Bioequivalent Product definition

Bioequivalent Product means, with respect to a given Product sold in a given country of the Territory by Roche, its Affiliate or sublicensee, a product sold by a Third Party in such country containing the same PDE4 inhibitor (or an acid, salt or ester thereof) as such Product.
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Bioequivalent Product means a drug product meeting the bioequivalence requirements imposed by the FDA for in vitro and/or in vivo testing as set forth in the regulations of the FDA at 21 C.F.R. ss.320 ("AB Equivalent Rating"), as they may be amended from time to time.
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Bioequivalent Product means, with respect to any Covered Product, a product which has the same (or substantially similar) amino acid sequence as such Covered Product and is authorized on the basis of a reference to a Covered Product under either (1) Article 10.1 or (2) Article 10.4 and Part II.4 of Annex I of Parliament and Council Directive 2001/83/EC as amended by Directive 2004/27/EC, in each case as amended from time to time, or successor legislation in each case, and equivalent provisions of applicable law in other jurisdictions for biosimilar, follow-on, or generic biologic products.
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Examples of Bioequivalent Product in a sentence

  • For a period of twelve (12) months following the notice of termination, RiconPharma shall not develop, apply for Regulatory Approval for, manufacture, import, market, sell or promote any product that is a direct substitute for the Product, including any Bioequivalent Product.

  • In addition, the terminating Party shall not pursue the development, manufacture, marketing, distribution or sale of such Product or a Bioequivalent Product manufactured by a Third Party for a period of five (5) years after the effective date of such termination.

  • For a period of twelve (12) months following the notice of termination, ANI shall not develop, apply for Regulatory Approval for, manufacture, import, market, sell or promote any product that is a direct substitute for the Product, including any Bioequivalent Product.

  • For a period of twelve (12) ​ ​ months following the notice of termination, ANI shall not develop, apply for Regulatory Approval for, manufacture, import, market, sell or promote any product that is a direct substitute for the Product, including any Bioequivalent Product.


More Definitions of Bioequivalent Product

Bioequivalent Product means, with respect to a given Product sold in a given country of the Territory by MedImmune, its Affiliate or Sublicensee, a product sold by a Third Party in such country that is approved as a biosimilar or interchangeable biological product under 42 U.S.C. 262(k) or equivalent Regulatory Approval outside the US.
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Bioequivalent Product means with respect to a Product, a drug product that is a bioequivalent, as that term is used in the FDA Orange Book and that is identical in strength or concentration, contains the same active ingredient(s), is in the same dosage form, and utilizes the same route of administration as the Product.
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Bioequivalent Product means, with respect to a given Memory Product or Product sold in a given country of the Territory by Memory, a product sold by a Third Party in such country containing a pharmaceutically equivalent PDE4 inhibitor (or an acid, salt or ester thereof) as such Memory Product or Product.
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Bioequivalent Product means, with respect to a particular Product, any Third Party pharmaceutical product that contains an anti-GM-CSF [***] or an [***], in each case, with [***] and [***] to the Product.
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Bioequivalent Product means, with respect to ***in a given country *** ***, a *** that contains *** (i) that has been *** that relies in whole or in part *** and *** for the *** as determined by *** in such country and (ii) *** *** *** can be *** in such country.
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Bioequivalent Product means, with respect to a given Product or Memory Product sold in a given country of the Territory by Memory, its Affiliate or sublicensee, a product sold by a Third Party in such country containing [*], as the case may be, as such Product or Memory Product, as the case may be.
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Related to Bioequivalent Product

  • Therapeutically equivalent drug products means drug products that contain the same active ingredients and are identical in strength or concentration, dosage form, and route of administration and that are classified as being therapeutically equivalent by the U.S. Food and Drug Administration pursuant to the definition of "therapeutically equivalent drug products" set forth in the most recent edition of the Approved Drug Products with Therapeutic Equivalence Evaluations, otherwise known as the "Orange Book."

  • 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.

  • 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.

  • Therapeutic equivalent means that a Covered Drug can be expected to produce essentially the same therapeutic outcome and toxicity.

  • Nicotine product means the same as that term is defined in Section 76-10-101.