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.

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 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.

Examples of Authorized Generic Product in a sentence

• If there are no Directors able or willing to act, then any two members may summon a general meeting for the purpose of appointing directors.

• 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.

• Section 3.1.7 of the Seller Disclosure Schedules sets forth a statement of revenues and direct expenses, in each case attributable to the Product and the Authorized Generic Product, for (x) the year ended December 31, 2015 and (y) for the six months ended June 30, 2016 (the “Financial Statement”).

• Subject to the terms and conditions of this Agreement, Seller hereby grants to Buyer, effective as of the Closing, an exclusive right of reference to the DMF for the sole purpose of Exploiting the Product and the Authorized Generic Product in the Territory.

More Definitions of Authorized Generic Product

Authorized Generic Product means the pharmaceutical product that is AB rated by the FDA for the Product and marketed, distributed and sold by or on behalf of Endo Ventures Limited (as successor by assignment to Par Pharmaceutical, Inc.) pursuant to the AG Agreement.

Authorized Generic Product means a Generic Product that is manufactured, used, sold, offered for sale or distributed pursuant to the Somaxon NDA, but that is not marketed under the Trademark.

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.

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 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.