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 Product” shall mean, as to a Product or Process, any product (including a “generic product” approved by way of an Abbreviated New Drug Application or approved under a [section 505(b)(2)] application, by the FDA (or equivalent regulatory mechanism for another regulatory authority)) that is sold by a third party and # in the United States, is “therapeutically equivalent,” “comparable,” “biosimilar,” or “interchangeable,” as evaluated by the FDA, applying the definition of “therapeutically equivalent” set forth in the preface to the then-current edition of the FDA publication “Approved Drug Products With Therapeutic Equivalence Evaluations” or any other definitions set forth in the U.S. Code, FDA regulations, or other source of U.S. Law or # outside the United States, meets such equivalent determination by the applicable regulatory authorities (including a determination that the product is “comparable,” “interchangeable,” “bioequivalent,” or “biosimilar” with respect to the Product or Process).

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 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 by a Regulatory Authority 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 Drug or Biosimilar Product. If during any Calendar Quarter during the ​ Royalty Term, on an ​ Licensed Product-by-​ Licensed Product and country-by-country basis, the aggregate number of units of Generic Drug or Biosimilar Products with respect to such ​ Licensed Product sold during such Calendar Quarter in such country, in the market segment in which such ​ Licensed Product competes in such country, equals or exceeds ​ of the aggregate units of the sum of all such Generic Drug or Biosimilar Products and such ​ Licensed Product sold in such Calendar Quarter in such country (as determined by data obtained from a mutually agreed upon Third Party source), then the applicable royalty rate set forth in [Section 9.3(c)(i)] as applied to Net Sales of such ​ Licensed Product in such country shall be reduced by ​ for such Calendar Quarter, subject to [Section 9.3(c)(iii)(D)].

Generic Drug or Biosimilar Product. If during any Calendar Quarter during the [[Unknown Identifier]] Royalty Term, on an [[Unknown Identifier]] Licensed Product-by-MECP2 Licensed Product and country-by-country basis, the aggregate number of units of Generic Drug or Biosimilar Products with respect to such [[Unknown Identifier]] Licensed Product sold during such Calendar Quarter in such country, in the market segment in which such [[Unknown Identifier]] Licensed Product competes in such country, equals or exceeds ​ of the aggregate units of the sum of all such Generic Drug or Biosimilar Products and such [[Unknown Identifier]] Licensed Product sold in such Calendar Quarter in such country (as determined by data obtained from a mutually agreed upon Third Party source), then the applicable royalty rate set forth in [Section 9.2(c)(i)] as applied to Net Sales of such [[Unknown Identifier]] Licensed Product in such country shall be reduced by ​ for such Calendar Quarter, subject to [Section 9.2(c)(iii)(D)].

“Generic Product” shall mean, as to a Product or Process, any product (including a “generic product” approved by way of an Abbreviated New Drug Application or approved under a [section 505(b)(2)] application, by the FDA (or equivalent regulatory mechanism for another regulatory authority)) that is sold by a third party and # in the United States, is “therapeutically equivalent,” “comparable,” “biosimilar,” or “interchangeable,” as evaluated by the FDA, applying the definition of “therapeutically equivalent” set forth in the preface to the then-current edition of the FDA publication “Approved Drug Products With Therapeutic Equivalence Evaluations” or any other definitions set forth in the U.S. Code, FDA regulations, or other source of U.S. Law or # outside the United States, meets such equivalent determination by the applicable regulatory authorities (including a determination that the product is “comparable,” “interchangeable,” “bioequivalent,” or “biosimilar” with respect to the Product or Process).

“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 Drug or Biosimilar Product. If during any Calendar Quarter during the [[Unknown Identifier]] Royalty Term, on an [[Unknown Identifier]] Opt-Out Product-by-SYNGAP1 Opt-Out Product and country-by-country basis, the aggregate number of units of Generic Drug or Biosimilar Products with respect to such [[Unknown Identifier]] Opt-Out Product sold during such Calendar Quarter in such country, in the market segment in which such [[Unknown Identifier]] Opt-Out Product competes in such country, equals or exceeds ​ of the aggregate units of the sum of all such Generic Drug or Biosimilar Products and such [[Unknown Identifier]] Opt-Out Product sold in such Calendar [[Person A:Person]] Quarter in such country (as determined by data obtained from a mutually agreed upon Third Party source), then the applicable royalty rate set forth in Section 9.5(a) as applied to Net Sales of such [[Unknown Identifier]] Opt-Out Product in such country shall be reduced by ​ for such Calendar Quarter, subject to [Section 9.5(c)(iv)].

“Generic Drug or Biosimilar Product” means, with respect to a Product, and on a Product-by-Product and country-by-country basis, any product (including a “generic product,” “generic drug,” “biogeneric,” “follow-on biologic,” “follow-on biological product,” “follow-on protein product,” “similar biological medicinal product,” or “biosimilar product”) approved by way of an abbreviated regulatory mechanism by the relevant Regulatory Authority in a country in reference to such Product, that in each case: # is sold in the same country (or is commercially available in the same country via import from another country) as such Product by any Third Party that is not a Sublicensee of the applicable Party or any of its Affiliates and that did not purchase such product in a chain of distribution that included any of the applicable Party or any of its Affiliates or its Sublicensees; and # meets the applicable equivalency determination by the applicable Regulatory Authority in such country (including, as applicable, a determination that the product is “comparable,” “interchangeable,” “bioequivalent,” “biosimilar” or other term of similar meaning, with respect to the Product), in each case, as is necessary to permit substitution of such product for the Product under Applicable Laws in such country, including, with respect to the U.S., a Product with an approved Abbreviated New Drug Application under Section 505(j) of the Act (21 U.S.C. 355(j)) or a Product licensed as a “biosimilar” or “interchangeable” biological product under [Section 351(k)] of the PHSA (42 U.S.C. 262(k)), or, outside the United States, in accordance with European Directive 2001/83/EC on the Community Code for medicinal products ([Article 10(4)] and Section 4, [Part II of Annex I]) and European Regulation EEC/2309/93 establishing the Community procedures for the authorization and evaluation of medicinal products, each as amended, and together with all associated guidance, and any counterparts thereof or equivalent process inside or outside of the United States or EU to the foregoing.