Authorized Generic Product definition

Authorized Generic Product means a therapeutically equivalent, bioequivalent and legally substitutable generic version of the brand-name product Lovenox® (including the brand name product sold as a generic) that is sold and distributed in the Territory by any one or more of Aventis Pharma S.A., Aventis Pharmaceuticals, Inc., their respective Affiliates, successors or assigns and/or licensees of any of the foregoing.

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Authorized Generic Product means generically labeled Shire Product approved for sale by the FDA pursuant to a labeling supplement to Shire’s NDA for the Shire Product. Payment of the FTE fees shall not be affected by the launch of a Generic Product. Shire’s ability to grant Impax the right to promote the Authorized Generic Product above shall be conditioned on Shire’s ability to provide reasonably adequate quantities of such product for launch at or prior to the Third Party launch of the Generic Product, and Impax’s acceptance of such quantity as being reasonably adequate. If Impax does not accept the quantity as being reasonably adequate, Shire shall pay to Impax the Year 3 Bonus at such time as such payment would otherwise have been due.

Authorized Generic Product means the pharmaceutical product that is AB rated by the FDA for Atacand and marketed, distributed and sold by or on behalf of Sweden Seller pursuant to the AG Agreement or otherwise.

Examples of Authorized Generic Product in a sentence

Without limiting the foregoing, Sublicensor shall provide Sublicensee with not less than [*] ([*]) days’ prior notice of the date on which any commercial scale quantities of an Authorized Generic Product are anticipated to be sold in the Territory.
LICENSEE will send to the Council any and all verifiable evidence that a Third Party intends to launch a Generic Equivalent in the United States and will notify the Council promptly in writing in the event that LICENSEE or any of its Affiliates or sublicensees decides to use, distribute, sell, offer for sale, have sold and import Technology as an Authorized Generic Product in the Territory.
In the event a Generic Product is launched, or a Competing Product is launched by Shire, in the Territory during the Services Term, the number of Prescriptions of such Generic Product and/or of any Competing Product launched by Shire shall be considered Prescriptions for the Shire Product in calculating the Gain Share Fees, provided, for clarity, that such calculation shall not include any Prescriptions of any Authorized Generic Product distributed by Impax.
Notwithstanding anything to the contrary in this Agreement, Par shall be allowed to enter into an agreement with the owner of the Branded Product under which Par shall sell an Authorized Generic Product (an “AG Agreement”).
During the two years prior to the Execution Date, neither Seller nor any of its Affiliates has received any written notices including any warning letter, notice of adverse finding, or notice of deficiency, or similar communication of any alleged violation of any Law with respect to, the Product Business, the Manufacture of the Product or the Authorized Generic Product, the Purchased Assets or the Assumed Liabilities.

More Definitions of Authorized Generic Product

Authorized Generic Product means a finished pharmaceutical product for sale in the prescription drug marketplace as a generic to Neurontin® that contains the same active ingredients in the same dosage form and strength as any Product, and which is either supplied by, or sold under a license from, Pfizer, Inc. or its successors in interest.

Authorized Generic Product means any Drug Product other than the Product herein, promoted, distributed, marketed, offered for sale and/or sold in the Territory as a Generic of the Brand Product or is sold under the NDA for the Branded Product under and pursuant to an agreement with the owner of the Brand Product.

Authorized Generic Product means a generic version of a Licensed Product for which an application for Regulatory Approval is submitted to the applicable Regulatory Authority by or on behalf of, or pursuant to authorization granted by, Otsuka or its Affiliate, and which is manufactured by the same manufacturer that manufactures the corresponding Licensed Product.

Authorized Generic Product means, with respect to IR Reference Product or XR Reference Product (in any dosage strength), as applicable, any product marketed or sold by or under license, waiver or other actual or effective authorization of, or supplied by or on behalf of, Wyeth or any of Wyeth’s Affiliates or licensees, as IR Reference Product or XR Reference Product, as applicable, as a generic in the Territory (other than by Teva or Teva’s Affiliates pursuant to this Agreement) not under the Effexor® trademark.

Authorized Generic Product means any prescription (for human use) 100 mg strength finished sapropterin dihydrochloride tablet product, 100 mg finished sapropterin dihydrochloride powder product, and/or 500 mg finished sapropterin dihydrochloride powder product manufactured or sold for use in the Territory pursuant to the BioMarin NDAs but not under the Kuvan® trademark.

Authorized Generic Product means a Generic Product that is manufactured, used, sold, offered for sale or distributed pursuant to the Somaxon [New Drug Application], but that is not marketed under the Trademark.” (D.I. 292-1 ex. A § 1.3). A New Drug Application (NDA) refers to stand-alone applications submitted under § 355(b)(1) of the Federal Food, Drug, and Cosmetic Act. 21 U.S.C. § 355(b)(1).

Authorized Generic Product means (a) any drug product containing SP distributed under New Drug Application No. 021-892, but not under the trade name Osmoprep® or, (b) subject to the Head License, any Generic SP Product that is sold in the Territory by a Third Party pursuant to a license or other authorization from Sublicensor, CDC III or the General Partnership.