definiens: shall mean [COMPANY] 's contract manufacturing cost ( or, if made internally, its variable costs plus directly allocable ( a ) fixed and ( b ) manufacturing overhead costs relating to the manufacture or acquisition ) of Oxymorphone to be provided to [COMPANY] or its Affiliates or sublicensees hereunder, as shall be determined and adjusted no more often than annually plus the costs directly relating, to the quality control testing referred to in Section 6.8.4(i ) hereof plus the allocable indirect costs and fees referred to in the last two sentences of this Section 1.30 ; provided, however, that any amounts paid or payable by [COMPANY] for third - party royalties ( or for materials acquisition costs to the extent attributable to third - party intellectual properties and essentially equivalent to royalties ) which are the responsibility of [COMPANY] under Section 9.6 hereof shall not be counted as part of the Oxymorphone Price .. Costs and fees related to and arising out of patent enforcement litigation ensuing from a third party certifying against a patent covering [COMPANY] Product Technology held by [COMPANY] and listed in the FDA 's shall ( to the extent not reflected in the Certification Budget and the reconciliations under Section 3.7 hereof ) be part of the allocable indirect costs of the manufacture or acquisition of any Oxymorphone ADS provided for use in the Product . If any patent applications are filed or prosecuted by [COMPANY] on [COMPANY] Product Technology, as provided in Section 6.2 hereof, the reasonable costs thereof, and of the maintenance of any patents that issue therefrom, shall ( to the extent not reflected in the Certification Budget and the reconciliations under Section 3.7 hereof ) be part of the allocable indirect costs of the manufacture or Confidential 48 acquisition of any Oxymorphone provided for use in the Product that would be disclosed in whole or in part in such patent or patent application