SOCIETAL CDMO SAN DIEGO, LLC

PLACEBO & ACTIVE IMIQUIMOD

IRISYS LLC:1259725 [18-003692]

THIS TASK ORDER (TO) IS TO PROVIDE DOSAGE FORM DEVELOPMENT, MANUFACTURE AND STABILITY STUDIES OF ORC-13661 FOR PHASE II CLINICAL TRIAL

FOR PAYMENT ONLY PO. RATIFICATION OF UNAUTHORIZED COMMITMENT NUMBER 20045; IRISYS; $13,375.00;NOVEMBER 6, 2018.

METARRESTIN CGMP MANUFACTURING AND STABILITY TESTING SERVICES

PRODUCTION OF A CGMP BATCH OF TRIAPINE INJECTION

DOSAGE FORM DEVELOPMENT, MANUFACTURE, AND STABILITY STUDIES OF AVE-1625 (DRINABANT. DRINABANT) IV BAG STUDY

DOSAGE FORM DEVELOPMENT, MANUFACTURE, AND STABILITY STUDIES OF NCGC72

NEXT DTP-22-013, PRODUCTION OF TAK-243 INJECTABLE FOR CLINICAL USE AND STUDY THE SHELF-LIFE. CONTRACT/TO#DCTC-2022-1006, DEVELOPMENT & MANUFACTURE OF ORAL & TOPICAL DOSAGE FORMS - PRB

NEXT DTP-22-018, GMP PRODUCTION OF 40 MG Z-ENDOXIFEN (NSC 774768) CAPSULES CONTRACT/TO#DCTD-2022-1007 DEVELOPMENT & MANUFACTURE OF ORAL & TOPICAL DOSAGE FORMS - PRB

AZA-TDC CAPSULES FOR USE IN CLINICAL TRIAL FOR POSSIBLE CANCER TREATMENT. THE DRUG PRODUCT (DP) WILL BE A 4 MG STRENGTH CAPSULE WHICH IS NOT AVAILABLE IN THE MARKET, AND NO OTHER ALTERNATIVE EXIST EXCEPT THE USE OF THE CONTRACT PROCESS. THE REQUIREME

EXERCISE OPTIONAL TASK 3 AND EXTEND POP ACCORDINGLY

TASK ORDER IS TO HAVE THE ENGINEERING BATCH AND THE PRODUCTION BATCH COMPLETED UNDER THE CGMP PROVIDED TO THE GOVERNMENT ALONG WITH THE SHELF-LIFE STUDY FOR THE INITIAL AMOUNTS. THE BASE AMOUNTS OF BOTH ENGINEERING BATCH AND THE CGMP BATCH CONDITIONS

DOSAGE FORM DEVELOPMENT, MANUFACTURE, AND STABILITY STUDIES OF R-VK4-116, PERIOD OF PERFORMANCE 6/1/2021 - 5/31/2025.

TASK ORDER IS TO HAVE THE ENGINEERING BATCH AND THE PRODUCTION BATCH COMPLETED UNDER THE CGMP PROVIDED TO THE GOVERNMENT ALONG WITH THE SHELF-LIFE STUDY FOR THE INITIAL AMOUNTS. THE BASE AMOUNTS OF BOTH ENGINEERING BATCH AND THE CGMP BATCH CONDITIONS

SOCIETAL IS A SMALL BUSINESS CONCERN FOR DOSAGE FORM DEVELOPMENT, MANUFACTURE, AND STABILITY STUDIES OF NCGC72

METARRESTIN STORAGE AND STABILITY TESTING SERVICES

DOSAGE FORM DEVELOPMENT, MANUFACTURE, AND STABILITY STUDIES OF R-VK4-116, PERIOD OF PERFORMANCE 6/1/2021 - 5/31/2025.

DOSAGE FORM DEVELOPMENT, MANUFACTURE, AND STABILITY STUDIES OF NES-100 NASAL SPRAY

DOSAGE FORM DEVELOPMENT, MANUFACTURE, AND STABILITY STUDIES OF AVE-1625 (DRINABANT. DRINABANT) IV BAG STUDY

PLACEBO & ACTIVE IMIQUIMOD

NEXT DTP-23-017, PRODUCTION OF 0.25MG OF AZATDC AND TDCYD CAPSULES

PLACEBO & ACTIVE IMIQUIMOD

DTP-23-019 PRB NEXT, PRODUCTION OF 40MG CAPSULES OF Z-ENDOXIFEN

NEXT DTP-23-017, PRODUCTION OF 0.25MG OF AZATDC AND TDCYD CAPSULES

EXERCISE OPTIONAL TASK 3 AND EXTEND POP ACCORDINGLY

NEXT DTP-22-013, PRODUCTION OF TAK-243 INJECTABLE FOR CLINICAL USE AND STUDY THE SHELF-LIFE. CONTRACT/TO#DCTC-2022-1006, DEVELOPMENT & MANUFACTURE OF ORAL & TOPICAL DOSAGE FORMS - PRB

DOSAGE FORM DEVELOPMENT, MANUFACTURE, AND STABILITY STUDIES OF AVE-1625 (DRINABANT. DRINABANT ADDITIONAL METHOD DEVELOPMENT

CGMP CLINICAL SUPPLIES MANUFACTURING QUALIFICATION AND STABILITY TESTING OF TARP 1-20 AND 21-40 ME TARP PEPTIDE AND TWS-119 STABILITY STUDY PERIOD OF PERFORMANCE: 09/27/2019 - 09/26/2023

ANALYTICAL METHOD REQUALIFICATION

IMIQUIMOD

THIS TASK ORDER (TO) IS TO PROVIDE DOSAGE FORM DEVELOPMENT, MANUFACTURE AND STABILITY STUDIES OF ORC-13661 FOR PHASE II CLINICAL TRIAL

DOSAGE FORM DEVELOPMENT, MANUFACTURE, AND STABILITY STUDIES OF NES-100 NASAL SPRAY

NEXT DTP-22-013, PRODUCTION OF TAK-243 INJECTABLE FOR CLINICAL USE AND STUDY THE SHELF-LIFE. CONTRACT/TO#DCTC-2022-1006, DEVELOPMENT & MANUFACTURE OF ORAL & TOPICAL DOSAGE FORMS - PRB

LABORATORY TESTING - SAMPLES

NEXT DTP-22-018, GMP PRODUCTION OF 40 MG Z-ENDOXIFEN (NSC 774768) CAPSULES CONTRACT/TO#DCTD-2022-1007 DEVELOPMENT & MANUFACTURE OF ORAL & TOPICAL DOSAGE FORMS - PRB

THIS MODIFICATION IS WRITTEN TO: EXTEND THE PERIOD OF PERFORMANCE (POP) OF THE CONTRACT FOR THE BASE TASK 1 CGMP BATCH TO APRIL 15, 2021 - JULY 14, 2022 AT NO ADDITIONAL COST TO THE GOVERNMENT. NOVOBIOCIN BATCH.

NEXT DTP-22-013, PRODUCTION OF TAK-243 INJECTABLE FOR CLINICAL USE AND STUDY THE SHELF-LIFE. CONTRACT/TO#DCTC-2022-1006, DEVELOPMENT & MANUFACTURE OF ORAL & TOPICAL DOSAGE FORMS - PRB