Biosimilar Entry. For any Pfizer Quarter in the applicable Royalty Term for a Product in a country in the Territory during which (1) a Biosimilar Product with respect to such Product is being sold in such country; and (2) the unit volume of such Biosimilar Product sold in such country in such Pfizer Quarter exceeds [ * ] of the combined unit volume of such Product and such Biosimilar Product sold in such country in such Pfizer Quarter, subject to Section 5.3(d)(vi), the royalties payable on Net Sales of such Product in such country in such Pfizer Quarter would be reduced by [ * ] of the amounts of royalties otherwise payable on such Net Sales pursuant to Section 5.3(a) for the remainder of the applicable Royalty Term, such reduction to be prorated appropriately in aggregate for the then-current Pfizer Quarter. The unit volume of the Product and Biosimilar Product shall be calculated using a mutually acceptable method and using market share data provided by a reputable and mutually agreed upon provider, such as IQVIA (f/k/a QuintilesIMS Health).
Biosimilar Entry. Any royalty otherwise payable to Spark under this Agreement with respect to Net Sales of a Licensed Product would be reduced (i) by [**] percent ([**]%) of the amounts otherwise payable pursuant to Section 3.4.1 with respect to such Licensed Product in such country beginning in any Pfizer Quarter during the applicable Royalty Term in a country when any Third Party Biosimilar Product(s) approved via an abbreviated regulatory approval pathway that relies on the Regulatory Approval or data submitted to the applicable Regulatory Authority for such Licensed Product achieves more than a [**] percent ([**]%) market share in the corresponding Calendar Quarter in such country, by unit volume, of combined unit sales of such Licensed Product and such Third Party Biosimilar Product(s) in such country, and (ii) by [**] percent ([**]%) beginning in any Pfizer Quarter during the applicable Royalty Term in a country when any Third Party Biosimilar Product(s) approved via an abbreviated regulatory approval pathway that relies on the Regulatory Approval or data submitted to the applicable Regulatory Authority for such Licensed Product achieves more than a [**] percent ([**]%) market share in such country in the corresponding Calendar Quarter, by unit volume, of combined unit sales of such Licensed Product and such Third Party Biosimilar Product(s) in such country. Any reductions in the royalty rate pursuant to this Section 3.4.4 shall be irreversible.
Biosimilar Entry. After the entry of a Biosimilar Version of a Licensed Product in a country in the Territory, the royalties due under Section 9.5 for such Licensed Product in such country shall be reduced as follows:
(i) by [*] in subsequent [*] if in [*]; and
(ii) by [*] in subsequent [*] if in [*].
Biosimilar Entry. Notwithstanding the foregoing, for any royalty otherwise payable to BioNTech under this Agreement with respect to Net Sales based on sales of a Product in a given country in the Territory, any payments owed with respect to such Product in such country pursuant to this Section 3.5 [***].
Biosimilar Entry. If, upon entry of one or more Biosimilar Product(s) with respect to Licensed Product in Territory such that annual Net Sales of the Licensed Product by or on behalf of Hansoh, its Affiliates and sublicensees in the Territory decrease by [***] ([***]), as compared to the average annual Net Sales of Licensed Product in the Territory for [***] prior to entry of the first Biosimilar Product in the Territory, then the amount of Hansoh’s royalty payments to Viela under Section 5.4(a) shall be reduced by [***] ([***]), subject to Section 5.4(d)(iii).
Biosimilar Entry. Subject to Section 4.6.6 (Cumulative Adjustments), on a Licensed Product-by-Licensed Product and country-by-country basis, if during any portion of the Royalty Term for a given Licensed Product in a given country in the Territory, (i) there is no longer a Valid Claim that covers the composition of matter of such Licensed Product (or any active ingredient thereof) in such country, (ii) there is Biosimilar Competition with respect to such Licensed Product in such country for a period of [***] ([***]) [***] and (iii) there is at least a [***]% decrease in revenue for Licensee on sales of such Licensed Product to Third Party purchasers in the calendar quarter in such country as compared to the average revenue received by Licensee on sales of such Licensed Product in such country during the calendar quarter immediately preceding the entry of the first Biosimilar Product, then the royalty rate that would otherwise be owed and payable under Section 4.6.1, in each case, with respect to Net Sales of such Licensed Product in such country shall be reduced by [***] percent ([***]%) for the remainder of the Royalty Term for such Licensed Product in such country. “Biosimilar Competition” shall be deemed to exist in a particular country with respect to a particular Licensed Product in a given calendar quarter if in such country from and after the first calendar quarter during which one or more Biosimilar Products (other than one or more Authorized Biosimilar Products)) in the aggregate account(s) for more than [***] percent ([***]%) of the sum of (i) the aggregate unit sales of such Licensed Product by Licensee or its Affiliates or by a sublicensee in such country, and (ii) the aggregate unit sales of such Biosimilar Product(s) in such country, as measured by a data source as reasonably agreed upon by Inhibrx and Licensee no later than the First Commercial Sale of the applicable Licensed Product. If no data is commercially available for a country, then [***]. “Authorized Biosimilar Product” means a Biosimilar Product sold by Licensee or any of its Affiliates or sublicensee or other Third Party under a license granted by Licensee or its Affiliate, or distributed under a Regulatory Approval held by Licensee or any of its Affiliates.
Biosimilar Entry. If a Product is generating Net Sales in a Region during the applicable Royalty Term at a time when a Biosimilar Product with respect to such Product is being sold in such Region, and such Biosimilar Product(s) obtain (x) a market share of at least [***] in such Region on a volume basis, then, subject to Section 8.4(c)(iv), the royalty rates applicable to Net Sales of such Product in such Region shall be reduced to [***] of the royalty rate set forth in Section 8.4(a), or (y) a market share of at least [***] in such Region on a volume basis, then, subject to Section 8.4(c)(iv), the royalty rates applicable to Net Sales of such Product in such Region shall be reduced to [***] of the royalty rate set forth in Section 8.4(a), but in each case of (x) and (y) only for so long as the Biosimilar Product with respect to such Product is being sold in such Region with such market share.
Biosimilar Entry. Notwithstanding the foregoing, for any royalty otherwise payable to Pfizer under this Agreement with respect to Net Sales based on sales of a Product in a given country in the Territory, any such payments owed with respect to such Product in such country pursuant to this Section 6.6.2 will be reduced by [***] for the remainder of the applicable Royalty Term for such Product in such country, such reduction to be prorated for the then-current calendar quarter, once one or more Biosimilar Products of such Product become available, are being sold in such country and cumulatively have at least [***] of the total market in such country, based on unit sales, over a [***] period.
Biosimilar Entry. Notwithstanding the foregoing, for Net Sales based on sales of a Product in a country in the Territory, on a country-by-country basis, any payments owed with respect to such Product pursuant to this Section 3.7 will be reduced by [***] for the remainder of the applicable Royalty Term, if at any time (i) one or more Biosimilar Versions of such Product is available in such country and (ii) such one or more Biosimilar Versions in the aggregate have achieved in excess of [***] market penetration (based on unit volume).
Biosimilar Entry. If a Biosimilar Product to a Licensed Product is sold in a country in the Collaborative Territory in any Calendar Quarter during the Royalty Term for such Licensed Product in such country, then on a Licensed Product-by-Licensed Product basis, following the First Commercial Sale of a Biosimilar Product in such country in a Calendar Quarter once (a) Net Sales of the applicable Licensed Product in such country decline by the percentage described below relative to the average quarterly Net Sales of the Licensed Product in such country achieved in four (4) Calendar Quarters immediately to such launch of such Biosimilar Product; and (b) all Biosimilar Products in such country have a combined market share of [***] or more of the total market (i.e., Licensed Product and Biosimilar Products combined) in the Field in such country, then the royalty rates applicable to Net Sales of the Licensed Product in such country set forth in the table in Section 4.2.1 (Royalty Rates) shall permanently be reduced as follows:
