Commercialization. To avoid disruption in the availability of Terminated Products to patients, if this Agreement is terminated after the First Commercial Sale of a Terminated Product, AbbVie, 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 AbbVie, its Affiliates and its Sublicensees shall cease such activities, or any portion thereof, in a given country upon [***] notice by 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, AbbVie’s and its Affiliates’ and Sublicensees’ rights with respect to Terminated Products shall be non-exclusive and, without limiting the foregoing, Licensor shall have the right to engage one or more other distributor(s) and/or licensee(s) of the Product in all or part of the Territory. Any Product sold or disposed of by AbbVie, its Affiliates or its Sublicensees in the Territory during the Commercialization Wind-down Period shall be subject to applicable payment obligations under ARTICLE 6 above. Within [***] of expiration of the Commercialization Wind-down Period, AbbVie shall notify Licensor of any quantity of the Product remaining in AbbVie’s inventory and Licensor shall have the option, upon notice to AbbVie, to repurchase any such quantities of the Product from AbbVie at a price equal to AbbVie’s Manufacturing Cost of such quantities.
Appears in 2 contracts
Samples: Development and Option Agreement (Alector, Inc.), Development and Option Agreement (Alector, Inc.)
Commercialization. To avoid disruption in Provided that the availability termination of Terminated Products to patients, if this Agreement is terminated after the First Commercial Sale of not a Terminated Producttermination by Galderma pursuant to Section 12.2.4, AbbVieif requested by NovaBay, Galderma and 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 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 a period requested by NovaBay not to exceed two (2) years from the effective date of any such expiration or termination (for purposes of this Section 12.6.3, the Agreement (the “Commercialization Wind-down Down Period”); provided that AbbVie, 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 Licensor requesting that such activities (or portion thereof) be ceasedto Galderma. 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 Agreement Wind-down Down Period, AbbVie’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, Licensor 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 Product Field in all or part of the Galderma Territory. Any Product Collaboration Products sold or disposed of by AbbVie, 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 6 aboveSection 8.5. Within [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. ***] of expiration of Confidential treatment requested pursuant to a request for confidential treatment filed with the Commercialization Wind-down Period, AbbVie shall notify Licensor of any quantity of Securities and Exchange Commission. Omitted portions have been filed separately with the Product remaining in AbbVie’s inventory and Licensor shall have the option, upon notice to AbbVie, to repurchase any such quantities of the Product from AbbVie at a price equal to AbbVie’s Manufacturing Cost of such quantitiesCommission.
Appears in 2 contracts
Samples: Collaboration and License Agreement (NovaBay Pharmaceuticals, Inc.), Collaboration and License Agreement (NovaBay Pharmaceuticals, Inc.)
Commercialization. To avoid a disruption in the availability supply of Terminated Products to patients, if this the Agreement is terminated after the First Commercial Sale first commercial sale of a Terminated Productany Product in the Excluded Region, AbbVieCephalon, 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, in each country for which Regulatory Approval therefor has been obtained, until [***] after the date on which Licensor Angioblast notifies AbbVie Cephalon in writing that Licensor Angioblast has secured an alternative distributor or licensee for the Terminated Product Products in such country, but in no event more for than [***] after during the effective date of any expiration or termination of this Agreement (the “Commercialization Wind-down Period”); provided that AbbVieCephalon, 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 Licensor Angioblast 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, AbbVieCephalon’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, Licensor 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 Product any Products in all or part of the TerritoryExcluded Region. Any Product Products sold or disposed of by AbbVie, 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 6 VI above. Within [***] of expiration of the Commercialization Wind-down Period, AbbVie shall notify Licensor of any quantity of the Product remaining in AbbVie’s inventory and Licensor shall have the option, upon notice to AbbVie, to repurchase any such quantities of the Product from AbbVie at a price equal to AbbVie’s Manufacturing Cost of such quantities.
Appears in 2 contracts
Samples: Development and Commercialization Agreement (Mesoblast LTD), Development and Commercialization Agreement (Mesoblast LTD)
Commercialization. To avoid disruption Except to the extent the applicable termination was made in the availability of Terminated Products to patientsaccordance 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, AbbVieTakeda, 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 AbbVieTakeda, its Affiliates and its Sublicensees shall cease such activities, or any portion thereof, in a given country upon [***] days’ notice by Licensor Denali 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, AbbVieTakeda’s and its Affiliates’ and Sublicensees’ rights with respect to Terminated Products shall be non-exclusive and, without limiting the foregoing, Licensor 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 AbbVieTakeda, its Affiliates or its Sublicensees in the Territory during the Commercialization Wind-down Period shall be subject to applicable payment obligations under ARTICLE 6 aboveArticle 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, AbbVie Takeda shall notify Licensor Denali of any quantity of the Terminated Product remaining in AbbVieTakeda’s inventory and Licensor Denali shall have the option, upon notice to AbbVieTakeda, to repurchase any such quantities of the Terminated Product from AbbVie Takeda at a price equal to AbbVie’s Manufacturing Cost [***] of such quantitiesquantities (to the extent [***]).
Appears in 2 contracts
Samples: Option and Collaboration Agreement (Denali Therapeutics Inc.), Option and Collaboration Agreement (Denali Therapeutics Inc.)
Commercialization. To avoid a disruption in the availability supply of Terminated XenoPort Products to patients, if this Agreement is terminated after the First Commercial Sale first commercial sale of a Terminated Productany XenoPort Product in the Territory, AbbVie, Xanodyne and 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, in each country for which Regulatory Approval therefor has been obtained, until [***] after the date on which Licensor XenoPort notifies AbbVie Xanodyne in writing that Licensor XenoPort has secured an alternative distributor or licensee for the Terminated Product Compound and XenoPort Products in such countrythe Territory, but in no event for more for than [***] six(6) months after the effective date of any expiration or such termination of this Agreement (the “Commercialization "Wind-down Period”"); provided that AbbVie, 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 Licensor XenoPort 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, AbbVie’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, Licensor XenoPort shall have the right to engage one or more other distributor(s) and/or licensee(s) of the Compound and/or any XenoPort Product in all or part of the Territory. Any Product Products sold or disposed of by AbbVie, 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 Article 6 aboveabove and all relevant deductions or credits due to Xanodyne in accordance with this Agreement. Within [***] thirty (30) days of expiration of the Commercialization Wind-down Period, AbbVie Xanodyne shall notify Licensor XenoPort of any quantity of the Product Intermediate, Compound and/or XenoPort Products remaining in AbbVie’s Xanodyne's inventory and Licensor XenoPort shall have the option, upon notice to AbbVieXanodyne, to repurchase any such quantities of the Product Intermediate, Compound and/or XenoPort Products, as applicable, from AbbVie Xanodyne at a price equal to AbbVie’s Manufacturing Cost 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 quantitiesfully burdened costs shall not include any margins or other markup.
Appears in 1 contract
Commercialization. To avoid disruption in the availability of Terminated Products to patients, if Unless this Agreement is terminated after the First Commercial Sale of a Terminated Productexpires by its terms or pursuant to Section 13.4, AbbVieGalderma, 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, in each country for which Regulatory Approval therefor has been obtained, until [***] three (3) months after the date on which Licensor ZARS notifies AbbVie Galderma in writing that Licensor ZARS has secured an alternative distributor or licensee for the Terminated Product such Product(s) in such country, but in no event for more for than [***] nine (9) months after the effective date of any expiration or termination of this Agreement (the “Commercialization Wind-down Period”); provided that AbbVieGalderma, its Affiliates and its Sublicensees shall cease such activities, or any portion thereof, in a given country upon [***] sixty (60) days notice by Licensor ZARS 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, AbbVie(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, Licensor ZARS shall have the right to engage one or more other distributor(s) and/or licensee(s) of the a Product in all or part of the TerritoryGalderma Territory and (B) Galderma shall be relieved of its obligations under Section 6.4. Any Product sold or disposed of by AbbVie, 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 Article 5 and Article 6 above. Within [***] thirty (30) days of expiration of the Commercialization Wind-down Period, AbbVie Galderma shall notify Licensor ZARS of any quantity of the Product remaining in AbbVieGalderma’s inventory and Licensor ZARS shall have the option, upon notice to AbbVie, to repurchase purchase from Galderma any such quantities of the Product from AbbVie having at least twelve (12) additional months of shelf life, at a price equal to AbbVie’s Manufacturing Cost the Galderma COGS for such Products, up to maximum amount of such quantitiesquantities 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)
Commercialization. To avoid a disruption in the availability supply of Terminated XenoPort Products to patients, if this Agreement is terminated after the First Commercial Sale first commercial sale of a Terminated Productany XenoPort Product in the Territory, AbbVie, Xanodyne and 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 [***] 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 such termination of this Agreement (the “Commercialization Wind-down Period”); provided that AbbVie, Xanodyne and its Affiliates and its Sublicensees shall cease such activities, or any portion thereof, in a given country upon [***... * ...] notice by Licensor XenoPort 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, AbbVieXanodyne’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, Licensor XenoPort shall have the right to engage one or more other distributor(s) and/or licensee(s) of the Compound and/or any XenoPort Product in all or part of the Territory. Any Product Products sold or disposed of by AbbVie, 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 Article 6 aboveabove and all relevant deductions or credits due to Xanodyne in accordance with this Agreement. Within [***... * ...] of expiration of the Commercialization Wind-down Period, AbbVie Xanodyne shall notify Licensor XenoPort of any quantity of the Product Intermediate, Compound and/or XenoPort Products remaining in AbbVieXanodyne’s inventory and Licensor XenoPort shall have the option, upon notice to AbbVieXanodyne, to repurchase any such quantities of the Product Intermediate, Compound and/or XenoPort Products, as applicable, from AbbVie Xanodyne at a price equal to AbbVie[... * ...] calculated in accordance with GAAP and Xanodyne’s Manufacturing Cost then-prevailing standard procedures for calculating costs of good sold. For the sake of clarity, such quantities[... * ...].
Appears in 1 contract
Samples: Licensing Agreement (Xenoport Inc)
Commercialization. To avoid disruption in the availability of Terminated Products to patients, if If this Agreement is terminated after the First Commercial Sale of a Terminated ProductDenali Product in the Terminated Area, AbbVieSanofi, 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 [***] 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 [***]; provided, further, that AbbVieSanofi, 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 [***] notice by Licensor Denali 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, AbbVieSanofi’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, Licensor 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 Product in all or part of the TerritoryTerminated Area. Any Terminated Denali Product sold or disposed of by AbbVieSanofi, 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 6 aboveArticle 7 (Payments). Within 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 FTE Costs or Out-of-Pocket Costs incurred by Sanofi or its Affiliates in accordance with such plan for the wind down of expiration of Sanofi’s activities shall be (a) reimbursed by Denali if the Commercialization Wind-down Periodrelevant Terminated Denali Product is not, AbbVie shall notify Licensor of any quantity of immediately prior to the Product remaining in AbbVie’s inventory and Licensor shall have the option, upon notice to AbbVie, to repurchase any such quantities of the Product from AbbVie at a price equal to AbbVie’s Manufacturing Cost effective date of such quantitiestermination, 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 effective date of such termination.
Appears in 1 contract
Samples: Collaboration and License Agreement (Denali Therapeutics Inc.)