Common use of Reduction in Royalty for Generic Products Clause in Contracts

Reduction in Royalty for Generic Products. Subject to Section 6.4.4 below, in the event that one or more Generic Product(s) (defined below) are sold in a country and such Generic Product(s) account for at least ***% of the aggregate unit sales of such Generic Product(s) and the Licensed Product in such country, the applicable patent royalty rates set forth in Section 6.4.1(a), (b), (c) or (d) shall be reduced by *** percent (***%) for such Licensed Product sold in such country. The term “Generic Product” means: (i) with respect to a Licensed Product comprising a Compound sold in a country and approved for a particular indication, an AB-rated Generic Product that: (A) is owned by a Third Party that has not obtained the rights to such product as a sublicensee or distributor of GSK or any of its Affiliates; (B) contains as an active ingredient the same Licensed Product (or salt, metabolite, prodrug or other physical form thereof, or equivalent as determined by the relevant regulatory authority) as contained in such Licensed Product; and (C) is approved for use in the same country as such Licensed Product pursuant to 21 U.S.C. 355(b)(2), an abbreviated new drug application, a separate NDA (excluding any NDA owned by GSK or any of its Affiliates), compendia listing, or other drug approval application (excluding any NDA owned by GSK or any of its Affiliates), including any and all foreign equivalents of the foregoing; and (ii) with respect to a Licensed Product comprising a Biologic, a biologic product that: (A) is owned by a Third Party that has not obtained the rights to such product as a sublicensee or distributor of GSK or any of its Affiliates; and either (B) for countries in which an abbreviated review process has been enacted to allow a biologic product to be approved for use in the same country by relying on clinical data of the Licensed Product, such Third Party product has been approved for use in the same county as such Licensed Product pursuant to such abbreviated review process; or (C) for any other country, such Third Party product contains as an active ingredient the same biologic (i.e., identical relevant amino acid sequence) as contained in such Licensed Product and has been approved for use in the same country as such Licensed Product. *** INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT WAS REQUESTED. ALL SUCH OMITTED MATERIAL WAS FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED.

Reduction in Royalty for Generic Products. Subject to Section 6.4.4 below, in the event that one or more Generic Product(s) (defined below) are sold in a country and such Generic Product(s) account for at least ***% of the aggregate unit sales of such Generic Product(s) and the Licensed Product in such country, the applicable patent royalty rates set forth in Section 6.4.1(a), ) and/or (b), (c) or (d) above shall be reduced by *** percent (***%) for such Licensed Product sold in such country. The term “Generic Product” means: (i) with respect to a Licensed Product comprising a Compound sold in a country and approved for a particular indication, an AB-rated Generic Product that: (A) is owned by a Third Party that has not obtained the rights to such product as a sublicensee or distributor of GSK or any of its Affiliates; (B) contains as an active ingredient the same Licensed Product (or salt, metabolite, prodrug or other physical form thereof, or equivalent as determined by the relevant regulatory authority) as contained in such Licensed Product; and (C) is approved for use in the same country as such Licensed Product pursuant to 21 U.S.C. 355(b)(2), an abbreviated new drug *** INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT WAS REQUESTED. ALL SUCH OMITTED MATERIAL WAS FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED. application, a separate NDA (excluding any NDA owned by GSK or any of its Affiliates), compendia listing, or other drug approval application (excluding any NDA owned by GSK or any of its Affiliates), including any and all foreign equivalents of the foregoing; and (ii) with respect to a Licensed Product comprising a Biologic, a biologic product that: (A) is owned by a Third Party that has not obtained the rights to such product as a sublicensee or distributor of GSK or any of its Affiliates; and either (B) for countries in which an abbreviated review process has been enacted to allow a biologic product to be approved for use in the same country by relying on clinical data of the Licensed Product, such Third Party product has been approved for use in the same county as such Licensed Product pursuant to such abbreviated review process; or (C) for any other country, such Third Party product contains as an active ingredient the same biologic (i.e., identical relevant amino acid sequence) as contained in such Licensed Product Product; and has been (C) is approved for use in the same country as such Licensed Product. *** INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT WAS REQUESTED. ALL SUCH OMITTED MATERIAL WAS FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED.