Civica Inc

ALLEVIATE SUPPLY SHORTAGES FOR ESSENTIAL GENERIC MEDICATIONS AND ENSURE AFFORDABILITY FOR 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) CONTINUED CUSTOMER GROWTH WITH 83.1 MILLION PATIENTS SERVED TO DATE AND 10 ESSENTIAL MEDICINES LAUNCHED IN 2023. NEW CUSTOMERS ENROLLED INCLUDE NATIONWIDE NON-MEMBER 340B HOSPITALS THAT SERVE A DISPROPORTIONATE POPULATION OF HIGH-NEED PATIENTS, VETERANS AFFAIRS HOSPITALS, AND THE DEPARTMENT OF DEFENSE. DURING THE COVID-19 PANDEMIC, IN ADDITION TO SERVING THE NEEDS OF HOSPITAL SYSTEMS FOR 11 EMERGENCY MEDICATIONS. (2) CONTINUED LAUNCH OF ESSENTIAL MEDICINES DEEMED IN SHORT SUPPLY PER THE FDA OR ASHP DRUG SHORTAGES LISTS.(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 FACILITYTHE COVID-19 PANDEMIC, WHICH RESULTED IN A SPIKE IN DEMAND FOR MEDICATIONS IN HOSPITALS MANAGING SIGNIFICANT PATIENT SURGES, BROUGHT TO LIGHT THE DEPENDENCE OF THE UNITED STATES ON FOREIGN MANUFACTURERS OF GENERIC, ESSENTIAL, LIFE-SAVING 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 CONTRACT NO. 75A50120C00092 ("PRIME CONTRACT") TO PHLOW CORP., ("PHLOW") TO CREATE END-TO-END MANUFACTURING IN THE UNITED STATES. PHLOW IS A DELAWARE PUBLIC BENEFIT CORPORATION ENGAGED IN THE BUSINESS OF THE RESEARCH, DEVELOPMENT, AND COMMERCIALIZATION OF PHARMACEUTICAL PRODUCTS. PHLOW 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. THE FILL-FINISH FACILITY WILL BE CAPABLE OF, AMONG OTHER THINGS, PROVIDING AT LEAST 90 MILLION ASEPTIC OR TERMINALLY STERILIZED VIALS AND 50 MILLION PRE-FILLED SYRINGES ANNUALLY. DURING 2022, CIVICA COMPLETED SUBSTANTIAL CONSTRUCTION OF THE FACILITY AND EQUIPMENT DELIVERIES COMMENCED IN 2022. SUBMISSION OF THE APPLICATION FOR THE APPROVAL OF THE FACILITY IS COMPLETED WITH INSPECTION PENDING; THE FIRST PRODUCTS AND COMMENCEMENT OF COMMERCIAL PRODUCTION, ARE ANTICIPATED IN 2025. 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 CAUSE 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 TAX PURPOSES. HOWEVER, CIVICASCRIPT HAS APPLIED FOR TAX-EXEMPT STATUS AS A PUBLIC CHARITY. IF APPROVED, THE EFFECTIVE DATE OF EXEMPTION WOULD BE SEPTEMBER 1, 2023.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 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.