Tecovirimat 75A50325Q00027

NOTICE OF INTENT TO AWARD A SOLE SOURCE CONTRACT Agency: Department of Health and Human Services Office: Administration for Strategic Preparedness and Response (ASPR), Center for the Strategic National Stockpile (SNS) Location: 2945 Flowers Road, Atlanta GA, 30341 The NAICS code for this procurement is 325412, Pharmaceutical Preparation Manufacturing. The anticipated period of performance includes one (1) base year and two (2) one-year optional ordering periods. The Office of the Administration for Strategic Preparedness and Response (ASPR), Center for the Strategic National Stockpile (SNS) intends to award a sole source firm fixed price contract to: Manufacturer Name The U.S. Government, in accordance with RFO 6.103-3 Industrial mobilization; engineering, developmental, or research capability; or expert services, intends to award a sole source contract to SIGA Technologies, Inc., 31 East 62nd Street, New York, NY 10065. Requirement: The Government requires replenishment and stockpiling of TPOXX™ (tecovirimat) 200 mg oral capsules and Tecovirimat injection (200 mg/vial, 10 mg/mL, single-dose) to support national biodefense and public health preparedness initiatives. Oral capsules provide the primary treatment option for patients able to take medication by mouth, while the IV formulation is critical for patients unable to swallow, with impaired absorption, or requiring inpatient care. Maintaining access to both dosage forms ensures operational flexibility and readiness to respond to orthopoxvirus threats, including smallpox. Requirement: 387,096 QTY- Oral Capsules (200 mg): Store at 20°C–25°C (68°F–77°F); permitted excursions 15°C–30°C (59°F–86°F); protect from excessive heat and moisture. 525,030 QTY- IV Injection (200 mg/vial, 10 mg/mL): Store frozen at –20°C (–4°F); Authority: This acquisition will be conducted under the authority of RFO 6.103-3), which permits other than full and open competition when necessary to maintain facilities, producers, manufacturers, or suppliers in case of a national emergency or to achieve industrial mobilization. SIGA Technologies is the only FDA-approved source of supply for tecovirimat, and continued procurement is required to sustain production capability and ensure availability of this critical medical countermeasure. Notice: This notice is for informational and planning purposes and does not constitute a solicitation. This notice of intent is NOT a request for competitive proposals. A determination by the Government not to compete this procurement based upon response(s) to this notice is solely within the discretion of the Government. Interested parties who believe they possess the capabilities to satisfy this requirement must submit in writing their name, address, telephone number, email, UEI/CAGE code, business size, National Drug Code (NDC), and a statement of capability demonstrating their ability to meet this requirement. The Government will not be responsible for any costs incurred in responding to this notice. All responses must be received by September 26, 2025, at 2:00 PM Eastern Standard Time. All responses must be in writing and submitted via email to: Kimberly Golden at OSContracting@hhs.gov.

NOTICE OF INTENT TO AWARD A SOLE SOURCE CONTRACT Agency: Department of Health and Human Services Office: Administration for Strategic Preparedness and Response (ASPR), Center for the Strategic National Stockpile (SNS) Location: 2945 Flowers Road, Atlanta GA, 30341 The NAICS code for this procurement is 325412, Pharmaceutical Preparation Manufacturing. The anticipated period of performance includes one (1) base year and two (2) one-year optional ordering periods. The Office of the Administration for Strategic Preparedness and Response (ASPR), Center for the Strategic National Stockpile (SNS) intends to award a sole source firm fixed price contract to: Manufacturer Name The U.S. Government, in accordance with RFO 6.103-3 Industrial mobilization; engineering, developmental, or research capability; or expert services, intends to award a sole source contract to SIGA Technologies, Inc., 31 East 62nd Street, New York, NY 10065. Requirement: The Government requires replenishment and stockpiling of TPOXX (tecovirimat) 200 mg oral capsules and Tecovirimat injection (200 mg/vial, 10 mg/mL, single-dose) to support national biodefense and public health preparedness initiatives. Oral capsules provide the primary treatment option for patients able to take medication by mouth, while the IV formulation is critical for patients unable to swallow, with impaired absorption, or requiring inpatient care. Maintaining access to both dosage forms ensures operational flexibility and readiness to respond to orthopoxvirus threats, including smallpox. Requirement: 387,096 QTY- Oral Capsules (200 mg): Store at 20C 25C (68F 77F); permitted excursions 15C 30C (59F 86F); protect from excessive heat and moisture. 525,030 QTY- IV Injection (200 mg/vial, 10 mg/mL): Store frozen at 20C ( 4F); Authority: This acquisition will be conducted under the authority of RFO 6.103-3), which permits other than full and open competition when necessary to maintain facilities, producers, manufacturers, or suppliers in case of a national emergency or to achieve industrial mobilization. SIGA Technologies is the only FDA-approved source of supply for tecovirimat, and continued procurement is required to sustain production capability and ensure availability of this critical medical countermeasure. Notice: This notice is for informational and planning purposes and does not constitute a solicitation. This notice of intent is NOT a request for competitive proposals. A determination by the Government not to compete this procurement based upon response(s) to this notice is solely within the discretion of the Government. Interested parties who believe they possess the capabilities to satisfy this requirement must submit in writing their name, address, telephone number, email, UEI/CAGE code, business size, National Drug Code (NDC), and a statement of capability demonstrating their ability to meet this requirement. The Government will not be responsible for any costs incurred in responding to this notice. All responses must be received by September 26, 2025, at 2:00 PM Eastern Standard Time. All responses must be in writing and submitted via email to: Kimberly Golden at OSContracting@hhs.gov.