Commercialization Plan. The Parties will discuss, through the Joint Commercialization Subcommittee, the Commercialization of the Products as provided in Section 4.2.2(b) and this Article VI and will agree upon a global commercialization plan (the “Global Commercialization Plan”), which will form the guiding principles for Commercialization activities for the Products in the Amicus Territory and the GSK Territory. An initial draft of the guiding principles to be used by the Joint Commercialization Subcommittee in developing the Global Commercialization Plan is attached hereto as Schedule 6.1. Promptly after the Restatement Effective Date, and in any event within ****** prior to the first projected Launch of a Product in the Territory, the Joint Commercialization Subcommittee shall develop and the Parties shall mutually agree upon a Global Commercialization Plan in accordance with the Global Commercialization Plan guiding principles set forth on Schedule 6.1. Thereafter, the Joint Commercialization Subcommittee will review and make any necessary mutually-agreed upon changes to the then-current Global Commercialization Plan and will provide quarterly updates to the JSC with respect thereto in accordance with Section 4.2.2(c). The development of the Global Commercialization Plan and any changes thereto must be made by mutual agreement of the Parties, and neither Party shall have final decision making authority with respect to the Global Commercialization Plan. In the event that the JCS disagrees with respect to any proposed changes to the Global Commercialization Plan, such dispute shall be submitted for review by the JSC at the next regularly scheduled JSC meeting. If the Parties via the JSC are unable to mutually agree on such disputed proposed changes to the then-current Global Commercialization Plan, the then-current Global Commercialization Plan shall remain unmodified and such disagreement shall not be subject to further escalation or to dispute resolution in accordance with Section 4.1.5 or Section 16.2. The Parties will coordinate Commercialization activities in their respective territories, including coordination of marketing and branding activities, via the Joint Commercialization Subcommittee. Notwithstanding the foregoing, pursuant to Section 4.1.5(c), each Party shall have final decision-making authority with respect to Commercialization of Products in its respective territory pursuant to this Agreement, provided that each Party shall exercise its final decision-making authority in its respective territory in a manner that is consistent with the Global Commercialization Plan. ****** - Material has been omitted and filed separately with the Commission.
Appears in 1 contract
Samples: Trademark License Agreement (Amicus Therapeutics Inc)
Commercialization Plan. The Parties JCC will discuss, through the Joint Commercialization Subcommittee, oversee the Commercialization of Products in the Field in the Territory. A designated Party or its relevant Affiliate shall be the lead Commercializing Party for Products as provided in Section 4.2.2(b) and this Article VI and will agree upon a global commercialization plan the Field in the Territory (the “Global Lead Commercialization Plan”), Party”)2. The Lead Commercialization Party shall be agreed to by the Parties after holding good faith discussions regarding which will form the guiding principles for Commercialization activities for the Products Party is best positioned to serve in the Amicus Territory and function during the GSK Territory. An initial draft negotiation of the guiding principles to be used by Joint Development & Commercialization Agreement as set forth in Section 4.1.1 of the Joint Commercialization Subcommittee in developing the Global Commercialization Plan is attached hereto as Schedule 6.1Research Collaboration Agreement. Promptly after the Restatement Effective Date, and in any event within ****** No later than twelve months prior to the anticipated first projected Launch commercial launch of a Product in the first country in the Territory, the Joint Commercialization Subcommittee shall JCC, will develop and the Parties shall mutually agree upon a Global Commercialization Plan in accordance with the Global Commercialization Plan guiding principles set forth on Schedule 6.1. Thereafter, the Joint Commercialization Subcommittee will review and make any necessary mutually-agreed upon changes to the then-current Global Commercialization Plan and will provide quarterly updates submit to the JSC with respect thereto in accordance with Section 4.2.2(c). The development of for approval, a Commercialization plan (as may be amended, the Global “Commercialization Plan and any changes thereto must Plan”) that sets forth the Commercialization activities to be made undertaken by mutual agreement of the Parties, and neither Party shall have final decision making authority Parties with respect to the Global Commercialization Planof such Product in the Field in the Territory. In allocating responsibilities between the event that Parties, the JCS disagrees with respect JCC will take into consideration each Party’s expertise, capabilities, staffing and available resources to any proposed changes take on such activities. The Commercialization Plan may include activities on a region-by-region or country-by-country basis, as determined by the JCC. The JCC will update the Commercialization Plan on an annual basis (or more frequently as needed) and submit it to the Global Commercialization Plan, such dispute shall be submitted JSC for review by the JSC at the next regularly scheduled JSC meetingapproval. If the Parties via the JSC are unable to mutually agree on such disputed proposed changes to the then-current Global Commercialization Plan, the then-current Global The Commercialization Plan shall remain unmodified will include (a) the Global Branding Strategy, (b) a marketing strategy, (c) a communications strategy that includes plans for public relations, conferences and exhibitions and other external meetings, internal meetings and communications, publications and symposia, internet activities and core brand package, (d) a high level operating plan for the implementation of such disagreement shall not be subject to further escalation or to dispute resolution in accordance with Section 4.1.5 or Section 16.2. The Parties will coordinate Commercialization activities in their respective territoriesstrategies on an annual basis, including coordination of marketing information related to Product positioning, core messages to be communicated and branding activitiespricing strategies, via (e) a detailing strategy, (f) a pricing strategy, (g) all other material activities to be conducted in connection with the Joint Commercialization Subcommittee. Notwithstanding the foregoing, pursuant to Section 4.1.5(c), each Party shall have final decision-making authority with respect to Commercialization of Products the Product in its respective territory pursuant to this Agreement, provided that each Party shall exercise its final decision-making authority the Field in its respective territory in the Territory and (h) a manner that is consistent with budget for activities conducted under the Global Commercialization Plan. ****** - Material has been omitted and filed separately with Plan (the Commission“Commercialization Budget”).
Appears in 1 contract
Samples: Research Collaboration Agreement (CRISPR Therapeutics AG)
Commercialization Plan. The Parties will discuss, through the Joint Commercialization Subcommittee, the Commercialization of the Products as provided in Section 4.2.2(b) and this Article VI and will agree upon a global commercialization plan (the “Global Commercialization Plan”), which will form the guiding principles for Commercialization activities for the Products in the Amicus Territory and the GSK Territory. An initial draft of the guiding principles to be used by the Joint Commercialization Subcommittee in developing the Global Commercialization Plan is attached hereto as Schedule 6.1. Promptly after the Restatement Effective Date, and in any event within Within [****** prior to ] the first projected Launch of Approval Application for a Product in the TerritoryCo-Promote Territory is filed, the Joint Steering Committee, or appropriate JPT, shall meet to discus the strategy for commercialization of Product in the Co-Promote Territory. Within [***] the foregoing meeting of the Steering Committee or appropriate JPT, Genentech PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE BEEN FILED SEPARATELY WITH THE SECRETARY OF THE COMMISSION PURSUANT TO THE COMPANY'S APPLICATION REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24B-2 OF THE EXCHANGE ACT. shall submit to the Steering Committee, or appropriate JPT, an annual plan for the commercialization of such Product in the Co-Promote Territory (the "Commercialization Subcommittee Plan"). Although Genentech shall develop be responsible for the creation of the Commercialization Plan, Altus, through the Steering Committee, or appropriate JPT, shall have the opportunity to comment on the Commercialization Plan, and Genentech shall reasonably consider Altus's comments with respect to the Parties Commercialization Plan. Genentech shall mutually agree upon a Global update the Commercialization Plan in accordance with on [***]. Prior to each [***] of the Global Commercialization Plan guiding principles set forth on Schedule 6.1. ThereafterPlan, the Joint Commercialization Subcommittee will Steering Committee, or appropriate JPT, shall meet to broadly review the past year's commercialization of Products in the Co-Promote Territory and make any necessary mutuallydiscuss plans for commercialization of Products in the Co-agreed upon Promote Territory in the upcoming year. Altus shall be kept apprised of the commercialization activity by and through the Steering Committee, or appropriate JPT. In addition, Genentech shall, as reasonably practicable, inform Altus between meetings of the Steering Committee, or appropriate JPT, of significant changes to the then-current Global Commercialization Plan and will provide quarterly updates to the JSC with respect thereto in accordance with Section 4.2.2(c). The development of the Global Commercialization Plan and any changes thereto must be made by mutual agreement of material events in the Parties, and neither Party shall have final decision making authority with respect to the Global Commercialization Plan. In the event that the JCS disagrees with respect to any proposed changes to the Global Commercialization Plan, such dispute shall be submitted for review by the JSC at the next regularly scheduled JSC meeting. If the Parties via the JSC are unable to mutually agree on such disputed proposed changes to the then-current Global Commercialization Plan, the then-current Global Commercialization Plan shall remain unmodified and such disagreement shall not be subject to further escalation or to dispute resolution in accordance with Section 4.1.5 or Section 16.2. The Parties will coordinate Commercialization activities in their respective territories, including coordination of marketing and branding activities, via the Joint Commercialization Subcommittee. Notwithstanding the foregoing, pursuant to Section 4.1.5(c), each Party shall have final decision-making authority with respect to Commercialization sales of Products in its respective territory pursuant to this Agreement, provided that each Party shall exercise its final decisionthe Co-making authority in its respective territory in a manner that is consistent with the Global Commercialization Plan. ****** - Material has been omitted and filed separately with the CommissionPromote Territory.
Appears in 1 contract
Commercialization Plan. The Parties will discuss, through the Joint Commercialization Subcommittee, the Commercialization of the Products as provided in Section 4.2.2(b) Licensed Compounds and this Article VI and will agree upon the Licensed Product for the Territory shall be conducted pursuant to a global comprehensive, Territory-wide commercialization plan approved by the JSC (which shall be broken down by region, including, at a minimum, for the SeaGen Territory, Merck Territory and Collaboration Territory) (each, a “Global Commercialization Plan”), which will form the guiding principles for Commercialization activities for the Products in the Amicus Territory and the GSK Territory. An initial draft of the guiding principles to be used by the Joint Commercialization Subcommittee in developing the Global Commercialization Plan is attached hereto as Schedule 6.1. Promptly after the Restatement Effective Date, and in any event within ****** prior to the first projected Launch of a Product in the Territory, the Joint Commercialization Subcommittee shall develop and the Parties shall mutually agree upon a Global Commercialization Plan in accordance with the Global Commercialization Plan guiding principles set forth on Schedule 6.1. Thereafter, the Joint Commercialization Subcommittee will review and make any necessary mutually-agreed upon changes to the then-current Global Commercialization Plan and will provide quarterly updates to the JSC with respect thereto in accordance with Section 4.2.2(c). The development of the Global Commercialization Plan and any changes thereto must be made by mutual agreement of the Parties, and neither Party shall have final decision making authority ; provided that with respect to the Global Commercialization Plan. In SeaGen Territory and the event that the JCS disagrees with respect to any proposed changes to the Global Commercialization Plan, such dispute shall be submitted for review by the JSC at the next regularly scheduled JSC meeting. If the Parties via the JSC are unable to mutually agree on such disputed proposed changes to the then-current Global Commercialization PlanMerck Territory, the then-current Global Commercialization Plan shall remain unmodified be a higher level plan (with more specific details to be set forth in the applicable Regional Commercialization Sub-Plans as set forth in Section 6.2.4). Each Commercialization Plan shall include (i) a Commercialization Budget (which shall be further broken down by region, including, at a minimum, for the SeaGen Territory, Merck Territory and such disagreement Collaboration Territory), (ii) the Licensed Product forecast for Commercialization purposes and (iii) a plan for the launch sequence of the Licensed Product in the applicable countries in the Territory. The Commercialization Plan shall not be (a) subject to further escalation Section 4.1.2, allocate Commercialization activities between the Parties in the Collaboration Territory (including the Promotion of the Licensed Product in and the preparation of the Promotional Materials and Other Field-Based Materials for, in each case, the applicable countries or regions in the Collaboration Territory), including an allocation of the Commercialization Budget for such activities, (b) unless otherwise agreed to dispute resolution by the Parties in accordance with Section 4.1.5 or Section 16.2. The Parties will coordinate writing, allocate all Commercialization activities in their respective territoriesthe SeaGen Territory (including the Promotion of the Licensed Product in and the preparation of the Promotional Materials and Other Field-Based Materials for, in each case, the SeaGen Territory) to SeaGen, and (c) unless otherwise agreed to by the Parties in writing, allocate all Commercialization activities in the Merck Territory (including coordination the Promotion of marketing the Licensed Product in and branding activitiesthe preparation of the Promotional Materials and Other Field-Based Materials for, via in each case, the Joint Merck Territory) to Merck, but in all cases, the Commercialization Subcommittee. Notwithstanding the foregoingPlan shall be -73- [ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, pursuant to Section 4.1.5(c)MARKED BY BRACKETS, each Party shall have final decision-making authority with respect to Commercialization of Products in its respective territory pursuant to this Agreement, provided that each Party shall exercise its final decision-making authority in its respective territory in a manner that is consistent with the Global Commercialization Plan. ****** - Material has been omitted and filed separately with the Commission.HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM IF PUBLICLY DISCLOSED
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Commercialization Plan. The Parties will discuss, through the Joint Commercialization Subcommittee, the Commercialization of the Licensed Products as provided in Section 4.2.2(b) shall be conducted pursuant to an annual plan and this Article VI and will agree upon a global commercialization plan budget to be prepared by Licensee with respect to the Americas/Europe Territory (the “Global Americas/Europe Commercialization Plan”) and the Asia/ROW Territory (the “Asia/ROW Commercialization Plan”) (the Americas/Europe Commercialization Plan and the Asia/ROW Commercialization Plan, collectively the “Commercialization Plans”), which will form the guiding principles for Commercialization activities for the Products in the Amicus Territory plans and the GSK Territory. An initial draft of the guiding principles to budgets shall be used by the Joint Commercialization Subcommittee in developing the Global Commercialization Plan is attached hereto as Schedule 6.1. Promptly after the Restatement Effective Date, and in any event within ****** prior to the first projected Launch of a Product in the Territory, the Joint Commercialization Subcommittee shall develop and the Parties shall mutually agree upon a Global Commercialization Plan in accordance consistent with the Global Commercialization Plan guiding principles Licensee’s obligations set forth on Schedule 6.1. Thereafter, the Joint Commercialization Subcommittee will review and make any necessary mutually-agreed upon changes to the then-current Global Commercialization Plan and will provide quarterly updates to the JSC with respect thereto in accordance with Section 4.2.2(c)4.1. The development of the Global Commercialization Plan Plans shall include, when and any changes thereto must be made as formulated by mutual agreement of the Parties, and neither Party shall have final decision making authority Licensee: with respect to the Global Americas/Europe Territory or the Asia/ROW Territory, as applicable, (i) general strategies for the promoting, Detailing, marketing, sales and distribution of the Licensed Products in each applicable countries, including the identification of any Third Parties engaged or to be engaged in connection with such activities and the arrangements with them that have been or are proposed to be agreed upon (including policies and procedures for adjustments, rebates, bundling and the like), (ii) estimated launch date, market and sales forecasts, in numbers of patients and local currency, and competitive analysis for the Licensed Products for the Licensee Territory and for each country within the Licensee Territory, (iii) product positioning and promotional plans (including examples of planned Promotional Materials), (iv) Phase IV clinical trial support, if applicable, (v) managed care contracting strategy, (vi) conduct of Licensed Product-specific training programs for sales representatives, (viii) a detailed manufacturing plan, (ix) pre-launch commercialization activities and the expected date of launch, (x) sales force size and allocation throughout the Licensee Territory and, during the Co-Promotion Period, (xi) a detailed budget for the Commercialization Plan. In the event that the JCS disagrees Costs to be incurred in connection with respect to any proposed changes to the Global performing such Americas/Europe Commercialization Plan, such dispute shall be submitted for review by the JSC at the next regularly scheduled JSC meeting. If Plan and (xii) an allocation of specific responsibilities of each of the Parties via the JSC are unable to mutually agree on such disputed proposed changes to the then-current Global Commercialization Plan, the then-current Global Commercialization Plan shall remain unmodified and such disagreement shall not be subject to further escalation or to dispute resolution in accordance with Section 4.1.5 or Section 16.2. The Parties will coordinate Commercialization activities in their respective territories, including coordination of marketing and branding activities, via the Joint Commercialization Subcommittee. Notwithstanding the foregoing, pursuant to Section 4.1.5(c), each Party shall have final decision-making authority with respect to Commercialization objectives, including a specification of Products target market segments and Detailing requirements and strategy to be achieved during the calendar year to which the Commercialization Plans relate. The Parties agree that any forecasts provided by Licensee as part of the Commercialization Plans shall be regarded as Licensee’s good faith estimates based upon conditions then existing and shall not be binding upon Licensee. The first such Commercialization Plans shall be prepared by Licensee and furnished to Licensor through the JSC by no later than twelve months before the anticipated launch of the first Licensed Product in its respective territory pursuant each of the Americas/Europe Territory and Asia/ROW Territory, respectively, and shall thereafter be updated annually, with delivery of draft Commercialization Plans to this Agreement, provided that Licensor by no later than November 1 of each Party shall exercise its successive Calendar Year and delivery of the final decision-making authority in its respective territory in a manner that is consistent with Commercialization Plans following the Global approval of such Commercialization Plan. ****** - Material has been omitted and filed separately with Plans by the Commissionboard of directors of Licensee.
Appears in 1 contract
Commercialization Plan. The Parties Partner shall be responsible for the creation and implementation of an annual plan and budget for the commercialization of Products in the Field in the Territory, which will discuss, through include any Post Marketing Studies (as defined below) of Products in the Joint Commercialization Subcommittee, Field in the Commercialization of the Products as provided in Section 4.2.2(b) and this Article VI and will agree upon a global commercialization plan Territory (the “Global Commercialization Plan”), which will form the guiding principles for Commercialization activities for the Plan shall include, without limitation, identification of, and proposed plans to address, potential challenges with respect to commercialization of Products in the Amicus Territory and Field in the GSK Territory. An Partner shall prepare and submit to Optimer the initial draft of the guiding principles to be used by the Joint Commercialization Subcommittee in developing the Global Commercialization Plan is attached hereto as Schedule 6.1. Promptly after the Restatement Effective Date, and in any event within no later than […****** prior to …] after the first projected Launch submission of a MAA for Product in the Territory, the Joint Commercialization Subcommittee shall develop and the Parties shall mutually agree upon a Global Commercialization Plan in accordance with the Global Commercialization Plan guiding principles set forth on Schedule 6.1. Thereafter, the Joint Commercialization Subcommittee will Territory for review and make any necessary mutually-agreed upon changes to discussion through the then-current Global JSC. Subsequent updated Commercialization Plan and will provide quarterly updates to the JSC with respect thereto in accordance with Section 4.2.2(c). The development of the Global Commercialization Plan and any changes thereto must be made by mutual agreement of the Parties, and neither Party shall have final decision making authority with respect to the Global Commercialization Plan. In the event that the JCS disagrees with respect to any proposed changes to the Global Commercialization Plan, such dispute Plans shall be submitted by Partner to Optimer on an annual basis on or before the end of February each Calendar Year for review by and discussion through the JSC at JSC. Through the next JSC, Partner shall regularly scheduled JSC meetingconsult with and provide ***Confidential Treatment Requested updates to Optimer regarding the commercialization strategy and the commercialization of Products in the Field in the Territory. If Partner shall consider in good faith Optimer’s input regarding such commercialization strategy and the Parties via the JSC are unable to mutually agree on such disputed proposed changes to the then-current Global Commercialization Plan; provided, the then-current Global Commercialization Plan shall remain unmodified and such disagreement shall not be subject to further escalation or to dispute resolution in accordance with Section 4.1.5 or Section 16.2. The Parties will coordinate Commercialization activities in their respective territorieshowever, including coordination of marketing and branding activities, via the Joint Commercialization Subcommittee. Notwithstanding the foregoing, pursuant to Section 4.1.5(c), each Party that Partner shall have final decision-making authority with respect to Commercialization commercialization of Products in the Field in the Territory, including the right to set the terms of sales and book all sales of Products in the Field in the Territory, subject to Section 5.1(c) below. Partner shall provide Optimer with access to KOLs as may reasonably be requested by Optimer, where “KOLs” means all healthcare providers in the Territory that have administered a Product in clinical trials, have published academic articles relating to a Product, or are otherwise regarded by Partner, its respective territory pursuant Affiliates and Sublicensees, as the case may be, as a key opinion leader for a Product in the Territory. Optimer shall provide Partner with access to this AgreementKOLs as may reasonably be requested by Partner, provided where “KOLs” means all healthcare providers outside the Territory and XXXX Territory that each Party shall exercise have administered a Product in clinical trials, have published academic articles relating to a Product, or are otherwise regarded by Optimer, its final decision-making authority in its respective territory in Affiliates and Sublicensees, as the case may be, as a manner that is consistent with key opinion leader for a Product outside the Global Commercialization Plan. ****** - Material has been omitted Territory and filed separately with the CommissionXXXX Territory.
Appears in 1 contract
Samples: Collaboration and License Agreement (Optimer Pharmaceuticals Inc)
