Equivalent Product definition

Equivalent Product means, as it pertains to a particular Licensed Product for which there are Net Sales, a product that contains an oral formulation of PTH where such formulation is (a) claimed by a Unigene Formulation Patent and (b) includes the identical PTH molecule as in that particular Licensed Product.

Equivalent Product means any product other than Generic Product, which (a) is manufactured and distributed by a Person pursuant to an ANDA which was approved by the FDA or (b) is otherwise an A-Rated generic version of the Branded Product.

Equivalent Product has the meaning set forth in Section 6.2.

Examples of Equivalent Product in a sentence

• For purposes of this Section, competent and reliable scientific evidence shall consist of human clinical testing of the Covered Product, or of an Essentially Equivalent Product, that is sufficient in quality and quantity based on standards generally accepted by experts in the relevant disease, condition, or function to which the representation relates, when considered in light of the entire body of relevant and reliable scientific evidence, to substantiate that the representation is true.

• Persons covered by this Section have the burden of proving that a product satisfies the definition of Essentially Equivalent Product.

• Defendants shall have the burden of proving that a product satisfies the definition of Essentially Equivalent Product.

• Section wise Energy metering (Electrical and Thermal) is required for making Equivalent Product in Textile sub-sectors.

• For purposes of this Provision, competent and reliable scientific evidence must consist of human clinical testing of the Covered Product, or of an Essentially Equivalent Product, that is sufficient in quality and quantity based on standards generally accepted by experts in the relevant disease, condition, or function to which the representation relates, when considered in light of the entire body of relevant and reliable scientific evidence, to substantiate that the representation is true.

More Definitions of Equivalent Product

Equivalent Product means a pharmaceutical product that (i) contains hydrocortisone as an active ingredient, (ii) is rectally administered or anally applied and (iii) is intended for use for the indications set forth on Schedule 6.2 hereto. Seller acknowledges and agrees that the covenants regarding the restrictions above are separate and distinct covenants and that if any such covenant is determined to be void and unenforceable, in whole or in part, the same shall, and shall be deemed, not to affect or impair the validity of any of the covenants set forth in this Section 6.2. [*] Confidential treatment requested; certain information omitted and filed separately with the SEC.

Equivalent Product means any pharmaceutical product which is manufactured by a party other than Seller or its Affiliate pursuant to an ANDA which was approved by the FDA, which ANDA was approved as bioequivalent to the NDA Product.

Equivalent Product has the meaning set forth in Section 8.23.2.

Equivalent Product means any oral dosage form of the product containing acitretin as the active ingredient, which is manufactured pursuant to an ANDA, 505(b)(2) application or other regulatory filing which was approved by the FDA and which filing was filed on the basis of CONNETIC’s NDA for Soriatane® (other than any product in any strength or dosage under the trademark or trade name Soriatane®).

Equivalent Product means any product formulated by Linchitz that substantially replicates the Products as to the combination of specific ingredients, nutrients, and functional features with Linchitz’s own ingredients and/or formulations.

Equivalent Product means any product, other than a Product that Seller is obligated to supply to Purchaser hereunder, which (i) is manufactured by a Party pursuant to an ANDA which was approved by the FDA, which ANDA was filed on the basis of the original NDA for the brand equivalent of such Product or (ii) is otherwise a generic version of the brand equivalent of such Product.

Equivalent Product means, with respect to a particular Product in a particular country, a product on the market in such country commercialized by any Third Party that is not a Sublicensee and that did not purchase such product in a chain of distribution that included any of Vertex or its Affiliates or Sublicensees, that: (a) is approved by the applicable Regulatory Authority, under any then-existing laws and regulations in the applicable country pertaining to approval of generic or biosimilar biologic products, as a “generic” or “biosimilar” (or foreign equivalent) version of such Product, which approval relies on or references information in the Approval Application for such Product; or (b) is otherwise recognized by the applicable Regulatory Authority as a biosimilar or interchangeable product (or foreign equivalent) to such Product.