usarmy.detrick.dod-jpeo-cbrnd.mbx.deliverable@mail.mil

4.2 Post Award Conference/Periodic Progress Meetings: The Contractor agrees to attend any post award conference convened by the contracting activity or contract administration office otherwise designated in the contract. The Government Contracting Officer, COR, and other Government personnel, as appropriate, will meet Quarterly with the Contractor to review the Contractor's performance and assess inventory. At these meetings the COR may apprise the Contractor of how the Government views the Contractor's performance, and the Contractor will apprise the Government of problems, if any, being experienced. Appropriate action shall be taken to resolve outstanding issues.