Biosimilar Competition Clause Samples
The Biosimilar Competition clause defines the rights and obligations of the parties in the event that a biosimilar product enters the market and competes with the original biologic product covered by the agreement. Typically, this clause outlines how pricing, royalties, or other financial terms may be adjusted if a biosimilar is approved and sold, potentially reducing the market share or profitability of the original product. Its core function is to address the financial impact of biosimilar entry, ensuring that both parties have a clear understanding of how their commercial relationship will adapt to increased competition.
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Biosimilar Competition. The royalty rate under Sections 6.3(a) shall be reduced by [****] percent ([****]%), on a country-by-country basis and Product-by-Product basis, in each country in which Biosimilar Competition exists with respect to such Product in a country of the Territory.
Biosimilar Competition. On a Product-by-Product and country-by-country basis, if, during the Royalty Term for a Product in a country, sales of Biosimilars of such Product account for [**]% or more of aggregate unit sales of such Product and such Biosimilars in such country in a calendar quarter, as determined by reference to applicable sales data obtained from a reputable independent source (e.g., IMS Health), then for the remainder of the Royalty Term for such Product in such country, the royalties that would otherwise be payable by Arsanis under Section 4.3(a) (Royalty Payments) (as adjusted pursuant to Section 4.3(b) (Adjustment for Third Party IP), to the extent applicable), with respect to Net Sales of such Product in such country shall be reduced by [**] percent ([**]%).
Biosimilar Competition. During the portion of the applicable Royalty Term in a particular country where there are one or more products being sold in such country that are Biosimilar Products with respect to such Product, then the Base Royalty Rates set forth in Section 8.5(b), as adjusted by Section 8.5(c)(ii), with respect to such Product shall be reduced as follows:
(i) by [***], in the event that in any calendar quarter such Biosimilar Product(s), by unit equivalent volume in such country, exceed a [***] share of the market;
(ii) by [***], in the event that in any calendar quarter such Biosimilar Product(s), by unit equivalent volume in such country, exceed a [***] share of the market; and
(iii) by [***] in the event that in any calendar quarter such Biosimilar Product(s), by unit equivalent volume in such country, exceed a [***] share of the market. For purposes of this Section 8.5(d), “market” refers to the aggregate of the sales of the Biosimilar Product(s) and the applicable Product in a country.
Biosimilar Competition. During the portion of the applicable Royalty Term in a particular country where there are one or more products being sold in such country that are Biosimilar Products with respect to such Product, then the Base Royalty Rates set forth in Section 8.3(b), as adjusted by Section 8.3(c)(ii), with respect to such Product shall be reduced as follows:
(i) by [***], in the event that in any calendar quarter such Biosimilar Product(s), by unit equivalent volume in such country, exceed a [***] share of the market; and ***Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions.
(ii) by [***] in the event that in any calendar quarter such Biosimilar Product(s), by unit equivalent volume in such country, exceed a [***] share of the market.
Biosimilar Competition. If, in a particular country, a Third Party obtains approval for and sells a Biosimilar Product with respect to a particular Product and achieves Biosimilar Competition in such country with respect to such Product, then the Net Sales for such Product in such country will be reduced by [***] for the remainder of the Royalty Term for such Product in such country, subject to Section 5.5.4 (Mechanics of Adjustment to Royalties).
Biosimilar Competition. During the portion of the applicable Royalty Term in a particular country where there are one or more products being sold in such country that are Biosimilar Products with respect to such Product, then the Base Royalty Rates set forth in Section 8.4(b), as adjusted by Section 8.4(c)(ii), with respect to such Product shall be reduced as follows:
(i) by [***], in the event that in any calendar quarter such Biosimilar Product(s), by unit equivalent volume in such country, exceed a [***] share of the market; and
(ii) by [***], in the event that in any calendar quarter such Biosimilar Product(s), by unit equivalent volume in such country, exceed a [***] share of the market.
Biosimilar Competition. During the portion of the applicable Initial TC Term in a particular country where one or more Biosimilar Products with respect to a Product are sold in that country, BMS’s Net Sales Compensation obligations with respect to such Product in such country shall be reduced by reducing the percentages set forth in the table in Section 8.5(a) above by [***] percent ([***]%), in respect of any Calendar Quarter in which the sales of such Biosimilar Product(s), by unit equivalent volume in such country, exceed a [***] percent ([***]%) share of the market in that country; provided that the Total Compensation payable to BN during the Initial TC Term shall not be reduced pursuant to this Section 8.5(c) below the sum of (A) [***] percent ([***]%) of Net Sales, plus (B) the [***]. For purposes of this Section 8.5(c), “market” refers to the aggregate of the sales of the Biosimilar Product(s) and the applicable Product in a country.
Biosimilar Competition. On a country-by-country and Product-by-Product basis, following the marketing approval and launch of a Biosimilar Version, the then-applicable royalty rates for the calculation of the royalty payments on Net Sales of the Product corresponding to the Biosimilar Version for the applicable country for any calendar quarter or portion thereof shall, thereafter, be reduced by [***] and, if the Net Sales of such Product in such country have declined by more than [***] as compared with the average Net Sales in the [***] immediately prior to the entry of the Biosimilar Version in such country for more than [***], the then-applicable royalty rates for the calculation of the royalty payments on Net Sales of such Product shall, thereafter, be reduced by an additional [***]; provided, that, after the removal of such Biosimilar Version from such country, the royalty shall revert to being paid in full for the remainder of the Royalty Term.
Biosimilar Competition. Notwithstanding the foregoing, on a country-by-country basis in the Territory, the royalty rate for Net Sales of a Revenue Bearing Product set forth in Section 4.1(b) shall be reduced (A) by [*****], following a launch of a Biosimilar Product, if the unit sales of all Biosimilar Products in such country exceed [*****] of the sum of unit sales of Revenue Bearing Products plus unit sales of all Biosimilar Products in such country, (B) by [*****] following a launch of a Biosimilar Product, if the unit sales of all Biosimilar Products in such country exceed [*****] of the sum of unit sales of Revenue Bearing Products plus unit sales of all Biosimilar Products in such country, or (C) by [*****] to become [*****] following a launch of Biosimilar Product, if the unit sales of all Biosimilar Products in such country exceed [*****] of the sum of unit sales of Revenue Bearing Products plus unit sales of all Biosimilar Products in such country. Unless otherwise agreed by the Parties, the unit sales of each such Biosimilar Product sold during a Reporting Period shall be as reported by [*****] or any other independent sales auditing firm reasonably agreed upon by the Parties.
Biosimilar Competition. During the portion of the applicable Royalty Term in a particular country where there are one or more products being sold in such country that are Biosimilar Products with respect to such Product, then the Base Royalty Rates set forth in Section 8.5(b), as adjusted by Section 8.5(c)(ii), with respect to such Product shall be reduced as follows:
(i) by twenty five percent (25%), in the event that in any calendar quarter such Biosimilar Product(s), by unit equivalent volume in such country, exceed a twenty-five percent (25%) share of the market;
(ii) by thirty-seven and one-half percent (37.5%), in the event that in any calendar quarter such Biosimilar Product(s), by unit equivalent volume in such country, exceed a thirty-seven and one-half percent (37.5%) share of the market; and
(iii) by fifty percent (50%), in the event that in any calendar quarter such Biosimilar Product(s), by unit equivalent volume in such country, exceed a fifty percent (50%) share of the market. For purposes of this Section 8.5(d), “market” refers to the aggregate of the sales of the Biosimilar Product(s) and the applicable Product in a country.