Reference Drug definition

Reference Drug. Reference Drug means (a) with respect to the Copaxone-Referenced Product, Branded Copaxone, (b) with respect to the Lovenox-Referenced Product, Branded Clexane, (c) with respect to the [**]-Referenced Product, Branded [**], and (d) with respect to the [**]-Referenced Product, Branded [**].
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Reference Drug means the drug product identified by the FDA as the drug product to which an applicant refers in seeking Regulatory Approval, as set forth in the Approved Drug Products With Therapeutic Equivalence Evaluations issued by the FDA or any successor thereto, or for jurisdictions outside of the United States, the drug product similarly identified by the applicable Regulatory Authority.
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Examples of Reference Drug in a sentence

  • Reference Drug means (a) with respect to the Copaxone-Referenced Product, Branded Copaxone, (b) with respect to the Lovenox-Referenced Product, Branded Clexane, (c) with respect to the [**]-Referenced Product, Branded [**], and (d) with respect to the [**]-Referenced Product, Branded [**].

  • The Product Development Committee shall consider all factors relevant to developing a non-infringing Product (in compliance with Applicable Law) that is bio-equivalent to the related Reference Drug and obtaining Regulatory Approval as expeditiously as possible.

  • Related Product means, with respect to a Glycoprotein Product, an injectable product (a) with (i) [**], (ii) [**], and (iii) [**], and (b) for which an Application cites the marketing approval file for the relevant Reference Drug or, with respect to the [**]-Referenced Product, [**]as the reference listed drug.