Authorized Generic definition

Authorized Generic means a Drug Product that is manufactured pursuant to an NDA and Marketed in the United States under a name other than the proprietary name identified in the NDA.

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Authorized Generic means a generic product indicated for the treatment of a human for multiple sclerosis that is therapeutically equivalent to, and substitutable for an Infringing Product by orally administering dimethyl fumarate, wherein the therapeutically effective amount of dimethyl fumarate is 480 mg per day, that is (a) sold by or on behalf of Licensee or any of Licensee’s Affiliates, or its or their respective sublicensees, or (b) authorized by Licensee or any of Licensee’s Affiliates or its or their respective sublicensees by license, covenant not to sue, settlement agreement, release or by any other arrangement or means (including with respect to ANDA filers) (i) for distribution in the U.S. under New Drug Application No. 204063 and/or any and all amendments or supplements thereto; or (ii) for distribution in a Designated Country.

Authorized Generic means any intranasal formulation of dihydroergotamine (other than Migranal) promoted or otherwise commercialized in the Territory by Valeant or its Affiliates, including without limitation, the intranasal dihydroergotamine mesylate product (4mg/mL nasal spray) promoted or otherwise commercialized in the Territory by Oceanside Pharmaceuticals, an Affiliate of Valeant.

Examples of Authorized Generic in a sentence

• From and after the Effective Date until the earlier of (i) the termination of this Agreement, or (ii) a Generic Equivalent becomes available for sale in the Territory, Distributor shall not, and shall cause its Affiliates and SubDistributors to not, Market a Competing Product, other than a Cipher-supplied Authorized Generic, in the Territory.

• For purposes of clarity, except pursuant to Section 2.5, in no event shall Eagle, itself or through its Affiliates or any Third Party, launch any Authorized Generic version of a Product in the Territory.

• Santarus and its Affiliates shall pay to Shore [***] of the Authorized Generic Revenues received by Santarus and its Affiliates during the Term ***Certain information on this page has been omitted and filed separately with the Securities and Exchange Commission.

• Notwithstanding anything to the contrary, each of the diligence requirements set forth in this Section 5.1(b) shall terminate upon the first commercial sale of an Authorized Generic or Generic Equivalent.

• CHRP and Shore shall provide access to, and ensure that Santarus is able to use, (itself or on its behalf) the two (2) skid-mounted hot melt tanks and associated equipment (the “Tank Equipment”) currently situated at Catalent in the manufacture of Licensed Products and Authorized Generic Products (as defined in the Impax Sublicense Agreement).

More Definitions of Authorized Generic

Authorized Generic means a Generic Version sold by or on behalf of a party hereto in the Territory, including by an Authorized Generic Distributor, but excluding by any ANDA Settlement Distributor.

Authorized Generic of a Brand-Name Drug means a drug product that: (a) is manufactured pursuant to (i) the NDA for the Brand-Name Drug, or (ii) an ANDA or a 505(b)(2) application for which the Brand-Name Drug is identified as the reference listed drug; and (b) is sold, offered for sale or distributed by—or on behalf of— the holder of the NDA, but not sold or distributed under the proprietary name of the Brand-Name Drug.

Authorized Generic. AG”) drug” means any drug sold, licensed or marketed under an NDA approved by the FDA under 21 U.S.C. § 355(c); and marketed, sold or distributed

Authorized Generic shall have the meaning set forth in Section 6.9(e).

Authorized Generic means an unbranded, generic, finished, packaged form version of a Product approved or otherwise authorized for distribution in the Territory under the same applicable Marketing Authorization for the applicable Product.

Authorized Generic means a generic product: (a) having the Compound as the sole active ingredient; (b) that is Marketed in the Territory without the Trademark; and (c) that is Marketed under the Neos NDA.

Authorized Generic means a pharmaceutical product that would otherwise satisfy the requirements for a Generic Product under this Agreement, but which (a) is or will be manufactured, sold or otherwise distributed under the Product NDA and is (b) (i) manufactured, sold or otherwise distributed by a Third Party whose operations relating to such pharmaceutical product use rights received, directly or indirectly, from the Buyer pursuant to a license, settlement or other agreement or (ii) otherwise authorized, directly or indirectly, by the Buyer. For the avoidance of doubt, any pharmaceutical product that is manufactured, sold or otherwise distributed under an ANDA shall not be deemed to be an “Authorized Generic”.