definiens: has the meaning in the United States given to it by the FDA in the current edition of the ( i.e., the ), as the same may be amended from time totime during the term of this Agreement, and in countries outside the United States a substantially similar meaning, namely, two drug products are therapeutic equivalents which are : ( 1 ) pharmaceutical equivalents in that they contain identicalamounts of the same active drug ingredient in the same dosage form and route of administration, and ( 2 ) are substitutable inthat ( a ) they can be substituted at the pharmacy level without prior physician approval, or ( b ) they are mandated or required tobe substituted by any applicable Regulatory Authority or under Applicable Law . The Parties agree that Dantrium ®, approvedin NDA # 018264 and currently marketed by Procter & Gamble in the United States, shall not be considered a TherapeuticEquivalent of the Product