Common use of Royalty Reduction for Biosimilars Clause in Contracts

Royalty Reduction for Biosimilars. (a) If a Biosimilar version(s) of any Licensed Product is commercialized in any country in which there are Royalty-Bearing Sales, then the royalty rate payable to AEVI pursuant to Sections 8.5.1, 8.5.2 and 8.5.3 applicable for the sale of Licensed Products in such country will be reduced by (i) (***) applicable for the first Contract Quarter during which the market share of such Biosimilars is (***) in such country, (ii) (***) applicable for the first Contract Quarter during which the market share of such Biosimilars is (***) in such country, (iii) (***) applicable for the first Contract Quarter during which the market share of such Biosimilars is (***) in such country, (iv) (***) applicable for the first Contract Quarter during which the market share of such Biosimilars is (***) in such country; and (v) (***) applicable for the first Contract Quarter during which the market share of such Biosimilars is (***) in such country. For clarity, the reduction in royalty rates permitted pursuant to this Section 8.5.4 will be taken after any reduction taken pursuant to Section 8.5.2 and Section 8.5.3. For the avoidance of doubt, the minimum EU Royalty Rate will be (***), each of the minimum KKC Territory Royalty Rate and the minimum Other Royalty Rate will be (***) and the minimum Territory Royalty Rate (on a country-by-country basis) will be no less than (***) of the Territory Royalty Rate (on a country-by-country basis) then in-effect prior to the adjustments permitted by this Section 8.5.4; provided that, if such reduction permitted under this Section 8.5.4 exceeds the amount of payments withheld by KKC under this Section 8.5.4 in any Contract Quarter, the excess may be carried over as a credit on the same basis into succeeding Contract Quarters. (b) The Parties will utilize a mutually-agreed (such agreement not to be unreasonably withheld, delayed, or conditioned) measure of the market share of any relevant Biosimilars in each country where a Biosimilar version(s) of a Licensed Product is being commercialized and will adjust the royalty rate payable to AEVI for the sale of Licensed Products in such country every (***), to the extent permitted pursuant to Section 8.5.4(a). If the royalty rate payable to AEVI for the sale of Licensed Products has been adjusted pursuant to Section 8.5.4(a), then such royalty rates in such country may not thereafter be adjusted upwards.

Appears in 1 contract

Samples: Clinical Development and Option Agreement (Cerecor Inc.)

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Royalty Reduction for Biosimilars. (a) If a Biosimilar version(s) of any Licensed Product is commercialized in any country in which there are Royalty-Bearing Sales, then the royalty rate payable to AEVI pursuant to Sections 8.5.1, 8.5.2 and 8.5.3 applicable for the sale of Licensed Products in such country will be reduced by (i) (***) applicable for the first Contract Quarter during which the market share of such Biosimilars is at least (***) in such country, (ii) (***) applicable for the first Contract Quarter during which the market share of such Biosimilars is at least (***) in such country, (iii) (***) applicable for the first Contract Quarter during which the market share of such Biosimilars is at least (***) in such country, (iv) (***) applicable for the first Contract Quarter during which the market share of such Biosimilars is at least (***) in such country; and (v) (***) applicable for the first Contract Quarter during which the market share of such Biosimilars is at least (***) in such country. For clarity, the reduction in royalty rates permitted pursuant to this Section 8.5.4 will be taken after any reduction taken pursuant to Section 8.5.2 and Section 8.5.3. For the avoidance of doubt, the minimum EU Royalty Rate will be (***), each of the minimum KKC Territory Royalty Rate and the minimum Other Royalty Rate will be (***) and the minimum Territory Royalty Rate royalty under Section 8.5.1 (on a country-by-country basis) will be no less than (***) of the Territory Royalty Rate (on a country-by-country basis) then in-effect royalty otherwise due under Section 8.5.1 prior to the adjustments permitted by this Section 8.5.4; provided that, if such reduction permitted under this Section 8.5.4 exceeds the amount of payments withheld by KKC under this Section 8.5.4 in any Contract Quarter, the excess may be carried over as a credit on the same basis into succeeding Contract Quarters. (b) The Parties will utilize a mutually-agreed (such agreement not to be unreasonably withheld, delayed, or conditioned) measure of the market share of any relevant Biosimilars in each country where a Biosimilar version(s) of a Licensed Product is being commercialized and will adjust the royalty rate payable to AEVI for the sale of Licensed Products in such country every six (***)6) months, to the extent permitted pursuant to Section 8.5.4(a). If the royalty rate payable to AEVI for the sale of Licensed Products has been adjusted pursuant to Section 8.5.4(a), then such royalty rates in such country may not thereafter be adjusted upwards.

Appears in 1 contract

Samples: Clinical Development and Option Agreement (Cerecor Inc.)

Royalty Reduction for Biosimilars. (a) If a Biosimilar version(s) of any Licensed Product is commercialized in any country in which there are Royalty-Bearing Sales, then the royalty rate payable to AEVI pursuant to Sections 8.5.1, 8.5.2 and 8.5.3 applicable for the sale of Licensed Products in such country will be reduced by (i) (***) applicable for the first Contract Quarter during which the market share of such Biosimilars is (***) in such country, (ii) (***) applicable for the first Contract Quarter during which the market share of such Biosimilars is (***) in such country, (iii) (***) applicable for the first Contract Quarter during which the market share of such Biosimilars is (***) in such country, (iv) (***) applicable for the first Contract Quarter during which the market share of such Biosimilars is (***) in such country; and (v) (***) applicable for the first Contract Quarter during which the market share of such Biosimilars is (***) in such country. For clarity, the reduction in royalty rates permitted pursuant to this Section 8.5.4 will be taken after any reduction taken pursuant to Section 8.5.2 and Section 8.5.3. For the avoidance of doubt, the minimum EU Royalty Rate will be (***), each of the minimum KKC Territory Royalty Rate and the minimum Other Royalty Rate will be (***) and the minimum Territory Royalty Rate (on a country-by-country basis) will be no less than (***) of the Territory Royalty Rate (on a country-by-country basis) then in-effect prior to the adjustments permitted by this Section 8.5.4; provided that, if such reduction permitted under this Section 8.5.4 exceeds the amount of payments withheld by KKC under this Section 8.5.4 in any Contract Quarter, the excess may be carried over as a credit on the same basis into succeeding Contract Quarters. (b) The Parties will utilize a mutually-agreed (such agreement not to be unreasonably withheld, delayed, or conditioned) measure of the market share of any relevant Biosimilars in each country where a Biosimilar version(s) of a Licensed Product is being commercialized and will adjust the royalty rate payable to AEVI for the sale of Licensed Products in such country every six (***)6) months, to the extent permitted pursuant to Section 8.5.4(a). If the royalty rate payable to AEVI for the sale of Licensed Products has been adjusted pursuant to Section 8.5.4(a), then such royalty rates in such country may not thereafter be adjusted upwards.

Appears in 1 contract

Samples: Clinical Development and Option Agreement (Cerecor Inc.)

Royalty Reduction for Biosimilars. (a) If a Biosimilar version(s) of any Licensed Product is commercialized in any country in which there are Royalty-Bearing Sales, then the royalty rate payable to AEVI Medgenics pursuant to Sections 8.5.1, 8.5.2 and 8.5.3 applicable for the sale of Licensed Products in such country will be reduced by (i) (***) **applicable for the first Contract Quarter during which the market share of such Biosimilars is (***) ** in such country, (ii) (***) ** applicable for the first Contract Quarter during which the market share of such Biosimilars is (***) ** in such country, (iii) (***) ** applicable for the first Contract Quarter during which the market share of such Biosimilars is (***) ** in such country, (iv) (***) ** applicable for the first Contract Quarter during which the market share of such Biosimilars is (***) ** in such country; and (v) (***) ** applicable for the first Contract Quarter during which the market share of such Biosimilars is (***) ** in such country. For clarity, the reduction in royalty rates permitted pursuant to this Section 8.5.4 will be taken after any reduction taken pursuant to Section 8.5.2 and Section 8.5.3. For the avoidance of doubt, the minimum EU Royalty Rate will be (***), each of the minimum KKC KHK Territory Royalty Rate and the minimum Other Royalty Rate will be (***) ** and the minimum Territory Royalty Rate (on a country-by-country basis) will be no less than (***) ** of the Territory Royalty Rate (on a country-by-country basis) then in-effect prior to the adjustments permitted by this Section 8.5.4; provided that, if such reduction permitted under this Section 8.5.4 exceeds the amount of payments withheld by KKC KHK under this Section 8.5.4 in any Contract Quarter, the excess may be carried over as a credit on the same basis into succeeding Contract Quarters. (b) The Parties will utilize a mutually-agreed (such agreement not to be unreasonably withheld, delayed, or conditioned) measure of the market share of any relevant Biosimilars in each country where a Biosimilar version(s) of a Licensed Product is being commercialized and will adjust the royalty rate payable to AEVI Medgenics for the sale of Licensed Products in such country every six (***)6) months, to the extent permitted pursuant to Section 8.5.4(a). If the royalty rate payable to AEVI Medgenics for the sale of Licensed Products has been adjusted pursuant to Section 8.5.4(a), then such royalty rates in such country may not thereafter be adjusted upwards.

Appears in 1 contract

Samples: Clinical Development and Option Agreement (Medgenics, Inc.)

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Royalty Reduction for Biosimilars. (a) If a Biosimilar version(s) of any Licensed Product is commercialized in any country in which there are Royalty-Bearing Sales, then the royalty rate payable to AEVI Medgenics pursuant to Sections 8.5.1, 8.5.2 and 8.5.3 applicable for the sale of Licensed Products in such country will be reduced by (i) (***) ** applicable for the first Contract Quarter during which the market share of such Biosimilars is (***) ** in such country, (ii) (***) ** applicable for the first Contract Quarter during which the market share of such Biosimilars is (***) ** in such country, (iii) (***) **applicable for the first Contract Quarter during which the market share of such Biosimilars is (***) ** in such country, (iv) (***) ** applicable for the first Contract Quarter during which the market share of such Biosimilars is (***) ** in such country; and (v) (***) ** applicable for the first Contract Quarter during which the market share of such Biosimilars is (***) ** in such country. For clarity, the reduction in royalty rates permitted pursuant to this Section 8.5.4 will be taken after any reduction taken pursuant to Section 8.5.2 and Section 8.5.3. For the avoidance of doubt, the minimum EU Royalty Rate will be (***)**, each of the minimum KKC KHK Territory Royalty Rate and the minimum Other Royalty Rate will be (***) ** and the minimum Territory Royalty Rate (on a country-by-country basis) will be no less than (***) ** of the Territory Royalty Rate (on a country-by-country basis) then in-effect prior to the adjustments permitted by this Section 8.5.4; provided that, if such reduction permitted under this Section 8.5.4 exceeds the amount of payments withheld by KKC KHK under this Section 8.5.4 in any Contract Quarter, the excess may be carried over as a credit on the same basis into succeeding Contract Quarters. (b) The Parties will utilize a mutually-agreed (such agreement not to be unreasonably withheld, delayed, or conditioned) measure of the market share of any relevant Biosimilars in each country where a Biosimilar version(s) of a Licensed Product is being commercialized and will adjust the royalty rate payable to AEVI Medgenics for the sale of Licensed Products in such country every (***)**, to the extent permitted pursuant to Section 8.5.4(a). If the royalty rate payable to AEVI Medgenics for the sale of Licensed Products has been adjusted pursuant to Section 8.5.4(a), then such royalty rates in such country may not thereafter be adjusted upwards.

Appears in 1 contract

Samples: Clinical Development and Option Agreement (Medgenics, Inc.)

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