Cross Territory Sales. 3.10.1 Each Party shall use Commercially Reasonable Efforts (consistent with any applicable Law) to obligate its sublicensees, distributors or wholesalers to not deliver or cause to be delivered Product outside such Party’s Territory and to not sell any Product to a purchaser if in either case such sublicensees, distributors or wholesalers know, or have reason to believe, that such purchaser intends to remove such Product from such Party’s Territory for the purpose of sales or use by patients of Product in the other Party’s Territory. 3.10.2 If either Party becomes aware that (i) a Product distributed and sold by a Party (the “Distributing Party”), its Affiliates, sublicensees, distributors or wholesalers is imported, distributed or sold in or to a country in the other Party’s Territory (“Cross-Territory Sales”), and (ii) such Cross-Territory Sales (calculated by reference to the other Party’s relevant average selling price(s), adjusted for different dosages) in such country in any calendar year reach or exceed [**] percent ([**]%) of the aggregate Net Sales (with such net sales by Akcea, its Affiliates or licensees determined in the same manner as Net Sales hereunder, mutatis mutandis) of the applicable Product in such country during the same period, then such Distributing Party shall promptly notify the other Party (the “Cross-Territory Sales Notice”). 3.10.3 Within [**] after receipt or delivery, as the case may be, of such Cross-Territory Sales Notice, the Distributing Party shall prepare and submit to the other Party a written plan providing in reasonable detail the commercially reasonable steps and actions the Distributing Party, its Affiliates and its sublicensees, wholesalers and distributors shall take (consistent with any applicable Law) to prevent or limit the continued entry of Products into the other Party’s Territory from the Distributing Party’s Territory (the “Cross-Territory Sales Report”) and present such report to the JSC for review and comment. From and after the JSC’s adoption of such report, amended as the JSC may decide, the Distributing Party shall (a) use Commercially Reasonable Efforts (consistent with any applicable Laws) to implement the measures specified in such Cross-Territory Sales Report, (b) monitor and evaluate compliance with the requirements of the Cross-Territory Sales Report, and (c) assess, on a regular basis and in no event less often than [**], whether the conduct of the activities required by the Cross-Territory Sales Report have been successful in preventing or limiting the entry of Products from the Distributing Party’s Territory into the other Party’s Territory; provided that so long as the Distributing Party is in compliance with Sections 3.10.1 and 3.10.3(a)-(c), the failure of the measures specified in the applicable Cross-Territory Sales Report to actually prevent or limit the entry of Product from the Distributing Party’s Territory into the other Party’s Territory shall not be considered a material breach of this Agreement.
Appears in 1 contract
Sources: Collaboration and License Agreement (PTC Therapeutics, Inc.)
Cross Territory Sales. 3.10.1 Each Party shall use Commercially Reasonable Efforts The Parties recognize that it is possible that:
(consistent with any applicable Lawa) Licensed Products originally sold by GSK (or its Affiliate, Sublicensee or Distributor) in the GSK Territory may be imported and resold in the Gilead Territory, to obligate Gilead's detriment in that this would diminish sales of Licensed Products by Gilead (and its sublicenseesAffiliates, distributors or wholesalers to not deliver or cause to be delivered Product outside such Party’s Territory and to not sell any Product to a purchaser if in either case such sublicensees, distributors or wholesalers know, or have reason to believe, that such purchaser intends to remove such Product from such Party’s Territory for the purpose of sales or use by patients of Product Other Licensees) in the other Party’s Gilead Territory.; or
3.10.2 If either Party becomes aware (b) Licensed Products sold by Gilead in the Gilead Territory may be imported and resold in the GSK Territory, to GSK's detriment in that this would diminish sales of Licensed Products by GSK (and its Affiliates, Distributors and Permitted Sublicensees) in the GSK Territory. Both GSK and Gilead shall [ * ] to the extent permitted by law, including without limitation by: (i) a [ * ] quantities of Licensed Products to [ * ], (ii) contractually requiring each of its sublicensees and distributors of Licensed Products to [ * ] quantities of Licensed Products to any [ * ] of the Party with which it is not in privity, (iii) [ * ] of Licensed Product distributed and sold by a Party (the “Distributing Party”), its Affiliates, sublicensees, distributors it [ * ] Territory or wholesalers is imported, distributed or sold in or to a country in the other Party’s Territory (“Cross-Territory Sales”)specified countries thereof, and (iiiv) contractually requiring its sublicensees and distributors to [ * ] such Cross-Territory Sales quantities of Licensed Product (calculated by reference to the other Party’s relevant average selling price(s)extent that they, adjusted for different dosages) in such country in any calendar year reach instead of GSK or exceed [**] percent ([**]%) of the aggregate Net Sales (with such net sales by Akcea, its Affiliates or licensees determined in the same manner as Net Sales hereunder, mutatis mutandis) of the applicable Product in such country during the same period, then such Distributing Party shall promptly notify the other Party (the “Cross-Territory Sales Notice”).
3.10.3 Within [**] after receipt or delivery, Gilead as the case may be, are [ * ] of Licensed Product that [ * ]). If, however, either Gilead or GSK believes that such Cross-importation into or reselling in its Territory Sales Notice, the Distributing Party shall prepare and submit to the other Party a written plan providing of quantities of Licensed Products originally sold in reasonable detail the commercially reasonable steps and actions the Distributing Party, its Affiliates and its sublicensees, wholesalers and distributors shall take (consistent with any applicable Law) to prevent or limit the continued entry of Products into the other Party’s 's Territory from is occurring [ * ], the Distributing Party’s Territory (Joint Committee shall discuss the “Crossmatter in good faith and examine any market data that is available, and shall determine whether any such cross-Territory Sales Report”importation and sales of Licensed Products is occurring. If the Joint Committee determines in good faith that such cross-Territory sales are occurring, then (i) and present such report to the JSC for review and comment. From and after the JSC’s adoption it shall establish an [ * ] of such report, amended as the JSC may decide, the Distributing Party shall (a) use Commercially Reasonable Efforts (consistent with any applicable Laws) to implement the measures specified in such Cross-Territory Sales Report, (b) monitor and evaluate compliance with the requirements of the Cross-Territory Sales Reportsales, and (cii) assess, on a regular basis and in no event less often than [**], whether the conduct of the activities required by the Crossit shall discuss any [ * ] that GSK or Gilead [ * ] such cross-Territory Sales Report have been successful in preventing sales. In addition, GSK or limiting Gilead (and their respective Affiliates, and distributors and sublicensees for Licensed Products) shall [ * ] Licensed Product to [ * ] Licensed Products the entry of Products applicable Territory that to either GSK's or Gilead's knowledge (including without limitation by notice from the Distributing Party’s Territory into the other Party’s Territory; provided that so long as the Distributing Party is in compliance with Sections 3.10.1 and 3.10.3(a)-(c), the failure of the measures specified in the applicable Cross-Territory Sales Report to actually prevent or limit the entry of Product from the Distributing Party’s Territory into the other Party’s Territory shall not be considered a material breach of this Agreement) [ * ] Licensed Products [ * ] hereunder.
Appears in 1 contract
Cross Territory Sales. 3.10.1 Each Party shall use Commercially Reasonable Efforts (consistent with any applicable Law) to obligate its sublicensees, distributors or wholesalers to not deliver or cause to be delivered Product outside such Party’s Territory and to not sell any Product to a purchaser if in either case such sublicensees, distributors or wholesalers know, or have reason to believe, that such purchaser intends to remove such Product from such Party’s Territory for the purpose of sales or use by patients of Product in the other Party’s Territory.. ActiveUS 169009360v.1
3.10.2 If either Party becomes aware that (i) a Product distributed and sold by a Party (the “Distributing Party”), its Affiliates, sublicensees, distributors or wholesalers is imported, distributed or sold in or to a country in the other Party’s Territory (“Cross-Territory Sales”), and (ii) such Cross-Territory Sales (calculated by reference to the other Party’s relevant average selling price(s), adjusted for different dosages) in such country in any calendar year reach or exceed [***] percent ([***]%) of the aggregate Net Sales (with such net sales by Akcea, its Affiliates or licensees determined in the same manner as Net Sales hereunder, mutatis mutandis) of the applicable Product in such country during the same period, then such Distributing Party shall promptly notify the other Party (the “Cross-Territory Sales Notice”).
3.10.3 Within [***] after receipt or delivery, as the case may be, of such Cross-Territory Sales Notice, the Distributing Party shall prepare and submit to the other Party a written plan providing in reasonable detail the commercially reasonable steps and actions the Distributing Party, its Affiliates and its sublicensees, wholesalers and distributors shall take (consistent with any applicable Law) to prevent or limit the continued entry of Products into the other Party’s Territory from the Distributing Party’s Territory (the “Cross-Territory Sales Report”) and present such report to the JSC for review and comment. From and after the JSC’s adoption of such report, amended as the JSC may decide, the Distributing Party shall (a) use Commercially Reasonable Efforts (consistent with any applicable Laws) to implement the measures specified in such Cross-Territory Sales Report, (b) monitor and evaluate compliance with the requirements of the Cross-Territory Sales Report, and (c) assess, on a regular basis and in no event less often than [***], whether the conduct of the activities required by the Cross-Territory Sales Report have been successful in preventing or limiting the entry of Products from the Distributing Party’s Territory into the other Party’s Territory; provided that so long as the Distributing Party is in compliance with Sections 3.10.1 and 3.10.3(a)-(c), the failure of the measures specified in the applicable Cross-Territory Sales Report to actually prevent or limit the entry of Product from the Distributing Party’s Territory into the other Party’s Territory shall not be considered a material breach of this Agreement.
Appears in 1 contract
Sources: Collaboration and License Agreement (Akcea Therapeutics, Inc.)