TYSABRI definition

TYSABRI means any formulation containing as an active constituent the compound that is more fully characterized on Schedule 1.1(tt) to this Agreement, and any biosimilar or branded generic thereof.
TYSABRI has the meaning set forth in Section 1.1(tt) of the Original Asset Purchase Agreement.

Examples of TYSABRI in a sentence

  • Annually, during our long-range planning cycle, we perform an analysis of anticipated lifetime revenues of AVONEX and TYSABRI.

  • Our most significant intangible assets are related to our AVONEX and TYSABRI products.

  • Eisai will also distribute and book sales for AVONEX, TYSABRI, TECFIDERA and PLEGRIDY (peginterferon beta-1a) in India and other Asia-Pacific markets (excluding China).

  • ENTSO-E recommends that further clarity in zone delimitation could be added by establishing one zonal delimitation (i.e. one bidding area) for all timeframes in paragraph1.2.2. This implies that each bidding area would remain in place across all timeframes.

  • Our analysis included an increase in the expected future product revenues of TYSABRI, resulting in a decrease in the rate of amortization expense as compared to prior quarters.

  • The results of our TYSABRI and AVONEX analyses were impacted by changes in the estimated impact of TECFIDERA, as well as other existing and potential oral and alternative MS formulations, including PLEGRIDY, that may compete with TYSABRI and AVONEX.

  • Other includes FAMPYRA, ELOCTATE, ALPROLIX and FUMADERMProduct sales for TECFIDERA, AVONEX and TYSABRI and unconsolidated joint business revenues for RITUXAN each accounted for more than 10% of our total revenue for the years ended December 31, 2015, 2014 and 2013.

  • However, sales of TYSABRI in the U.S. are recognized on the “sell-through” model, that is, upon shipment of the product by Elan Pharma International, Ltd.

  • Anti-CD20 therapeutic programs includes revenues from RITUXAN, RITUXAN HYCELA, GAZYVA and OCREVUS.Product sales for TECFIDERA, AVONEX and TYSABRI as well as our share of pre-tax profits in the U.S. for RITUXAN each accounted for more than 10% of our total revenues for the years ended December 31, 2018, 2017 and 2016.

  • We currently have four marketed products: AVONEX, RITUXAN, TYSABRI, and FUMADERM.

Related to TYSABRI

  • Licensed Products means tangible materials which, in the course of manufacture, use, sale, or importation, would be within the scope of one or more claims of the Licensed Patent Rights that have not been held unpatentable, invalid or unenforceable by an unappealed or unappealable judgment of a court of competent jurisdiction.

  • 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.

  • Licensed Service means performance of a service for any consideration using a Licensed Product, or the practice of a Licensed Process. For clarity, research and development of Licensed Products by Licensee, its Affiliates, or a Sublicensee does not constitute a Licensed Service.

  • Diagnostic Product means an assemblage of reagents, including but not limited to reagents packaged in the form of a kit, useful in performing a Licensed Service.

  • Generic Product means, with respect to a particular Licensed Product in a particular country in the Territory, any pharmaceutical or biological product that (a) is distributed by a Third Party under a Drug Approval Application or Abbreviated New Drug Application (or similar applications) approved by a Regulatory Authority in reliance, in whole or in part, on the prior Drug Approval Application (or on safety or efficacy data submitted in support of the prior approval) of such Licensed Product, including any product authorized for sale (i) in the U.S. pursuant to Section 505(b)(2) or Section 505(j) of the FFDCA (21 U.S.C. § 355(b)(2) and 21 U.S.C. § 355(j), respectively), (ii) in the EU pursuant to a provision of Articles 10, 10a or 10b of Parliament and Council Directive 2001/83/EC as amended (including an application under Article 6.1 of Parliament and Council Regulation (EC) No. 726/2004 that relies for its content on any such provision) or (iii) in any other country pursuant to an equivalent of such provisions or (b) is substitutable under Applicable Law for such Licensed Product when dispensed without the intervention of a physician or other health care provider with prescribing authority.

  • Licensed Product means any product or part thereof which:

  • Licensed Services means all functions performed by the Licensed System.

  • Hemp products or “hemp-infused products” means all products with the federally defined tetrahydrocannabinol concentration level for hemp derived from, or made by, processing hemp plants or plant parts that are prepared in a form available for commercial sale, including cosmetics, personal care products, food intended for animal or human consumption, cloth, cordage, fiber, fuel, paint, paper, construction materials, plastics, and any product containing one or more hemp-derived cannabinoids, such as cannabidiol.

  • Nondesignated country end product means any end product that is not a U.S.-made end product or a designated country end product.

  • 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.

  • Covered Products means any product which falls into one or more of the following categories, so long as the Company is producing, marketing, selling or licensing such product anywhere in the world: beverages, including without limitation carbonated soft drinks, tea, water, juice drinks, sports drinks, coffee drinks, and value added dairy drinks; juices and juice products; snacks, including salty snacks, sweet snacks, meat snacks, granola and cereal bars, and cookies; hot cereals; pancake mixes; value-added rice products; pancake syrup; value-added pasta products; ready-to-eat cereals; dry pasta products; or any product or service which the Participant had reason to know was under development by the Company during the Participant’s employment with the Company.

  • Commercialization means any and all activities directed to the preparation for sale of, offering for sale of, or sale of a Product, including activities related to marketing, promoting, distributing, and importing such Product, and interacting with Regulatory Authorities regarding any of the foregoing. When used as a verb, “to Commercialize” and “Commercializing” means to engage in Commercialization, and “Commercialized” has a corresponding meaning.

  • Covered Product means the eligible wireless device owned by you and for which the unique identification number (International Mobile Equipment Identity (IMEI), Electronic Serial Number (ESN), Mobile Equipment ID (MEID), or Serial Number) is on record with us when the Wireless Device first fails to operate properly. To be considered Covered Product, the wireless device must have logged outgoing airtime with your Wireless Service Provider after the request for coverage for the Covered Product and within sixty (60) days prior to reporting the Wireless Device failure, and for which You can provide Us proof of ownership.

  • Licensed producer means a person or entity licensed to produce medical cannabis.

  • Roll-on product means any antiperspirant or deodorant that dispenses active ingredients by rolling a wetted ball or wetted cylinder on the affected area.

  • Pre-Licensed Therapist means an individual who has obtained a Master’s Degree in Social Work or Marriage and Family Therapy and is registered with the BBS as an Associate CSW or MFT Intern acquiring hours for licensing. An individual’s registration is subject to regulations adopted by the BBS.

  • Marihuana-infused product means a topical formulation, tincture, beverage, edible substance, or similar product containing any usable marihuana that is intended for human consumption in a manner other than smoke inhalation. Marihuana-infused product shall not be considered a food for purposes of the food law, 2000 PA 92, MCL 289.1101 to 289.8111.

  • Licensed service area means the geographic area in which the home service provider is authorized by law or contract to provide commercial mobile radio service to the customer.

  • Licensed Territory means worldwide.

  • Royalty Product means, either (a) an Alnylam Royalty Product, or (b) an Inex Royalty Product.

  • New Product means a Program that may include, as a component of such product, another Program or a portion thereof, but that has substantial additional features or functionalities that are not Enhancements, Revisions, Versions, rebundling or repackaging of pre-existing Programs, and is priced separately from a pre-existing Program.

  • 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.

  • Moroccan end product means an article that—

  • Combination Product means a Product that is comprised of or contains a Collaboration Compound as an active ingredient together with one (1) or more other active ingredients and is sold either as a fixed dose/unit or as separate doses/units in a single package.

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

  • Biosimilar Product means, with respect to a Collaboration Product, and on a country-by-country basis, any product (including a generic product, biogeneric, follow-on biologic, follow-on biological product, follow-on protein product, similar biological medicinal product, or biosimilar product) that has received Regulatory Approval by way of: (a) a Regulatory Approval process governing approval of interchangeable or biosimilar biologics as described in 42 U.S.C. § 262 (or its foreign equivalents, as applicable) based on the Collaboration Product, or is the subject of a notice with respect to such Collaboration Product under 42 U.S.C. § 262(l)(2) (or its foreign equivalents, as applicable); or (b) an abbreviated regulatory mechanism or equivalent process for Regulatory Approval to those set forth in subsection (a) by the relevant Regulatory Authority in a country, where such approval referred to or relied on (1) the Marketing Approval for such Collaboration Product held by iBio or Sublicensee in such country or (2) the data contained or incorporated by reference in the Marketing Approval for such Collaboration Product held by iBio or a Sublicensee in such country, and that in each case: (i) is sold in the same country (or is commercially available in the same country) as such Collaboration Product by any Third Party that is not a Sublicensee and that did not purchase such product in a chain of distribution that included any of iBio or any of Sublicensees; and (ii) either (A) contains an active ingredient that is “highly similar” to such Collaboration Product (as the phrase “highly similar” is used in 42 U.S.C. § 262(i)(2), and subject to the factors set forth in FDA’s Guidance for Industry, “Quality Considerations in Demonstrating Biosimilarity of a Therapeutic Protein Collaboration Product to a Reference Collaboration Product,” (April 2015), at Section V, and any successor FDA guidance thereto), or (B) meets the equivalency determination by the applicable Regulatory Authority in any country or jurisdiction outside the United States (including a determination that the product is “comparable,” “interchangeable,” “bioequivalent,” “biosimilar” or other term of similar meaning, with respect to the Collaboration Product).