Formulated TIMERx Price definition

Formulated TIMERx Price means Penwest’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 Endo 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 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 Penwest 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 Penwest under Sections 9.5.1 or 9.5.2 hereof shall not be counted as part of the Formulated TIMERx Price. Costs and fees related to and arising out of patent enforcement litigation ensuing from a third party certifying against a Penwest Patent or a patent covering Penwest Product Technology held by Penwest and listed in the FDA’s “Orange Book” may (to the extent not reflected in the Certification Budget and the reconciliations under Section 3.7 hereof) be included, at the option of Penwest 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 Endo to Penwest pursuant to Section 11.7. If any patent applications are filed or prosecuted by Penwest on Penwest Product Technology, as provided in Section 6.2 hereof, the reasonable costs thereof, and of the maintenance of any patents that issue there-from, 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 Formulated TIMERx provided for use in the Product that would be disclosed in whole or in part in such patent or patent application; to the extent that such costs and fees are not reimbursed by Endo to Penwest pursuant to Section 6.2.
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Formulated TIMERx Price means ********************************* ******************************************************************************* ************************************************************ to be provided to Endo or its Affiliates or sublicensees hereunder, as shall be determined and adjusted ********** ***********************; provided, however, that any amounts paid or payable by PPG 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 PPG under Sections 9.5.1 or 9.5.2 ********************************* 44 CONFIDENTIAL MATERIAL OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. ASTERISKS DENOTE SUCH OMISSIONS. ********************************. If any patent applications are filed or prosecuted by PPG on Joint Technology, as provided in Section 6.2, the reasonable costs thereof, and of the maintenance of any patents that issue therefrom, shall (to the extent not reflected in a Development Budget or a Certification Budget and the reconciliations under Sections 2.5 or 3.7) be part of the allocable indirect costs of the manufacture or acquisition of any Formulated TIMERx provided for use in a Designated Product that would be disclosed in whole or in part in such patent or patent application.
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Formulated TIMERx Price means PPG's contract manufacturing cost ----------------------- or, if made internally, its variable costs plus directly allocable fixed costs relating to the manufacture or acquisition of the Formulated TIMERx to be provided to Endo or its Affiliates or sublicensees hereunder, as shall be determined and adjusted no more often than annually; provided, however, that any amounts paid or payable by PPG 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 PPG under Sections 9.5.1 or 9.5.2 shall not be counted as part of the Formulated TIMERx Price. If any patent applications are filed or prosecuted by PPG on Joint Technology, as provided in Section 6.2, the reasonable costs thereof, and of the maintenance of any patents that issue therefrom, shall (to the extent not reflected in a Development Budget or a Certification Budget and the reconciliations under Sections 2.5 or 3.7) be part of the allocable indirect costs of the manufacture or acquisition of any Formulated TIMERx provided for use in a Designated Product that would be disclosed in whole or in part in such patent or patent application.
Sample 1

Examples of Formulated TIMERx Price in a sentence

  • The costs incurred relating to such suit(s) shall be addressed in the definitions of Formulated TIMERx Price and Oxymorphone Price.

  • The costs of such materials will be treated as among the parties' respective expenditures pursuant to the applicable Certification Budget, using for this purpose the Formulated TIMERx Price as to the TIMERx and the Oxymorphone Price as to the Oxymorphone.

  • The price for all Formulated TIMERx sold hereunder shall equal the Formulated TIMERx Price.

  • The price for all Formulated TIMERx sold hereunder shall equal the applicable Formulated TIMERx Price, and shall be payable by Endo to PPG within forty-five (45) days after the shipping of the Formulated TIMERx to Endo.

Related to Formulated TIMERx Price

  • ex-works price means the price paid for the product ex works to the manufacturer in the EU or in a SADC EPA State in whose undertaking the last working or processing is carried out, provided the price includes the value of all the materials used, minus any internal taxes paid which are, or may be, repaid when the product obtained is exported;

  • Supply Price has the meaning set forth in Section 6.2.

  • API means American Petroleum Institute.

  • Biosimilar Product means, with respect to a Licensed Product in any country, any biosimilar product sold by a Third Party not authorized by or on behalf of Celgene, its Affiliates or Sublicensees, (a) that is a biosimilar biological product, as defined in 21 USC 379j-51 (or any successor or replacement thereof), a similar biological medicinal product, as defined in Annex I to Directive 2001/83/EC (or any successor or replacement thereof), or any similar biosimilar or generic product under the Laws of any country or jurisdiction, or (b) regarding which Regulatory Approval is obtained by referencing Regulatory Data of such Licensed Product.

  • Index Price on a given date shall mean the weighted average (weighted in accordance with the factors listed above) of the closing prices of the companies composing the Index Group.

  • Active Ingredient means the clinically active material(s) that provide pharmacological activity in a pharmaceutical product (excluding formulation components such as coatings, stabilizers, excipients or solvents, adjuvants or controlled release technologies).

  • Active Pharmaceutical Ingredient or “API” means the active pharmaceutical substance of the Drug in bulk form prior to incorporation into the Product.

  • Finished Product means a cannabis product in its final form to be sold at a retail premises.

  • Product means any deliverable under the Contract, which may include commodities, services, technology or software.

  • Established catalogue price means the price included in a catalogue, price list, schedule, or other form that:

  • Cannabis product means cannabis that has undergone a process whereby the plant material has been transformed into a concentrate, including, but not limited to, concentrated cannabis, or an edible or topical product containing cannabis or concentrated cannabis and other ingredients.

  • Drug Product means a specific drug in dosage form from a known source of manufacture, whether

  • Bulk Product means Licensed Product supplied in a form other than Finished Product which can be converted into Finished Product.

  • Tobacco product means any substance containing tobacco leaf, including but not limited to, cigarettes, cigars, pipe tobacco, hookah tobacco, snuff, chewing tobacco, dipping tobacco, bidis, blunts, clove cigarettes, or any other preparation of tobacco; and any product or formulation of matter containing biologically active amounts of nicotine that is manufactured, sold, offered for sale, or otherwise distributed with the expectation that the product or matter will be introduced into the human body by inhalation; but does not include any cessation product specifically approved by the U.S. Food and Drug Administration for use in treating nicotine or tobacco dependence.

  • Drug Substance means an active ingredient that is intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease or to affect the structure or any function of the human body, but does not include intermediates used in the synthesis of such ingredient.

  • Product Labeling means (a) the full prescribing information for the Product approved by the applicable Regulatory Authority, and (b) all labels and other written, printed or graphic information included in or placed upon any container, wrapper or package insert used with or for the Product.

  • Combination Product means a product (a) containing a Licensed Product together with one or more other active ingredients, or (b) with one or more products, devices, pieces of equipment or components, but sold for an integrated price (e.g., with the purchase of one product the customer gets a coupon for the other) or for a single price.

  • Hemp product means the same as that term is defined in § 3.2-4112.