Document 9xvYEmQv816Z0Bgx2LYkgMeD

Annex III - Honeywell ACLAR packaging cost estimates and analysis In this document, Honeywell reviews the testing requirements and on this basis calculates cost estimates to requalify and repackage drugs packed using Aclar barrier films. Economic Analysis Registration & Testing Activities Stability Cost / Package 1 Materials 2 Compliance Testing 3 Physical Testing 4 Informal Stability & Analytical Dev 5 Line Trials 6 Registration Costs 7 Cost (CFF Switch) 100,000 35,000 35,000 10,000 50,000 75,000 94,000 Tooling & Change Parts 8 Registration & Testing Costs Percentage of drugs impacted 75,000 474,000 100% New Capital Investment Blister forming machinery 9 CFF coldforming speeds are up to 50% slower than Aclar thermoforming. Secondary Equipment (carton & case packing) 10 Percentage of drugs impacted 11 Adjusted new capital investment per drug Cost (CFF Switch) 4,120,000 1,000,000 50% 2,560,000 Estimated Conversion Cost per Drug 12 Number of Drugs packaged in Aclar 13 Total Conversion Cost per drug 14 Assumes Euro to USD conversion rate of 1:1 Summary of Econmic Impacts to Industry 3,034,000 625 1,896,250,000 1.896 Billion Other Societal Factors When comparing high-barrier thermoformed blister packages to cold-form packages, there are additional societal impacts to consider. Cold-form blister packages have an average size difference of 55% greater. Along with the efficiency impacts referenced above, this leads to further packaging waste and an increased carbon footprint. The carbon footprint of the package (embodied carbon) and from transportation are both higher with cold-form blisters vs thermoformed blisters containing Aclar. Annual Increases in material waste & carbon footprint for the same number of doses (Aclar blisters vs Cold-Form Foil blisters) Size of the package (area) - 55% larger to package the same no. of doses Volume of packaging (cubic meters) - 280.8Mm3, equivalent to 4212 shipping containers Weight of packaging (metric tons) - 14,620 tons, equivalent to 5.85M reams of A4 office paper Deforestation (100% virgin material) - 124,726 more trees for cardboard in 2 & 3 packaging Total Carbon Footprint 15 - 4,956 metric tons CO2e Embodied carbon equivalent 15 - 3,634 metric tons CO2e within the packaging Transport carbon equivalent 15 - 1,322 metric tons CO2e from transportation of higher volumes 1- Industry Estimate-GMP (SGS) 2- Industry Estimate 3- Industry Estimate (NAMSA) ISO 10993 & USP 661, 87/88, 212/213 4- Industry Estimate (AMRI) REF QUOTE: Q-51938 5- Industry Estimate-Non-GMP (SGS) 6- Industry Estimate 7- TYPE II VARIATION, Commision Reg (EC)No.1234/2008, 24NOV2008, EMA FEE TABLE https://www.ema.europa.eu/en/human-regulatory/overview/feespayable-european-medicines-agency 8- Industry Estimate 9- Industry Estimate (Pharmaworks). two new coldforming machines needed for every switch from Aclar thermoforming. 10- One required for each thermoforming line 11- Assumes each packaging line has capacity to package 2 drug products 12- Per above calculations & reference from File: Vaccine & Vial Dev. 13- Per Honewell internal sales pipeline data 14- Of thermoformed blisters containing Aclar to high-barrier multilayer (Aluminum/PVC/Nylon) coldform blisters 15- Per estimated 2.06 Billion blister cards sold annually in Europe, size 0 capsule, only road transportation considered for carbon footprint