Generic Equivalent. During the Royalty Term, on a country-by-country and Product-by-Product basis, if the cumulative unit volume of such Generic Equivalent(s) sold by Third Parties in such country are equal to or greater than ****** of the combined unit volume of such Product and such Generic Equivalent(s) for all indications in the aggregate in such country in any calendar quarter determined by the number of prescriptions given for the Product and such Generic Equivalent(s), in the aggregate during such calendar quarter (as measured by a ▇▇▇▇▇ ▇▇▇▇▇ Associates audit or other mechanism mutually agreed by the Parties), then the royalty rates applicable to Net Sales of such Product by GSK, its Affiliate or Sublicensee in such country shall be ****** of the royalty rates specified above in Section 3.4.1 with respect to Net Sales of such Product in such country for so long as such competition exists, and such reduced royalty shall be paid by GSK for the shorter of ****** from the date upon which GSK’s royalty obligations were reduced pursuant to this Section 3.5.1 as a result of the sales of such Generic Equivalent(s), or ****** from the date of the first Launch of the Product in such county, after which time GSK’s license with respect to such Product would be converted into a perpetual, exclusive, fully-paid, royalty-free (subject to Section 3.5.2(b)) license under the Licensed Technology to make, have made, use, sale, offer for sale and import such Product in such country in the Territory; provided, however, that GSK shall no longer be entitled to reduce the royalty rates nor the period of GSK’s royalty obligations as set forth above in this Section 3.5.1 if at any time following a reduction in royalty rate pursuant to this Section 3.5.1 and prior to the expiration of the Royalty Term set forth in this Section 3.5.1, such Generic Equivalent(s) cease to equal ****** or more of the combined unit volume of such Product and such Generic Equivalent(s) for all indications in the aggregate in such country in any calendar quarter determined by the number of prescriptions given for the Product and such Generic Equivalent(s), in the aggregate during such calendar quarter (as measured by a ▇▇▇▇▇ ▇▇▇▇▇ Associates audit or other mechanism mutually agreed by the Parties).
Appears in 2 contracts
Sources: Licensing, Development, Manufacturing and Marketing Agreement, License and Collaboration Agreement (Amicus Therapeutics Inc)
Generic Equivalent. During the GSK Terminated Product Royalty Term, on a country-by-country and Terminated Product-by-Terminated Product basis, if the cumulative unit volume of such Generic Equivalent(s) sold by Third Parties in such country the Affected Area are equal to or greater than ****** of the combined unit volume of such the applicable Terminated Product and such Generic Equivalent(s) for all indications in the aggregate in such country the Affected Area in any calendar quarter determined by the number of prescriptions given for the such Terminated Product and such Generic Equivalent(s), in the aggregate during such calendar quarter in the Affected Area (as measured by a ▇▇▇▇▇ ▇▇▇▇▇ Associates audit or other mechanism mutually agreed by the Parties), then the royalty rates applicable to Net Sales of such Terminated Product by GSK, its Affiliate or Sublicensee in such country the Affected Area shall be ****** of the applicable royalty rates specified above in clause a) or b) of Section 3.4.1 14.2.3(b)(i), as applicable, with respect to Net Sales of such Terminated Product in such country for so long as such competition exists, and such reduced royalty shall be paid by GSK for the shorter of ****** from the date upon which GSK’s ****** - Material has been omitted and filed separately with the Commission. royalty obligations were reduced pursuant to this Section 3.5.1 14.2.3(b)(iii) as a result of the sales of such Generic Equivalent(s)) in the Affected Area, or ****** from the date of the first Launch of the such Terminated Product in such countythe Affected Area, after which time time, and subject to GSK’s obligations under Sections 3.4.3(b) and 14.2.3(b)(iv)b), GSK’s license with respect to such Terminated Product would be converted into as set forth in Section 14.2.1 shall become a perpetual, exclusive, fullyfully paid-paidup, royalty-free (subject to Section 3.5.2(b)) license under the Licensed Technology to make, have made, use, sale, offer for sale right and import such Product in such country in the Territory; provided, however, that GSK shall no longer be entitled to reduce the royalty rates nor the period of GSK’s royalty obligations as set forth above in this Section 3.5.1 if at any time following a reduction in royalty rate pursuant to this Section 3.5.1 and prior to the expiration of the Royalty Term set forth in this Section 3.5.1, such Generic Equivalent(s) cease to equal ****** or more of the combined unit volume of such Product and such Generic Equivalent(s) for all indications in the aggregate in such country in any calendar quarter determined by the number of prescriptions given for the Product and such Generic Equivalent(s), in the aggregate during such calendar quarter (as measured by a ▇▇▇▇▇ ▇▇▇▇▇ Associates audit or other mechanism mutually agreed by the Parties)license.
Appears in 1 contract
Sources: License and Collaboration Agreement (Amicus Therapeutics Inc)
Generic Equivalent. During the Amicus Terminated Product Royalty Term, on a Terminated Product-by-Terminated Product and country-by-country and Product-by-Product basis, if the cumulative unit volume of such Generic Equivalent(s) sold by Third Parties in such the applicable country of the Affected Area are equal to or greater than ****** of the combined unit volume of such the applicable Terminated Product and such Generic Equivalent(s) for all indications in the aggregate in such country in the Affected Area in any calendar quarter determined by the number of prescriptions given for the Terminated Product and such Generic Equivalent(s), in the aggregate during such calendar quarter in such country in the Affected Area (as measured by a ▇▇▇▇▇ ▇▇▇▇▇ Associates audit ****** - Material has been omitted and filed separately with the Commission. or other mechanism mutually agreed by the Parties), then the royalty rates applicable to Net Sales of such the Terminated Product by GSK, its Affiliate or Sublicensee in such country in the Affected Area shall be ****** of the royalty rates specified above in clause a) or b) of Section 3.4.1 14.3.3(b)(i), as applicable, with respect to the Net Sales of such Terminated Product in such country in the Affected Area for so long as such competition exists, and such reduced royalty shall be paid by GSK Amicus for the shorter of ****** from the date upon which GSK’s Amicus’ royalty obligations were reduced pursuant to this Section 3.5.1 14.3.3(b)(iii) as a result of the sales of such Generic Equivalent(s)) in such country in the Affected Area, or ****** from the date of the first Launch of the Product in such county, after which time GSK’s license with respect to such Product would be converted into a perpetual, exclusive, fully-paid, royalty-free (subject to Section 3.5.2(b)) license under the Licensed Technology to make, have made, use, sale, offer for sale and import such Terminated Product in such country in the Territory; providedAffected Area, howeverafter which time, that GSK shall no longer be entitled and subject to reduce Section 14.3.3(b)(iv)b) if the royalty rates nor the period of GSK’s royalty obligations Terminated Product is a Royalty Bearing Co-Formulation Product, Amicus’ license rights with respect to such Terminated Product as set forth above in this Section 3.5.1 if at any time following 14.3.1 shall become a reduction in royalty rate pursuant to this Section 3.5.1 fully paid-up and prior to the expiration of the Royalty Term set forth in this Section 3.5.1, such Generic Equivalent(s) cease to equal ****** or more of the combined unit volume of such Product and such Generic Equivalent(s) for all indications in the aggregate in such country in any calendar quarter determined by the number of prescriptions given for the Product and such Generic Equivalent(s), in the aggregate during such calendar quarter (as measured by a ▇▇▇▇▇ ▇▇▇▇▇ Associates audit or other mechanism mutually agreed by the Parties)royalty-free.
Appears in 1 contract
Sources: License and Collaboration Agreement (Amicus Therapeutics Inc)