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1010 Exhibit: Ex 1009 Berge

Document IPR2021-01132, No. 1010-10 Exhibit - Ex 1009 Berge (P.T.A.B. Jun. 17, 2021)

THE “DUMB cops" IMAGE One day this past fall we Were going through the daily Washington ritual of reviewing the current issue of the Federal Register—which is the principal means of keeping track of what is happening in the executive branch of government—when we spotted reference to a Presidential Proclamation which caught our eye.

In recent months, we have seen repeated instances where official notices, proposals, or finalized regulations issuing from DEA and published in the Federal Register have used terminology and nomenclature to describe the drugs involved which have been confusing, inconsistent, or otherwise inaccurate.

Iodide Isethionate' Lactate Lactobionate Malate Maleate Mandelate Mesylate Methylbromide Methylnitrate Methylsulfate Mucate Napsylate Nitrate Pamoate (Embonate) Pantothenate Phosphate/diphosphate Polygalacturonate - Salicylate Stearate Subacetate Succinate Sulfate Tannate Tartrate _ TeoclateJ Triethiodide Cation Metallic: Aluminum Calcium Lithium Magnesium Potassium Sodium Zinc 2.02 0.88 0.76 0.13 0.13 .

I Table II—Non-FDA—Approved Commercially Marketed Saltsf——————-—— Anion Percent‘zW Adipate Alginate _ Aminosalicylate Anhydromethylenecrtrate Arecolirie Aspartate Bisulfate Butylbromide Camphflrate Digluconate _ Dihydrobromide Disuccinate Glycerophosphate Hemisulfate Hydrofluoride Hydroiodide Methylenebis(salicylate) _ Napadisylate” , Oxalate Pectinate Persulfate Phenylethylbarbiturate Picrate Propionate Thiocyanate Tosylate Undecanoate ‘ .

molecules and colloidal particles have an affinity for the 3' 13mlphatic system, streptomycin, neomycin, viomycin, and streptothrycin were combined with high molecular weight compounds such as polyacrylic acids, sulfonic or phos- phorylated polysaccharides, and polyuronic derivatives.