Biosimilar Competition definition

Biosimilar Competition has the meaning set forth in Section 7.6.3(a).

Biosimilar Competition means, with respect to a Product in any country in a given calendar quarter, that, during such calendar quarter, (a) one or more generic products are commercially available in such country, and (b) aggregate Net Sales of such Product in such country in such calendar quarter equal [****] percent ([****]%) of the average aggregate Net Sales of the Product over the four (4) calendar quarters immediately prior to the calendar quarter in which one or more Generic Products first became commercially available in such country.

Biosimilar Competition means, on a Product-by-Product, country-by-country, and Calendar Year-by-Calendar Year basis, a Biosimilar Product with respect to such Product is being marketed and sold by a Third Party in such Calendar Year in such country.

Examples of Biosimilar Competition in a sentence

• 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.

• In no event will the Royalties payable to ARScience Bio in a given Calendar Quarter be reduced by more than [***] of the aggregate amount that would otherwise be payable to ARScience Bio in respect to such Royalties in such Calendar Quarter as a result of the aggregate reductions permitted pursuant to Section 5.5.1 (Valid Claims Expiration), Section 5.5.2 (Biosimilar Competition), and Section 5.5.3 (Third Party Payments).

• In the event of any termination of this Agreement, unless otherwise expressly provided, any liabilities previously accrued (including the obligation of Amgen to pay royalties pursuant to Section 8.3 (Royalty Payments and Royalty Reduction for Biosimilar Competition)) with respect to sales of the Product made prior to the effective date of such termination shall survive.

• The maximum aggregate reduction with respect to the royalty rate for a Product in any calendar quarter during the applicable Royalty Term in any country pursuant to Sections 3.1.5 (Royalty Reduction), 3.1.6 (Biosimilar Competition) and 3.1.7 (Third-Party Intellectual Property) shall be [***].

• Partner will promptly notify Kiniksa of the occurrence of Biosimilar Competition, which notice will specify the applicable Biosimilar Products, Indication, and country or region in the Territory.

More Definitions of Biosimilar Competition

Biosimilar Competition means, with respect to a Licensed Product in a country in the Territory, the sale of one (1) or more Biosimilar Product(s), as applicable, with respect to such Licensed Product in such country.

Biosimilar Competition means, with respect to any country in the Licensed Territory, that any one or more Third Parties sell Biosimilar Products in such country that have, in the aggregate, achieved [**]% or more of the aggregate market share of Products and Biosimilar Products (based on data provided by IMS Health Incorporated, Fairfield, Connecticut) in any Calendar Quarter as measured on an aggregate sales basis (in unit sales), or if such data is not available, a methodology to be mutually agreed upon by the Parties for estimating the percentage of aggregate sales (in unit sales) based on market share of Biosimilar Products in such country.

Biosimilar Competition has the meaning set forth in Section 6.5.4(a). *** Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request.

Biosimilar Competition means, with respect to a Biosimilar Product in a country or region in the Territory and particular Calendar Quarter following the Biosimilar Launch Quarter for such Biosimilar Product in such country or region, the decrease in the Net Sales in such country or region for the Licensed Product during the applicable Calendar Quarter, as compared to the average quarterly Net Sales of the Licensed Product in such country or region during the four Calendar Quarters immediately preceding such Biosimilar Launch Quarter.

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 Competition means, on a Licensed Product-by-Licensed Product, country-by-country, and Calendar Quarter-by-Calendar Quarter basis, that (a) there are [**] or more Biosimilar Products being sold in such country with respect to such Licensed Product in such Calendar Quarter and (b) such Biosimilar Product(s), by unit equivalent volume in such country in such Calendar Quarter, exceed a [**] percent ([**]%) share of the aggregate market in such country of such Licensed Product and all such Biosimilar Product(s) (based on the number of units of such Licensed Product and such Biosimilar Product(s) in the aggregate sold in such country, as reported by a well-known reporting service agreed between the Parties acting reasonably (e.g., IQVIA)).

Biosimilar Competition means, on a country or other jurisdiction and Licensed Product basis, [***] of such Licensed Product sold in that country or other jurisdiction by AbbVie, its Affiliates and Sublicensees. Unless otherwise agreed by the Parties, the [***] shall be as [***] or any other [***] by the Parties; [ ] = Certain confidential information contained in this document, marked by brackets, is filed with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.