AB Rated Product definition

AB Rated Product means a pharmaceutical product that (i) is “therapeutically equivalent” to a Licensed Product, applying the definition of “therapeutically equivalent” set forth in the Preface to the current edition of the FDA publication “APPROVED DRUG PRODUCTS WITH THERAPEUTIC EQUIVALENCE EVALUATIONS” (the “Orange Book”), as such requirements may be amended in the future, (ii) has been approved by a regulatory agency having an approved application that contains adequate scientific evidence establishing, through in vitro and/or in vivo studies, the bioequivalence of such product to a Licensed Product developed under this Agreement and which product contains the same active pharmaceutical ingredient as such Licensed Product, such that, in the case of (i) or (ii), such pharmaceutical product would be substitutable by a pharmacist for such Licensed Product when filling a prescription written for such Licensed Product without having to seek authorization to do so from the physician writing such prescription.

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AB Rated Product means a product which has been approved by a Regulatory Agency having an approved application that contains adequate scientific evidence establishing, through in vitro and/or in vivo studies, the bioequivalence of such product to a Licensed Product developed under this Agreement and which product contains the same active pharmaceutical ingredient as such Licensed Product.

AB Rated Product means “therapeutically equivalent” as set forth in the Preface to the current edition of the Orange Book, as such requirements may be amended in the future, as evidenced by the assignment of any ‘A’ rating, such that one pharmaceutical product that is therapeutically equivalent to another pharmaceutical product is generally substitutable by the pharmacist for such other pharmaceutical product when filling a prescription written for such other pharmaceutical product without having to seek authorization to do so from the physician writing such prescription.

Examples of AB Rated Product in a sentence

Upon RBX’s reasonable determination that a Third Party is expected to launch within six (6) months an AB Rated Product in a country of the Territory, RBX may at such time request [*] launch of its co-marketed product in such country upon exercise of its co-marketing right as set forth in subsection (a) of this Section 3.04.
In the event that such AB Rated Product subsequently ceases to be sold or marketed in such country, the reduction of the royalty rate with respect to such Licensed Product in such country under this Section 6.2(c) shall no longer apply, effective with respect to sales of such Licensed Product in such country occurring after the last day on which such AB Rated Product is sold or marketed in such country.
In the event that such AB Rated Product subsequently ceases to be sold or marketed in such country, the reduction of the royalty rate with respect to such Licensed Product in such country under this Section 6.3(c) shall no longer apply, effective with respect to sales of such Licensed Product in such country occurring after the last day on which such AB Rated Product is sold or marketed in such country.

More Definitions of AB Rated Product

AB Rated Product means a pharmaceutical product that (a) is “therapeutically equivalent” to a Licensed Product, applying the definition of “therapeutically equivalent” set forth in the Preface to the current edition of the FDA publication “Approved Drug Products with Therapeutic Equivalence Evaluations” (the “Orange Book”), as such requirements may be amended in the future, and (b) has been approved by a Regulatory Authority based upon an application that contains scientific evidence establishing, through in vitro and/or in vivo studies, the bioequivalence of such product to a Licensed Product developed under this Agreement and which product contains the same active pharmaceutical ingredient as such Licensed Product, such that such pharmaceutical product would be substitutable by a pharmacist for such Licensed Product when filling a prescription written for such Licensed Product without having to seek authorization to do so from the physician writing such prescription.