Common use of Generic Competition Clause in Contracts

Generic Competition. Royalties payable following establishment of Generic Competition with respect to the sale by a Third Party of product that is a Biosimilar Biologic Product to such Agreement Product in such country shall be payable at *** of the otherwise applicable rate prior to application of this Section 5.4.3(a) “Generic Competition” means with respect to a given Calendar Year with respect to an Agreement Product in any country, that during such Calendar Year, *** have received Regulatory Approval to sell in such country a Biosimilar Biologic Product, such Biosimilar Biologic Product shall be commercially available in such country and such Biosimilar Biologic Product shall have, in the aggregate, *** or more market share of the aggregate of such Agreement Product and Biosimilar Biologic Product (based on data provided by IMS International, or if such data is not available, such other reliable data source as reasonably determined by Pfizer and agreed by MacroGenics (such agreement not to be unreasonably withheld)) as measured by sales. In the event IMS International data (or such other agreed data source) is not sufficient to determine the percentage market share for each country in the EU, the percent market share for the EU countries for which data is not available will be deemed to be the average percent market share for those EU countries in which the data is available. A product shall be a “Biosimilar Biologic Product” with respect to an Agreement Product if such product (1) 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, stature or regulation, (2) has been licensed as a similar biological medicinal product by EMEA pursuant to Directive 2001/83/EC, as may be amended, or any subsequent or superseding law, stature or regulation, or (3) has otherwise achieved analogous Regulatory Marketing Approval from another applicable Regulatory Authority.

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 Agreement Licensed Product in such country shall be payable at [*** *] of the otherwise applicable rate prior to application of this Section 5.4.3(a) 5.5.2(a). “Generic Competition” means means, with respect to a given Calendar Year with respect to an Agreement a Licensed Product in any country, that during such Calendar Year, *** (x) one (1) or more Third Parties have received Regulatory Marketing Approval to sell in such country a Biosimilar Biologic Product, (y) such Biosimilar Biologic Product Product(s) shall be commercially available in such country and (z) such Biosimilar Biologic Product Product(s) shall have, in the aggregate, a [*** or more *] market share of the aggregate of such Agreement Licensed Product and Biosimilar Biologic Product Product(s) (based on data provided by IMS International, or if such data is not available, such other reliable data source as reasonably determined designated by Pfizer and agreed by MacroGenics (such agreement not to be unreasonably withheld)Pfizer) as measured by salesthe number of prescriptions. In the event IMS International data (or such other agreed designated data source) is not sufficient to determine the percentage market share for each country in the EUEuropean Union, the percent market share for the EU European Union countries for which data is not available will be deemed to be the average percent market share for those EU European Union countries in which the data is available. A product shall be a “Biosimilar Biologic Product” with respect to an Agreement a Licensed Product if such product (1) 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, stature statute or regulation, (2) has been licensed as a similar biological medicinal product by EMEA EMA pursuant to Directive 2001/83/EC, as may be amended, or any subsequent or superseding law, stature statute or regulation, or (3) has otherwise achieved analogous Regulatory Marketing Approval from another applicable Regulatory Authority. In no event will the royalty payable to CytomX for such Licensed Product be reduced below three percent (3%) by operation of this Section 5.5.2(a).

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 Agreement Licensed Product in such country shall be payable at [*** *] of the otherwise applicable rate prior to application of this Section 5.4.3(a) 5.5.2(a). “Generic Competition” means means, with respect to a given Calendar Year with respect to an Agreement a Licensed Product in any country, that during such Calendar Year, *** (x) one (1) or more Third Parties have received Regulatory Marketing Approval to sell in such country a Biosimilar Biologic Product, (y) such Biosimilar Biologic Product Product(s) shall be commercially available in such country and (z) such Biosimilar Biologic Product Product(s) shall have, in the aggregate, a [*** or more *] market share of the aggregate of such Agreement Licensed Product and Biosimilar Biologic Product Product(s) (based on data provided by IMS International, or if such data is not available, such other reliable data source as reasonably determined designated by Pfizer and agreed by MacroGenics (such agreement not to be unreasonably withheld)Pfizer) as measured by salesthe number of prescriptions. In the event IMS International data (or such other agreed designated data source) is not sufficient to determine the percentage market share for each country in the EUEuropean Union, the percent market share for the EU European Union countries for which data is not available will be deemed to be the average percent market share for those EU European Union countries in which the data is available. A product shall be a “Biosimilar Biologic Product” with respect to an Agreement a Licensed Product if such product (1) 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, stature statute or regulation, (2) has been licensed as a similar biological medicinal product by EMEA EMA pursuant to Directive 2001/83/EC, as may be amended, or any subsequent or superseding law, stature statute or regulation, or (3) has otherwise achieved analogous Regulatory Marketing Approval from another applicable Regulatory Authority.. [***]

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 Agreement Licensed Product in such country shall be payable at *** fifty percent (50%) of the otherwise applicable rate prior to application of this Section 5.4.3(a) 5.5.2(a). “Generic Competition” means means, with respect to a given Calendar Year with respect to an Agreement a Licensed Product in any country, that during such Calendar Year, *** (x) one (1) or more Third Parties have received Regulatory Marketing Approval to sell in such country a Biosimilar Biologic Product, (y) such Biosimilar Biologic Product Product(s) shall be commercially available in such country and (z) such Biosimilar Biologic Product Product(s) shall have, in the aggregate, *** a twenty-five percent (25%) or more market share of the aggregate of such Agreement Licensed Product and Biosimilar Biologic Product Product(s) (based on data provided by IMS International, or if such data is not available, such other reliable data source as reasonably determined designated by Pfizer and agreed by MacroGenics (such agreement not to be unreasonably withheld)Pfizer) as measured by salesthe number of prescriptions. In the event IMS International data (or such other agreed designated data source) is not sufficient to determine the percentage market share for each country in the EUEuropean Union, the percent market share for the EU European Union countries for which data is not available will be deemed to be the average percent market share for those EU European Union countries in which the data is available. A product shall be a “Biosimilar Biologic Product” with respect to an Agreement a Licensed Product if such product (1) 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, stature statute or regulation, (2) has been licensed as a similar biological medicinal product by EMEA EMA pursuant to Directive 2001/83/EC, as may be amended, or any subsequent or superseding law, stature statute or regulation, or (3) has otherwise achieved analogous Regulatory Marketing Approval from another applicable Regulatory Authority. In no event will the royalty payable to CytomX for such Licensed Product be reduced below three percent (3%) by operation of this Section 5.5.2(a).