“Generic Competition” shall mean, with respect to a Product or Process in a given country, one or more Generic Products are commercially available in such country.

“Generic Competition” shall mean, with respect to a Product or Process in a given country, one or more Generic Products are commercially available in such country.

“Generic Competition” means, with respect to a Licensed Product in any country in a given calendar quarter, if, during such calendar quarter, one or more Generic Products ​.

The term “Generic Product” shall mean a product that is not produced, licensed or owned by the Roche Group that # contains a pharmaceutically active ingredient that is the same as the Compound in the Product which is approved through in reliance, in whole or in part, on the prior Regulatory Approval (or on safety or efficacy data submitted in support of the prior Regulatory Approval) of such Product, pursuant to Section 505(j) of the Act (21 U.S.C. 355(j)), or for countries outside the US, any international equivalent laws, and # has the same or substantially the same labelling as the applicable Product for at least one indication of such Product.

Generic Entry. If # a Generic Product is sold by a Third Party in the Territory in any Calendar Quarter during the Royalty Term for a Licensed Product and the Generic Competition Percentage in the Territory for such Calendar Quarter is greater than or equal to ​ or # a LP Generic Product is sold by a Third Party in the Territory in any Calendar Quarter during the Royalty Term for a Licensed Product and the LP Generic Competition Percentage in the Territory for such Calendar Quarter is greater than or equal to ​, then the royalty rate under [Section 7.4(a)] shall be reduced by ​ in such Calendar Quarter.

Generic Entry. 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 Royalty Territory or Territory, as applicable, there is an entry of a Licensed Product sold by a Compulsory Sublicensee, a Competitive Product sold by Relay, its Affiliates or Relay Sublicensees or any Generic Product, in each case in a given country in the Territory when such Licensed Product is sold in such country by Licensee, its Affiliates or Licensee Sublicensees and # there has been a decline of the Sales of the applicable Licensed Product in such country greater than ​ of the average quarterly Sales of Licensed Product in such country ​ before the entry of such Licensed Product sold by a Compulsory Sublicensee, Generic Product or Competitive Product in such country, then the royalty rate that would otherwise be owed and payable under Section 11.6.1, 11.6.2 or 11.6.3 (as applicable), in each case, with respect to Net Sales of such Licensed Product in such country will be reduced ​ for ​ of the Royalty Term for such Licensed Product in such country or, if sooner, until further royalty reduction applies pursuant to clause (b) or (c) below, # there has been a decline of the Sales of the applicable Licensed Product in such country ​ of the average quarterly Sales of Licensed Product in such country ​ before the entry of such Licensed Product sold by a Compulsory Sublicensee, Generic Product or Competitive Product in such country, then the royalty rate that would otherwise be owed and payable under Section 11.6.1, 11.6.2 or 11.6.3 (as applicable), in each case, with respect to Net Sales of such Licensed Product in such country will be reduced by ​ for ​ of the Royalty Term for such Licensed Product in such country or, if sooner, until further royalty reduction applies pursuant to clause (c) below, or # there has been a decline of the Sales of the applicable Licensed Product in such country greater than ​ of the average quarterly Sales of Licensed Product in such country ​ before the entry of such Licensed Product sold by a Compulsory Sublicensee, Generic Product or Competitive Product in such country, then the royalty rate that would otherwise be owed and payable under Section 11.6.1, 11.6.2 or 11.6.3, in each case, with respect to Net Sales of such Licensed Product in such country will be reduced to ​ after which time the license for such Licensed Product in such country shall thereafter be fully paid-up and irrevocable for such Licensed Product in such country for so long as such Licensed Product is sold in such country. The royalty reductions in this Section 11.6.6 and the royalty reductions in Section 11.6.5 taken together shall not exceed ​ reduction for a Licensed Product in a country, except where [clause (c) of this Section 11.6.6] applies, in which case the royalty rate will be reduced to ​ and the license for such Licensed Product in such country shall thereafter be fully paid-up and irrevocable for such Licensed Product in such country for so long as such Licensed Product is sold in such country. For the avoidance of doubt, royalty reductions pursuant to Section 11.6.4 will be applied to the royalty as reduced pursuant to Section 11.6.5 and 11.6.6.

“Generic Product”. Generic Product means, with respect to a given Product, any pharmaceutical preparation that contains a Compound as its active pharmaceutical ingredient and # is approved for sale in reliance, in whole or in part, on the prior approval (or on safety or efficacy data submitted in support of the prior approval) of such Product as determined by the applicable Regulatory Authority or is approved for sale in reliance, in whole or in part, on the existing drug standard already approved by the applicable Regulatory Authority, or # is otherwise substitutable for such Product under applicable Laws by a pharmacist without the intervention of the prescribing physician.

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 Entry. On a Licensed Product-by-Licensed Product and country-by-country basis, and subject to [Section 6.6(c)(iv)], if one or more applicable Generic Products is sold in such country, and if during the Royalty Term for such Licensed Product in such country such Generic Products gain a market share of at least ​ of the aggregate market share of such Licensed Product and Generic Products (based on data provided by IQVIA, or if such data is not available, such other reliable data source as reasonably determined by Anteris in consultation with vTv) as measured by unit volume, then commencing the Calendar Quarter in which such Generic Products gain such market share and for the remainder of the applicable Royalty Term, the royalty rate provided in [Section 6.6(a)] for such Licensed Product shall be reduced in such country by ​.

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.