Example ContractsClausesRoyalty Adjustment for Generic Competition
Royalty Adjustment for Generic Competition
Royalty Adjustment for Generic Competition contract clause examples

Royalty Adjustment for Generic Competition. In the event that there is Generic Competition (as defined below) with respect to an Orphazyme Product in any country during the Royalty Term, then the Royalties payable for Net Sales in respect of such Orphazyme Product in such country shall be reduced by ​ following the first occurrence of Generic Competition in such country and for long as Generic Competition prevails in such country. In this Section, “Generic Competition” means the initiation of commercial sales of a generic version of an Orphazyme Product in a country.

Royalty Adjustment for Generic Competition. If there is Generic Competition with respect to a particular Product in a particular Region, then, for so long as such Generic Competition exists with respect to such Product in such Region, the royalties payable as to such Product in such Region under this [Section 6.5] shall be reduced to ​ of the royalties otherwise payable as to such Product in such Region pursuant to [Section 6.5(a)].

Royalty Adjustment for Generic Competition. In the event that in any jurisdiction in the Territory during the Royalty Term for a Licensed Product in a particular mode of administration there is Generic Competition for such Licensed Product in such mode of administration in such jurisdiction in any particular Calendar Quarter, then the royalty rate set forth in [Section 8.4(a)] (Royalty Rate) with respect to such Licensed Product in such jurisdiction in such Calendar Quarter shall be reduced by ​ percent (​); provided that in no event shall any royalty payment payable to NPLH for any Licensed Product in a jurisdiction in a given Calendar Quarter be reduced as a result of the payment reduction set forth in this subsection # of this [Section 8.5] (Royalty Adjustments), in the aggregate, to less than ​ percent (​) of the amount otherwise payable to the NPLH with respect to such Licensed Product in such jurisdiction in such Calendar Quarter in accordance with [Section 8.4] (Royalty Payments); and

Royalty Adjustment for Generic Competition. If there is Generic Competition with respect to a particular Product in a particular Region, then, for so long as such Generic Competition exists with respect to such Product in such Region, the royalties payable as to such Product in such Region under this [Section 6.5] shall be reduced to ​ of the royalties otherwise payable as to such Product in such Region pursuant to [Section 6.5(a)].

Adjustment for Generic Competition. With respect to Products resulting from the TIGIT Research Program, on a country-by-country and Product-by-Product basis, if during a calendar quarter for which royalties are being calculated hereunder for a particular Product, one or more products being sold in a particular country are Generic Products with respect to such Product, and the market penetration (based on sales of units of such Product and such Generic Product(s) in the aggregate, as reported by IMS International, or if such data are not available, such other reliable data source as reasonably agreed by the Parties) of such Generic Product exceeds ​, then the royalty rate otherwise applicable to the Net Sales of the Product in such country during such quarter and thereafter (for as long as such Generic Products are sold in such country) will be reduced to ​ of Net Sales in such country. For the avoidance of doubt, such reduction will only apply for those calendar quarters in which the market penetration exceeds ​.

Royalty Reduction for Generic Competition. If at any time Generic Product Competition exists in a given country with respect to a Product, then the royalty rate set forth in Section 8.5(a) with respect to sales of such Product in such country shall be reduced by ​. For clarity, if Generic Product Competition ceases to exist, then the royalty rate shall no longer be reduced.

Royalty Reduction for Generic Competition. If at any time Generic Product Competition exists in a given country with respect to a Product, then the royalty rate set forth in Section 8.5(a) with respect to sales of such Product in such country shall be reduced by ​. For clarity, if Generic Product Competition ceases to exist, then the royalty rate shall no longer be reduced.

Generic Competition. Royalties payable following establishment of Generic Competition with respect to the sale by a Third Party of a product that is a Biosimilar Biologic Product to such Allogene Licensed Product in such country will be payable at ​ of the otherwise applicable rate prior to application of this Section 5.2.2(a). “Generic Competition” means, with respect to a given Calendar Year with respect to an Allogene Licensed Product in any country, that during such Calendar Year, one (1) or more Third Parties have received Regulatory Approval to sell in such country a Biosimilar Biologic Product, such Biosimilar Biologic Product(s) will be commercially available in such country and such Biosimilar Biologic Product(s) will have, in the aggregate. A product will be a “Biosimilar Biologic Product” with respect to an Allogene Licensed Product if such product # has been licensed as a biosimilar or interchangeable product by FDA pursuant to Section 351(k) of the Public Health Service Act (42 U.S.C. 262(k)), as may be amended, or any subsequent or superseding law, statute or regulation, # has been licensed as a similar biological medicinal product by EMA pursuant to Directive 2001/83/EC, as may be amended, or any subsequent or superseding law, statute or regulation, or # has otherwise achieved analogous Regulatory Approval from another applicable Regulatory Authority.

Generic Competition”. Generic Competition means, with respect to a Product in any Region of the Territory in a given Calendar Quarter, that, during such Calendar Quarter, one or more Generic Products shall be commercially available in such Region and sold by a Third Party not authorized by Newsoara or any of its Affiliates, and such Generic Products shall have a market share of at least ​ of the aggregate market share of Products and Generic Products (based on data provided by IMS International, or if such data is not available, such other reliable data source as reasonably determined by Newsoara in consultation with vTv) as measured by unit volume.

Generic Competition. In the event that, in a country, a Generic Version of the Licensed Product has been approved for commercialization in such country, Janssen may reduce the royalty rate for calculating royalties payable to Arrowhead based on Janssen’s and ​ = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.

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