Civica Inc

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. The facility is complete along with submission of the application for the approval of the facility. The first products, and commencement of commercial production, are anticipated in 2026. 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.

Civica entered into a master service agreement with a us based for profit pharma company on april 18, 2024, to support the global supply of (fill and finish) sterile injectable medications which were on the fda drug shortage list, and for which the partnering company is delaying launches in markets due to production capacity constraints. Pursuant to work orders under this agreement, civica is producing both pre-filled syringes and cartridges for assembly into injection devices. This program advances civica's mission to increase access to essential, affordable medications by supporting a low-cost, reliable production of high-demand, clinically important treatments for patients.