Generic Licensed Product definition

Generic Licensed Product means, on a Licensed Product-by-Licensed Product (including Combination Product-by-Combination Product) and country-by-country basis, any pharmaceutical product sold by a Third Party in such country, other than as a Sublicensee under this Agreement that: (a) contains the same active ingredient or active ingredients as the applicable Licensed Product in the same dosage form (e.g., oral, injectable, or intranasal) as the applicable Licensed Product and (b) is categorized by the applicable Regulatory Authority in such country to be therapeutically equivalent to, or interchangeable with, such Licensed Product, such that the pharmaceutical product may be substituted for the Licensed Product at the point of dispensing without any intervention by the prescribing physician in such country.

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Generic Licensed Product means a pharmaceutical product that contains the same active ingredient as a Licensed Product and is bioequivalent to such Licensed Product; provided, that, any product sold by DS or any Affiliate or licensee of DS shall not be a Generic Licensed Product for purposes of this Agreement.

Generic Licensed Product means, with respect to ▇▇▇▇▇-SC, any pharmaceutical product sold by a Third Party, other than as a sublicensee to this Agreement, that is approved by the Regulatory Authority in Japan as a substitutable generic for ▇▇▇▇▇-SC and contains the active ingredients in ▇▇▇▇▇-SC.

Examples of Generic Licensed Product in a sentence

For purposes of this Section 4.3.1(a)(ii), a “Generic Licensed Product” means a pharmaceutical product that contains the same active ingredient as a Licensed Product and is bioequivalent to such Licensed Product; provided, that, any product sold by DS or any Affiliate or licensee of DS shall not be a Generic Licensed Product for purposes of this Agreement.
Except for the rights granted in the prior sentence, ENDO shall not use any of the NOVARTIS Parties’ trademarks, trade names or trade dress or any trademarks, trade names or trade dress which are confusingly similar to any of NOVARTIS Parties’ trademarks, trade names or trade dress, in connection with the Commercialization of Generic Licensed Product.
Without limiting the foregoing, in no event is ENDO or its Affiliates granted any rights or licenses to or with respect to any generic pharmaceutical product (other than the Generic Licensed Product), any OTC Product or any other diclofenac topical gel.
If there is no Valid Claim, then Roche may reduce the royalties otherwise due for Licensed Product in a given country by *** percent (***%) if, in the country, sales of units of Generic Licensed Product in aggregate total at least *** percent (***%) of the aggregate sales of units of (i) Licensed Product sold by the Roche Group and (ii) Generic Licensed Products.
For clarity, (a) the market share of Generic Licensed Product for a given half Fiscal Year shall be calculated based on the total sales of all Generic Licensed Products commercially available in such a half Fiscal Year in Japan and (b) if Generic Entry occurs and thereafter ceases, the foregoing royalty rate reduction shall not apply unless the price of ▇▇▇▇▇-SC, if reduced following Generic Entry, [*].
Except as expressly set forth herein and subject to the rights reserved to ENDO and its Affiliates in Section 2.5, ENDO shall have no rights in or to the Product Trademark or the goodwill pertaining thereto or in any Product Trade Dress, trademark, tradename or goodwill in respect of the Generic Licensed Product.
The initial quantities of Generic Licensed Product included in the Generic Rolling Forecast shall be provided from the quantities manufactured and delivered pursuant to Section 4.2, after SANDOZ has provided a Certificate of Analysis (in the form attached hereto as Schedule 4.7(a)) with respect to such quantities.
Excluding during a Failure of Supply, ENDO or an Affiliate thereof shall use commercially reasonable efforts to maintain levels of safety stock of Generic Licensed Product, if applicable, consistent with its own practices.
To be clear, ENDO is responsible for 100% of any cost or expenses, and net losses, resulting from the sales of Generic Licensed Product, without any contribution hereunder by NOVARTIS or any of its Affiliates, even if the NOVARTIS Profit Share would otherwise be calculated as an amount less than zero dollars.
In lieu of any royalties on the Generic Licensed Product (but with no effect on any royalties payable on the Branded Licensed Product), ENDO shall pay the NOVARTIS Parties (as designated by SANDOZ) Profits relating to Net Sales of the Generic Licensed Product for the remainder of the Term as follows: ENDO shall receive *** and the NOVARTIS Parties (as designated by SANDOZ) shall receive *** of all Profits resulting from sales of the Generic Licensed Product.

More Definitions of Generic Licensed Product

Generic Licensed Product means, with respect to a particular Licensed Product in a country, a pharmaceutical product that: (a) contains the same Compound as such Licensed Product; and (b) is approved for use in such country pursuant to 21 U.S.C. 355(b)(2), an ANDA, a separate NDA, Compendia Listing, or equivalent drug approval application.

Generic Licensed Product means the authorized generic of the Branded Licensed Product, under the Licensed Product NDA and for sale as an Rx Product in the Field in the Territory.

Generic Licensed Product means, on a Licensed Product-by-Licensed Product (including Combination Product-by-Combination Product) and country-by-country basis in the Territory, any pharmaceutical product sold by a Third Party in such country that: (a) contains the [***] the applicable Licensed Product in the same [***] (e.g., oral, injectable, or intranasal) as the applicable Licensed Product, and (b) is categorized by the applicable Regulatory Authority in such country to be [***] to, [***], such Licensed Product, such that the pharmaceutical product may be substituted for such Licensed Product at the point of dispensing without any intervention by the prescribing physician in such country.

Generic Licensed Product with respect to a Licensed Product, any pharmaceutical or biological product that is distributed by a Third Party under a Regulatory Approval approved by a Regulatory Authority in reliance, in whole or in part, on the prior approval (or on safety or efficacy data submitted in support of the prior approval) of such Licensed Product, including any product authorized for sale (a) in the U.S. pursuant to Section 505(b)(2) or Section 505(j) of the Act (21 U.S.C. 355(b)(2) and 21 U.S.C. 355(j), respectively), (b) in the EU pursuant to a provision of Articles 10, 10a or 10b of Parliament and Council Directive 2001/83/EC as amended (including an application under Article 6.1 of Parliament and Council Regulation (EC) No 726/2004 that relies for its content on any such provision) or

Generic Licensed Product means a product that contains Compound which is offered for sale in a country by a Third Party.