Know-How Royalty. On a country-by-country basis, if, at any time after First Commercial Sale of a GSK Product, (i) if the country of sale is initially included in 6.3(a)(1) above, all Valid Claims within the Exclusively Licensed IP covering the composition of matter, manufacture, use or sale of the Compound included in such GSK Product have expired or no longer exist; and (ii) if the country if sale is initially included in 6.3(a)(2) above, and either (x) all Valid Claims within the Exclusively Licensed IP covering the composition of matter, manufacture, use or sale of the Compound included in such GSK Product have expired, or otherwise do not exist or no longer exist, in the United States and all Major Market EU Countries, or (y) there is Generic Competition in the country of sale with respect to such GSK Product; and (iii) if the country of sale is initially included in 6.3(a)(3) above, GSK does not have Market Exclusivity Rights in effect at the relevant time of sale in the relevant country; then, in lieu of the Patent/Market Exclusivity Royalty, GSK will pay PROSENSA a know-how royalty on Net Sales of such GSK Product(s) at a royalty rate of * * * * * of the royalty rates as set forth in the table in 6.3(a) above (the “Know-How Royalty”) until the date that is no later than * * * * * years after First Commercial Sale of such GSK Product in such country. Notwithstanding the foregoing, where a pending patent application that does not include a Valid Claim becomes an issued patent and such issued patent contains a Valid Claim within the Exclusively Licensed IP which covers the composition of matter, manufacture, use or sale of such GSK Product(s), GSK shall pay * * * * * of the Patent/Market Exclusivity Royalty rate on all Net Sales following the date that such patent application becomes issued, pursuant to and for the term stated in Section 6.3(a) above.
Appears in 2 contracts
Sources: Research and Development Collaboration and License Agreement (Prosensa Holding B.V.), Research and Development Collaboration and License Agreement (Prosensa Holding B.V.)
Know-How Royalty. On If, on a country-by-country and Licensed Product-by-Licensed Product basis, if(i) at any time during the period within [...***...] years after the date of First Commercial Sale of such Licensed Product in such country, the only Valid Claims or Pending Claims within the [...***...] in each case which cover the [...***...] of the Licensed Product, are claims that cover [...***...] a ▇▇▇▇▇ Compound or a ▇▇▇▇▇ Therapeutic, or (ii) there [...***...], at any time during the period within [...***...] years after the date of First Commercial Sale of such Licensed Product in such country, Valid Claims or Pending Claims within the [...***...] in each case which covered the [...***...]of the Licensed Product, but such Valid Claims and Pending Claims [...***...], then, during such time described in clauses (i) or (ii), not to extend beyond [...***...] years from the date of First Commercial Sale of such Licensed Product in such country, GSK will pay Regulus a royalty at the rate of [...***...] of the GSK Patent Royalty rates as described in Section 6.6.1 above. For example, but not limitation, if at the time of First Commercial Sale of a GSK ProductLicensed Product in a given country Regulus has a Valid Claim described in paragraph (a) above that has been pending for [...***...] years, then for the first [...***...] years after such First Commercial Sale the royalty rate shall be determined under paragraph (ia) above and, if such claim does not issue within such [...***...] year period, then for a period of [...***...] years the country of sale is initially included in 6.3(a)(1) above, all Valid Claims within the Exclusively Licensed IP covering the composition of matter, manufacture, use or sale of the Compound included in such GSK Product have expired or no longer exist; and royalty rate shall be determined under paragraph (ii) if the country if sale is initially included in 6.3(a)(2b) above, and either (x) all Valid Claims within for the Exclusively Licensed IP covering remaining [...***...] years after such First Commercial Sale, the composition of matter, manufacture, use or sale of the Compound included in such GSK Product have expired, or otherwise do not exist or no longer exist, in the United States and all Major Market EU Countries, or (y) there is Generic Competition in the country of sale with respect to such GSK Product; and (iii) if the country of sale is initially included in 6.3(a)(3) above, GSK does not have Market Exclusivity Rights in effect at the relevant time of sale in the relevant country; then, in lieu of the Patent/Market Exclusivity Royalty, GSK will pay PROSENSA a know-how royalty on Net Sales of such GSK Product(s) at a royalty rate of * * * * * of shall be determined under this paragraph (c). In no event shall the royalty rates as set forth described in the table in 6.3(athis paragraph (c) above (the “Know-How Royalty”) until the date that is no later be paid for more than * * * * * [...***...] years after First Commercial Sale of such GSK Licensed Product in such the relevant country. Notwithstanding , and in all cases the foregoing, where a pending patent application that does not include a Valid Claim becomes an issued patent and such issued patent contains a Valid Claim within the Exclusively Licensed IP which covers the composition of matter, manufacture, use or sale of such GSK Product(sroyalty shall be subject to paragraphs (d), GSK (e) and (f) below. For the sake of clarity, the [...***...] year period described in this paragraph (c) shall pay * * * * * of not reduce the Patent/Market Exclusivity Royalty rate on all Net Sales following the date that such patent application becomes issued, period during which royalties are payable pursuant to and for the term stated in Section 6.3(aparagraphs (a) or (b) above, as applicable.
Appears in 2 contracts
Sources: Product Development and Commercialization Agreement (Regulus Therapeutics Inc.), Product Development and Commercialization Agreement (Regulus Therapeutics Inc.)
Know-How Royalty. On If, on a country-by-country and Licensed Product-by-Licensed Product basis, if(i) at any time during the period within [***] years after the date of First Commercial Sale of such Licensed Product in such country, the only Valid Claims or Pending Claims within the [***]in each case which cover the [***] of the Licensed Product, are claims that cover [***] a ▇▇▇▇▇ Compound or a ▇▇▇▇▇ Therapeutic, or (ii) there [***], at any time during the period within [***] years after the date of First Commercial Sale of such Licensed Product in such country, Valid Claims or Pending Claims within the [***]in each case which covered the[***] of the Licensed Product, but such Valid Claims and Pending Claims [***], then, during such time described in clauses (i) or (ii), not to extend beyond [***] years from the date of First Commercial Sale of such Licensed Product in such country, GSK will pay Regulus a royalty at the rate of [***] of the GSK Patent Royalty rates as described in Section 6.6.1 above. For example, but not limitation, if at the time of First Commercial Sale of a GSK ProductLicensed Product in a given country Regulus has a Valid Claim described in paragraph (a) above that has been pending for [***] years, then for the first [***] years after such First Commercial Sale the royalty rate shall be determined under paragraph (ia) above and, if such claim does not issue within such [***] year period, then for a period of [***] years the country of sale is initially included in 6.3(a)(1) above, all Valid Claims within the Exclusively Licensed IP covering the composition of matter, manufacture, use or sale of the Compound included in such GSK Product have expired or no longer exist; and royalty rate shall be determined under paragraph (ii) if the country if sale is initially included in 6.3(a)(2b) above, and either (x) all Valid Claims within for the Exclusively Licensed IP covering remaining [***] years after such First Commercial Sale, the composition of matter, manufacture, use or sale of the Compound included in such GSK Product have expired, or otherwise do not exist or no longer exist, in the United States and all Major Market EU Countries, or (y) there is Generic Competition in the country of sale with respect to such GSK Product; and (iii) if the country of sale is initially included in 6.3(a)(3) above, GSK does not have Market Exclusivity Rights in effect at the relevant time of sale in the relevant country; then, in lieu of the Patent/Market Exclusivity Royalty, GSK will pay PROSENSA a know-how royalty on Net Sales of such GSK Product(s) at a royalty rate of * * * * * of shall be determined under this paragraph (c). In no event shall the royalty rates as set forth described in the table in 6.3(athis paragraph (c) above (the “Know-How Royalty”) until the date that is no later be paid for more than * * * * * [***] years after First Commercial Sale of such GSK Licensed Product in such the relevant country. Notwithstanding , and in all cases the foregoing, where a pending patent application that does not include a Valid Claim becomes an issued patent and such issued patent contains a Valid Claim within the Exclusively Licensed IP which covers the composition of matter, manufacture, use or sale of such GSK Product(sroyalty shall be subject to paragraphs (d), GSK (e) and (f) below. For the sake of clarity, the [***] year period described in this paragraph (c) shall pay * * * * * of not reduce the Patent/Market Exclusivity Royalty rate on all Net Sales following the date that such patent application becomes issued, period during which royalties are payable pursuant to and for the term stated in Section 6.3(aparagraphs (a) or (b) above, as applicable.
Appears in 1 contract
Sources: Product Development and Commercialization Agreement (Isis Pharmaceuticals Inc)