definiens: or . or means ( a)with respect to a Collaboration Product or, for the relevant purposes of Section 4.2, a Copaxone - Equivalent Product orLovenox - Equivalent Product, the authorized claim of A - rated therapeutically equivalent or otherwise therapeuticallyequivalent, as defined in the Orange Book, with respect to the U.S. Territory, or the foreign equivalent thereof in the relevantcountry in the relevant Territory ( outside the U.S. Territory ), and ( b ) with respect to a Glycoprotein Product, ( i ) with respect tothe U.S. Territory, a determination by the FDA of therapeutic equivalence or other interchangeability with the relevantReference Drug, and ( ii ) with respect to the applicable Territory ( outside the U.S. Territory ), ( A ) a determination ofinterchangeability with the relevant Reference Drug permitting the physician to switch the relevant Reference Drug with therelevant Glycoprotein Product, which determination has been made by the appropriate Regulatory Authority or by applicablelaws or regulations, or ( B ) other substitutability with the relevant Reference Drug for the relevant Territory for the purpose ofpayor reimbursement, which has been established by a grant of the competent Regulatory Authority or by applicable laws orregulations