Biosimilar Products. On a country-by-country and Licensed Product-by-Licensed Product basis: (a) upon the first commercial sale of one or more Biosimilar Products with respect to a Licensed Product in any country in the Territory during the Royalty Term, the Royalty rates provided in Section 9.4.2 above for the Licensed Product will be reduced in such country by [***] from the date of first commercial sale of such Biosimilar Product(s) in such country; and (b) [***].
Biosimilar Products. The royalties payable by Astellas with respect to Net Sales of Licensed Products shall be reduced, on a Licensed Product-by-Licensed Product and country-by-country basis, to [**] percent ([**]%) of the amounts otherwise due to Pandion pursuant to Section 8.5 during any portion of the Royalty Term if one or more Biosimilar Products becomes commercially available in such country.
Biosimilar Products. On a country-by-country and Licensed Product-by-Licensed Product basis, with respect to a Licensed Product Directed Against an RT Target that is subject to royalties under this Section 7.9 (Royalties on Products Directed Against an RT Target), from and after the first Calendar Year in which a Biosimilar Product is sold in a given country and has achieved (i) [***] unit sales in such country in the market segment in which such Licensed Product competes in such country, the royalties payable pursuant to Section 7.9.1 (Royalties) for such Licensed Product shall be reduced in such country by [***] of the royalties otherwise payable under Section 7.9.1 (Royalties) and (ii) [***] unit sales in such country in the market segment in which such Licensed Product competes in such country, the royalties payable pursuant to Section 7.9.1 (Royalties) for such Licensed Product shall be reduced in such country by [***] of the royalties otherwise payable under Section 7.9.1 (Royalties).
Biosimilar Products. If one or more Biosimilar Products with respect to a Licensed Product is sold commercially by one Biosimilar (or Interchangeable) Applicant in a particular country in the Territory during a particular calendar quarter (“Biosimilar Product Presence”), and during such calendar quarter the Net Sales of such Licensed Product has decreased by [***] percent ([***]%) or more when compared to peak Net Sales of such Licensed Product in such country in [***], and such decrease is attributable to such Biosimilar Product Presence, then the royalty rate (used with Net Sales to determine royalty payments) for such Licensed Product in such country during such calendar quarter and for the remainder of the Royalty Term will be reduced by [***] percent ([***]%) for purposes of determining Arcus’s obligation to make royalty payments under this Agreement. Notwithstanding any other provision of this Agreement, Arcus will at all times pay a minimum royalty of [***] percent ([***]%) of Net Sales under Section 5.4.
Biosimilar Products. On a Licensed Product-by-Licensed Product basis, if in any country in the Territory during the Royalty Term for a Licensed Product a Biosimilar Product launches with respect to such Licensed Product in such country, then the royalties that would otherwise be owed and payable under Section 5.4.1 for the Net Sales of such Licensed Product in such country shall be reduced by [***], from the date of launch of such Biosimilar Product in such country until the end of the Royalty Term for such Licensed Product in such country. In the event that Gilead does not learn of such launch until after royalties are paid, Gilead shall be entitled to such adjustment retroactively to such launch date in the form of a credit against future royalty obligations of Gilead under this Agreement.
Biosimilar Products. On a country-by-country and Product-by-Product basis: (a) upon the first commercial sale of one or more Biosimilar Products with respect to a Product in any country in the Territory during the Royalty Term, the royalty rates provided in Section 7.3.2 for the Product will be reduced in such country by [* * *] percent ([* * *]%) (in addition to Sections 7.3.3 and 7.3.5, but subject to Section 7.3.6); and (b) from and after the first Calendar Quarter in which Biosimilar Products (individually or in the aggregate) have a market share of [* * *] percent ([* * *]%) or more in a given country (measured in local currency, over the Calendar Quarter, as reported by a customary market intelligence service used by Lilly), the royalty rates provided in Section 7.3.2 for the Product will be reduced in such country to [* * *] percent ([* * *]%) of the royalties otherwise payable under Section 7.3.2.
Biosimilar Products. (i) If during the portion of the applicable Royalty Term in a particular country in the Novartis Territory, (A) one or more Biosimilar Products with respect to the Licensed Product are being sold in such country, other than any Biosimilar Product that is sold by any Affiliate or Sublicensee of Novartis or Sandoz AG and its Affiliates (solely for such time as Sandoz AG and its Affiliates remain Affiliates of Novartis), (B) the Net Sales of such Licensed Product in that country in any Calendar Year are less than […***…] as compared with the Net Sales of such Licensed Product in that country in the Calendar Year immediately preceding the Calendar Year in which such Biosimilar Product(s) is/are first sold, and (C) the decline in Net Sales of the Licensed Product is reasonably attributable in material part to the marketing or sale in such country of such Biosimilar Product(s) ((A) through (C), a “Loss of Marketing Exclusivity”), then, for purposes of determining the royalties payable with respect to the Licensed Product as set forth in Section 8.3.1, as may be further reduced by Section 8.3.3(a), the Net Sales with respect to the Licensed Product in such country shall be reduced to […***…] of the Net Sales otherwise calculated for such country(ies) during such portion of the Royalty Term for so long as the Loss of Market Exclusivity continues during the Royalty Term for the Licensed Product in such country.
Biosimilar Products. If, in any country in the Territory during the Royalty Term in such country for a Licensed Product, a Biosimilar Product with respect to such Licensed Product is launched in such country, then, starting with any Calendar Quarter in which the Net Sales of such Licensed Product in such country is at least [**] percent ([**]%) less than the Net Sales of such Licensed Product in such country in the last full Calendar Quarter immediately prior to such Biosimilar Product’s launch in such country, the royalty rate for such Licensed Product with respect to such country shall thereafter be reduced by [**] percent ([**]%) from the applicable rate(s) set forth in Section 10.3.1 (as adjusted by Section 10.3.2 or Section 10.5.3).
Biosimilar Products. Drugs that (a) are highly similar to a US-licensed referenced biological product, notwithstanding minor differences in clinically inactive components, where there are no clinically meaningful differences between the biological product and the reference product in terms of the safety, purity, and potency of the product; and/or (b) are approved pursuant to 42 USC Section 262(k) or any successor legislative provision thereto. • Brand Name Prescription Drug or Brand Drug. Single-source and/or multi-source non-Generic Prescription Drugs set forth by utilizing Medi-Span drug identification. A Prescription Drug product that is indicated as either “O”, “M”, or “N”.
Biosimilar Products. (a) If following the first commercial sale of a Biosimilar in a country, Net Sales of a Shared Antigen TCR Product in such country in a given [***] month period fall by [***] percent ([***]%) from the Net Sales in the calendar year immediately preceding the calendar year in which such launch of the Biosimilar occurred, the royalties due and payable by GNE under Section 9.4.1 for all such Shared Antigen TCR Product shall be reduced by [***] percent ([***]%) in such country.
