Competitive Generic Licensed Product. In the event that one or more Third Parties sells a Generic Product (as defined below) in a country in which a Licensed Product is then being sold, then during any Calendar Quarter in which sales of Generic Products by all such Third Parties are equal to at least [***] percent ([***]%) of Ophthotech’s volume-based market share of the Licensed Product in such country (as measured by prescriptions or other similar information available in such country), the applicable payments in effect with respect to such Licensed Product in such country as specified in Sections 4.2.1 and/or 4.3.1 shall be reduced to [***] percent ([***]%) of the rates otherwise applicable under Sections 4.2.1(a) and/or 4.3.1(a). Notwithstanding the foregoing, the royalty rate reductions specified in the foregoing sentence shall cease, and the otherwise applicable royalty rates shall be reinstated, on the first day of the Calendar Quarter immediately following the Calendar Quarter in which sales of such Generic Products account for less than [***] percent ([***]%) of Ophthotech’s volume-based market share in such country. For purposes of this Section 4.2.2, a “Generic Product” means a pharmaceutical product that is a “pharmaceutical equivalent” or “pharmaceutical alternative” (as those terms are used in the Approved Drug Products with Therapeutic Equivalence Evaluations (a.k.a. the Orange Book) published by the FDA Center for Drug Evaluation and Research or any successor publication) with respect to the Licensed Product.
Competitive Generic Licensed Product. In the event that one or more Third Parties sells a Generic Product (as defined below) in a country in which a Licensed Product is then being sold, then during any Calendar Quarter in which sales of Generic Products by all such Third Parties are equal to at least [**] percent ([**]%) of Ophthotech’s volume-based market share of the Licensed Product in such country (as measured by prescriptions or other similar information available in such country), the applicable payments in effect with respect to such Licensed Product in such country as specified in Sections 4.2.1 and/or 4.3.1 shall be reduced to [**] percent ([**]%) of the rates otherwise applicable under Sections 4.2.1(a) and/or 4.3.1(a). Notwithstanding the foregoing, the royalty rate reductions specified in the foregoing sentence shall cease, and the otherwise applicable royalty rates shall be reinstated, on
Competitive Generic Licensed Product. Royalties will be paid regardless of the patentability of the Licensed Product; provided, that, if patents fail to issue or expire such that no Valid Claim covers the Licensed Product in a country in the Territory and a competitor offers a generic version of the Licensed Product that captures a greater than * share of the aggregate market of the combined generic version and Licensed Product in such country (measured on a product volume basis rather than dollar sales amount basis), then the royalty rates in such country due shall be reduced by * of the amounts set forth in Section 7.3 above. For purposes of this Section 7.5, the royalty rate(s) payable to ArQule with respect to Net Sales of a Licensed Product in a given country (before the * reduction) shall be deemed to be the rate(s) which would apply if Net Sales of such Licensed Product in such country subject to each of the royalty rates under Section 7.3 were proportional to Net Sales of such Licensed Product in all countries subject to each of the royalty rates under Section 7.3. For clarity, an example of the application of the preceding sentence is as follows: If sales in a calendar year in countries without generic products capturing more than * are $ * and sales in countries with generic products capturing more than * are *, the royalties will * calculated as follows: $* + $* + $*
