definiens: means, for any dosage strength and formulation of the Drug Product, actual direct out of pocket cost finally incurred by Forest for the acquisition of Drug Substance and actual direct out of pocket costs incurred by Forest for the acquisition, manufacture, shipping from the manufacturer to Forest 's initial distribution site, storage at such site, and final labeling and packaging of the Drug Product, as recognized and recorded in accordance with United States generally accepted accounting principles . If the royalty payable by REPLIDYNE to DAP under Section 6.2.1 for such calendar quarter is necessary to be reduced as described hereof, REPLIDYNE shall provide DAP, within sixty ( 60 ) days after the end of such calendar quarter, a report showing the total reduction of the royalty for such calendar quarter in accordance with the calculation method stipulated above, with detailed information as is reasonably necessary to determine how the amount of such reduction was calculated . Failure to Meet Sales and Marketing Plan8.3 Failure to Meet Sales and Marketing Plan