Authorized Generic ANDA Product definition

Authorized Generic ANDA Product means a ** authorized, whether pursuant to a ** or **, for Marketing pursuant to an agreement between Supernus and a Third Party. For the avoidance of doubt, if Supernus enters into an agreement with a Third Party that ** the ** of a ** in the Territory, and such agreement includes a **, **, **, ** or the like with respect to ** of such **, such ** shall not be considered an ** by virtue of such **, **, **, ** or the like, provided such ** is no longer being Marketed in the Territory.
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Authorized Generic ANDA Product means [**].
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Authorized Generic ANDA Product means a [**] or [**] to a [**] the [**] as the [**], whether pursuant to a [**] or [**], for Marketing pursuant to an agreement between Supernus and a Third Party which had originally filed an ANDA or 505(b)(2) application with respect to a Generic Equivalent Product or [**]to a [**] the [**] as the [**]after [**], with a “Paragraph IV Certification” under 21 U.S.C. § 355(j)(2)(A)(vii)(IV) (as amended or replaced) or 21 U.S.C. § 355(b)(2)(A)(iv) (as amended or replaced). For the avoidance of doubt, if Supernus has entered or enters into an agreement with a Third Party which had [**] with respect to a [**] or [**] as the reference listed drug after [**], with a “Paragraph IV Certification” under 21 U.S.C. § 355(j)(2)(A)(vii)(IV) (as amended or replaced) or 21 U.S.C. § 355(b)(2)(A)(iv) (as amended or replaced) that [**] the [**] of a [**] or [**]to a [**] the [**] as the [**] in the Territory, and such agreement includes a [**], or the like with respect to [**] of such [**] or [**]to a [**] the [**] as the [**], such [**] or [**]to a [**] the [**] as the [**] shall not be considered an [**] by virtue of such [**], or the like, provided such [**] or [**]to a [**] the [**] as the [**]is no longer being Marketed in the Territory.
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More Definitions of Authorized Generic ANDA Product

Authorized Generic ANDA Product means a ** authorized, whether pursuant to a ** or **, for Marketing pursuant to an agreement between Supernus and a Third Party. For the avoidance of doubt, if Supernus enters into an agreement with a Third Party that ** the ** of a ** in the Territory, and such agreement includes a **, **, **, ** or the like with respect to ** of such **, such ** shall not be considered an ** by virtue of such
Sample 1
Authorized Generic ANDA Product means a [**] or [**] to a [**] the [**] as the [**], whether pursuant to a [**] or [**], for Marketing pursuant to an agreement between Supernus and a Third Party which had originally filed an ANDA or 505(b)(2) application with respect to a Generic Equivalent Product or [**]to a [**] the [**] as the [**]after [**], with a “Paragraph IV Certification” under 21 U.S.C. § 355(j)(2)(A)(vii)(IV) (as amended or replaced) or 21 U.S.C. § 355(b)(2) (A)(iv) (as amended or replaced). For the avoidance of doubt, if Supernus has entered or enters into an agreement with a Third Party which had [**] with respect to a [**] or [**] as the reference listed drug after [**], with a “Paragraph IV Certification” under 21 U.S.C. § 355(j)(2)(A)(vii)(IV) (as amended or replaced) or 21 U.S.C. § 355(b)(2)(A)(iv) (as amended or replaced) that [**] the [**] of a [**] or [**]to a [**] the [**] as the [**] in the Territory, and such agreement includes a [**], or the like with respect to [**] of such [**] or [**]to a [**] the [**] as the [**], such [**] or [**]to a [**] the [**] as the [**] shall not be considered an [**] by virtue of such [**], or the like, provided such [**] or [**]to a [**] the [**] as the [**]is no longer being Marketed in the Territory.
Sample 1

Related to Authorized Generic ANDA Product

  • Generic Product means a product which (a) contains as its active pharmaceutical ingredient a compound that is (or is substantially the same as) the Licensed Compound, and (b) has been placed on the market pursuant to a validly granted marketing authorization.

  • Licensed Product means a product, method or service in the Licensed Field of Use, the making, having made, using, importing or selling of which, absent this license, infringes, induces infringement, or contributes to infringement of a Licensed Patent.

  • Drug Product means a specific drug in dosage form from a known source of manufacture, whether

  • Generic Drug means any Prescription Drug approved by the FDA that has the same bio-equivalency as a specific Brand Name Drug.

  • Tobacco product manufacturer means an entity that after the date of enactment of this act directly (and not exclusively through any affiliate) meets 1 or more of the following:

  • Aerosol product means a pressurized spray system that dispenses product ingredients by means of a propellant contained in a product or a product's container, or by means of a mechanically induced force. “Aerosol Product” does not include “Pump Spray.”

  • Biological product means a virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, protein other than a chemically synthesized polypeptide, or analogous product, or arsphenamine or any derivative of arsphenamine or any other trivalent organic arsenic compound, applicable to the prevention, treatment, or cure of a disease or condition of human beings.

  • Milk product or "dairy product" means cottage cheese, dry curd cottage cheese, reduced fat cottage cheese, lowfat cottage cheese, cream, light cream, light whipping cream, heavy cream, heavy whipping cream, whipped cream, whipped light cream, sour cream, acidified sour cream, cultured sour cream, half-and-half, sour half-and-half, acidified sour half-and-half, cultured sour half-and-half, reconstituted or recombined milk and milk products, concentrated milk, concentrated milk products, skim milk, lowfat milk, frozen milk concentrate, flavored milk, eggnog, buttermilk, cultured milk, cultured lowfat milk, cultured skim milk, yogurt, lowfat yogurt, nonfat yogurt, acidified milk, acidified lowfat milk, acidified skim milk, low-sodium milk, low-sodium lowfat milk, low-sodium skim milk, lactose-reduced milk, lactose-reduced lowfat milk, lactose-reduced skim milk, aseptically processed and packaged milk, milk products with added safe and suitable microbial organisms, and any other milk product made by the addition or subtraction of milkfat or addition of safe and suitable optional ingredients for protein, vitamin, or mineral fortification. Unless a product is considered a milk product under this subdivision, milk product does not include dietary products, infant formula, ice cream or other desserts, cheese, or butter. Milk products include the following:

  • Tobacco product means any substance containing tobacco leaf, including but not limited to, cigarettes, cigars, pipe tobacco, hookah tobacco, snuff, chewing tobacco, dipping tobacco, bidis, blunts, clove cigarettes, or any other preparation of tobacco; and any product or formulation of matter containing biologically active amounts of nicotine that is manufactured, sold, offered for sale, or otherwise distributed with the expectation that the product or matter will be introduced into the human body by inhalation; but does not include any cessation product specifically approved by the U.S. Food and Drug Administration for use in treating nicotine or tobacco dependence.

  • Existing Product means any formulation of the same product category and form sold, supplied, manufactured, or offered for sale in California prior to the following dates, or any subsequently introduced identical formulation:

  • Regulatory Approval means, with respect to a Product in any country or jurisdiction, any approval (including where required, pricing and reimbursement approvals), registration, license or authorization from a Regulatory Authority in a country or other jurisdiction that is necessary to market and sell such Product in such country or jurisdiction.

  • Marijuana product means marijuana as defined in 50-32-101 and marijuana-infused products

  • Product means any deliverable under the Contract, which may include commodities, services, technology or software.