definiens: means, with respect to a Product and on a country - by - country basis, a product that ( a ) is marketed for sale insuch country [ * * * ], ( b ) contains or comprises an antibody with the [ * * * ], ( c ) is approved [ * * * ], and ( d ) such product, as and to the extentrequired, is approved through an abbreviated process based in reliance, at least in part, on the safety and efficacy data generated for theprior Regulatory Approval of such Product by [COMPANY] or an [COMPANY] Agreement Entity in such country ( similar, with respect to the UnitedStates, to an Abbreviated New Drug Applications under Section 505(j ) of the FD&C Act ( 21 USC 355(j ) ) ) or is approved as a under Title VII, Subtitle A Biologics Price Competition and Innovation Act of 2009, Section 42 U.S.C. 262, Section 351 ofthe PHSA, 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 theauthorization and evaluation of medicinal products, each as amended, and together with all associated guidance, and any counterpartsthereof or equivalent process inside or outside of the United States or EU to the foregoing