Commercialization. To avoid disruption of supply of any Terminated Products to patients if this Agreement is terminated after the Launch of a Terminated Product in the Affected Area, GSK, its Affiliates and Sublicensees shall continue to sell the Terminated Products in each country of the Affected Area for which Marketing Approval of such Terminated Product has been obtained, in accordance with the terms and conditions of this Agreement, until the date on which Amicus notifies GSK that Amicus has secured an alternative distributor or licensee for such Terminated Product in such country of the Affected Area, but in no event more than ****** after the effective date of any such termination of this Agreement (“Wind-Down Period”); provided that Amicus may terminate the Wind-Down Period in any country(ies) of the Affected Area upon ****** written notice to GSK; provided further that GSK shall not be obligated to promote the sale of Terminated Products in the Affected Area during the Wind-Down Period. Notwithstanding any other provision of this Agreement, during the Wind-down Period, GSK’s and its Affiliates’ and Sublicensees’ rights with respect to the Terminated Products in the Affected Area shall be non-exclusive and, without limiting the foregoing, Amicus shall have the right to engage one or more other distributor(s) and/or licensee(s) of any Terminated Product in all or part of the Affected Area; provided, however, that in the event that Amicus does so engage one or more other distributor(s) and/or licensee(s) of any Terminated Product in all or part of the Affected Area, GSK shall have no further obligation to continue to sell the Terminated Products in the Affected Area or such part thereof, as applicable. Any Terminated Product sold or disposed by GSK in the Affected Area during the Wind-down Period shall be subject to applicable royalty payment obligations under Section 3.4 above, and for such purposes, Sections 3.4, 3.5, 3.7, 3.8, 3.9 and 3.11 shall survive. Within ****** following the expiration of the Wind-Down Period, GSK shall notify Amicus of any quantities of Compound or Terminated Product(s) remaining in GSK’s or its Affiliate’s inventory, as well as any components necessary for the Manufacture of the Compound and Terminated Product(s) in GSK’s or its Affiliate’s inventory, and Amicus shall have the option, upon notice to GSK, to repurchase any such quantities of the Compound and/or Terminated Product(s) and/or components from GSK at a price to be mutually agreed by the Parties. If Amicus so elects to purchase any remaining quantities of Compound or Terminated Products or components from GSK as set forth herein, GSK will transfer to Amicus such quantities of inventory of Compound or Terminated Product(s) or components. ****** - Material has been omitted and filed separately with the Commission.
Appears in 1 contract
Sources: License and Collaboration Agreement (Amicus Therapeutics Inc)
Commercialization. To avoid disruption of supply of any Terminated Products to patients if this Agreement is terminated after the Launch of a Terminated Product in the Affected Area, GSK, MEI and its Affiliates and Sublicensees shall continue to sell distribute (but shall not be obligated to market or promote) such Product(s) in the Terminated Products in each country of the Affected Area for which Marketing Territory if Regulatory Approval of such Terminated Product therefor has been obtained, in accordance with the terms and conditions of this Agreement, until the date on which Amicus notifies GSK that Amicus has secured an alternative distributor or licensee for such Terminated Product in such country of the Affected Area, but in no event more than ****** after up to twelve (12) months following the effective date of any such termination of this Agreement (the “Wind-Down Wind down Period”); provided that Amicus may terminate provided, that, the Wind-Down Period Parties shall enter into a transition services agreement pursuant to which MEI will continue to distribute such Product(s) in any such country(ies) [*CONFIDENTIAL*]. At Presage’s request, such transition services agreement shall be negotiated in good faith during the applicable notice period preceding termination of this Agreement. In any event, MEI shall, and shall cause its Affiliates and Sublicensees to, cease distribution of the Affected Area Product, or any portion thereof, upon [*CONFIDENTIAL***** written ] notice to GSK; provided further by Presage requesting that GSK shall not such activities (or portion thereof) be obligated to promote ceased at any time following the sale expiration of Terminated Products in the Affected Area during the Wind-Down Wind down Period). Notwithstanding any other provision of this Agreement, during the Wind-Wind down Period, GSKMEI’s and its Affiliates’ and Sublicensees’ rights with respect to the Terminated Products Compound and Product in the Affected Area Territory shall be non-exclusive and, without limiting the foregoing, Amicus and Presage shall have the right to engage one or more other distributor(s) and/or licensee(s) of any Terminated the Compound and Product in all or part of the Affected Area; provided, however, that in the event that Amicus does so engage one or more other distributor(s) and/or licensee(s) of any Terminated Product in all or part of the Affected Area, GSK shall have no further obligation to continue to sell the Terminated Products in the Affected Area or such part thereof, as applicableTerritory. Any Terminated Product Products sold or disposed by GSK MEI, its Affiliates and/or Sublicensees, in the Affected Area Territory during the Wind-Wind down Period shall be subject to applicable royalty payment obligations payments under and in accordance with Section 3.4 5 above, and for such purposes, Sections 3.4, 3.5, 3.7, 3.8, 3.9 and 3.11 shall survive. Within [*CONFIDENTIAL***** following the ] of expiration of the Wind-Down Wind down Period, GSK MEI shall notify Amicus Presage of any quantities quantity of Compound or Terminated Product(s) and/or Product remaining in GSKMEI’s or its Affiliate’s inventory, as well as any components necessary for the Manufacture of the Compound inventory and Terminated Product(s) in GSK’s or its Affiliate’s inventory, and Amicus Presage shall have the option, upon notice to GSK, to repurchase any such quantities of Compound and/or Product, as applicable, from MEI at a price equal to the supply price paid by MEI for such Compound and/or Product plus [*CONFIDENTIAL*]; except with respect to any such quantities of such Compound and/or Product manufactured by MEI (or its contract manufacturer), in respect of which the price shall be equal to MEI’s actual costs for such quantities of Compound and/or Product, as applicable, plus [*CONFIDENTIAL*]. In addition, MEI shall use Commercially Reasonable Efforts to cooperate, at Presage’s sole cost and expense, to transition to Presage upon Presage’s request any arrangement with any contractor from which MEI was obtaining supply of any Compound and/or Product to the extent such arrangement solely pertains to the Compound and/or Terminated Product(s) and/or components from GSK at Product and no other products of MEI. Notwithstanding anything to the contrary in this Section 10.4(c)(iii), in the event of a price safety or ethical concern regarding the continued Commercialization or use of the Product, MEI shall not be obligated to be mutually agreed by continue Commercializing the Parties. If Amicus so elects to purchase any remaining quantities of Compound or Terminated Products or components from GSK as set forth herein, GSK will transfer to Amicus such quantities of inventory of Compound or Terminated Product(s) or components. ****** - Material has been omitted and filed separately with the CommissionProduct.
Appears in 1 contract
Sources: License Agreement (MEI Pharma, Inc.)
Commercialization. To avoid disruption of supply of any Terminated Products to patients if this Agreement is terminated after the Launch of a Terminated Product in the Affected Area, GSK, Exactus BioSolutions and its Affiliates and Sublicensees shall be entitled to continue to sell (but not to actively promote after the Terminated effective date of termination) any existing inventory of Products in each terminated country of the Affected Area Territory for which Marketing Regulatory Approval of such Terminated Product therefor has been obtainedobtained (provided that such Products shall have launched in each such terminated country as of the applicable effective date of termination), in accordance with the terms and conditions of this Agreement, until the date on which Amicus notifies GSK that Amicus has secured an alternative distributor or licensee for such Terminated Product in such country of the Affected Area, but in no event more than ****** after a period not to exceed twelve (12) months from the effective date of any such termination of this Agreement (the “Commercialization Wind-Down Period”); provided that Amicus may terminate . Any Products sold or disposed of by Exactus BioSolutions or its Affiliates or during the Commercialization Wind-Down Period in any country(ies) of the Affected Area upon ****** written notice to GSK; provided further that GSK shall not be obligated to promote the sale of Terminated Products in the Affected Area during the Wind-Down Period. Notwithstanding any other provision of this Agreement, during the Wind-down Period, GSK’s and its Affiliates’ and Sublicensees’ rights with respect to the Terminated Products in the Affected Area shall be non-exclusive and, without limiting the foregoing, Amicus shall have the right to engage one or more other distributor(s) and/or licensee(s) of any Terminated Product in all or part of the Affected Area; provided, however, that in the event that Amicus does so engage one or more other distributor(s) and/or licensee(s) of any Terminated Product in all or part of the Affected Area, GSK shall have no further obligation to continue to sell the Terminated Products in the Affected Area or such part thereof, as applicable. Any Terminated Product sold or disposed by GSK in the Affected Area during the Wind-down Period shall be subject to applicable royalty payment obligations the same royalties under Section 3.4 above, 8.4 as would have applied had this Agreement otherwise remained in force and for effect with respect to such purposes, Sections 3.4, 3.5, 3.7, 3.8, 3.9 terminated Product and 3.11 shall surviveterminated country(ies). Within ****** following After the expiration of the Commercialization Wind-Down Period, GSK Exactus BioSolutions and its Affiliates shall notify Amicus not sell such terminated Products in such terminated country(ies) or make any representation regarding Exactus BioSolutions’ status as a Exactus BioSolutions of any quantities such Product in such country(ies). Either (i) at the request of Compound Digital Diagnostics at the end of the Commercialization Wind-Down Period or Terminated Product(s(ii) remaining prior to the end of the Commercialization Wind-Down Period, if Digital Diagnostics has assumed responsibilities for regulatory activities under the Regulatory Approval, has received all clearances and Regulatory Approvals needed to sell and import the terminated Product in GSK’s a given terminated country, and provides written notice to Exactus BioSolutions that it is wishes to assume sale of the terminated Product in a terminated country, then, in either case (i) or (ii), Exactus BioSolutions shall sell and transfer to Digital Diagnostics such portion of the terminated Product inventory then held by Exactus BioSolutions or its Affiliate’s inventory, Affiliates’ as well as any components necessary for had been allocated to the Manufacture of the Compound and Terminated Product(sterminated country(ies) in GSK’s or its Affiliate’s inventory, and Amicus shall have the option, upon notice to GSK, to repurchase any such quantities of the Compound and/or Terminated Product(s) and/or components from GSK at a price equal to be mutually agreed the lowest price at which such Product was sold to a non-Related Party in such terminated country during the preceding twelve (12) month period. This Section 13.7(b) shall not apply in the case of termination by the Parties. If Amicus so elects to purchase any remaining quantities of Compound or Terminated Products or components from GSK as set forth herein, GSK will transfer to Amicus such quantities of inventory of Compound or Terminated Product(sExactus BioSolutions under Section 13.2(b) or components. ****** - Material has been omitted and filed separately with the Commissionbased on Safety Reasons.
Appears in 1 contract
Sources: Collaboration and License Agreement (Exactus, Inc.)
Commercialization. To avoid disruption Sanofi and its Affiliates and sublicensees shall continue, to the extent that Sanofi and its Affiliates and sublicensees continue to have stocks of supply of any Terminated Products usable Product, to patients if this Agreement is terminated after the Launch of a Terminated fulfill orders received from customers for Product in the Affected Area, GSK, its Affiliates and Sublicensees shall continue Field in the Territory until up to sell 180 days after the Terminated Products in each country later of the Affected Area for which Marketing Approval of such Terminated Product has been obtained, in accordance with the terms and conditions of this Agreement, until (A) the date on which Amicus MannKind notifies GSK Sanofi in writing that Amicus MannKind intends to Commercialize such Product or has secured an alternative distributor or licensee for such Terminated the Product and (B) Sanofi has initiated transition of the ▇▇▇▇ and Marketing Approvals for Product in the Field in the Territory to MannKind or such country of the Affected Areadistributor or licensee, but in no event for more for than ****** 12 months after the date of notice of termination. For Product sold by Sanofi after the effective date of a termination (i.e., after the expiration of the applicable termination notice period), the profit-or-loss provisions in Section 6.3 shall continue to apply. Notwithstanding the foregoing, Sanofi and its Affiliates and sublicensees shall cease such activities in the Territory upon 60 days written notice given by MannKind at any time after the effective date of a termination requesting that such activities (or portion thereof) cease. In the case of a termination of this Agreement (“Wind-Down Period”); provided that Amicus may terminate the Wind-Down Period in any country(ies) of the Affected Area upon ****** written its entirety, within 30 days after MannKind has given notice to GSK; provided further that GSK shall not be obligated Sanofi requesting the cessation of activities pursuant to promote the sale of Terminated Products in the Affected Area during the Wind-Down Period. Notwithstanding any other provision of this AgreementSection, during Sanofi shall notify MannKind of an estimate of the Wind-down Period, GSK’s quantity of Product and its Affiliates’ shelf life remaining in Sanofi’s inventory and Sublicensees’ rights with respect to the Terminated Products in the Affected Area shall be non-exclusive and, without limiting the foregoing, Amicus MannKind shall have the right to engage one or more other distributor(s) and/or licensee(s) of any Terminated Product in all or part of the Affected Area; provided, however, that in the event that Amicus does so engage one or more other distributor(s) and/or licensee(s) of any Terminated Product in all or part of the Affected Area, GSK shall have no further obligation to continue to sell the Terminated Products in the Affected Area or such part thereof, as applicable. Any Terminated Product sold or disposed by GSK in the Affected Area during the Wind-down Period shall be subject to applicable royalty payment obligations under Section 3.4 above, and for such purposes, Sections 3.4, 3.5, 3.7, 3.8, 3.9 and 3.11 shall survive. Within ****** following the expiration of the Wind-Down Period, GSK shall notify Amicus of any quantities of Compound or Terminated Product(s) remaining in GSK’s or its Affiliate’s inventory, as well as any components necessary for the Manufacture of the Compound and Terminated Product(s) in GSK’s or its Affiliate’s inventory, and Amicus shall have the option, upon notice to GSK, to repurchase purchase any such quantities of the Compound and/or Terminated Product(s) and/or components Product from GSK Sanofi at a price to be mutually agreed by the Parties. If Amicus so elects to To the extent MannKind does not purchase any remaining quantities of Compound or Terminated Products or components from GSK as set forth hereinsuch quantities, GSK will transfer to Amicus Sanofi may sell such quantities during the 180 days after the effective date of inventory of Compound or Terminated Product(s) or components. ****** - Material has been omitted and filed separately with such termination within the Commissionshelf life remaining for Product.
Appears in 1 contract
Sources: License and Collaboration Agreement (Mannkind Corp)
Commercialization. To avoid disruption of supply of any Terminated Products to patients if Unless this Agreement is terminated after the Launch of a Terminated Product in the Affected Areaexpires by its terms or pursuant to Section 13.4, GSKGalderma, its Affiliates and its Sublicensees shall continue to sell the Terminated market, promote, distribute and otherwise commercialize Products in each country of in the Affected Area Galderma Territory for which Marketing Approval of such Terminated Product therefor has been obtained, in accordance with the terms and conditions of this Agreement, until three (3) months after the date on which Amicus ZARS notifies GSK Galderma in writing that Amicus ZARS has secured an alternative distributor or licensee for such Terminated Product Product(s) in such country of the Affected Areacountry, but in no event for more than ****** nine (9) months after the effective date of any such termination of this Agreement (the “Wind-Down down Period”); provided that Amicus may terminate the Wind-Down Period Galderma, its Affiliates and its Sublicensees shall cease such activities, or any portion thereof, in any country(iesa given country upon sixty (60) of the Affected Area upon ****** written days notice to GSK; provided further by ZARS requesting that GSK shall not such activities (or portion thereof) be obligated to promote the sale of Terminated Products in the Affected Area during the Wind-Down Periodceased. Notwithstanding any other provision of this Agreement, during the Wind-down Period, GSK(A) Galderma’s and its Affiliates’ and Sublicensees’ rights with respect to the Terminated Products a Product in the Affected Area Galderma Territory shall be non-exclusive and, without limiting the foregoing, Amicus ZARS shall have the right to engage one or more other distributor(s) and/or licensee(s) of any Terminated a Product in all or part of the Affected Area; provided, however, that in the event that Amicus does so engage one or more other distributor(sGalderma Territory and (B) and/or licensee(s) Galderma shall be relieved of any Terminated Product in all or part of the Affected Area, GSK shall have no further obligation to continue to sell the Terminated Products in the Affected Area or such part thereof, as applicableits obligations under Section 6.4. Any Terminated Product sold or disposed by GSK in the Affected Area Galderma Territory during the Wind-down Period shall be subject to the other applicable royalty payment obligations under Section 3.4 Article 5 and Article 6 above, and for such purposes, Sections 3.4, 3.5, 3.7, 3.8, 3.9 and 3.11 shall survive. Within ****** following the thirty (30) days of expiration of the Wind-Down down Period, GSK Galderma shall notify Amicus ZARS of any quantities quantity of Compound or Terminated Product(s) Product remaining in GSKGalderma’s or its Affiliate’s inventory, as well as any components necessary for the Manufacture of the Compound inventory and Terminated Product(s) in GSK’s or its Affiliate’s inventory, and Amicus ZARS shall have the option, upon notice to GSK, to repurchase purchase from Galderma any such quantities of the Compound and/or Terminated Product(sProduct having at least twelve (12) and/or components from GSK additional months of shelf life, at a price equal to be mutually agreed by the PartiesGalderma COGS for such Products, up to maximum amount of such quantities equal to the number of Products sold in the preceding six (6) months. If Amicus so elects ZARS shall have the right, but not the obligation, to purchase any remaining additional quantities of Compound 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 Terminated 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 components 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 GSK the date of notice of such termination until such time as set forth hereinZARS is able, GSK will transfer using reasonable efforts to Amicus 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 inventory of Compound or Terminated Product(s) or components. ****** - Material has been omitted and filed separately with the CommissionGalderma COGS.
Appears in 1 contract
Sources: Development and Commercialization Agreement (Zars Inc/Ut)
Commercialization. To avoid a disruption of in the supply of any Terminated XenoPort Products to patients patients, if this Agreement is terminated after the Launch first commercial sale of a Terminated any XenoPort Product in the Affected AreaTerritory, GSK, Xanodyne and its Affiliates and Sublicensees shall continue to sell market, promote, distribute and otherwise commercialize (including with the Terminated assistance of any Co-Promotion Partner, to the extent permitted by any agreement with such Co-Promotion Partner) the XenoPort Products in each country of the Affected Area Territory for which Marketing Approval of such Terminated Product by the FDA has been obtainedobtained (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, until the date on which Amicus notifies GSK that Amicus has secured an alternative distributor or licensee for such Terminated Product in such country of the Affected Area[... * ...], but in no event more than *****[... * ...] after the effective date of any such termination of this Agreement (the “Wind-Down down Period”); provided that Amicus may terminate the Wind-Down Period in Xanodyne and its Affiliates shall cease such activities, or any country(iesportion thereof, upon [... * ...] notice by XenoPort requesting that such activities (or portion thereof) of the Affected Area upon ****** written notice to GSK; provided further that GSK shall not be obligated to promote the sale of Terminated Products in the Affected Area during the Wind-Down Periodceased. Notwithstanding any other provision of this Agreement, during the Wind-down Period, GSKXanodyne’s and its Affiliates’ and Sublicensees’ rights with respect to the Terminated Compound and XenoPort Products in the Affected Area Territory shall be non-exclusive and, without limiting the foregoing, Amicus XenoPort shall have the right to engage one or more other distributor(s) and/or licensee(s) of the Compound and/or any Terminated XenoPort Product in all or part of the Affected Area; provided, however, that in the event that Amicus does so engage one or more other distributor(s) and/or licensee(s) of any Terminated Product in all or part of the Affected Area, GSK shall have no further obligation to continue to sell the Terminated Products in the Affected Area or such part thereof, as applicableTerritory. Any Terminated Product Products sold or disposed by GSK Xanodyne in the Affected Area Territory during the Wind-down Period shall be subject to the applicable royalty payment obligations under Section 3.4 above, Article 6 above and for such purposes, Sections 3.4, 3.5, 3.7, 3.8, 3.9 and 3.11 shall surviveall relevant deductions or credits due to Xanodyne in accordance with this Agreement. Within *****[... * following the ...] of expiration of the Wind-Down down Period, GSK Xanodyne shall notify Amicus XenoPort of any quantities quantity of the Intermediate, Compound or Terminated Product(s) and/or XenoPort Products remaining in GSKXanodyne’s or its Affiliate’s inventory, as well as any components necessary for the Manufacture of the Compound inventory and Terminated Product(s) in GSK’s or its Affiliate’s inventory, and Amicus XenoPort shall have the option, upon notice to GSKXanodyne, to repurchase any such quantities of the Intermediate, Compound and/or Terminated Product(s) and/or components XenoPort Products, as applicable, from GSK Xanodyne at a price equal to be mutually agreed by [... * ...] calculated in accordance with GAAP and Xanodyne’s then-prevailing standard procedures for calculating costs of good sold. For the Parties. If Amicus so elects to purchase any remaining quantities sake of Compound or Terminated Products or components from GSK as set forth hereinclarity, GSK will transfer to Amicus such quantities of inventory of Compound or Terminated Product(s) or components. *****[... * - Material has been omitted and filed separately with the Commission...].
Appears in 1 contract
Sources: Licensing Agreement (Xenoport Inc)
Commercialization. To avoid disruption of supply of any Terminated Products to patients if this Agreement is terminated after the Launch of a Terminated Product in the Affected Area, GSK, its Affiliates and Sublicensees shall continue to sell the Terminated Products in each country of the Affected Area for which Marketing Approval of such Terminated Product has been obtained, in accordance with the terms and conditions of this Agreement, until the date on which Amicus notifies GSK that Amicus has secured an alternative distributor or licensee for such Terminated Product in such country of the Affected Area, but in no event more than ****** after the effective date of any such termination of this Agreement (“Wind-Down Period”); provided that Amicus may terminate the Wind-Down Period in any country(ies) of the Affected Area upon ****** written notice to GSK; provided further that GSK shall not be obligated to promote the sale of Terminated Products in the Affected Area during the Wind-Down Period. Notwithstanding any other provision of this Agreement, during the Wind-down Period, GSK’s and its Affiliates’ and Sublicensees’ rights with respect to the Terminated Products in the Affected Area shall be non-exclusive and, without limiting the foregoing, Amicus shall have the right to engage one or more other distributor(s) and/or licensee(s) of any Terminated Product in all or part of the Affected Area; provided, however, that in the event that Amicus does so engage one or more other distributor(s) and/or licensee(s) of any Terminated Product in all or part of the Affected Area, GSK shall have no further obligation to continue to sell the Terminated Products in the Affected Area or such part thereof, as applicable. Any Terminated Product sold or disposed by GSK in the Affected Area during the Wind-down Period shall be subject to applicable royalty payment obligations under Section 3.4 above, and for such purposes, Sections 3.4, 3.5, 3.7, 3.8, 3.9 and 3.11 shall survive. Within ****** following the expiration of the Wind-Down Period, GSK shall notify Amicus of any quantities of Compound or Terminated Product(s) remaining in GSK’s or its Affiliate’s inventory, as well as any components necessary for the Manufacture of the Compound and Terminated Product(s) in GSK’s or its Affiliate’s inventory, and Amicus shall have the option, upon notice to GSK, to repurchase any such quantities of the Compound and/or Terminated Product(s) and/or components from GSK at a price to be mutually agreed by the Parties. If Amicus so elects to purchase any remaining quantities of Compound or Terminated Products or components from GSK as set forth herein, GSK will transfer to Amicus such quantities of inventory of Compound or Terminated Product(s) or components. ****** - Material has been omitted and filed separately with the Commission.. 63
Appears in 1 contract
Sources: Licensing, Development, Manufacturing and Marketing Agreement
Commercialization. To avoid disruption of supply of any Terminated Products GSK, its Affiliates and Sublicensees, shall continue, to patients if this Agreement is terminated after the Launch of a Terminated Product in the Affected Area, extent that GSK, its Affiliates and Sublicensees shall continue to sell have stocks of usable Product, to fulfill orders received from customers for the Terminated Products Product in each country the GSK Territory (or, if the termination is limited to a specific country, within such country) until up to [**] days after the later of the Affected Area for which Marketing Approval of such Terminated Product has been obtained, in accordance with the terms and conditions of this Agreement, until (A) the date on which Amicus Sepracor notifies GSK in writing that Amicus Sepracor has secured an alternative distributor or licensee for such Terminated the Product in such country the GSK Territory and (B) GSK has initiated transition of the Affected Area▇▇▇▇ and Marketing Approvals for the Product in the GSK Territory (or, if the termination is limited to a specific country, within such country) to such distributor or licensee, but in no event for more for than [****** ] after the date of notice of termination. For the Products sold by GSK after the effective date of a termination (i.e., after the expiration of the applicable termination notice period), GSK shall continue to pay royalties on the amount of Net Sales from such sales pursuant to Section 7.3. Notwithstanding the foregoing, GSK, its Affiliates and its Sublicensees shall cease such activities in the GSK Territory (or, if termination is limited to a specific country, within such country), as the case may be, upon [**] written notice given by Sepracor at any time after the effective date of a termination requesting that such activities (or portion thereof) cease. In the case of a termination of this Agreement (“Wind-Down Period”); provided that Amicus may terminate the Wind-Down Period in any country(ies) of the Affected Area upon its entirety, within [****** written ] after Sepracor has given notice to GSK; provided further that GSK shall not be obligated requesting the cessation of activities pursuant to promote the sale of Terminated Products in the Affected Area during the Wind-Down Period. Notwithstanding any other provision of this AgreementSection, during GSK shall notify Sepracor of an estimate of the Wind-down Period, quantity of the Product and its shelf life remaining in GSK’s inventory and its Affiliates’ and Sublicensees’ rights with respect to the Terminated Products in the Affected Area shall be non-exclusive and, without limiting the foregoing, Amicus Sepracor shall have the right to engage one or more other distributor(s) and/or licensee(s) of any Terminated Product in all or part of the Affected Area; provided, however, that in the event that Amicus does so engage one or more other distributor(s) and/or licensee(s) of any Terminated Product in all or part of the Affected Area, GSK shall have no further obligation to continue to sell the Terminated Products in the Affected Area or such part thereof, as applicable. Any Terminated Product sold or disposed by GSK in the Affected Area during the Wind-down Period shall be subject to applicable royalty payment obligations under Section 3.4 above, and for such purposes, Sections 3.4, 3.5, 3.7, 3.8, 3.9 and 3.11 shall survive. Within ****** following the expiration of the Wind-Down Period, GSK shall notify Amicus of any quantities of Compound or Terminated Product(s) remaining in GSK’s or its Affiliate’s inventory, as well as any components necessary for the Manufacture of the Compound and Terminated Product(s) in GSK’s or its Affiliate’s inventory, and Amicus shall have the option, upon notice to GSK, to repurchase purchase any such quantities of the Compound and/or Terminated Product(s) and/or components Product from GSK at a price to be mutually agreed by for [**], being the Partiesamount [**]. If Amicus so elects to To the extent Sepracor does not purchase any remaining quantities of Compound or Terminated Products or components from GSK as set forth hereinsuch quantities, GSK will transfer to Amicus may sell such quantities of inventory of Compound or Terminated Product(s) or components. in the GSK Territory during the [****** - Material has been omitted and filed separately with ] after the Commissioneffective date of such termination within the shelf life remaining for the Product.
Appears in 1 contract
Sources: Development, License and Commercialization Agreement (Sepracor Inc /De/)
Commercialization. To avoid disruption of supply of any Terminated Products Product(s) to patients if this Agreement is terminated termination occurs after the Launch of a Terminated Product Product(s) in the relevant Affected Area, GSK, its Affiliates and Sublicensees shall continue to sell the Terminated Products Product(s) in each country of the relevant Affected Area for which Marketing Approval of such Terminated Product has been obtainedArea, in accordance with the terms and conditions of this Agreement, until the date on which Amicus notifies GSK that Amicus has secured an alternative distributor or licensee for such Terminated Product in such country of the Affected Area, but in no event more than up to ****** or such shorter period of time as requested by Amicus as provided below, after the effective date of any such termination of this Agreement any such Terminated Product(s) (“GSK Wind-Down Period”); provided that Amicus may terminate the GSK Wind-Down Period in any country(ies) country of the relevant Affected Area upon ****** written notice to GSK; provided further that GSK shall not be obligated to promote the sale of Terminated Products in the Affected Area during the GSK Wind-Down Period. Notwithstanding any other provision Subject to the foregoing obligations of this AgreementGSK, during the GSK Wind-down Down Period, GSK may transfer any remaining inventory of Terminated Product(s) from the Affected Area to a country within the GSK Territory for which GSK’s and its Affiliates’ and Sublicensees’ rights with respect to the Terminated Products in the Affected Area shall be non-exclusive and, without limiting the foregoing, Amicus shall such Product(s) have the right to engage one or more other distributor(s) and/or licensee(s) of any Terminated Product in all or part of the Affected Area; provided, however, that in the event that Amicus does so engage one or more other distributor(s) and/or licensee(s) of any Terminated Product in all or part of the Affected Area, GSK shall have no further obligation to continue to sell the Terminated Products in the Affected Area or such part thereof, as applicable. Any Terminated Product sold or disposed by GSK in the Affected Area during the Wind-down Period shall be subject to applicable royalty payment obligations under Section 3.4 above, and for such purposes, Sections 3.4, 3.5, 3.7, 3.8, 3.9 and 3.11 shall survivenot been terminated. Within ****** following the expiration of the GSK Wind-Down Period, GSK shall notify Amicus of any quantities of Compound or Terminated Product(s) for the Affected Area remaining in GSK’s or its Affiliate’s inventory, as well as any components necessary for the Manufacture of the Compound and Terminated Product(s) in GSK’s or its Affiliate’s inventory, Affiliates’ inventory and Amicus shall have the option, upon notice to GSK, to repurchase any such quantities of the Compound and/or Terminated Product(s) and/or components from GSK at a price equal to be mutually agreed by the PartiesGSK’s Manufacturing Costs. If Amicus so elects to purchase any remaining quantities of Compound or Terminated Products or components Product(s) from GSK as set forth herein, GSK will transfer to Amicus such quantities of inventory of Compound or Terminated Products. If Amicus does not elect to purchase any such remaining quantities of inventory of Terminated Products, GSK may transfer any such remaining inventory of Terminated Product(s) or components. ****** - Material has to a country within the GSK Territory for which GSK’s rights with respect to such Product(s) have not been omitted and filed separately with the Commissionterminated.
Appears in 1 contract
Sources: License and Collaboration Agreement (Amicus Therapeutics Inc)
Commercialization. To Solely in the case of a termination of this Agreement by GSK pursuant to Section 13.2, to avoid disruption of supply of any Terminated Products Product(s) to patients if this Agreement is terminated termination occurs after the Launch of a Terminated Product Product(s) in the Affected Area, GSKAmicus, its Affiliates and Sublicensees shall continue to sell the Terminated Products Product(s) in each country of the Affected Area for which Marketing Approval of such Terminated Product has been obtained, in accordance with the terms and conditions of this Agreement, until the date on which Amicus notifies GSK that Amicus has secured an alternative distributor or licensee for such Terminated Product in such country of the Affected Area, but in no event more than up to ****** or such shorter period of time as requested by GSK as provided below, after the effective date of any such termination of this Agreement with respect to any such Terminated Product(s) (“Amicus Wind-Down Period”); provided that Amicus GSK may terminate the Amicus Wind-Down Period in any country(ies) of the Affected Area upon ****** written notice to GSKAmicus; provided further that GSK (i) Amicus shall not be obligated to promote the sale of such Terminated Products in the Affected Area during the Amicus Wind-Down Period. Notwithstanding any other provision of this Agreement; and (ii) if the Terminated Product is a Co-Formulation Product, during the Wind-down Period, GSK’s then GSK shall continue to supply Amicus with its (and its Affiliates’ and Sublicensees’ rights with respect to the Terminated Products in the Affected Area shall be non-exclusive and, without limiting the foregoing, Amicus shall have the right to engage one or more other distributor(ssublicensees’) and/or licensee(s) reasonable requirements of any such Terminated Product in all or part of the Affected Area; provided, however, that in the event that Amicus does so engage one or more other distributor(s) and/or licensee(s) of any Terminated Product in all or part of the Affected Area, GSK shall have no further obligation to continue to sell the Terminated Products in the Affected Area or such part thereof, as applicable. Any Terminated Product sold or disposed by GSK in the Affected Area during the Wind-down Period shall be subject to applicable royalty payment obligations under Section 3.4 above, and for such purposes, Sections 3.4, 3.5, 3.7, 3.8, 3.9 and 3.11 shall survive. Within ****** following the expiration of the Amicus Wind-Down Period, GSK Amicus shall notify Amicus GSK of any quantities of Compound or the Terminated Product(s) remaining in GSK’s Amicus’ or its Affiliate’s inventory, as well as any components necessary for the Manufacture of the Compound Affiliates’ inventory and Terminated Product(s) in GSK’s or its Affiliate’s inventory, and Amicus GSK shall have the option, upon notice to GSKAmicus, to repurchase any such quantities of the Compound and/or Terminated Product(s) and/or components from GSK Amicus at a price equal to be mutually agreed by the PartiesAmicus’ Manufacturing Costs. If Amicus GSK so elects to purchase any remaining quantities of Compound or the Terminated Products or components Product(s) from GSK Amicus as set forth herein, GSK Amicus will transfer to Amicus GSK such quantities of inventory of Compound or the Terminated Product(s) or components. ****** - Material has been omitted and filed separately with the Commission).
Appears in 1 contract
Sources: License and Collaboration Agreement (Amicus Therapeutics Inc)