THE SCOPE OF WORK FOR THIS CONTRACT INCLUDES THE FOLLOWING DEVELOPMENT ESSENTIALS: CMC DEVELOPMENT, PRE-CLINICAL AND CLINICAL STUDIES, DEVICE DEVELOPMENT ACTIVITIES, HUMAN FACTORS TESTING, MARKET VIABILITY ASSESSMENTS ALONG WITH ALL ASSOCIATED REGULA RAFA LABORATORIES LTD $147,503,604 OFFICE OF ASSISTANT SECRETARY FOR PREPAREDNESS AND RESPONSE OFFICE OF ASSISTANT SECRETARY FOR PREPAREDNESS AND RESPONSE — 541714 Research and Development in Biotechnology (except Nanobiotechnology) AN44 HEALTH R&D SERVICES; HEALTH CARE - OTHER; R&D ADMINISTRATIVE EXPENSES Sep 30, 2025 Sep 29, 2025 Jun 30, 2036
RAFA ATROPINE AUTO-INJECTORS (0.5 MG, 1 MG, AND 2 MG) RAFA LABORATORIES LTD $46,212,577 OFFICE OF ASSISTANT SECRETARY FOR PREPAREDNESS AND RESPONSE OFFICE OF ASSISTANT SECRETARY FOR PREPAREDNESS AND RESPONSE — 325412 Pharmaceutical Preparation Manufacturing 6505 DRUGS AND BIOLOGICALS Sep 30, 2025 Sep 30, 2025 Sep 29, 2028
THE OVERALL OBJECTIVE OF THIS CONTRACT IS TO ADVANCE THE DEVELOPMENT, INCLUDING U.S. FOOD AND DRUG ADMINISTRATION (FDA) APPROVAL, OF ATROPINE AUTOINJECTOR FOR PEDIATRIC USE USING AN IMPROVED VERSION OF RAFA LABORATORIES, LTD.S (RAFAS) FDA-APPROVED SI RAFA LABORATORIES LTD $14,715,580 OFFICE OF ASSISTANT SECRETARY FOR PREPAREDNESS AND RESPONSE OFFICE OF ASSISTANT SECRETARY FOR PREPAREDNESS AND RESPONSE — 541714 Research and Development in Biotechnology (except Nanobiotechnology) AN13 HEALTH R&D SERVICES; HEALTH CARE SERVICES; EXPERIMENTAL DEVELOPMENT Sep 19, 2023 Sep 19, 2023 Jan 1, 2030
RAFA DO 6 RAFA LABORATORIES LTD $22,501,800 OFFICE OF ASSISTANT SECRETARY FOR PREPAREDNESS AND RESPONSE OFFICE OF ASSISTANT SECRETARY FOR PREPAREDNESS AND RESPONSE — 325412 Pharmaceutical Preparation Manufacturing 6505 DRUGS AND BIOLOGICALS Sep 21, 2021 Sep 22, 2021 Jun 30, 2022
ATROPINE SULFATE AUTO-INJECTOR, TRAINING DEVICE RAFA LABORATORIES LTD $7,813,800 OFFICE OF ASSISTANT SECRETARY FOR PREPAREDNESS AND RESPONSE OFFICE OF ASSISTANT SECRETARY FOR PREPAREDNESS AND RESPONSE — 325412 Pharmaceutical Preparation Manufacturing 6505 DRUGS AND BIOLOGICALS Sep 29, 2020 Sep 29, 2020 Dec 31, 2021
TASK ORDER FOR ADDITIONAL PRODUCTS RAFA LABORATORIES LTD $15,946,200 OFFICE OF ASSISTANT SECRETARY FOR PREPAREDNESS AND RESPONSE OFFICE OF ASSISTANT SECRETARY FOR PREPAREDNESS AND RESPONSE — 325412 Pharmaceutical Preparation Manufacturing 6505 DRUGS AND BIOLOGICALS Aug 8, 2019 Aug 8, 2019 May 31, 2020
ATROPINE SULFATE AUTO-INJECTOR, TRAINING DEVICE, TRAINING - MASTER IDIQ RAFA LABORATORIES LTD $35,393,850 OFFICE OF ASSISTANT SECRETARY FOR PREPAREDNESS AND RESPONSE OFFICE OF ASSISTANT SECRETARY FOR PREPAREDNESS AND RESPONSE — 325412 Pharmaceutical Preparation Manufacturing 6505 DRUGS AND BIOLOGICALS Mar 13, 2018 Mar 9, 2018 May 29, 2019
ATROPINE SULFATE AUTO-INJECTOR, TRAINING DEVICE, TRAINING - MASTER IDIQ RAFA LABORATORIES LTD $27,948,400 CENTERS FOR DISEASE CONTROL AND PREVENTION CENTERS FOR DISEASE CONTROL AND PREVENTION — 325412 Pharmaceutical Preparation Manufacturing 6505 DRUGS AND BIOLOGICALS Jun 30, 2017 Jun 30, 2017 Jul 31, 2018
ATROPINE SULFATE AUTO-INJECTOR, TRAINING DEVICE, TRAINING - TO1 RAFA LABORATORIES LTD $7,047,000 CENTERS FOR DISEASE CONTROL AND PREVENTION CENTERS FOR DISEASE CONTROL AND PREVENTION — 325412 Pharmaceutical Preparation Manufacturing 6505 DRUGS AND BIOLOGICALS Jan 31, 2017 Jan 31, 2017 Sep 15, 2017