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 the Formulated TIMERx 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 referr ed to in Section 7.2 hereof plus the allocable indirect costs and fees referred to in the last two sentences of this Section 1.23 ; 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 Sections 9.5.1 or 9.5.2 hereof shall not be counted as part of the Formulated TIMERx Price . Costs and f ees related to and arising out of patent enforcement litigation ensuing from a third party certifying against a [COMPANY] Patent or a patent covering [COMPANY] Product Technology held by [COMPANY] and listed in the FDA ’s may ( to the extent not refl ected in the Certification Budget and the reconciliations under Section 3.7 hereof ) be included, at the option of [COMPANY] and without prejudice to its other rights, as part of the allocable indirect costs of the manufacture or acquisition of any Formulated TIMERx provided for use in the Product ; to the extent that such costs and fees are not reimbursed by [COMPANY] to [COMPANY] pursuant to Section 11.7 . If any patent applications are filed or prosecuted by [COMPANY] on [COMPANY] Product Technology, as provided in Sect ion 6.2 hereof, the reasonable costs thereof, and of the maintenance of any patents Second Amendment to the Amended and Restated Strategic Alliance Agreement 7/11/2009 that issue therefrom, shall ( to the extent not reflected in the Certification Budg et and the reconciliations under Section 3.7 hereof ) be part of the allocable indirect costs of the manufacture or acquisition of any Formulated TIMERx provided for use in the Product that would be disclosed in whole or in part in such patent or patent app lication