Common use of Commercialization Clause in Contracts

Commercialization. Except to the extent the applicable termination was made in accordance with Section 14.6, if this Agreement is terminated after the First Commercial Sale of a Terminated Product and Takeda is the Commercial Lead with respect to the applicable Terminated Product, Takeda, its Affiliates and its Sublicensees shall continue to distribute such Terminated Product, in accordance with the terms and conditions of this Agreement, in each country for which Regulatory Approval therefor has been obtained, until [***] after the effective date of termination (the “Commercialization Wind-down Period”); provided that Takeda, its Affiliates and its Sublicensees shall cease such activities, or any portion thereof, in a given country upon [***] days’ notice by Denali requesting that such activities (or portion thereof) be ceased. Notwithstanding any other provision of this Agreement, during the Commercialization Wind-down Period, Takeda’s and its Affiliates’ and Sublicensees’ rights with respect to Terminated Products shall be non-exclusive and, without limiting the foregoing, Denali shall have the right to engage one or more other distributor(s) and/or licensee(s) of the Terminated Product in all or part of the Territory. Any Terminated Product sold or disposed of by Takeda, its Affiliates or its Sublicensees in the Territory during the Commercialization Wind-down Period shall be subject to applicable payment obligations under Article 8. Unless [***], any Terminated Product sold or disposed of by Denali, its Affiliates or its Sublicensees (but not, for clarity any sales during such period by Takeda, its Affiliates, or Sublicensees) in the Territory during the Commercialization Wind-down Period shall be subject to applicable payment obligations to Takeda under Section 14.7.1. Within [***] days of expiration of the Commercialization Wind-down Period, Takeda shall notify Denali of any quantity of Terminated Product remaining in Takeda’s inventory and Denali shall have the option, upon notice to Takeda, to repurchase any such quantities of the Terminated Product from Takeda at a price equal to [***] of such quantities (to the extent [***]).

Appears in 2 contracts

Samples: Option and Collaboration Agreement (Denali Therapeutics Inc.), Option and Collaboration Agreement (Denali Therapeutics Inc.)

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Commercialization. Except To avoid a disruption in the supply of Products to the extent the applicable termination was made in accordance with Section 14.6patients, if this the Agreement is terminated after the First Commercial Sale first commercial sale of a Terminated any Product and Takeda is in the Commercial Lead with respect to the applicable Terminated ProductExcluded Region, TakedaCephalon, its Affiliates and its Sublicensees Marketing Partners shall continue to distribute such Terminated Productthe Products in each country of the Excluded Region for which Marketing Approval therefor has been obtained, in accordance with the terms and conditions of this Agreement, until the date on which Angioblast notifies Cephalon in each country writing that Angioblast has secured an alternative distributor or licensee for which Regulatory Approval therefor has been obtainedthe Products in such country, until [***] after during the effective date of termination (the “Commercialization Wind-down Period”); provided that TakedaCephalon, its Affiliates and its Sublicensees Marketing Partners shall cease such activities, or any portion thereof, in a given country of the Excluded Region upon [***] sixty (60) days’ notice by Denali Angioblast requesting that such activities (or portion thereof) be ceased. Notwithstanding any other provision of this Agreement, during the Commercialization Wind-down Period, TakedaCephalon’s and its Affiliates’ and SublicenseesMarketing Partners’ rights with respect to Terminated the Products in the Excluded Region shall be non-exclusive and, without limiting the foregoing, Denali Angioblast shall have the right to engage one or more other distributor(s) and/or THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. licensee(s) of the Terminated Product any Products in all or part of the TerritoryExcluded Region. Any Terminated Product Products sold or disposed of by Takeda, its Affiliates or its Sublicensees Cephalon in the Territory Excluded Region during the Commercialization Wind-down Period shall be subject to applicable payment obligations under Article 8. Unless [***], any Terminated Product sold or disposed of by Denali, its Affiliates or its Sublicensees (but not, for clarity any sales during such period by Takeda, its Affiliates, or Sublicensees) in the Territory during the Commercialization Wind-down Period shall be subject to applicable payment obligations to Takeda under Section 14.7.1. Within [***] days of expiration of the Commercialization Wind-down Period, Takeda shall notify Denali of any quantity of Terminated Product remaining in Takeda’s inventory and Denali shall have the option, upon notice to Takeda, to repurchase any such quantities of the Terminated Product from Takeda at a price equal to [***] of such quantities (to the extent [***])ARTICLE VI above.

Appears in 2 contracts

Samples: Development and Commercialization Agreement (Mesoblast LTD), Development and Commercialization Agreement (Mesoblast LTD)

Commercialization. Except To avoid disruption in the availability of Terminated Products to the extent the applicable termination was made in accordance with Section 14.6patients, if this Agreement is terminated after the First Commercial Sale of a Terminated Product and Takeda is the Commercial Lead with respect to the applicable Terminated Product, TakedaAbbVie, its Affiliates and its Sublicensees shall continue to distribute such Terminated Product, in accordance with the terms and conditions of this Agreement, in each country for which Regulatory Approval therefor has been obtained, until [***] after the date on which Licensor notifies AbbVie in writing that Licensor has secured an alternative distributor or licensee for the Terminated Product in such country, but in no event more for than [***] after the effective date of any expiration or termination of this Agreement (the “Commercialization Wind-down Period”); provided that TakedaAbbVie, its Affiliates and its Sublicensees shall cease such activities, or any portion thereof, in a given country upon [***] days’ notice by Denali Licensor requesting that such activities (or portion thereof) be ceased. Notwithstanding any other provision of this *** Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request. Agreement, during the Commercialization Wind-down Period, TakedaAbbVie’s and its Affiliates’ and Sublicensees’ rights with respect to Terminated Products shall be non-exclusive and, without limiting the foregoing, Denali Licensor shall have the right to engage one or more other distributor(s) and/or licensee(s) of the Terminated Product in all or part of the Territory. Any Terminated Product sold or disposed of by TakedaAbbVie, its Affiliates or its Sublicensees in the Territory during the Commercialization Wind-down Period shall be subject to applicable payment obligations under Article 8. Unless [***], any Terminated Product sold or disposed of by Denali, its Affiliates or its Sublicensees (but not, for clarity any sales during such period by Takeda, its Affiliates, or Sublicensees) in the Territory during the Commercialization Wind-down Period shall be subject to applicable payment obligations to Takeda under Section 14.7.1ARTICLE 6 above. Within [***] days of expiration of the Commercialization Wind-down Period, Takeda AbbVie shall notify Denali Licensor of any quantity of Terminated the Product remaining in TakedaAbbVie’s inventory and Denali Licensor shall have the option, upon notice to TakedaAbbVie, to repurchase any such quantities of the Terminated Product from Takeda AbbVie at a price equal to [***] AbbVie’s Manufacturing Cost of such quantities (to the extent [***])quantities.

Appears in 2 contracts

Samples: Development and Option Agreement (Alector, Inc.), Development and Option Agreement (Alector, Inc.)

Commercialization. Except to Provided that the extent the applicable termination was made in accordance with Section 14.6, if of this Agreement is terminated after the First Commercial Sale of not a Terminated Product termination by Galderma pursuant to Section 12.2.4, if requested by NovaBay, Galderma and Takeda is the Commercial Lead with respect to the applicable Terminated Product, Takeda, its Affiliates and its Sublicensees Marketing Partners shall continue to distribute such Terminated Productand sell Collaboration Products in the Field in each country of the Galderma Territory for which Marketing Approval therefor has been obtained, in accordance with the terms and conditions of this Agreement, in each country for which Regulatory Approval therefor has been obtained, until [***] after a period requested by NovaBay not to exceed two (2) years from the effective date of such expiration or termination (for purposes of this Section 12.6.3, the “Commercialization Agreement Wind-down Down Period); provided that Takeda, its Affiliates and its Sublicensees shall cease such activities, or any portion thereof, in a given country NovaBay may terminate the Agreement Wind-Down Period upon [***] sixty (60) days’ notice by Denali requesting that such activities (or portion thereof) be ceasedto Galderma. Notwithstanding any other provision of this Agreement, during the Commercialization Agreement Wind-down Down Period, Takeda’s and Galderma’s, its Affiliates’ and Sublicenseesits Marketing Partners’ rights with respect to Terminated Collaboration Products (including the licenses granted under Section 7.1.1) shall be non-exclusive and, without limiting the foregoing, Denali and NovaBay shall have the right to engage one or more other partner(s) or distributor(s) and/or licensee(s) of Collaboration Products in the Terminated Product Field in all or part of the Galderma Territory. Any Terminated Product Collaboration Products sold or disposed of by Takeda, Galderma or its Affiliates or its Sublicensees in the Territory Marketing Partners during the Commercialization Agreement Wind-down Down Period shall be subject to the applicable payment obligations royalties under Article 8Section 8.5. Unless [After the Agreement Wind-Down Period, Galderma and its Affiliates and Marketing Partners shall not make any representation regarding their status as a licensee of or distributor for NovaBay for any Collaboration Product. In addition, Galderma shall promptly provide NovaBay copies of customer lists and other customer information relating to Collaboration Products reasonably necessary in Galderma’s reasonable opinion for NovaBay to continue to Commercialize such Collaboration Products, which NovaBay shall have the right to use and disclose for any purpose during the Agreement Wind-Down Period and thereafter. ***], any Terminated Product sold or disposed of by Denali, its Affiliates or its Sublicensees (but not, Confidential treatment requested pursuant to a request for clarity any sales during such period by Takeda, its Affiliates, or Sublicensees) in confidential treatment filed with the Territory during Securities and Exchange Commission. Omitted portions have been filed separately with the Commercialization Wind-down Period shall be subject to applicable payment obligations to Takeda under Section 14.7.1. Within [***] days of expiration of the Commercialization Wind-down Period, Takeda shall notify Denali of any quantity of Terminated Product remaining in Takeda’s inventory and Denali shall have the option, upon notice to Takeda, to repurchase any such quantities of the Terminated Product from Takeda at a price equal to [***] of such quantities (to the extent [***])Commission.

Appears in 2 contracts

Samples: Collaboration and License Agreement (NovaBay Pharmaceuticals, Inc.), Collaboration and License Agreement (NovaBay Pharmaceuticals, Inc.)

Commercialization. Except To avoid a disruption in the supply of XenoPort Products to the extent the applicable termination was made in accordance with Section 14.6patients, if this Agreement is terminated after the First Commercial Sale first commercial sale of a Terminated any XenoPort Product in the Territory, Xanodyne and Takeda is the Commercial Lead with respect to the applicable Terminated Product, Takeda, its Affiliates and its Sublicensees shall continue to market, promote, distribute and otherwise commercialize (including with the assistance of any Co-Promotion Partner, to the extent permitted by any agreement with such Terminated ProductCo-Promotion Partner) the XenoPort Products in the Territory for which Marketing Approval by the FDA has been obtained (unless the FDA or a court of competent jurisdiction in the Territory issues a directive or order that a particular XenoPort Product be recalled or withdrawn in the Territory, or the Parties mutually agree that a particular XenoPort Product should be recalled or withdrawn in the Territory) and in accordance with the terms * Certain confidential information contained in this document, marked by brackets, is filed with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. and conditions of this Agreement, in each country for which Regulatory Approval therefor has been obtained, until [***... * ...], but in no event [... * ...] after the effective date of any such termination of this Agreement (the “Commercialization Wind-down Period”); provided that Takeda, Xanodyne and its Affiliates and its Sublicensees shall cease such activities, or any portion thereof, in a given country upon [***... * ...] days’ notice by Denali XenoPort requesting that such activities (or portion thereof) be ceased. Notwithstanding any other provision of this Agreement, during the Commercialization Wind-down Period, TakedaXanodyne’s and its Affiliates’ and Sublicensees’ rights with respect to Terminated the Compound and XenoPort Products in the Territory shall be non-exclusive and, without limiting the foregoing, Denali XenoPort shall have the right to engage one or more other distributor(s) and/or licensee(s) of the Terminated Compound and/or any XenoPort Product in all or part of the Territory. Any Terminated Product Products sold or disposed of by Takeda, its Affiliates or its Sublicensees Xanodyne in the Territory during the Commercialization Wind-down Period shall be subject to the applicable payment obligations under Article 8. Unless [***], any Terminated Product sold 6 above and all relevant deductions or disposed of by Denali, its Affiliates or its Sublicensees (but not, for clarity any sales during such period by Takeda, its Affiliates, or Sublicensees) credits due to Xanodyne in the Territory during the Commercialization Wind-down Period shall be subject to applicable payment obligations to Takeda under Section 14.7.1accordance with this Agreement. Within [***... * ...] days of expiration of the Commercialization Wind-down Period, Takeda Xanodyne shall notify Denali XenoPort of any quantity of Terminated Product the Intermediate, Compound and/or XenoPort Products remaining in TakedaXanodyne’s inventory and Denali XenoPort shall have the option, upon notice to TakedaXanodyne, to repurchase any such quantities of the Terminated Product Intermediate, Compound and/or XenoPort Products, as applicable, from Takeda Xanodyne at a price equal to [***... * ...] calculated in accordance with GAAP and Xanodyne’s then-prevailing standard procedures for calculating costs of good sold. For the sake of clarity, such quantities (to the extent [***... * ...]).

Appears in 1 contract

Samples: Licensing Agreement (Xenoport Inc)

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Commercialization. Except To avoid a disruption in the supply of XenoPort Products to the extent the applicable termination was made in accordance with Section 14.6patients, if this Agreement is terminated after the First Commercial Sale first commercial sale of a Terminated any XenoPort Product in the Territory, Xanodyne and Takeda is the Commercial Lead with respect to the applicable Terminated Product, Takeda, its Affiliates and its Sublicensees shall continue to market, promote, distribute and otherwise commercialize (including with the assistance of any Co-Promotion Partner, to the extent permitted by any agreement with such Terminated ProductCo-Promotion Partner) the XenoPort Products in the Territory for which Marketing Approval by the FDA has been obtained (unless the FDA or a court of competent jurisdiction in the Territory issues a directive or order that a particular XenoPort Product be recalled or withdrawn in the Territory, or the Parties mutually agree that a particular XenoPort Product should be recalled or withdrawn in the Territory) and in accordance with the terms and conditions of this Agreement, until the date on which XenoPort notifies Xanodyne in each country writing that XenoPort has secured an alternative distributor or licensee for which Regulatory Approval therefor has been obtainedthe Compound and XenoPort Products in the Territory, until [***] but in no event for more than six(6) months after the effective date of any such termination of this Agreement (the “Commercialization "Wind-down Period"); provided that Takeda, Xanodyne and its Affiliates and its Sublicensees shall cease such activities, or any portion thereof, in a given country upon [***] sixty (60) days' notice by Denali XenoPort requesting that such activities (or portion thereof) be ceased. Notwithstanding any other provision of this Agreement, during the Commercialization Wind-down Period, Takeda’s and its Affiliates’ and Sublicensees’ Xanodyne's rights with respect to Terminated the Compound and XenoPort Products in the Territory shall be non-exclusive and, without limiting the foregoing, Denali XenoPort shall have the right to engage one or more other distributor(s) and/or licensee(s) of the Terminated Compound and/or any XenoPort Product in all or part of the Territory. Any Terminated Product Products sold or disposed of by Takeda, its Affiliates or its Sublicensees Xanodyne in the Territory during the Commercialization Wind-down Period shall be subject to the applicable payment obligations under Article 8. Unless [***], any Terminated Product sold 6 above and all relevant deductions or disposed of by Denali, its Affiliates or its Sublicensees (but not, for clarity any sales during such period by Takeda, its Affiliates, or Sublicensees) credits due to Xanodyne in the Territory during the Commercialization Wind-down Period shall be subject to applicable payment obligations to Takeda under Section 14.7.1accordance with this Agreement. Within [***] thirty (30) days of expiration of the Commercialization Wind-down Period, Takeda Xanodyne shall notify Denali XenoPort of any quantity of Terminated Product the Intermediate, Compound and/or XenoPort Products remaining in Takeda’s Xanodyne's inventory and Denali XenoPort shall have the option, upon notice to TakedaXanodyne, to repurchase any such quantities of the Terminated Product Intermediate, Compound and/or XenoPort Products, as applicable, from Takeda Xanodyne at a price equal to [***] the fully burdened costs (excluding overhead) incurred by Xanodyne to manufacture or have manufactured such Intermediate, Compound and/or XenoPort Products, as applicable, calculated in accordance with GAAP and Xanodyne's then-prevailing standard procedures for calculating costs of good sold. For the sake of clarity, such quantities (to the extent [***])fully burdened costs shall not include any margins or other markup.

Appears in 1 contract

Samples: Licensing Agreement (Xanodyne Pharmaceuticals Inc)

Commercialization. Except to the extent the applicable termination was made in accordance with Section 14.6, if If this Agreement is terminated after the First Commercial Sale of a Terminated Denali Product and Takeda is in the Commercial Lead with respect to the applicable Terminated ProductArea, TakedaSanofi, its Affiliates and its Sublicensees shall continue to distribute fulfill orders for the Terminated Area through their respective then-existing distribution network of internal and external distributors of such Terminated Denali Product, in accordance with the terms and conditions of this Agreement, in each country for which Regulatory Approval therefor has been obtained, until for [***] after the effective date of termination (the “Commercialization Wind-down Period”); provided [***]; provided, further, that TakedaSanofi, its Affiliates and its Sublicensees shall cease any such activitiesactivities being conducted pursuant to this Section (f)(ii), or any portion thereof, in a given country within the Terminated Area upon [***] days’ notice by Denali requesting that such activities (or portion thereof) be ceased. Notwithstanding any other provision of this Agreement, during the Commercialization Wind-down Period, TakedaSanofi’s and its Affiliates’ and Sublicensees’ rights with respect to applicable Terminated Products Denali Product(s) in the Terminated Area shall be non-exclusive and, without limiting the foregoing, Denali shall have the right to engage one or more other distributor(s) and/or or licensee(s) of such Terminated Denali Product(s) in any country within the Terminated Product in all or part of the TerritoryArea. Any Terminated Denali Product sold or disposed of by TakedaSanofi, its Affiliates or its Sublicensees in any country within the Territory Terminated Area during the Commercialization Wind-down Period shall be subject to applicable payment obligations under Article 87 (Payments). Unless In addition, if at the effective time of such termination, Sanofi or its Affiliates are undertaking Detailing or MSL Activities with respect to a particular Terminated Denali Product in any country within the Terminated Area, then, at Denali’s request, the Parties will negotiate and agree upon a plan for the orderly wind down of such activities for a period not to exceed [***], any Terminated Product sold . Any FTE Costs or disposed of Out-of-Pocket Costs incurred by Denali, Sanofi or its Affiliates or its Sublicensees in accordance with such plan for the wind down of Sanofi’s activities shall be (but a) reimbursed by Denali if the relevant Terminated Denali Product is not, for clarity any sales during such period by Takeda, its Affiliates, or Sublicensees) in immediately prior to the Territory during the Commercialization Wind-down Period shall be subject to applicable payment obligations to Takeda under Section 14.7.1. Within [***] days of expiration of the Commercialization Wind-down Period, Takeda shall notify Denali of any quantity of Terminated Product remaining in Takeda’s inventory and Denali shall have the option, upon notice to Takeda, to repurchase any such quantities of the Terminated Product from Takeda at a price equal to [***] effective date of such quantities termination, a Cost Profit Sharing Product; or (b) continue to be allocated towards Allowable Expenses until such wind down is complete, if the relevant Terminated Denali Product is a Cost Profit Sharing Product immediately prior to the extent [***])effective date of such termination.

Appears in 1 contract

Samples: Collaboration and License Agreement (Denali Therapeutics Inc.)

Commercialization. Except to the extent the applicable termination was made in accordance with Section 14.6, if Unless this Agreement is terminated after the First Commercial Sale of a Terminated Product and Takeda is the Commercial Lead with respect expires by its terms or pursuant to the applicable Terminated ProductSection 13.4, TakedaGalderma, its Affiliates and its Sublicensees shall continue to market, promote, distribute such Terminated Productand otherwise commercialize Products in each country in the Galderma Territory for which Marketing Approval therefor has been obtained, in accordance with the terms and conditions of this Agreement, until three (3) months after the date on which ZARS notifies Galderma in each country writing that ZARS has secured an alternative distributor or licensee for which Regulatory Approval therefor has been obtainedsuch Product(s) in such country, until [***] but in no event for more than nine (9) months after the effective date of any termination of this Agreement (the “Commercialization Wind-down Period”); provided that TakedaGalderma, its Affiliates and its Sublicensees shall cease such activities, or any portion thereof, in a given country upon [***] days’ sixty (60) days notice by Denali ZARS requesting that such activities (or portion thereof) be ceased. Notwithstanding any other provision of this Agreement, during the Commercialization Wind-down Period, Takeda(A) Galderma’s and its Affiliates’ and Sublicensees’ rights with respect to Terminated Products a Product in the Galderma Territory shall be non-exclusive and, without limiting the foregoing, Denali ZARS shall have the right to engage one or more other distributor(s) and/or licensee(s) of the Terminated a Product in all or part of the TerritoryGalderma Territory and (B) Galderma shall be relieved of its obligations under Section 6.4. Any Terminated Product sold or disposed of by Takeda, its Affiliates or its Sublicensees in the Galderma Territory during the Commercialization Wind-down Period shall be subject to the other applicable payment obligations under Article 8. Unless [***], any Terminated Product sold or disposed of by Denali, its Affiliates or its Sublicensees (but not, for clarity any sales during such period by Takeda, its Affiliates, or Sublicensees) in the Territory during the Commercialization Wind-down Period shall be subject to applicable payment obligations to Takeda under Section 14.7.15 and Article 6 above. Within [***] thirty (30) days of expiration of the Commercialization Wind-down Period, Takeda Galderma shall notify Denali ZARS of any quantity of Terminated Product remaining in TakedaGalderma’s inventory and Denali ZARS shall have the option, upon notice to Takeda, to repurchase purchase from Galderma any such quantities of the Terminated Product from Takeda having at least twelve (12) additional months of shelf life, at a price equal to [***] the Galderma COGS for such Products, up to maximum amount of such quantities equal to the number of Products sold in the preceding six (6) months. ZARS shall have the right, but not the obligation, to purchase any additional quantities of Product remaining in Galderma’s inventory that do not meet the foregoing requirements, at a price equal to the Galderma COGS for such Products. If any Product was manufactured by any Third Party for Galderma, or Galderma had contracts with vendors which contracts are necessary or useful for ZARS to take over responsibility for the Products in the Galderma Territory, then Galderma shall to the extent [***]possible and as requested in writing by ZARS, assign all of the relevant Third-Party contracts to ZARS. If Galderma or its Affiliate manufactured any Product at the time of termination, then Galderma (or its Affiliate) shall, to the extent practicable, continue to provide for manufacturing of such Product for ZARS, from the date of notice of such termination until such time as ZARS is able, using reasonable efforts to do so, to secure an acceptable alternative commercial manufacturing source from which sufficient quantities of Product may be procured and legally sold in the Galderma Territory (but in no event for longer than fifteen (15) months after notice of termination is delivered), and ZARS shall compensate Galderma for such quantities at a transfer price equal to [ * ] of Galderma COGS.

Appears in 1 contract

Samples: Development and Commercialization Agreement (Zars Inc/Ut)

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