Civica Inc

ALLEVIATE SUPPLY SHORTAGES FOR ESSENTIAL GENERIC MEDICATIONS AND ENSURE AFFORDABILITY TO EVERYONE.

GENERIC DRUG DISTRIBUTIONDEVELOP AN OPEN AND GROWING NETWORK OF HOSPITALS TO EXPAND THE REACH OF CIVICA'S MISSION AND ITS BENEFITS TO BOTH MEMBERS AND NON-MEMBERS. ALLEVIATE SHORTAGES OF ESSENTIAL DRUG PRODUCTS AND STABILIZE PRICING BY SECURING AVAILABILITY FROM EXISTING MANUFACTURERS FOR THE BENEFIT OF PATIENTS SERVED BY THESE MEMBERS AND NON-MEMBER CUSTOMERS. CIVICA'S MAJOR ACCOMPLISHMENTS TO DATE INCLUDE THE FOLLOWING:(1) CUSTOMER GROWTH COVERING MORE THAN 30% OF U.S. LICENSED HOSPITAL BEDS. NEW CUSTOMERS ENROLLED INCLUDE NATIONWIDE NON-MEMBER 340B HOSPITALS THAT SERVE A DISPROPORTIONATE PATIENT POPULATION OF HIGH-NEEDS PATIENTS, VETERANS AFFAIRS HOSPITALS AND DEPARTMENT OF DEFENSE. DURING THE COVID-19 PANDEMIC, IN ADDITION TO SERVING THE NEEDS OF HOSPITAL SYSTEMS FOR 11 EMERGENCY MEDICATIONS. (2) LAUNCHED 54 ESSENTIAL MEDICINES WITH MORE THAN 67 PRESENTATIONS AS OF DECEMBER 2021; THESE MEDICATIONS WERE DEEMED IN SHORT SUPPLY PER FDA DRUG SHORTAGE LIST OR PER ASHP DRUG SHORTAGE LIST. WHEN THE COVID-19 PANDEMIC HIT THE U.S., CIVICA WAS ONE OF THE FEW COMPANIES THAT HAD SUFFICIENT AVAILABILITY OF THESE ESSENTIAL MEDICATIONS TO SERVE THE HOSPITALS THAT NEEDED THESE MEDICATIONS.(3) ESTABLISHED AND MAINTAINED APPROXIMATELY 6 MONTHS OF FINISHED GOODS INVENTORY TO BUFFER ANY SUPPLY CHAIN SHOCKS TYPICALLY EXPERIENCED IN THE INDUSTRY FOR ESSENTIAL STERILE INJECTABLE MEDICINES. (4) SINGLE TRANSPARENT AFFORDABLE PRICING TO ALL MEMBERS AND NON-MEMBERS REGARDLESS OF MEMBERSHIP STATUS, SIZE OF THE HOSPITAL, VOLUME OF DRUGS PURCHASED FROM CIVICA OR RELATIONSHIP LONGETIVITY WITH CIVICA.

FILL - FINISH FACILITYAFTER THE EMERGENCE OF COVID-19 PANDEMIC AND THE RESULTING SPIKE IN DEMAND FOR ESSENTIAL MEDICATIONS IN HOSPITALS TO MANAGE THE PATIENT SURGE, THERE WAS A HIGHER RECOGNITION OF DEPENDENCE BY THE UNITED STATES ON FOREIGN MANUFACTURERS FOR THESE LIFE-SAVING ESSENTIAL MEDICATIONS, ESPECIALLY STERILE INJECTABLES. IN AN EFFORT TO ON-SHORE END-TO-END MANUFACTURING OF SUCH STERILE INJECTABLES AND AS A NATIONAL SECURITY MEASURE, BIOMEDICAL ADVANCED RESEARCH AND DEVELOPMENT AUTHORITY ("BARDA"), A U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES ("HHS") GOVERNMENT OFFICE RESPONSIBLE FOR THE PROCUREMENT AND DEVELOPMENT OF MEDICAL COUNTERMEASURES, PRINCIPALLY AGAINST BIOTERRORISM, INCLUDING CHEMICAL, BIOLOGICAL, RADIOLOGICAL AND NUCLEAR THREATS, AS WELL AS PANDEMIC INFLUENZA AND EMERGING DISEASES AWARDED A CERTAIN CONTRACT NO. 75A50120C00092 ("PRIME CONTRACT") TO PHLOW CORP., ("PHLOW"). PHLOW IS A DELAWARE PUBLIC BENEFIT CORPORATION ENGAGED IN THE BUSINESS OF THE RESEARCH, DEVELOPMENT, AND COMMERCIALIZATION OF PHARMACEUTICAL PRODUCTS. GIVEN CIVICA'S EXPERIENCE AND EXPERTISE IN THE AREA, PHLOW HAS SUBCONTRACTED CERTAIN OF ITS OBLIGATIONS UNDER THE PRIME CONTRACT TO CIVICA WHEREBY CIVICA WILL QUALIFY, DESIGN, BUILD, EQUIP, OPERATE AND OWN A 120,000 SQUARE FOOT, TWO-STORY, CGMP COMPLIANT ASEPTIC FILL-FINISH FACILITY ("FILL-FINISH FACILITY"), TO BE FUNDED, AT LEAST PARTIALLY, WITH $100,000,000 PROVIDED BY BARDA, CAPABLE OF, AMONG OTHER THINGS PROVIDING AT LEAST 90 MILLION ASEPTIC OR TERMINALLY STERILIZED VIALS AND 50 MILLION PRE-FILLED SYRINGES ANNUALLY. DURING 2021, CIVICA COMPLETED SUBSTANTIAL CONSTRUCTION OF THE FACILITY AND EQUIPMENT DELIVERIES ARE DUE TO COMMENCE IN 2022, WHEN QUALIFICATION ACTIVITIES WILL BEGIN. THE PLAN IS TO SUBMIT AN APPLICATION FOR APPROVAL OF THE FACILITY AND FIRST PRODUCTS IN 2023, AND TO COMMENCE COMMERCIAL PRODUCTION IN 2024. CIVICA INTENDS TO USE THE FILL-FINISH FACILITY TO, AMONG OTHER THINGS, (1) MANUFACTURE STERILE INJECTABLES IN FURTHERANCE OF ITS GENERIC DRUG DISTRIBUTION PROGRAM IDENTIFIED PREVIOUSLY, (2) SUPPORT THE NEEDS OF THE U.S. GOVERNMENT FOR ANY FUTURE PANDEMICS OR SIMILAR EMERGENCIES, (3) PROVIDE SURPLUS MANUFACTURING CAPACITY TO OTHER U.S.-BASED STERILE INJECTABLE MANUFACTURERS WHO SERVE THE NEEDS OF THE COUNTRY FOR SHORTAGE MEDICATIONS AND (4) PRODUCE LOW-COST INSULIN FOR THE US MARKET TO ALLEVIATE DISTRESS THAT AFFORDABILITY CHALLENGES CAUSED TO PATIENTS.

OUT-PATIENT SERVICESON OR ABOUT JANUARY 23, 2020, CIVICA ANNOUNCED AN ARRANGEMENT WITH THE BLUE CROSS BLUE SHIELD ASSOCIATION ("BCBSA") AND A NUMBER OF INDEPENDENT BLUE CROSS AND BLUE SHIELD COMPANIES ("BCBSS; WITH BCBSA, THE "BLUES"). THE ARRANGEMENT INVOLVED THE CREATION OF A NEW BUSINESS ENTITY, CIVICASCRIPT, DEDICATED TO LOWERING THE COST OF SELECT OUTPATIENT GENERIC MEDICATIONS IN RESPONSE TO THE IMPACT OF HIGH DRUG COSTS ON THE HEALTH OF AMERICANS AND THE OVERALL AFFORDABILITY OF HEALTH CARE BY DEVELOPING AND MANUFACTURING GENERIC OUTPATIENT MEDICATIONS. IN FURTHERANCE OF THE ARRANGEMENT, ON OR ABOUT JANUARY 27, 2020, CIVICA CAUSED CIVICASCRIPT TO BE ORGANIZED AS A DELAWARE LIMITED LIABILITY COMPANY TO PROMOTE PUBLIC BENEFITS, INCLUDING PROMOTION OF AVAILABILITY OF AFFORDABLE OUTPATIENT GENERIC DRUGS. CIVICASCRIPT, A STATUTORY PUBLIC BENEFIT LLC UNDER DELAWARE LAW, IS TREATED AS A CORPORATION FOR U.S. FEDERAL INCOME TAXPURPOSES.BASED ON MARKET AND OTHER RESEARCH BY CIVICASCRIPT, AS APPROVED BY ITS BOARD, CIVICASCRIPT IS CURRENTLY IN THE PROCESS OF DEVELOPING GENERIC VERSIONS OF CERTAIN MEDICATIONS. IN ALIGNMENT WITH CIVICASCRIPT'S FOUNDING MISSION, THESE GENERIC MEDICATIONS WILL BE SOLD TO CIVICA-AFFILIATED HOSPITALS, ALL "340B HOSPITALS,", ALL VETERANS AFFAIRS ("VA") HOSPITALS, AND BROADLY TO RETAILERS.CIVICA, INC. ENTERED INTO A SERVICES AGREEMENT EFFECTIVE SEPTEMBER 1, 2020 WITH CIVICASCRIPT. CIVICA, INC. IS A MEMBER OF CIVICASCRIPT AND A RELATED PARTY. THE PROVISIONS OF THIS AGREEMENT ALLOW FOR CIVICA, INC. TO PROVIDE CIVICASCRIPT WITH ADMINISTRATIVE SUPPORT AND OTHER SERVICES TO ENABLE THE PUBLIC TO REALIZE THE BENEFITS CIVICASCRIPT INTENDS TO PROVIDE. THESE SERVICES INCLUDE EXECUTIVE MANAGEMENT SERVICES, PROFESSIONAL ASSISTANCE, RISK MANAGEMENT, QUALITY & REGULATORY SUPPORT AND OVERSIGHT, FINANCE & ACCOUNTING SERVICES, AND DATA ANALYTICS.