Common use of Commercialization Clause in Contracts

Commercialization. Provided that the termination of this Agreement is not a termination by Galderma pursuant to Section 12.2.4, if requested by NovaBay, Galderma and its Affiliates and Marketing Partners shall continue to distribute and 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, for 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 Agreement Wind-Down Period); provided that NovaBay may terminate the Agreement Wind-Down Period upon sixty (60) days’ notice to Galderma. Notwithstanding any other provision of this Agreement, during the Agreement Wind-Down Period, Galderma’s, its Affiliates’ and its Marketing Partners’ rights with respect to Collaboration Products (including the licenses granted under Section 7.1.1) shall be non-exclusive and NovaBay shall have the right to engage one or more other partner(s) or distributor(s) of Collaboration Products in the Field in all or part of the Galderma Territory. Any Collaboration Products sold or disposed by Galderma or its Affiliates or Marketing Partners during the Agreement Wind-Down Period shall be subject to the applicable royalties under Section 8.5. 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. ***Confidential treatment requested pursuant to a request for confidential treatment filed with the Securities and Exchange Commission. Omitted portions have been filed separately with the Commission.

Appears in 2 contracts

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

Commercialization. Provided that Except to the extent the applicable termination of was made in accordance with Section 14.6, if this Agreement is not terminated after the First Commercial Sale of a termination by Galderma pursuant Terminated Product and Takeda is the Commercial Lead with respect to Section 12.2.4the applicable Terminated Product, if requested by NovaBayTakeda, Galderma and its Affiliates and Marketing Partners its Sublicensees shall continue to distribute and sell Collaboration Products in the Field in each country of the Galderma Territory for which Marketing Approval therefor has been obtainedsuch Terminated Product, in accordance with the terms and conditions of this Agreement, in each country for a period requested by NovaBay not to exceed two (2) years from which Regulatory Approval therefor has been obtained, until [***] after the effective date of such expiration or termination (for purposes of this Section 12.6.3, the Agreement “Commercialization Wind-Down down Period); provided that NovaBay may terminate the Agreement Wind-Down Period Takeda, its Affiliates and its Sublicensees shall cease such activities, or any portion thereof, in a given country upon sixty (60) [***] days’ notice to Galdermaby Denali requesting that such activities (or portion thereof) be ceased. Notwithstanding any other provision of this Agreement, during the Agreement Commercialization Wind-Down down Period, Galderma’s, Takeda’s and its Affiliates’ and its Marketing PartnersSublicensees’ rights with respect to Collaboration Terminated Products (including the licenses granted under Section 7.1.1) shall be non-exclusive and NovaBay and, without limiting the foregoing, Denali shall have the right to engage one or more other partner(s) or distributor(s) and/or licensee(s) of Collaboration Products in the Field Terminated Product in all or part of the Galderma Territory. Any Collaboration Products Terminated Product sold or disposed of by Galderma or Takeda, its Affiliates or Marketing Partners its Sublicensees in the Territory during the Agreement Commercialization Wind-Down 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 royalties payment obligations to Takeda under Section 8.514.7.1. After Within [***] days of expiration of the Agreement Commercialization Wind-Down down Period, Galderma Takeda shall notify Denali of any quantity of Terminated Product remaining in Takeda’s inventory 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 Denali shall have the right option, upon notice to use and disclose for Takeda, to repurchase any purpose during such quantities of the Agreement Wind-Down Period and thereafter. Terminated Product from Takeda at a price equal to [***Confidential treatment requested pursuant ] of such quantities (to a request for confidential treatment filed with the Securities and Exchange Commission. Omitted portions have been filed separately with the Commissionextent [***]).

Appears in 2 contracts

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

Commercialization. Provided that 3.7.1 Prometheus shall solely control and assume all responsibility, at its own cost, for conducting all commercialization activities within the termination Prometheus Territory relating to the Product, including marketing, promotion, sales detailing and any other activities relating to the Exploitation of this Agreement is the Product or Sublicense of rights to the Product. 3.7.2 Prometheus may, in its sole discretion, package, label, market, promote and sell the Product in the Prometheus Territory under either or both of the Alizyme Trademark or another trademark owned or Controlled by Prometheus and may register upon notice to Alizyme one or more domain names in the Prometheus Territory utilizing the Alizyme Trademark alone (to the extent not a termination by Galderma pursuant registered to Section 12.2.4Alizyme in which case, if requested by NovaBayPrometheus, Galderma and its Affiliates and Marketing Partners Alizyme shall continue place a link from such Alizyme registered domain name to distribute and sell Collaboration Products in the Field in each country of the Galderma Territory for which Marketing Approval therefor has been obtained, a web page or website maintained in accordance with applicable Laws by Prometheus, its Affiliates and/or its Sublicensees in connection with the terms Exploitation of the Product in the Prometheus Territory) or in combination with another trademark owned or Controlled by Prometheus ("Prometheus Product Trademark") provided that Prometheus shall use Commercially Reasonable Efforts to ensure that its use of the Alizyme Trademark shall in no way reduce or diminish the reputation, image or prestige of the Alizyme Trademark. For the avoidance of doubt, Prometheus shall not be obligated to use any Alizyme Trademark in connection with the packaging, labeling, marketing, promotion or selling of the Product. Prometheus shall be responsible for the selection, registration, and conditions maintenance of this Agreementthe Prometheus Product Trademarks throughout the Prometheus Territory, for a period requested by NovaBay not as well as all expenses associated therewith; provided, however, that Prometheus shall provide advanced written notice to exceed two Alizyme of the name under which it intends to market the Product. With respect to the foregoing, Prometheus shall use good faith efforts to provide six (26) years from the effective date months advanced notice of any such use of such expiration or termination (for purposes name. 3.7.3 Each Party may, in its sole discretion, share marketing plans and materials with the other Party with the object of this Section 12.6.3, coordinating a world-wide marketing effort to maximize the Agreement Wind-Down Period); provided that NovaBay may terminate the Agreement Wind-Down Period upon sixty (60) days’ notice to Galderma. Notwithstanding any other provision of this Agreement, during the Agreement Wind-Down Period, Galderma’s, its Affiliates’ and its Marketing Partners’ rights with respect to Collaboration Products (including the licenses granted under Section 7.1.1) shall be non-exclusive and NovaBay shall have the right to engage one or more other partner(s) or distributor(s) of Collaboration Products in the Field in all or part commercial potential of the Galderma Territory. Any Collaboration Products sold or disposed by Galderma or its Affiliates or Marketing Partners during the Agreement Wind-Down Period shall be subject to the applicable royalties under Section 8.5. 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. ***Confidential treatment requested pursuant to a request for confidential treatment filed with the Securities and Exchange Commission. Omitted portions have been filed separately with the Commission.

Appears in 2 contracts

Sources: License Agreement (Prometheus Laboratories Inc), License Agreement (Prometheus Laboratories Inc)

Commercialization. Provided that the termination of If this Agreement is not terminated after the First Commercial Sale of a termination by Galderma pursuant to Section 12.2.4Terminated Denali Product in the Terminated Area, if requested by NovaBaySanofi, Galderma and its Affiliates and Marketing Partners its Sublicensees shall continue to distribute fulfill orders for the Terminated Area through their respective then-existing distribution network of internal and sell Collaboration Products in the Field in each country external distributors of the Galderma Territory for which Marketing Approval therefor has been obtainedsuch Terminated Denali Product, in accordance with the terms and conditions of this Agreement, in each country for a period requested by NovaBay not to exceed two (2) years from which Regulatory Approval therefor has been obtained, for [***] after the effective date of such expiration or termination (for purposes of “Commercialization Wind-down Period”); [***]; provided, further, that Sanofi, its Affiliates and its Sublicensees shall cease any such activities being conducted pursuant to this Section 12.6.3(f)(ii), or any portion thereof, in a given country within the Agreement Wind-Down Period); provided Terminated Area upon [***] notice by Denali requesting that NovaBay may terminate the Agreement Wind-Down Period upon sixty such activities (60or portion thereof) days’ notice to Galdermabe ceased. Notwithstanding any other provision of this Agreement, during the Agreement Commercialization Wind-Down down Period, Galderma’s, Sanofi’s and its Affiliates’ and its Marketing PartnersSublicensees’ rights with respect to Collaboration Products (including applicable Terminated Denali Product(s) in the licenses granted under Section 7.1.1) Terminated Area shall be non-exclusive and NovaBay and, without limiting the foregoing, Denali shall have the right to engage one or more other partner(sdistributor(s) or distributor(slicensee(s) of Collaboration Products such Terminated Denali Product(s) in any country within the Field in all or part of the Galderma TerritoryTerminated Area. Any Collaboration Products Terminated Denali Product sold or disposed of by Galderma or Sanofi, its Affiliates or Marketing Partners its Sublicensees in any country within the Terminated Area during the Agreement Commercialization Wind-Down down Period shall be subject to the applicable royalties payment obligations under Section 8.5. 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 ProductArticle 7 (Payments). In addition, Galderma shall promptly provide NovaBay copies if at the effective time of customer lists 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 other customer information relating agree upon a plan for the orderly wind down of such activities for a period not 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. exceed [***Confidential treatment requested pursuant ]. Any FTE Costs or Out-of-Pocket Costs incurred by Sanofi or its Affiliates in accordance with such plan for the wind down of Sanofi’s activities shall be (a) reimbursed by Denali if the relevant Terminated Denali Product is not, immediately prior to the effective date of such termination, a request for confidential treatment filed with Cost Profit Sharing Product; or (b) continue to be allocated towards Allowable Expenses until such wind down is complete, if the Securities and Exchange Commission. Omitted portions have been filed separately with relevant Terminated Denali Product is a Cost Profit Sharing Product immediately prior to the Commissioneffective date of such termination.

Appears in 1 contract

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

Commercialization. Provided that the termination of this Agreement is (a) So long as Company has not a termination by Galderma pursuant elected under Section 3.3(d) to Section 12.2.4, if requested by NovaBay, Galderma and its Affiliates and Marketing Partners shall continue to distribute and 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, for 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 Agreement Wind-Down Period); provided that NovaBay may terminate the Agreement Wind-Down Period upon sixty (60) days’ notice to Galderma. Notwithstanding any other provision of this Agreement, during the Agreement Wind-Down Period, Galderma’s, its Affiliates’ and its Marketing Partners’ rights reduce Company’s Development Cost Sharing Percentage with respect to Collaboration Products (including the licenses granted under Section 7.1.1) U.S., Company shall be non-exclusive the commercial lead for the U.S. From and NovaBay after [ * ], Novartis shall be the commercial lead for the U.S. At all times during the Term, Novartis shall be the commercial lead throughout the Territory outside of the U.S. The commercial lead, with respect to the U.S. or the Territory outside the U.S., respectively, shall be referred to herein as the “Lead Commercialization Party” for such jurisdiction (as applicable, the “Lead Commercialization Party”). (b) The applicable Lead Commercialization Party shall implement and have sole authority and responsibility for the right to engage one or more other partner(s) or distributor(s) Commercialization of Collaboration Products in the Field U.S. and Territory outside the U.S., in each case in accordance with the applicable Commercialization Plan and the terms of this Agreement. The applicable Lead Commercialization Party shall book all or part monies received by Selling Parties from Third Party customers for sale of Collaboration Products. All business decisions regarding Commercialization of Collaboration Products in the U.S. and Territory outside the U.S. shall be within the sole discretion of the Galderma Territoryapplicable Lead Commercialization Party. Any All materials used in the promotion of all Collaboration Products sold or disposed by Galderma or its Affiliates or Marketing Partners during in the Agreement Wind-Down Period shall be subject to U.S. and Territory outside the applicable royalties under Section 8.5. After U.S., including product packaging, materials used in detailing doctors, product messaging and content used in the Agreement Wind-Down Period, Galderma and its Affiliates and Marketing Partners shall not make any representation regarding their status as a licensee promotion 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 be within the right sole discretion of the applicable Lead Commercialization Party. The applicable Lead Commercialization Party shall permit the other Party, through its representatives on the JCC, to use provide advice and disclose commentary with respect to Commercialization activities performed by or on behalf of the applicable Lead Commercialization Party or the other Party, and the applicable Lead Commercialization Party shall in good faith consider any such advice and commentary; and such other Party shall cooperate and assist with the applicable Lead Commercialization Party’s Commercialization activities at the reasonable request of such applicable Lead Commercialization Party. (c) At least [ * ] prior to the anticipated First Commercial Sale of a Collaboration Product in the U.S. and Territory outside the U.S., the applicable Lead Commercialization Party shall submit to the JCC a comprehensive plan (each, a “Commercialization Plan”) that describes the pre-launch, launch and subsequent Commercialization of such Collaboration Product in the U.S. or the Territory outside the U.S., as applicable, (including anticipated activities relating to messaging, branding, pricing, advertising, planning, marketing, sales force training and allocation, and distribution), and strategies for implementing those activities and the associated budget for such activities. The applicable Lead Commercialization Party shall permit the other Party, through its representatives on the JCC, to provide advice and commentary on such Commercialization Plan, and the applicable Lead Commercialization Party shall in good faith consider any such advice and commentary. On an annual basis, or more often as the Parties deem appropriate, the applicable Lead Commercialization Party shall prepare amendments to the then-current applicable Commercialization Plans and shall submit such amendments to the JCC for review and comment by the other Party. The applicable Lead Commercialization Party shall not be required to obtain the JCC’s approval of the applicable Commercialization Plan or any amendment thereto prior to its implementation; provided, however, that the applicable Lead Commercialization Party may not allocate responsibility for any purpose during Commercialization activity to the Agreement Wind-Down Period and thereafter. ***Confidential treatment requested pursuant to a request for confidential treatment filed with other Party in the Securities and Exchange Commission. Omitted portions have Commercialization Plan or amendment thereof unless such allocation has been filed separately with the Commissionapproved by such other Party.

Appears in 1 contract

Sources: Collaboration and License Agreement (Aduro Biotech, Inc.)

Commercialization. Provided that the termination 6.1 Commercialization of this Agreement is not a termination by Galderma pursuant to Section 12.2.4, if requested by NovaBay, Galderma and its Affiliates and Marketing Partners shall continue to distribute and sell Collaboration VEGF Products in Co-Marketing Countries In the Field event (and for so long as) the Parties are not permitted under local Law to Co-Promote a VEGF Product in each a country in the Territory, but are permitted to Co-Market such VEGF Product in such country, then Regeneron may elect, prior to First Commercial Sale in such country of such VEGF Product, to Co-Market the Galderma Territory for which Marketing Approval therefor has been obtainedVEGF Product in such country in accordance with this Section 6.1 and, to the extent not inconsistent therewith and not prohibited by applicable Law in such country, in accordance with the terms obligations set forth in this Article 6 and conditions the other provisions of this Agreement. Aventis shall supply Regeneron at Aventis’ Manufacturing Cost with its Commercial Supply Requirements of VEGF Products in the Co-Marketing Countries to the extent reasonably available giving higher priority to the Commercial Supply Requirements of countries consistent with their relative contribution to the overall commercial potential of the VEGF Products, for a period requested by NovaBay not and giving equal priority to exceed two (2) years from Aventis’ Commercial Supply Requirements in such Co-Marketing Countries. In the effective date of event any such expiration or termination (for purposes provisions of this Agreement are prohibited by applicable Law in a Co-Marketing Country, then such provision shall be considered a Severed Clause under Section 12.6.3, the Agreement Wind-Down Period); provided that NovaBay may terminate the Agreement Wind-Down Period upon sixty (60) days’ notice to Galderma. Notwithstanding any other provision of this Agreement, during the Agreement Wind-Down Period, Galderma’s, its Affiliates’ and its Marketing Partners’ rights 20.7 solely with respect to Collaboration such Co-Marketing Country. 6.2 Co-Commercialization of VEGF Products in Co-Commercialization Countries (including a) Exercise of Option by Regeneron. In the licenses granted under Section 7.1.1event that Regeneron desires to Co-Promote a VEGF Product in a particular Co-Commercialization Country for use in a Therapeutic Area, Regeneron shall notify Aventis of [****************] If Regeneron does not timely notify Aventis of its preliminary indication or of its final decision within the periods set forth in clause (i) or (ii) above, as applicable, Regeneron shall not be entitled to exercise its option to Co-Promote such VEGF Product in such Co-Commercialization Country for use in such Therapeutic Area until on or after the [************************]. (b) Co-Commercialization. Aventis and Regeneron (through their respective Affiliates where appropriate) shall Co-Commercialize VEGF Products under the applicable Product Trademarks in each Co-Commercialization Country in accordance with the then-current and applicable Country Co-Commercialization Plan and Country Co-Commercialization Budget. Each Party shall use, or shall cause its local Affiliates to use, Commercially Reasonable Efforts to Co-Commercialize the VEGF Products in the Co-Commercialization Countries, carry out the activities assigned to it in the applicable Country Co-Commercialization Plan and conduct all such activities in compliance with applicable Laws. Each Party shall ensure that its Commercialization activities conform with the parameters in the approved Country Co-Commercialization Plan and the Global Co-Commercialization Plan. No Party may initiate or sponsor any Non-Approval Trial in a Co-Commercialization Country without prior approval from the applicable Joint Country Commercialization Sub-Committee. (c) Decision to Discontinue Co-Commercialization. In the event that Regeneron decides it no longer wishes to Co-Commercialize a VEGF Product in a particular Co-Commercialization Country for use in a Therapeutic Area or does not wish to maintain its minimum sales force FTE requirement for use in such Therapeutic Area, Regeneron must give Aventis [***] prior written notice of such decision. At the end of such [***] period, Regeneron shall cease all Co-Commercialization activities with respect to such VEGF Product in such Co-Commercialization Country for use in such Therapeutic Area. Once Regeneron exercises its rights to cease Co-Commercializing in a Co-Commercialization Country for use in a Therapeutic Area, Regeneron will not again be nonable to exercise its rights pursuant to Section 6.2(a) to Co-exclusive and NovaBay Commercialize such VEGF Product in such Co-Commercialization Country, except with the prior written consent of the Joint Country Commercialization Sub-Committee with respect to such Co-Commercialization Country, such consent not to be unreasonably withheld or delayed, it being understood that it shall not be unreasonable for such consent to be withheld if Aventis’ representatives on such Joint Country Commercialization Sub-Committee reasonably determine that such Co-Promotion would be inconsistent with the Collaboration Purpose or would require Aventis to unreasonably restructure its sales force. Regeneron shall have the right to engage one or more other partner(srecommence Co-Commercialization of a VEGF Product in a Co-Commercialization Country for use in a Therapeutic Area terminated pursuant to this Section 6.2(c) or distributor(s) only once. Any such recommencement will occur no earlier than [**********] after Regeneron’s request therefor. 6.3 Co-Commercialization Plans. The initial Country Co-Commercialization Plan and Country Co-Commercialization Budget for each VEGF Product in each Co-Commercialization Country will be prepared by the applicable Joint Country Commercialization Sub-Committee at least [**********] before the Anticipated First Commercial Sale of Collaboration Products such VEGF Product in such Co-Commercialization Country. Each Country Co-Commercialization Plan and Country Co-Commercialization Budget for each subsequent Contract Year shall be prepared by the Field in all or part applicable Joint Country Commercialization Sub-Committee at least [**********] prior to the end of the Galderma Territorythen current Contract Year. Any Collaboration Products sold For the avoidance of doubt any disputes regarding a Country Co-Commercialization Plan or disposed by Galderma or its Affiliates or Marketing Partners during the Agreement WindCountry Co-Down Period Commercialization Budget shall be subject determined in accordance with Section 3.12. Each Country Co-Commercialization Plan and Country Co-Commercialization Budget shall include, as applicable: (a) strategies for Co-Promoting the VEGF Products, including recommended target Professionals for such activities, Strengths, Weaknesses, Opportunities and Threats analysis and competitive analysis; (b) the allocation between the Parties of responsibilities for marketing, sales and promotional activities and, with respect to sales representatives, the percentage of such representatives’ time dedicated to the applicable royalties under Section 8.5. After the Agreement Wind-Down Period, Galderma and its Affiliates and Marketing Partners shall not make any representation regarding their status as a licensee sale 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 VEGF Products, which NovaBay shall have be commensurate with the right percentage of total annual incentive payments which will be payable to use such representatives in respect of their sales of VEGF Products; (c) anticipated marketing, sales and disclose for any purpose during promotion efforts by each Party (or its Affiliates); (d) market and sales forecasts in a form to be agreed between the Agreement WindParties via the applicable Joint Country Commercialization Sub-Down Period Committee; (e) advertising, public relations and thereafter. other promotional programs and sampling, to be used in the Co-Promotion; (f) patient advocacy programs, medical affairs programs, including professional symposia and other educational activities, and medical affairs studies based upon Joint Country Commercialization Sub-Committee-approved protocols; (g) reimbursement and patient assistance, [***Confidential treatment requested pursuant ******************]; (h) Non-Approval Trials in the applicable Co-Commercialization Country relating to the VEGF Products, which trials shall be based upon Joint Country Commercialization Sub-Committee-approved protocols; and (i) as appropriate, a request training plan for confidential treatment filed with the Securities Parties’ sales representatives. In addition to the detailed plan and Exchange Commission. Omitted portions have been filed separately with budget for the Commissionnext upcoming calendar year, each Country Co-Commercialization Plan and Country Co-Commercialization Budget will include an outline of the projected plan and estimated budget for the following calendar year.

Appears in 1 contract

Sources: Collaboration Agreement (Regeneron Pharmaceuticals Inc)

Commercialization. Provided that the termination of this Agreement is not a termination by Galderma pursuant to Section 12.2.4At MGI’s request, if requested by NovaBayMarketing Authorization has been or is obtained for the Licensed Products, Galderma then Licensee and its Affiliates and Marketing Partners shall continue to distribute and sell Collaboration Commercialize the Licensed Products in the Field same manner in each country of in the Galderma Territory for which Marketing Approval therefor Authorization therefore has been obtained, in accordance with the terms and conditions of this Agreement, for a period requested by NovaBay not to exceed two hundred forty (2240) years from the effective date of days following such expiration or termination (for purposes of this Section 12.6.3, the Agreement Wind-Down Period); provided it being understood that NovaBay may terminate the Agreement Wind-Down Period upon sixty (60) days’ notice MGI and Licensee will work diligently to Galdermatransition such activities as soon as reasonably practicable. Notwithstanding any other provision of this Agreement, during the Agreement Wind-Down down Period, Galderma’s, Licensee’s and its Affiliates’ and its Marketing Partners’ rights with respect to Collaboration the Licensed Products (including the licenses granted under Section 7.1.1) shall be non-exclusive exclusive, and NovaBay MGI shall have the right to engage one or more other partner(s) or distributor(s) and/or licensee(s) to Develop and Commercialize the Licensed Products in all portions of Collaboration the Territory that have been terminated. Article 3 shall continue to apply with respect to all the Licensed Products sold, used or disposed by Licensee and its Affiliates during the Wind-down Period or otherwise as set forth below. All rights of Licensee and its Affiliates with respect to the Licensed Products shall be terminated at the end of the Wind-down Period, and unless otherwise mutually agreed or unless rights have been terminated only with respect to a specified country, and Licensee retains rights to Develop and Commercialize the Licensed Products for other countries, all the Licensed Products in the Field in all or part possession of the Galderma Territory. Any Collaboration Products sold or disposed by Galderma or Licensee and its Affiliates or Marketing Partners that are not sold during the Agreement such Wind-Down down Period shall be subject destroyed, provided, however, that Licensee shall have a minimum of one hundred-eighty (180) days following termination of the Wind-down Period to sell its remaining inventory, without regard to the applicable royalties under Section 8.5. After actual length of the Agreement Wind-Down down Period, Galderma and its Affiliates and Marketing Partners . Any remaining unsold inventory 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 be transferred 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. ***Confidential treatment requested pursuant to a request for confidential treatment filed with the Securities and Exchange Commission. Omitted portions have been filed separately with the CommissionMGI at cost.

Appears in 1 contract

Sources: License Agreement (Mgi Pharma Inc)

Commercialization. Provided that 5.1.1 Subject to oversight by the termination of this Agreement is not a termination by Galderma pursuant JSC, Astellas shall be responsible for launching and commercializing, and shall use Diligent Efforts to Section 12.2.4launch and commercialize, if requested by NovaBay, Galderma and its Affiliates and Marketing Partners shall continue to distribute and sell Collaboration Products in the Field Product in each country of in the Galderma Territory for which Marketing Approval therefor has been obtained, in accordance with a commercialization plan submitted by Astellas to the terms JSC (“Commercialization Plan”). Without limiting the foregoing, Astellas agrees to use Diligent Efforts to launch the Product as soon as practicable in the Territory, and conditions thereafter to market, promote and sell such Product and to maximize the Net Sales of the Product in the Territory. Astellas agrees to provide to the JSC updated versions of the Commercialization Plan at least annually, and any material modification or addition to the Commercialization Plan within a reasonable period of time prior to adoption and implementation thereof. Astellas shall keep XenoPort reasonably informed as to the progress of its launch and commercialization activities relating to the Product in the Territory, by way of updates to the JSC at its meetings and as otherwise reasonably requested by XenoPort. It is understood and agreed that, subject to oversight by the JSC, and consistent with the other provisions of this Agreement, all commercialization efforts for a period requested by NovaBay not to exceed two (2) years from the effective date Product in the Territory shall be at the sole discretion and expense of such expiration or termination (for purposes of this Section 12.6.3, the Agreement Wind-Down Period); provided that NovaBay may terminate the Agreement Wind-Down Period upon sixty (60) days’ notice to Galderma. Notwithstanding any other provision of this Agreement, during the Agreement Wind-Down Period, Galderma’sAstellas, its Affiliates’ and Affiliates or Subdistributors. 5.1.2 XenoPort or its Marketing Partners’ rights with respect to Collaboration Products (including the licenses granted under Section 7.1.1licensee(s) shall be non-exclusive responsible for launching and NovaBay shall have commercializing the right to engage one or more other partner(s) or distributor(s) of Collaboration Products in Product outside the Field in all or part of the Galderma Territory. Any Collaboration Products sold or disposed by Galderma or its Affiliates or Marketing Partners during the Agreement Wind-Down Period XenoPort shall be subject keep Astellas reasonably informed as to the applicable royalties under Section 8.5. After the Agreement Wind-Down Period, Galderma progress of its and/or [... * ...] its other licensees’ launch 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 commercialization activities relating to Collaboration Products Product outside the Territory, by way of updates to the JSC at its meetings and as otherwise reasonably necessary requested by Astellas but no more often than once annually other than at the JSC meeting. It is understood and agreed that all commercialization efforts for the Product outside * Certain confidential information contained in Galderma’s reasonable opinion for NovaBay to continue to Commercialize such Collaboration Productsthis document, which NovaBay shall have the right to use marked by brackets, has been omitted and disclose for any purpose during the Agreement Wind-Down Period and thereafter. ***Confidential treatment requested pursuant to a request for confidential treatment filed separately with the Securities and Exchange CommissionCommission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. Omitted portions have been filed separately with the CommissionTerritory shall be at the sole discretion and expense of XenoPort, its Affiliates or its other licensees.

Appears in 1 contract

Sources: Distribution and License Agreement (Xenoport Inc)

Commercialization. Provided that To avoid disruption of supply of any Terminated Product(s) to patients if termination occurs after the termination Launch of this Agreement is not a termination by Galderma pursuant to Section 12.2.4Terminated Product(s) in the relevant Affected Area, if requested by NovaBayGSK, Galderma and its Affiliates and Marketing Partners Sublicensees shall continue to distribute and sell Collaboration Products the Terminated Product(s) in the Field in each country of the Galderma Territory for which Marketing Approval therefor has been obtainedrelevant Affected Area, in accordance with the terms and conditions of this Agreement, for a up to ****** or such shorter period of time as requested by NovaBay not to exceed two (2) years from Amicus as provided below, after the effective date of any such expiration or termination of any such Terminated Product(s) (for purposes of this Section 12.6.3, the Agreement “GSK Wind-Down Period); provided that NovaBay Amicus may terminate the Agreement GSK Wind-Down Period in any country of the relevant Affected Area upon sixty (60) days’ ****** written notice to GaldermaGSK; 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 Agreement GSK Wind-Down Period, Galderma’s, its Affiliates’ and its Marketing Partners’ 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 rights with respect to Collaboration Products (including such Product(s) have not been terminated. Within ****** following the licenses granted under Section 7.1.1) shall be non-exclusive and NovaBay shall have the right to engage one or more other partner(s) or distributor(s) of Collaboration Products in the Field in all or part expiration of the Galderma Territory. Any Collaboration Products sold or disposed by Galderma or its Affiliates or Marketing Partners during the Agreement Wind-Down Period shall be subject to the applicable royalties under Section 8.5. After the Agreement GSK Wind-Down Period, Galderma GSK shall notify Amicus of any quantities of Terminated Product(s) for the Affected Area remaining in GSK’s or its Affiliates’ inventory 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 Amicus shall have the right option, upon notice to use and disclose for GSK, to repurchase any purpose during such quantities of the Agreement Wind-Down Period and thereafterTerminated Product(s) from GSK at a price equal to GSK’s Manufacturing Costs. ***Confidential treatment requested pursuant If Amicus so elects to purchase any remaining quantities of Terminated Product(s) from GSK as set forth herein, GSK will transfer to Amicus such quantities of inventory of 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) to a request country within the GSK Territory for confidential treatment filed which GSK’s rights with the Securities and Exchange Commission. Omitted portions respect to such Product(s) have not been filed separately with the Commissionterminated.

Appears in 1 contract

Sources: License and Collaboration Agreement (Amicus Therapeutics Inc)

Commercialization. Provided that 6.1 Ortho as Marketing Party. Ortho will be the termination of this Agreement is not a termination by Galderma pursuant to Section 12.2.4, if requested by NovaBay, Galderma and its Affiliates and Marketing Partners shall continue to distribute and 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, for 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 Agreement Wind-Down Period); provided that NovaBay may terminate the Agreement Wind-Down Period upon sixty (60) days’ notice to Galderma. Notwithstanding any other provision of this Agreement, during the Agreement Wind-Down Period, Galderma’s, its Affiliates’ and its Marketing Partners’ rights marketing Party with respect to all Collaboration Products. As marketing Party Ortho shall have full and exclusive decision making authority with respect to all Commercialization Activities for all Collaboration Products, provided that such decisions are consistent with this Agreement and except as otherwise set forth in this Agreement. 6.2 GTx's Option to Co-Promote in the United States. GTx shall have an option to provide Details in the United States for each Collaboration Product Developed pursuant to the GTx/Ortho Development to urologists who are licensed to practice in the United States, provided that GTx meets the requirements set forth in this Article VI, and subject to the provisions of Section 6.3 and 6.7. Any such activities conducted by GTx pursuant to this Article VI, if GTx exercises such option, shall be deemed "Co-Promotion." GTx may exercise its option to Co-Promote on a Product by Product basis, and a decision not to Co-Promote a specific Product shall not affect GTx's rights to Co-Promote any other Product under this Agreement. However, if GTx fails to exercise its option to Co-Promote any specific Product, or later terminates its Co-Promotion of such Product, such non-exercise or termination shall be irrevocable as for such Product. Additional Collaboration Products will be Co-Promoted under the same terms as recited herein with respect to the first Collaboration Product. 6.3 GTx to Notify Ortho of its Election to Co-Promote; Changes in the GTx Audience. (including a) GTx may exercise its option by informing Ortho in writing of its decision to exercise the licenses granted under Section 7.1.1) Co-Promotion option for a Collaboration Product [ * ] after [ * ]. Upon GTx's exercise of such option, the United States shall be nonbecome the Co-exclusive and NovaBay Promotion Territory with respect to such Collaboration Product, GTx shall have the right to engage one or more other partner(sperform Details targeting the GTx Audience (determined in accordance with Section 6.3(b)) or distributor(s) with respect to such Collaboration Product, and the provisions of Collaboration Products in the Field in all or part of the Galderma Territory. Any Collaboration Products sold or disposed by Galderma or its Affiliates or Marketing Partners during the Agreement Wind-Down Period Article VII shall be subject used in determining additional compensation to the applicable royalties under Section 8.5. 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 be paid to Collaboration Products reasonably necessary in Galderma’s reasonable opinion for NovaBay to continue to Commercialize such Collaboration Products, which NovaBay GTx. (b) GTx shall have the right to use Co-Promote Collaboration Products to all of the practicing urologists in the United States, and disclose to elect to include a portion of, or all of, such physicians in the GTx Audience, subject to Section 6.7 and this Section 6.3. Within [ * ] after GTx first exercises its right to Co-Promote, GTx shall provide to Ortho a list of urologists licensed to practice in the United States that will constitute the GTx Audience, for Ortho's approval thereof, which shall not be unreasonably withheld or delayed, and which approval or disapproval shall be consistent with this Agreement. GTx shall periodically [ * ] update the list of urologists that constitute the GTx Audience, provided that any purpose such change shall not become effective until [ * ] after Ortho receives any updated list from GTx, and further provided that such changes shall be in accordance with Section 6.3(c). Ortho shall have [ * ], and [ * ] consistent with this Agreement. Except as provided in Section 6.7, GTx shall have the exclusive right to provide Details for the GTx Audience. (c) During the time GTx is Co-Promoting a Product, GTx shall not have the right to alter the number of physicians included in the GTx Audience for a given Product by [ * ] in any given [ * ] commencing after GTx begins to Co-Promote such Product without Ortho's approval, which shall not be unreasonably withheld or delayed and which shall be consistent with this Agreement. GTx shall notify Ortho in writing of any such change in the number of physicians included in the GTx Audience [ * ] before the end of any relevant [ * ] for which it desires such increase to apply. Additionally, if GTx has elected to Co-Promote Products pursuant to this Article VI but has not performed its obligations under Section 6.6(a)(iv), and therefore has [ * ], then GTx shall have the right to increase the proportion of the GTx Audience to which it has the right to provide Details by [ * ] in each [ * ] following the [ * ] of GTx's commencement of Co-Promotion of such Products, provided that GTx gives written notice to Ortho [ * ] before the end of any relevant [ * ] during which it is then Co-Promoting such Product to less than all of the GTx Audience stating the proportion of the GTx Audience by which GTx desires to increase its Detailing efforts during the Agreement Wind[ * ]. For clarity, GTx may only increase the proportion of the GTx Audience to which it will Co-Down Period Promote if GTx has [ * ]. 6.4 Marketing and thereafterSales Committee. ***Confidential treatment requested pursuant Ortho and GTx will form a Marketing and Sales Committee [ * ] to a request for confidential treatment filed the first anticipated Launch Date. The Marketing and Sales Committee shall meet from time to time [ * ], at mutual agreeable times and locations, to discuss and coordinate the Marketing and Co-Promotion of the Collaboration Product, including but not limited to, the assignment of Details and to discuss the Marketing and Sales Plan. Ortho will have the final responsibility (subject to GTx's rights to Co-Promote), with the Securities cooperation and Exchange Commissionassistance of GTx for defining the resources required for the marketing and sale of the Collaboration Product, and for establishing Detailing, Marketing, pricing and promotion strategies with respect to the Collaboration Product and budgets therefor. Omitted portions have been filed separately Any disagreements or disputes arising from the Marketing and Sales Committee shall be resolved in a matter consistent with the Commission[ * ] this Agreement.

Appears in 1 contract

Sources: Joint Collaboration and License Agreement (GTX Inc /De/)

Commercialization. Provided that the termination To avoid disruption of supply of any Terminated Products to patients if this Agreement is not terminated after the Launch of a termination by Galderma pursuant to Section 12.2.4Terminated Product in the Affected Area, if requested by NovaBayGSK, Galderma and its Affiliates and Marketing Partners Sublicensees shall continue to distribute and sell Collaboration the Terminated Products in the Field in each country of the Galderma Territory Affected Area for which Marketing Approval therefor 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 a period requested by NovaBay not to exceed two (2) years from such Terminated Product in such country of the Affected Area, but in no event more than ****** after the effective date of any such expiration or termination (for purposes of this Section 12.6.3, the Agreement (“Wind-Down Period); provided that NovaBay Amicus may terminate the Agreement Wind-Down Period in any country(ies) of the Affected Area upon sixty (60) days’ ****** written notice to GaldermaGSK; 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 Agreement Wind-Down down Period, Galderma’s, GSK’s and its Affiliates’ and its Marketing PartnersSublicensees’ rights with respect to Collaboration the Terminated Products (including in the licenses granted under Section 7.1.1) Affected Area shall be non-exclusive and NovaBay and, without limiting the foregoing, Amicus shall have the right to engage one or more other partner(s) or distributor(s) and/or licensee(s) of Collaboration Products in the Field any Terminated Product in all or part of the Galderma TerritoryAffected 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 Collaboration Products Terminated Product sold or disposed by Galderma or its Affiliates or Marketing Partners GSK in the Affected Area during the Agreement Wind-Down down Period shall be subject to the applicable royalties royalty payment obligations under Section 8.53.4 above, and for such purposes, Sections 3.4, 3.5, 3.7, 3.8, 3.9 and 3.11 shall survive. After Within ****** following the Agreement expiration of the Wind-Down Period, Galderma 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 Affiliates Affiliate’s inventory, 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 Amicus shall have the right option, upon notice to use and disclose for GSK, to repurchase any purpose during such quantities of the Agreement Wind-Down Period and thereafterCompound 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. ***Confidential treatment requested pursuant to a request for confidential treatment filed with the Securities *** - Material has been omitted and Exchange Commission. Omitted portions have been filed separately with the Commission.. 63

Appears in 1 contract

Sources: Licensing, Development, Manufacturing and Marketing Agreement

Commercialization. Provided Dermelix will have the exclusive right to Commercialize Licensed Products itself or through one or more Affiliates or Sublicensees selected by Dermelix, in its sole discretion. Subject to Section 9.7, Dermelix (itself or through one or more Affiliates or Sublicensees selected by Dermelix, in its sole discretion) shall be required to use Commercially Reasonable Efforts to Commercialize at least one (1) Licensed Product for the Primary Indication and at least one (1) Licensed Product for each Additional Indication selected by Dermelix under Section 2.4 or Section 2.5, in the Territory in the Field. If Exicure reasonably believes that the termination Dermelix (or its Affiliate or Sublicensee, as applicable) has failed to use Commercially Reasonable Efforts to Commercialize Licensed Products as described in this paragraph, then such failure, if not cured, shall be grounds for a material breach of this Agreement is not a termination by Galderma pursuant Agreement, subject to Section 12.2.4, if requested by NovaBay, Galderma and its Affiliates and Marketing Partners shall continue to distribute and 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 termination provisions of Section 9.4 and conditions the dispute resolution provisions of this AgreementArticle 10. Upon any final determination of an uncured material breach under the provisions of Section 9.4 and Article 10, for 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 Agreement Wind-Down Period); provided that NovaBay may terminate the Agreement Wind-Down Period upon sixty (60) days’ notice to Galderma. Notwithstanding any other provision of this Agreement, during the Agreement Wind-Down Period, Galderma’s, its Affiliates’ and its Marketing Partners’ rights with respect to Collaboration Products (including the licenses granted under Section 7.1.1) shall be non-exclusive and NovaBay Exicure shall have the right to engage one or more other partner(sterminate this Agreement immediately on written notice to Dermelix, with respect to the license rights granted to Dermelix under Article 2 with respect to the Indication(s) or distributor(s) to which the breach applies. Dermelix will bear all costs and expenses associated with Commercialization of Collaboration Licensed Products in the Field Field. Notwithstanding the foregoing, Dermelix will inform and consult with Exicure on important strategic matters, and in particular matters related to pricing of Licensed Products, as set out in the Guiding Principles. Notwithstanding the foregoing, this Agreement and the license rights granted under Article 2 shall continue in full force in effect with respect to all or part of the Galderma Territory. Any Collaboration Products sold or disposed by Galderma or its Affiliates or Marketing Partners during the Agreement Wind-Down Period shall be Indications that are not subject to the applicable royalties under Section 8.5. 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. ***Confidential treatment requested pursuant to a request for confidential treatment filed with the Securities and Exchange Commission. Omitted portions have been filed separately with the Commissiontermination.

Appears in 1 contract

Sources: License and Development Agreement (Exicure, Inc.)

Commercialization. Provided that To avoid a disruption in the termination supply of XenoPort Products to patients, if this Agreement is not a termination by Galderma pursuant to Section 12.2.4terminated after the first commercial sale of any XenoPort Product in the Territory, if requested by NovaBay, Galderma Xanodyne and its Affiliates and Marketing Partners shall continue to market, promote, distribute and sell Collaboration otherwise commercialize (including with the assistance of any Co-Promotion Partner, to the extent permitted by any agreement with such Co-Promotion Partner) the XenoPort Products in the Field in each country of the Galderma Territory for which Marketing Approval therefor 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 and conditions of this Agreement, until the date on which XenoPort notifies Xanodyne in writing that XenoPort has secured an alternative distributor or licensee for a period requested by NovaBay not to exceed two (2the Compound and XenoPort Products in the Territory, but in no event for more than six(6) years from months after the effective date of any such expiration or termination (for purposes of this Section 12.6.3, Agreement (the Agreement "Wind-Down down Period"); provided that NovaBay may terminate the Agreement Wind-Down Period Xanodyne and its Affiliates shall cease such activities, or any portion thereof, upon sixty (60) days' notice to Galdermaby XenoPort requesting that such activities (or portion thereof) be ceased. Notwithstanding any other provision of this Agreement, during the Agreement Wind-Down down Period, Galderma’s, its Affiliates’ and its Marketing Partners’ Xanodyne's rights with respect to Collaboration the Compound and XenoPort Products (including in the licenses granted under Section 7.1.1) Territory shall be non-exclusive and NovaBay and, without limiting the foregoing, XenoPort shall have the right to engage one or more other partner(s) or distributor(s) and/or licensee(s) of Collaboration Products the Compound and/or any XenoPort Product in the Field in all or part of the Galderma Territory. Any Collaboration Products sold or disposed by Galderma or its Affiliates or Marketing Partners Xanodyne in the Territory during the Agreement Wind-Down down Period shall be subject to the applicable royalties payment obligations under Section 8.5Article 6 above and all relevant deductions or credits due to Xanodyne in accordance with this Agreement. After Within thirty (30) days of expiration of the Agreement Wind-Down down Period, Galderma Xanodyne shall notify XenoPort of any quantity of the Intermediate, Compound and/or XenoPort Products remaining in Xanodyne's inventory 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 XenoPort shall have the right option, upon notice to use Xanodyne, to repurchase any such quantities of the Intermediate, Compound and/or XenoPort Products, as applicable, from 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 disclose Xanodyne's then-prevailing standard procedures for calculating costs of good sold. For the sake of clarity, such fully burdened costs shall not include any purpose during the Agreement Wind-Down Period and thereafter. ***Confidential treatment requested pursuant to a request for confidential treatment filed with the Securities and Exchange Commission. Omitted portions have been filed separately with the Commissionmargins or other markup.

Appears in 1 contract

Sources: Licensing Agreement (Xanodyne Pharmaceuticals Inc)

Commercialization. Provided that the termination of this Agreement is not a termination by Galderma pursuant The parties shall mutually agree to Section 12.2.4those Joint Development Products, if requested any, that shall be commercialized. A condition precedent to any commercialization shall be an agreement between NANX and SCOA for the manufacture by NovaBayNANX of the Joint Development Product on behalf of SCOA and/or its Affiliates. Any such agreement shall include (without limitation): (a) A royalty payment to NANX of [***] percent ([***]%) of gross profit from the sale of the Joint Development Product (the “Royalty”) where “gross profit” is defined as the sales price less “cost of production” discounts, Galderma product returns, rebates; (b) NANX shall sell the Joint Development Product to SCOA or an Affiliate at NANX cost of production, where “cost of production” is defined as the total cost of manufacturing the product to include all raw materials, direct and indirect labor costs, packaging and labeling, consumables associated with quality assurance testing, utilities, maintenance, and depreciation associated with the unit operations required to produce the Joint Development Product; (c) A minimum term of ten (10) years terminable (i) for cause and (ii) a right to terminate in the event SCOA or an Affiliate acquires a Competing Product; (d) A mutual audit right permitting access to books and records to confirm sales and costs of production; (e) NANX shall sell the joint development products to SCOA or an Affiliate based on firm PO’s placed by SCOA or an Affiliate and receipt of quarterly Rolling, Non-Binding annual forecasts, with no associated minimum purchase obligation; (f) SCOA and its Affiliates and Marketing Partners shall continue to distribute and 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, for 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 Agreement Wind-Down Period); provided that NovaBay may terminate the Agreement Wind-Down Period upon sixty (60) days’ notice to Galderma. Notwithstanding any other provision of this Agreement, during the Agreement Wind-Down Period, Galderma’s, its Affiliates’ and its Marketing Partners’ rights with respect to Collaboration Products (including the licenses granted under Section 7.1.1) shall be non-exclusive and NovaBay shall have the exclusive right to engage purchase the Joint Development Product and NANX shall not sell any Joint Development Product to any other party; and (g) NANX appointed as the exclusive manufacturer for sales in the Territory, provided, however, that if NANX lacks the capacity to produce a sufficient quantity of a Joint development Product, NANX shall be required to contract with one or more other partner(s) or distributor(s) of Collaboration Products in the Field in all or part of the Galderma Territory. Any Collaboration Products sold or disposed by Galderma or its Affiliates or Marketing Partners during the Agreement Wind-Down Period shall be subject third party manufacturers to the applicable royalties under Section 8.5. After the Agreement Wind-Down Period, Galderma and its Affiliates and Marketing Partners shall not make up 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. ***Confidential treatment requested pursuant to a request for confidential treatment filed with the Securities and Exchange Commission. Omitted portions have been filed separately with the Commissionshortfall.

Appears in 1 contract

Sources: Joint Development Agreement (NANOPHASE TECHNOLOGIES Corp)

Commercialization. Provided that the termination To avoid disruption of supply of any Terminated Products to patients if this Agreement is not terminated after the Launch of a termination by Galderma pursuant to Section 12.2.4Terminated Product in the Affected Area, if requested by NovaBayGSK, Galderma and its Affiliates and Marketing Partners Sublicensees shall continue to distribute and sell Collaboration the Terminated Products in the Field in each country of the Galderma Territory Affected Area for which Marketing Approval therefor 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 a period requested by NovaBay not to exceed two (2) years from such Terminated Product in such country of the Affected Area, but in no event more than ****** after the effective date of any such expiration or termination (for purposes of this Section 12.6.3, the Agreement (“Wind-Down Period); provided that NovaBay Amicus may terminate the Agreement Wind-Down Period in any country(ies) of the Affected Area upon sixty (60) days’ ****** written notice to GaldermaGSK; 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 Agreement Wind-Down down Period, Galderma’s, GSK’s and its Affiliates’ and its Marketing PartnersSublicensees’ rights with respect to Collaboration the Terminated Products (including in the licenses granted under Section 7.1.1) Affected Area shall be non-exclusive and NovaBay and, without limiting the foregoing, Amicus shall have the right to engage one or more other partner(s) or distributor(s) and/or licensee(s) of Collaboration Products in the Field any Terminated Product in all or part of the Galderma TerritoryAffected 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 Collaboration Products Terminated Product sold or disposed by Galderma or its Affiliates or Marketing Partners GSK in the Affected Area during the Agreement Wind-Down down Period shall be subject to the applicable royalties royalty payment obligations under Section 8.53.4 above, and for such purposes, Sections 3.4, 3.5, 3.7, 3.8, 3.9 and 3.11 shall survive. After Within ****** following the Agreement expiration of the Wind-Down Period, Galderma 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 Affiliates Affiliate’s inventory, 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 Amicus shall have the right option, upon notice to use and disclose for GSK, to repurchase any purpose during such quantities of the Agreement Wind-Down Period and thereafterCompound 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. ***Confidential treatment requested pursuant to a request for confidential treatment filed with the Securities *** - Material has been omitted and Exchange Commission. Omitted portions have been filed separately with the Commission.

Appears in 1 contract

Sources: License and Collaboration Agreement (Amicus Therapeutics Inc)

Commercialization. Provided that the termination of Unless this Agreement is not a termination expires by Galderma its terms or pursuant to Section 12.2.413.4, if requested by NovaBayGalderma, Galderma and its Affiliates and Marketing Partners its Sublicensees shall continue to market, promote, distribute and sell Collaboration otherwise commercialize Products in the Field in each country of 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 writing that ZARS has secured an alternative distributor or licensee for a period requested by NovaBay not to exceed two such Product(s) in such country, but in no event for more than nine (29) years from months after the effective date of such expiration or any termination (for purposes of this Section 12.6.3, Agreement (the Agreement Wind-Down down Period); provided that NovaBay may terminate the Agreement Wind-Down Period Galderma, its Affiliates and its Sublicensees shall cease such activities, or any portion thereof, in a given country upon sixty (60) days’ days notice to Galdermaby ZARS requesting that such activities (or portion thereof) be ceased. Notwithstanding any other provision of this Agreement, during the Agreement Wind-Down down Period, (A) Galderma’s, ’s and its Affiliates’ and its Marketing PartnersSublicensees’ rights with respect to Collaboration Products (including a Product in the licenses granted under Section 7.1.1) Galderma Territory shall be non-exclusive and NovaBay and, without limiting the foregoing, ZARS shall have the right to engage one or more other partner(s) or distributor(s) and/or licensee(s) of Collaboration Products in the Field a Product in all or part of the Galderma TerritoryTerritory and (B) Galderma shall be relieved of its obligations under Section 6.4. Any Collaboration Products Product sold or disposed by in the Galderma or its Affiliates or Marketing Partners Territory during the Agreement Wind-Down down Period shall be subject to the other applicable royalties payment obligations under Section 8.5Article 5 and Article 6 above. After Within thirty (30) days of expiration of the Agreement Wind-Down down Period, Galderma and its Affiliates and Marketing Partners shall not make notify ZARS of any representation regarding their status as a licensee quantity 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 Product remaining in Galderma’s reasonable opinion inventory and ZARS shall purchase from Galderma any such quantities of Product having at least twelve (12) additional months of shelf life, at a price equal to the Galderma COGS for NovaBay to continue to Commercialize such Collaboration Products, which NovaBay 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 right, but not the obligation, to use 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 disclose 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 any purpose during manufacturing of such Product for ZARS, from the Agreement Wind-Down Period 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 thereafter. ***Confidential treatment requested pursuant 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 a request for confidential treatment filed with the Securities and Exchange Commission. Omitted portions have been filed separately with the Commission[ * ] of Galderma COGS.

Appears in 1 contract

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

Commercialization. Provided the Non-Advice Investment Service, through which Monex may make general recommendations to the Client with respect to Securities considered as free commercialization, pursuant to the applicable Provisions issued for such purposes by the Commission. Any instruction that the termination Client may provide with respect to Securities other than those mentioned in the preceding paragraph, shall be deemed made under the Execution of Transactions service. The Client acknowledges and accepts that under the Commercialization service Monex shall not have the obligation to provide the reasonableness justification of the general recommendations made, nor that such recommendation shall be adjusted to its Client Investment Profile. When the Client requests a personalized recommendation with respect to Securities not considered as free commercialization, such personalized recommendation shall be provided by Monex under the Investment Counseling Service, so long as it adjusts to the Client Investment Profile and is within the concentration limits established in the Investment Strategy referred to in this Clause in letter a) of numeral I corresponding to the Investment Counseling Service. Monex shall have the obligation to provide the Client at the time of making general recommendations, the information regarding the Product Profile. For purposes of consulting the information regarding the Product Profile, Monex places at the disposal of the Client the address of the website ▇▇▇.▇▇▇▇▇.▇▇▇.▇▇, or, may be at the disposal of the Client at any of the offices or branch offices of Monex. In any event, if an Investment Advisor were appointed to manage the account, such account shall be considered as Non-Discretional and the Client shall be considered as Sophisticated, regardless of the fact that, in such case, recommendations are made by Monex to the referred Advisor. For purposes of preventing and detecting acts, omissions and transactions that may favor, provide assistance, aid or cooperation of any kind to commit the crimes set forth in articles 139 or 148 Bis of the Federal Criminal Code or that may be found within the provisions set forth in article 400 Bis of the same legal body, the Investment Advisors shall cooperate with Monex to comply with the provisions issued by the Commission, as well as be liable to identify and know the Client, pursuant to the terms set forth in the Law and its secondary provisions. The client acknowledges and agrees as of this date that only the instructions to celebrate transactions duly received by the Authorized Representative shall be valid and, in consequence, may be executed, acknowledging that the rest of the employees and/or directors of Monex are impeded to carry them out, without any liability for them or Monex. When the management of the account has been agreed as discretional, Clause Ninth herein shall be applied. In the case that it is not specified if the account is discretional or not, it shall be understood that the Client has chosen the non-discretional management of the account. Monex reserves the right to corroborate the existence of any demand or instruction of the Client and of requesting its confirmation by the means it judges convenient, being Monex able to suspend the execution of the instruction as long as the Client does not give attesting confirmation to the satisfaction of Monex. In such occurrence, upon not receiving the confirmation from the Client, Monex shall be liberated of the obligation of carrying out the instructions and shall have no liability derived from such non-execution for any change of price caused by the market flows, conclusion of the working hours and other situations of similar nature, until Monex receives the aforementioned confirmation. When the instruction by the Client differs from its Client Investment Profile, Monex shall warn about such circumstance and shall request its express consent by means of confirmation of such demand, as well as the execution of the Exhibit corresponding to the Non- Advice services regarding the Execution of Transactions. The Client authorizes Monex so that, in fulfilling with its instructions, it may appoint the Client Securities coming from global orders, whether of purchase or sale, as the case may be. Monex shall fulfill the mandate subject of this Agreement is not a termination by Galderma pursuant means of its Authorized Representatives, being authorized to Section 12.2.4entrust the carrying out of the requisition to another stock market, if requested by NovaBaywithout the need of obtaining the Client’s consent, Galderma and its Affiliates and Marketing Partners shall continue when talking about transactions to distribute and sell Collaboration Products be carried out in international markets or in other situations foreseen in the Field in each country applicable laws, but being responsible for the performance of the Galderma Territory for which Marketing Approval therefor has been obtained, in accordance with the terms and conditions of this Agreement, for 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 Agreement Wind-Down Period); provided that NovaBay may terminate the Agreement Wind-Down Period upon sixty (60) days’ notice to Galderma. Notwithstanding any other provision of this Agreement, during the Agreement Wind-Down Period, Galderma’s, its Affiliates’ and its Marketing Partners’ rights with respect to Collaboration Products (including the licenses granted under Section 7.1.1) shall be non-exclusive and NovaBay shall have the right to engage one or more other partner(s) or distributor(s) of Collaboration Products in the Field in all or part of the Galderma Territory. Any Collaboration Products sold or disposed by Galderma or its Affiliates or Marketing Partners during the Agreement Wind-Down Period shall be subject to the applicable royalties under Section 8.5. 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. ***Confidential treatment requested pursuant to a request for confidential treatment filed with the Securities and Exchange Commission. Omitted portions have been filed separately with the Commissionrelevant delegate.

Appears in 1 contract

Sources: Stock Exchange Intermediation Agreement

Commercialization. Provided that To avoid a disruption in the termination supply of XenoPort Products to patients, if this Agreement is not a termination by Galderma pursuant to Section 12.2.4terminated after the first commercial sale of any XenoPort Product in the Territory, if requested by NovaBay, Galderma Xanodyne and its Affiliates and Marketing Partners shall continue to market, promote, distribute and sell Collaboration otherwise commercialize (including with the assistance of any Co-Promotion Partner, to the extent permitted by any agreement with such Co-Promotion Partner) the XenoPort Products in the Field in each country of the Galderma Territory for which Marketing Approval therefor 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, for a period requested by NovaBay not to exceed two (2) years from until [... * ...], but in no event [... * ...] after the effective date of any such expiration or termination (for purposes of this Section 12.6.3, Agreement (the Agreement Wind-Down down Period); provided that NovaBay may terminate the Agreement Wind-Down Period Xanodyne and its Affiliates shall cease such activities, or any portion thereof, upon sixty [... * ...] notice by XenoPort requesting that such activities (60or portion thereof) days’ notice to Galdermabe ceased. Notwithstanding any other provision of this Agreement, during the Agreement Wind-Down down Period, Galderma’s, its Affiliates’ and its Marketing Partners’ Xanodyne’s rights with respect to Collaboration the Compound and XenoPort Products (including in the licenses granted under Section 7.1.1) Territory shall be non-exclusive and NovaBay and, without limiting the foregoing, XenoPort shall have the right to engage one or more other partner(s) or distributor(s) and/or licensee(s) of Collaboration Products the Compound and/or any XenoPort Product in the Field in all or part of the Galderma Territory. Any Collaboration Products sold or disposed by Galderma or its Affiliates or Marketing Partners Xanodyne in the Territory during the Agreement Wind-Down down Period shall be subject to the applicable royalties payment obligations under Section 8.5Article 6 above and all relevant deductions or credits due to Xanodyne in accordance with this Agreement. After Within [... * ...] of expiration of the Agreement Wind-Down down Period, Galderma Xanodyne shall notify XenoPort of any quantity of the Intermediate, Compound and/or XenoPort Products remaining in Xanodyne’s inventory 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 XenoPort shall have the right option, upon notice to use Xanodyne, to repurchase any such quantities of the Intermediate, Compound and/or XenoPort Products, as applicable, from Xanodyne at a price equal to [... * ...] calculated in accordance with GAAP and disclose Xanodyne’s then-prevailing standard procedures for any purpose during calculating costs of good sold. For the Agreement Wind-Down Period and thereafter. ***Confidential treatment requested pursuant to a request for confidential treatment filed with the Securities and Exchange Commission. Omitted portions have been filed separately with the Commissionsake of clarity, such [... * ...].

Appears in 1 contract

Sources: Licensing Agreement (Xenoport Inc)