FORMULATED TIMERx definition

FORMULATED TIMERx means TIMERx and certain additives in a formulation to be developed hereunder specifically for use in the Designated Product.
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FORMULATED TIMERx means TIMERx ********************************* **************************************************************************.
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FORMULATED TIMERx means TIMERx and certain additives in a formulation which has been developed by TIMERx Technologies specifically for use in the Designated Product and which is referred to by TIMERx Technologies as "TIMERx-N." The Formulated TIMERx will be identical in all respects to TIMERx (also referred to by TIMERx Technologies as "TIMERx-N") to be supplied by TIMERx Technologies to Mylan Pharmaceuticals pursuant to their license agreement calling for registration with the US FDA of the Designated Product using such TIMERx-N.
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Examples of FORMULATED TIMERx in a sentence

  • PENWEST MAKES NO REPRESENTATIONS OR WARRANTIES AS TO ANY TIMERx OR FORMULATED TIMERx SUPPLIED BY IT TO HORIZON EXCEPT AS ARE EXPLICITLY STATED HEREIN.


More Definitions of FORMULATED TIMERx

FORMULATED TIMERx means TIMERx and certain additives in a formulation to be developed hereunder specifically for use in the Designated Product. 3 1.13 "Horizon Test and Regulatory Data" shall mean any and all test data, test designs and protocols, clinical studies and results thereof, government licenses and applications therefor, government certifications and findings, and related materials, information and rights (including without limitation information regarding bioavailability and bioequivalence, and any adverse drug reactions), developed, commissioned or otherwise obtained by Horizon or any of its Affiliates or sublicensees during the term of this Agreement (or, with respect to such sublicensees, during the term of the respective sublicenses) relating to TIMERx, TIMERx Improvements, the Designated Product, Penwest Patents, Penwest Technology, and/or Penwest's Confidential Information, together with all intellectual property and other rights and interests of Horizon and its Affiliates or sublicensees thereto and therein, worldwide.
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Related to FORMULATED TIMERx

  • Reformulated Products means Products that contain concentrations less than or equal to 0.1% (1,000 parts per million (ppm)) of DEHP when analyzed pursuant to U.S. Environmental Protection Agency testing methodologies 3580A and 8270C or other methodology utilized by federal or state government agencies for the purpose of determining the phthalate content in a solid substance.

  • 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.

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

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

  • 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.

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

  • Cannabis products 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.

  • Kit means a set of components that are packaged together and intended to be used to perform a specific in vitro diagnostic examination, or a part thereof;

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

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

  • Pharmaceutical Product shall have the meaning ascribed to such term in Section 3.1(hh).

  • Recall campaign means the period of time beginning on the

  • Product Candidate means each of MYO-101, MYO-102, MYO-103, MYO-201 and MYO-301, as defined on Exhibit B, in each case in any form or formulation.

  • 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).

  • 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.

  • ingredient means any substance, including a food additive used in the manufacture or preparation of food and present in the final product, possibly in a modified form;