(iii) The total costs of materials, manufacturing
and distribution attributable to the drug for each of the
previous three years.
(iv) The costs accrued in the United States and paid
by an entity other than the manufacturer for research and
development, including, but not limited to, any amount
from Federal, State or other governmental programs or any
form of subsidies, grants or other support.
(v) Other costs to acquire the drug, including costs
for the purchase of or leasing the rights to patents,
licensing or acquisition of a corporate entity owning
rights to the drug while in development.
(vi) The marketing and advertising costs accrued in
the United States for the promotion of the drug directly
to consumers for each of the previous three years,
including, but not limited to:
(A) Costs associated with coupons or discounts
that are directed to consumers and the amount
redeemed in the United States.
(B) Marketing and advertising costs accrued in
the United States for promotion of the drug directly
or indirectly to prescribers.
(C) All other advertising costs accrued in the
United States for the drug.
(2) A five-year history of average wholesale acquisition
cost increases for the drug expressed as percentages,
including the months each average wholesale acquisition cost
increase took effect.
(3) The total profit attributable to the drug and
realized in the United States as represented:
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