Authorized Generic Version definition

Authorized Generic Version means, with respect to a pharmaceutical product, any other pharmaceutical product that (i) is sold under the Drug Approval Application for the first product or any supplement or amendment thereto, (ii) is sold under a different Trademark than the first product and (iii) has an NDC number that differs from the NDC number for the first product (other than on a temporary basis as may be necessary to launch the second product in the Territory).

AI-Powered Contracts

Draft, Review & Redline at the Speed of AI

Authorized Generic Version means any pharmaceutical product that (i) is sold under the Drug Approval Application for such [*] = Certain confidential information contained in this document, marked by brackets, is filed with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended. Licensed Product, (ii) is sold under a different Trademark than such Licensed Product, and (iii) has a National Drug Code (“NDC”) number that differs from the NDC number for such Licensed Product (other than on a temporary basis as may be necessary to launch such Licensed Product in the applicable market).

Authorized Generic Version means any pharmaceutical product that (i) is sold under the BLA filed by Gilead, an Affiliate of Gilead or Sublicensee for such Licensed Product, (ii) is sold under a different Trademark than such Licensed Product, and (iii) has a National Drug Code (“NDC”) number that differs from the NDC number for such Licensed Product (other than on a temporary basis as may be necessary to launch such Licensed Product in the applicable market).

Examples of Authorized Generic Version in a sentence

If Allergan launches an Authorized Generic Version of the Product in the Territory in accordance with this Section 9.4(a)(ii), Allergan shall pay Licensee [...***...] of Gross Profits from the sale of such Authorized Generic Version of the Product in the Territory during the Term in consideration for Licensee's efforts in building the branded market for the Product in the Territory.
If Allergan exercises its right to AG Launch an Authorized Generic Version of a Product pursuant to Section 2.10.1 while NexMed is the Commercializing Party, NexMed shall supply such Authorized Generic Version to Allergan at its cost plus [***] percent ([***]%).
Except as set forth below, NexMed shall not, during the Term, either directly or indirectly, through an Affiliate or under a contract with a Third Party, advertise, market, accept orders for, sell, ship or distribute any Authorized Generic Version of each Product in the Territory (“AG Launch”).
NexMed and Allergan shall communicate to each other on an ongoing basis regarding developments which may affect the applicable AG Launch Date, the delivery date for product necessary for commercial launch on the AG Launch Date, and information necessary to package and label the Authorized Generic Version for marketing and sale.
Allergan shall be solely responsible for handling all returns, recalls and withdrawals, order processing, invoicing and collection, distribution and inventory and receivables with respect to any Authorized Generic Version of a Product in the Territory.

More Definitions of Authorized Generic Version

Authorized Generic Version means a Generic Version of the Product which is being Commercialized by, or pursuant to a license or other authorization granted by, Allergan or its Affiliates.

Authorized Generic Version means any biological product that is sold under the BLA filed by Incyte or its an Affiliate or sublicensee for such Product. A Product licensed or produced by Incyte or its Affiliates will not constitute a Biosimilar Product.

Authorized Generic Version means: (i) in the United States, with respect to a pharmaceutical product that has been approved under Section 505(c) of the FFDCA (i.e., a “full” application under 505(b)(1) or an application under 505(b)(2)), any other pharmaceutical product that is sold under the Drug Approval Application for the first product or any supplement or amendment to such Drug Approval Application, and that is marketed, sold or distributed directly or indirectly to retail class of trade with labeling, packaging (other than repackaging as the listed drug in blister packs, unit doses or similar packaging for use in institutions), product code, labeler code, trade name or Trademark that differs from that of the listed pharmaceutical product; or (ii) with respect to a pharmaceutical product sold outside the United States, any other pharmaceutical product that is identical in terms of the qualitative and quantitative composition of the active substance(s) and the pharmaceutical form to the first product and that is sold under the Drug Approval Application for the first product or any supplement or amendment to such Drug Approval Application, and that is marketed, sold or distributed directly or indirectly to retail class of trade with labeling, packaging, product code, labeler code, trade name or Trademark that differs from that of the listed pharmaceutical product.

Authorized Generic Version means, with respect to a particular Licensed Product being sold in a particular country, any other pharmaceutical product that (a) is sold under the Health Registration Approval for such Licensed Product in such country by or under the authority of AstraZeneca or its Affiliate, (b) is sold under a different Trademark than such Licensed Product (as sold by AstraZeneca and it Affiliates), and (c) in the United States, has a National Drug Code (“NDC”) number that differs from the NDC number for such Licensed Product (other than on a temporary basis as may be necessary to launch the second product in the applicable market). For clarity, an “Authorized Generic Version” is a Licensed Product for all purposes of this Agreement.

Authorized Generic Version means, with respect to an Acorda Product being sold in a particular country, any other pharmaceutical product that (a) is sold under the Drug Approval Application for such Acorda Product in such country, (b) is sold under a different Trademark than such Acorda Product (as sold by Acorda, its Sublicensees or its or their Affiliates) or under a generic name with no Trademark in such country and (c) in the United States, has a National Drug Code number that differs from the National Drug Code number for such Acorda Product (other than on a temporary basis as may be necessary to launch the Authorized Generic Version in the applicable market).

Authorized Generic Version means the Product released under a generic label.

Authorized Generic Version means any Product that is distributed under no trademark or under a trademark other than ▇▇▇▇▇▇®.

Filter & Search

Related Definitions