Commercialization Plan. The JCC will oversee the Commercialization of Shared Products by the Parties in the Field in the Territory. No later than [***] prior to the anticipated launch of the Shared Product in the first country in the Territory, the JCC will develop and submit to the JSC for approval, a Commercialization plan (the “Commercialization Plan”) that sets forth the Commercialization activities to be undertaken by the Parties with respect to the Commercialization of the Shared Product in the Territory. 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 [***] (or more frequently as needed) and submit it to the JSC for approval. The Commercialization Plan 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 strategies on [***], including information related to Shared Product positioning, core messages to be communicated and pricing strategies, (e) a detailing strategy, (f) a pricing strategy, (g) all other material activities to be conducted in connection with the Commercialization of the Shared Product in the Field in the Territory and (h) a budget for activities conducted under the Commercialization Plan (the “Commercialization Budget”). The Commercialization Plan will include a meaningful role for both Parties. In allocating responsibilities between the Parties, the JCC will take into consideration each Party’s expertise, capabilities, staffing and available resources to take on such activities, as well as the Parties’ intention to provide CRISPR an opportunity to build and expand its expertise, capabilities, staffing and available resources in connection with performing Commercialization activities allocated to it. CRISPR shall be the Commercializing lead for Shared Products in the United States and Vertex shall be the Commercializing lead for Shared Products outside of the United States. The Commercializing lead, with respect to the United States or outside of the United States, respectively, shall be referred to herein as the “Lead Commercialization Party” for such jurisdiction (as applicable, the “Lead Commercialization Party” Unless otherwise specified in the Commercialization Plan, the Parties will jointly be responsible for conducting all Commercialization activities outside of the United States, such activities to be determined by the JSC.
Appears in 2 contracts
Sources: Strategic Collaboration, Option and License Agreement (CRISPR Therapeutics AG), Strategic Collaboration, Option and License Agreement (CRISPR Therapeutics AG)
Commercialization Plan. (a) The JCC will oversee the Commercialization of Shared Products by the Parties Product under this Agreement in the Field in the Territory. No later than [***] prior to the anticipated launch of the Shared Product in the first country in the Territory, the JCC will develop Cytokinetics Territory and submit to the JSC for approval, Astellas Territory shall be coordinated under a Commercialization plan (the “Commercialization Plan”) that sets forth the Commercialization activities to be undertaken by the Parties with respect to the Commercialization of the Shared Product in the Territory. 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 [***] (or more frequently as needed) and submit it to the JSC for approval. The Commercialization Plan 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 strategies on [***], including information related to Shared Product positioning, core messages to be communicated and pricing strategies, (e) a detailing strategy, (f) a pricing strategy, (g) all other material activities to be conducted in connection with the Commercialization of the Shared Product in the Field in the Territory and (h) a budget for activities conducted under the Commercialization Plan (the “Commercialization Budget”). The Commercialization Plan will shall include a meaningful role reasonably detailed description of and anticipated timeline for both Parties. In allocating responsibilities between the Parties’, the JCC will take into consideration each Party’s expertise, capabilities, staffing their respective Affiliates’ and available resources to take on such activities, as well as the Partiessublicensees’ intention to provide CRISPR an opportunity to build and expand its expertise, capabilities, staffing and available resources in connection with performing Commercialization activities allocated to it. CRISPR shall be the Commercializing lead for Shared Products in the United States and Vertex shall be the Commercializing lead for Shared Products outside of the United States. The Commercializing lead, with respect to the United States Product in their respective territory, including pre-launch plans, launch plans, market analytics, product forecasts, pricing assumptions and competitive intelligence.
(b) No later than [*], or outside promptly following the Effective Date (if the Effective Date occurs during such [*] period), the JCC shall prepare and approve the initial Commercialization Plan. Thereafter, from time to time during the Term (but no less than annually), the JCC shall prepare and approve updates and amendments, as appropriate, to the then-current Commercialization Plan to reflect changes in its plans, including in response to changes in the marketplaces and related product forecasts, relative success of the United States, respectively, Product and other relevant factors influencing such plans and activities. The JCC shall agree on the costs to be referred reimbursed in accordance with requests made under Section [*] (if any) and shared costs (if any) to herein as the “Lead Commercialization Party” for such jurisdiction (as applicable, the “Lead Commercialization Party” Unless otherwise specified be included in the Commercialization PlanPlan with appropriate lead times for planning purposes, including budgeting and a mechanism for payment from one Party to the other Party. By [*] of each calendar year starting on [*] or the Effective Date whichever is later, the Parties will jointly JCC shall agree upon a proposed budget for reimbursable and/or shared costs (if any) for the following Astellas fiscal year. Astellas shall use good faith efforts to [*]. Annual updates shall be responsible for conducting all finally approved no later than [*] before the beginning of next calendar year. Once approved by the JCC, such revised Commercialization activities outside Plan shall replace the prior Commercialization Plan.
(c) If the terms of the United StatesCommercialization Plan contradict, such activities to be determined by or create inconsistencies or ambiguities with, the JSCterms of this Agreement, then the terms of this Agreement shall govern.
Appears in 2 contracts
Sources: License and Collaboration Agreement (Cytokinetics Inc), License and Collaboration Agreement (Cytokinetics Inc)
Commercialization Plan. The JCC will oversee the Commercialization of Shared Products On a Product by the Parties in the Field in the Territory. No Product basis, not later than [***] prior to sixty (60) days after the anticipated launch filing of the Shared first application for Regulatory Approval of a Product in the first country in the Copromotion Territory, the JCC will develop MSC shall prepare and submit to the JSC approve a rolling multiyear (not less than three (3) years) plan for approval, a Commercialization plan (the “Commercialization Plan”) that sets forth the Commercialization activities to be undertaken by the Parties with respect to the Commercialization of the Shared Commercializing such Product in the Copromotion Territory (the "Copromotion Territory Commercialization Plan"), which plan includes a comprehensive market development, marketing, sales, supply and distribution strategy for such Product in the Copromotion Territory. The Copromotion Territory Commercialization Plan may include activities on a region-by-region or country-by-country basis, as determined shall be updated by the JCCMSC at least once each calendar year such that it addresses no less than the three (3) upcoming years. The JCC will update Not later than thirty (30) days after the Commercialization Plan on [***] (or more frequently as needed) and submit it to the JSC for approval. The Commercialization Plan 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 strategies on [***], including information related to Shared Product positioning, core messages to be communicated and pricing strategies, (e) a detailing strategy, (f) a pricing strategy, (g) all other material activities to be conducted in connection with the Commercialization filing of the Shared first application for Regulatory Approval of a Product in the Field Copromotion Territory and thereafter on or before September 30 of each calendar year, the MSC shall prepare an annual commercialization plan and budget (the "Annual Commercialization Plan and Budget"), which plan is based on the then current Copromotion Territory Commercialization Plan and includes a comprehensive market development, marketing, sales, supply and distribution strategy, including an overall budget for anticipated marketing, promotion and sales efforts in the Territory and (h) a budget for activities conducted under the Commercialization Plan upcoming calendar year (the “Commercialization Budget”first such Annual Development Plan and Budget shall cover the remainder of the calendar year in which such Product is anticipated to be approved plus the first full calendar year thereafter). The Annual Commercialization Plan and Budget will include a meaningful role specify which Target Markets and distribution channels each Party shall devote its respective Promotion efforts towards, the personnel and other resources to be devoted by each Party to such efforts, the number and positioning of Details to be performed by each Party, as well as market and sales forecasts and related operating expenses, for both Partiesthe Product in each country of the Copromotion Territory, and budgets for projected Pre-Marketing Expenses, Sales and Marketing Expenses and Post-Approval Research and Regulatory Expenses. In allocating responsibilities between preparing and updating the PartiesCopromotion Territory Commercialization Plan and each Annual Commercialization Plan and Budget, the JCC MSC will take into consideration each Party’s expertisefactors such as market conditions, capabilities, staffing regulatory issues and available resources to take on such activities, as well as the Parties’ intention to provide CRISPR an opportunity to build and expand its expertise, capabilities, staffing and available resources in connection with performing Commercialization activities allocated to it. CRISPR shall be the Commercializing lead for Shared Products in the United States and Vertex shall be the Commercializing lead for Shared Products outside of the United States. The Commercializing lead, with respect to the United States or outside of the United States, respectively, shall be referred to herein as the “Lead Commercialization Party” for such jurisdiction (as applicable, the “Lead Commercialization Party” Unless otherwise specified in the Commercialization Plan, the Parties will jointly be responsible for conducting all Commercialization activities outside of the United States, such activities to be determined by the JSCcompetition.
Appears in 2 contracts
Sources: Collaboration and License Agreement (Viropharma Inc), Collaboration and License Agreement (Viropharma Inc)
Commercialization Plan. The JCC will oversee In accordance with the Commercialization Plan (including the Launch Plan), Hutchmed (itself or through any other Hutchmed Entities) shall have the sole discretion and right to, and shall use Commercially Reasonable Efforts to, Commercialize (including booking sales, establishing pricing and related interactions with Governmental Authorities to be listed on the central or provincial reimbursement list, warehousing, commercial distribution, order processing, invoicing and collection) the Licensed Products in the Field in the Territory at its sole expense in each of Shared (a) Mainland China, (b) Taiwan and (c) Hong Kong and Macau (it being understood that, if Hutchmed Commercializes Licensed Products by in Hong Kong, it may be commercially reasonable to not separately also Commercialize Licensed Products in Macau). The Commercialization Plan will be developed on a [**] rolling basis and include the Parties then-current [**] and the following [**]. At least [**] prior to anticipated approval of the first Drug Approval Application for a Licensed Product in the Field in the Territory, Hutchmed shall present the draft Commercialization Plan (including the Launch Plan) to the JCC for review, discussion and approval (so long as it is consistent with the terms and conditions of this Agreement and Hutchmed has taken into consideration in good faith the Global Brand Strategy). No later than Notwithstanding the foregoing, if the first approval of the first Drug Approval Application for a Licensed Product in the Field in the Territory may be obtained such that is not possible for Hutchmed to present a draft Commercialization Plan [**] in advance, Hutchmed shall present such draft Commercialization Plan as soon as possible. Within [**] prior to the anticipated launch approval of the Shared Product in the first country in the Territory, the JCC will develop and submit to the JSC Drug Approval Application for approval, a Commercialization plan (the “Commercialization Plan”) that sets forth the Commercialization activities to be undertaken by the Parties with respect to the Commercialization of the Shared Product in the Territory. 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 [***] (or more frequently as needed) and submit it to the JSC for approval. The Commercialization Plan 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 strategies on [***], including information related to Shared Product positioning, core messages to be communicated and pricing strategies, (e) a detailing strategy, (f) a pricing strategy, (g) all other material activities to be conducted in connection with the Commercialization of the Shared Licensed Product in the Field in the Territory Territory, Hutchmed shall submit to the JCC the final Commercialization Plan (including the Launch Plan) for review, discussion, and (h) approval. Each [**] after the approval of the first Drug Approval Application for a budget for activities conducted under Licensed Product in the Field in the Territory, Hutchmed shall submit to the JCC the Commercialization Plan (the “Commercialization Budget”)for review, discussion, and approval. The Parties shall ensure at all times that the Commercialization Plan will include a meaningful role for both Parties. In allocating responsibilities between is consistent with the Partiesterms and conditions of this Agreement, and Hutchmed shall consider in good faith the JCC will take into consideration each Party’s expertise, capabilities, staffing Global Brand Strategy and available resources to take on such activities, as well as the Parties’ intention to provide CRISPR an opportunity to build and expand its expertise, capabilities, staffing and available resources in connection with performing Commercialization activities allocated to it. CRISPR shall be the Commercializing lead for Shared Products in the United States and Vertex shall be the Commercializing lead for Shared Products outside of the United States. The Commercializing lead, with respect to the United States or outside of the United States, respectively, shall be referred to herein as the “Lead Commercialization Party” for such jurisdiction (as applicable, the “Lead Commercialization Party” Unless otherwise specified in the Commercialization Plan, the Parties will jointly be responsible for conducting all Commercialization activities outside of the United States, such activities to be determined by the JSCGlobal Medical Affairs Strategy.
Appears in 2 contracts
Sources: License Agreement (HUTCHMED (China) LTD), License Agreement (Epizyme, Inc.)
Commercialization Plan. (i) The JCC will oversee the Commercialization of Shared Products by the Parties in the Field in the Territory. No later than [***] prior to the anticipated launch of the Shared Product in the first country in the Territory, the JCC will develop and submit to the JSC initial plan for approval, a Commercialization plan (the “Commercialization Plan”) that sets forth the Commercialization activities to be undertaken by the Parties with respect to the Commercialization of the Shared Product in the Territory. 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 [***] (or more frequently as needed) and submit it to the JSC for approval. The Commercialization Plan 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 strategies on [***], including information related to Shared Product positioning, core messages to be communicated and pricing strategies, (e) a detailing strategy, (f) a pricing strategy, (g) all other material activities to be conducted in connection with the Commercialization of the Shared Product in the Field in the Partner Territory and (h) a budget for activities conducted under the Commercialization Plan is attached to this Agreement as Exhibit 5.1 (the “Initial Commercialization BudgetPlan”). The Commercialization Plan will include a meaningful role for both Parties. In allocating responsibilities between , and includes in reasonable detail: the Partiesnumber of sales representatives to be deployed, an account/physician target-specific detail and coverage plan (including, “call points”), the JCC will take into consideration each Party’s expertisedollar amount and allocation of planned promotional and marketing expenses, capabilities, staffing and available resources to take on such activitiesthe projected dates for the First Commercial Sale of the Product in the Partner Territory, as well as an outline regarding the Parties’ intention to provide CRISPR an opportunity to build price and expand its expertisebrand positioning of the Product, capabilities, staffing and available resources in connection with performing Commercialization activities allocated to it. CRISPR which shall be consistent with the Commercializing lead minimum commercial diligences set forth in Section 5.2(b). The Initial Commercialization Plan can be adjusted by the JSC.
(ii) Partner shall prepare for Shared Products the JSC’s review updates of the Commercialization Plan on an ongoing basis, and in any event, the JSC shall review the then-current Commercialization Plan in the United States sixth (6th) and Vertex twelfth (12th) month of each calendar year.
(iii) Partner shall be carry out and manage, and shall cause its Affiliates and Sublicensees to carry out and manage, the Commercializing lead for Shared Products outside Commercialization of the United States. The Commercializing leadProduct in the Partner Territory in material accordance with the then-current Commercialization Plan and the provisions of this Agreement.
(iv) If, after taking into account all potential opportunities with respect to the United States or outside Product in a comprehensive analysis of the United Statesrelevant clinical science, respectivelyclinical need, published data and commercial considerations, the JSC determines that Partner should develop and present to Bioprojet a go-to-market Commercialization plan for the OSA Target Indication (the “OSA Proposal”), then Partner shall do so within ninety (90) days of such determination. The OSA Proposal shall take into account the Parties’ mutual agreement that the Product’s optimal brand positioning and pricing strategy in the Partner Territory are the Narcolepsy with Cataplexy and EDS Target Indications and include, among other things, (i) analysis of potential regulatory options for the Product in the Partner Territory for the Narcolepsy with Cataplexy, EDT and OSA Target Indications, including an assessment of the viability of different brand names, and simultaneous Commercialization of the same compound, for such three (3) Target Indications, (ii) commercial payor/pricing analysis for potential managed care contracting strategies for the OSA Target Indication and (iii) a full medical affairs development program to support the OSA Target Indication. The Parties shall discuss the OSA Proposal in good faith and, if the Parties mutually agree upon a go-to-market Commercialization plan for the OSA Target Indications (whether incorporating, in whole or in part, the elements of the OSA Proposal or otherwise), the Initial Commercialization Plan shall be referred to herein as the “Lead Commercialization Party” for such jurisdiction (as applicable, the “Lead Commercialization Party” Unless otherwise specified in the Commercialization Plan, amended by mutual written agreement of the Parties will jointly be responsible for conducting all to reflect such mutually agreed upon go-to-market Commercialization activities outside of the United States, such activities to be determined by the JSCplan.
Appears in 2 contracts
Sources: License and Commercialization Agreement (Harmony Biosciences Holdings, Inc.), License and Commercialization Agreement (Harmony Biosciences Holdings, Inc.)
Commercialization Plan. The JCC will oversee the Commercialization of Shared Products by the Parties in the Field in the Territory. No later than [***] prior to the anticipated launch of the Shared Product in the first country in the Territory(a) On an annual basis, the JCC will develop and submit to the JSC for approval, ACADIA shall prepare a Commercialization plan (the “Commercialization Plan”) that sets forth the Commercialization activities to be undertaken by the Parties with respect to the Commercialization of the Shared Product in the Territory. 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 [***] (or more frequently as needed) and submit it to the JSC for approval. The Commercialization Plan 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 strategies on [***], including information related to Shared Product positioning, core messages to be communicated and pricing strategies, (e) a detailing strategy, (f) a pricing strategy, (g) all other material activities to be conducted in connection with the Commercialization of the Shared each Product in the Field in the Territory and pursuant to this Agreement (h) a budget for activities conducted under the Commercialization Plan (as may be amended by ACADIA, the “Commercialization BudgetPlan”). The Commercialization Plan for the first full year following commercial launch of the first Product for which an NDA is filed with the FDA will include be provided to Neuren by ACADIA as soon as it is available but, in any event, no later than […***…] days after the filing of the NDA for such Product with the FDA. Such initial Commercialization Plan shall provide a meaningful role reasonably detailed plan for both Parties. In allocating responsibilities between the Parties, the JCC will take into consideration each PartyACADIA’s expertise, capabilities, staffing and available resources to take on such activities, as well as the Parties’ intention to provide CRISPR an opportunity to build and expand (or its expertise, capabilities, staffing and available resources in connection with performing Affiliate’s or Sub-Licensee’s) Commercialization activities allocated to it. CRISPR shall be the Commercializing lead for Shared Products in the United States and Vertex shall be the Commercializing lead for Shared Products outside of the United States. The Commercializing lead, with respect to such Product, including pre-launch plans and launch plans, pricing, label expansion and market positioning (which information may be preliminary). ACADIA may amend the United States or outside Commercialization Plan from time to time in its discretion.
(b) Throughout the Term, at each JSC meeting pursuant to clause 4.4, ACADIA shall update the JSC of progress in the Marketing Authorisations of the United StatesProduct in the Territory, respectivelyand Neuren shall provide the JSC updates of progress in the Marketing Authorisations of the Product outside the Territory.
(c) During the first […***…] years after launch, appropriate executives of Neuren and ACADIA shall be referred meet at least […***…] per calendar year to herein as the “Lead Commercialization Party” for such jurisdiction (as applicable, the “Lead Commercialization Party” Unless otherwise specified in discuss and review the Commercialization Plan, the Parties will jointly be responsible for conducting all Commercialization activities outside if provided, and ACADIA’s progress towards achievement of the United StatesCommercialization Plan and to discuss and review the marketing and sales of each Product in the Territory. Unless the parties otherwise agree, such activities to be determined by the JSCmeetings will take place in San Diego.
Appears in 2 contracts
Sources: Licence Agreement (Acadia Pharmaceuticals Inc), Licence Agreement (Acadia Pharmaceuticals Inc)
Commercialization Plan. The JCC will oversee the Commercialization of Shared Products by the Parties in the Field in the Territory. No later than [On a Product-by-Product basis, *** the JSC shall prepare and approve a rolling multiyear ( *] prior to the anticipated launch of the Shared ** ) plan for Commercializing such Product in the first country in the Territory, the JCC will develop and submit to the JSC for approval, a Commercialization plan Territory (the “Commercialization Plan”) that sets forth the Commercialization activities to be undertaken by the Parties with respect to the Commercialization of the Shared ), which plan includes a comprehensive market development, marketing, sales, supply and distribution strategy for such Product in the Territory. The Commercialization Plan may include activities on a region-by-region or country-by-country basis, as determined shall be updated by the JCC. The JCC will update JSC at least once each calendar year such that it addresses no less than the Commercialization Plan on [***] * . Not later than thirty (or more frequently as needed30) and submit it to days after the JSC for approval. The Commercialization Plan 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 strategies on [***], including information related to Shared Product positioning, core messages to be communicated and pricing strategies, (e) a detailing strategy, (f) a pricing strategy, (g) all other material activities to be conducted in connection with the Commercialization filing of the Shared first application for Regulatory Approval of a Product in the Field in the Territory and thereafter on or before September 30 of each calendar year, the JSC shall prepare an annual commercialization plan (h) the “Annual Commercialization Plan”), which plan is based on the then current Commercialization Plan and includes a comprehensive market development, marketing, customer support, sales, supply and distribution strategy, including an overall budget for activities conducted under anticipated marketing, promotion and sales efforts in the upcoming calendar year (the first such Annual Commercialization Plan shall cover the remainder of the calendar year in which such Product is anticipated to be approved plus the first full calendar year thereafter). The Annual Commercialization Plan will specify which audiences and distribution channels each Party shall devote its respective Promotion efforts towards, the personnel and other resources to be devoted by each Party to such efforts, the number and positioning of Details to be performed by each Party (which as much as is reasonably possible shall represent an equal effort on the part of each Party), as well as market and sales forecasts and related operating expenses, for the Product in each country of the Territory, and budgets for projected Pre-Marketing Expenses, Distribution Expenses, Third Party License Fees, Assigned Sales Force Adjustment Payment, Working Capital Charges, Sales and Marketing Expenses and Post- Approval Research and Regulatory Expenses. In preparing and updating the Commercialization Plan (the “and each Annual Commercialization Budget”). The Commercialization Plan will include a meaningful role for both Parties. In allocating responsibilities between the PartiesPlan, the JCC JSC will take into consideration each factors such as market conditions, regulatory issues and competition. The number of Details assigned to a Party by the JSC in accordance with this Section shall be such Party’s expertise, capabilities, staffing and available resources to take on such activities, as well as the Parties’ intention to provide CRISPR an opportunity to build and expand its expertise, capabilities, staffing and available resources in connection with performing Commercialization activities allocated to it. CRISPR shall be the Commercializing lead for Shared Products in the United States and Vertex shall be the Commercializing lead for Shared Products outside of the United States. The Commercializing lead, with respect to the United States or outside of the United States, respectively, shall be referred to herein as the “Lead Commercialization Party” for such jurisdiction (as applicable, the “Lead Commercialization Party” Unless otherwise specified in the Commercialization Plan, the Parties will jointly be responsible for conducting all Commercialization activities outside of the United States, such activities to be determined by the JSCAssigned Sales Force Effort.
Appears in 1 contract
Commercialization Plan. The JCC will oversee the (a) All Commercialization of Shared Products the Licensed Product by the Parties or on behalf of Bayer in the Field Licensed Territory under this Agreement shall be conducted in the Territory. No later than [***] prior accordance with a written plan that is submitted to the anticipated launch of the Shared Product in the first country in the Territory, the JCC will develop and submit to the JSC for approval, a Commercialization plan review by Bayer (the “Commercialization Plan”) that sets forth the Commercialization activities as amended from time to be undertaken by the Parties with respect to the Commercialization of the Shared Product in the Territorytime. 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 [***] (or more frequently as needed) and submit it to the JSC for approval. The initial Commercialization Plan will include be submitted by Bayer to the JCC no later than twelve (a12) months before 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 anticipated date of the submission of the first NDA for the implementation of such strategies on [***], including information related to Shared Product positioning, core messages to be communicated and pricing strategies, (e) a detailing strategy, (f) a pricing strategy, (g) all other material activities to be conducted in connection with the Commercialization of the Shared Licensed Product in the Field in the Territory and (h) a budget for activities conducted under the Commercialization Plan (the “Commercialization Budget”)Licensed Territory. The Commercialization Plan will include a meaningful role for both Parties. In allocating responsibilities between and any updates or amendments to the PartiesCommercialization Plan shall [*].
(b) From time to time, [*] Bayer shall prepare updates or amendments to the JCC will take into consideration each Party’s expertiseCommercialization Plan to reflect changes in such plans, capabilitiesincluding those in response to changes in the marketplace, staffing relative success of the Licensed Product, and available resources to take on other relevant factors influencing such plan and activities, as well as and submit any material updates or amendments to the Commercialization Plan to JCC for review and discussion, provided that, for clarity, notwithstanding any further changes that may result from the Parties’ intention discussion, such updates and amendments shall be immediately effective; and provided, further, that [*]. Subject to provide CRISPR an opportunity Applicable Law, except as expressly agreed by Cytokinetics in writing or to build the extent required by the applicable Regulatory Authority or to address specific operational requirements or local needs and expand its expertisepreferences in the Licensed Territory, capabilitiesthe Commercialization Plan shall not be [*] with the Global Commercialization Concepts, staffing and available resources in connection with performing meaning that Bayer’s Commercialization activities allocated to it. CRISPR shall be the Commercializing lead for Shared Products in the United States Licensed Territory will not deviate from the Global Commercialization Concepts in a manner that [*] impact on Exploitation of Compound and Vertex Licensed Product in the Field outside the Licensed Territory.
(c) Bayer shall be the Commercializing lead for Shared Products outside notify Cytokinetics in case of the United States. The Commercializing lead, with respect to the United States or outside of the United States, respectively, shall be referred to herein as the “Lead any concern that any Commercialization Party” for such jurisdiction (as applicable, the “Lead Commercialization Party” Unless otherwise specified activities contemplated in the Commercialization PlanPlan may be in violation of Applicable Law, and the Parties will jointly shall discuss any necessary revisions to the Commercialization Plan proposed by either Party to ensure that Commercialization of any Licensed Products is conducted in accordance with Applicable Law. For the avoidance of doubt, Bayer shall be solely responsible for conducting all ensuring that Bayer Parties’ Commercialization activities of any Licensed Product in the Licensed Territory is in accordance with Applicable Law, and Cytokinetics shall be solely responsible for ensuring that Cytokinetics’ and its Affiliates’ and Sublicensees’ Commercialization of any Licensed Product outside of the United States, such activities to be determined by the JSCLicensed Territory is in accordance with Applicable Law.
Appears in 1 contract
Sources: Collaboration and License Agreement (Cytokinetics Inc)
Commercialization Plan. The JCC will oversee the Commercialization of Shared Products by the Parties in the Field in the Territory. No later than [***] prior ], Astellas shall prepare and provide to the anticipated launch JCC for review and discussion a written plan for the Commercialization of the Shared such Collaboration Product in the first country in the Territory, the JCC will develop and submit to the JSC for approval, a Commercialization plan an Astellas’ fiscal year (the “Commercialization Plan”) that sets forth the Commercialization activities to be undertaken by the Parties with respect to the Commercialization of the Shared Product in the Territory. 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 [***] (or more frequently as needed) and submit it to the JSC for approval. The Commercialization Plan 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 strategies on [***], including information related to Shared Product positioning, core messages to be communicated and pricing strategies, (e) a detailing strategy, (f) a pricing strategy, (g) all other material activities to be conducted in connection with the Commercialization of the Shared Product in the Field in the Territory and (h) a budget for activities conducted under the Commercialization Plan (the “Commercialization Budget”). The Commercialization Plan will shall include a meaningful role reasonably detailed description of and anticipated timeline for both PartiesAstellas’, its Affiliates’ and sublicensees’ Commercialization activities with respect to such Collaboration Product, including, without limitation pre-launch plans, launch plans, market analytics, product forecasts, pricing assumptions and competitive intelligence. In allocating responsibilities between the PartiesIf Cytokinetics exercises its Co-Promotion option for a Collaboration Product, the JCC will take into consideration each Party’s expertise, capabilities, staffing Commercialization Plan shall also include a reasonably detailed description of and available resources to take on such activities, anticipated timeline for Cytokinetics’ Co-Promotion activities as well as a budget therefor, which shall be consistent with Section 8.6 below. Astellas shall periodically (at least on an annual basis) prepare updates and amendments to its Commercialization Plan to reflect changes in its plans, including in response to changes in the marketplaces and related product forecasts, relative success of the Collaboration Products and other relevant factors influencing such plans and activities. Astellas shall submit all updates and amendments to its Commercialization Plan to the JCC for review and discussion. The Commercialization Plan for any Collaboration Product [*] must be agreed by the Parties’ intention to provide CRISPR an opportunity to build and expand its expertise, capabilities, staffing and available resources in connection with performing Commercialization activities allocated to it. CRISPR Astellas shall be solely responsible for all costs incurred by or on behalf of either Party in performing their respective obligations under the Commercializing lead for Shared Products in the United States and Vertex shall be the Commercializing lead for Shared Products outside of the United States. The Commercializing leadCommercialization Plan and, with respect to the United States or outside of the United States, respectivelyif Cytokinetics exercises its Co-Promotion option, shall be referred to herein as the “Lead Commercialization Party” for such jurisdiction (as applicable, the “Lead Commercialization Party” Unless otherwise specified in the Commercialization Plan, the Parties will jointly be responsible for conducting all Commercialization activities outside of the United States, such activities to be pay Cytokinetics [*] determined by the JSCJCC) for its Co-Promotion activities as set forth in the Co-Promotion Agreement.
Appears in 1 contract
Sources: License and Collaboration Agreement (Cytokinetics Inc)
Commercialization Plan. The JCC will oversee the Commercialization of Shared Products by the Parties in the Field in the Territory. No Commencing no later than [***] ]* prior to the anticipated launch of the Shared first Licensed Product, Cubist shall prepare and deliver to the JCT, by no later than []* of each Calendar Year, a written plan and budget that describes in detail the Commercialization activities (including pre-launch and launch activities, if applicable) to be undertaken with respect to Licensed Product in the first country Profit-Share Territory in the Territory, next Calendar Year and the JCC will develop and submit dates by which such activities are targeted to the JSC for approvalbe accomplished (each, a Commercialization plan (the “Commercialization Plan”) that sets forth the Commercialization activities to be undertaken by the Parties with respect to the Commercialization of the Shared Product in the Territory. 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 [***] (or more frequently as needed) and submit it to the JSC for approval. The Commercialization Plan 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 strategies on [***], including information related to Shared Product positioning, core messages to be communicated and pricing strategies, (e) a detailing strategy, (f) a pricing strategy, (g) all other material activities to be conducted in connection with the Commercialization of the Shared Product in the Field in the Territory and (h) a budget for activities conducted under the Commercialization Plan (the “Commercialization Budget”). The Commercialization Plan will include a meaningful role for both Parties. In allocating responsibilities between (including the Parties, the JCC will take into consideration each Party’s expertise, capabilities, staffing and available resources to take on such activities, as well as the Parties’ intention to provide CRISPR an opportunity to build and expand its expertise, capabilities, staffing and available resources in connection with performing Commercialization activities allocated to it. CRISPR budget) shall be the Commercializing lead for Shared Products in the United States and Vertex shall be the Commercializing lead for Shared Products outside of the United States. The Commercializing lead, contain sufficient detail with respect to Commercialization tactics and other matters to enable the United States or outside JCT to conduct a meaningful review of the United StatesCommercialization Plan, respectively, and the JCT shall be referred approve the first Commercialization Plan for the Profit-Share Territory no later than []* prior to herein as launch of the “Lead Commercialization Party” for such jurisdiction (as applicablefirst Licensed Product in the Profit-Share Territory. Thereafter, the “Lead JCT shall review the Commercialization Party” Unless otherwise specified Plan not less frequently than annually and shall develop Commercialization Plan updates, which shall include updated budgets for the Profit-Share Territory, for each Calendar Year. Cubist may also develop and *Confidential Treatment Requested. Omitted portions filed separately with the Commission. submit to the JCT for review from time to time other proposed substantive amendments to the Commercialization Plan. Amendments and updates to the Commercialization Plan, including any budgets for the Profit-Share Territory contained in the Commercialization Plan, shall not be effective without the Parties will jointly be responsible for conducting all approval of the JCT. Notwithstanding anything in this Agreement to the contrary, if Cubist engages or uses a Third Party to perform any Commercialization activities outside of in the United StatesProfit-Share Territory under circumstances where such Third Party will be granted a sublicense under Alnylam Technology or where there will be a material penalty for early termination that is inconsistent with industry standards, such activities to be determined by the JSC[]*.
Appears in 1 contract
Sources: License and Collaboration Agreement (Cubist Pharmaceuticals Inc)
Commercialization Plan. The JCC will oversee All Commercialization with respect to a Product under this Agreement shall be conducted pursuant to a Commercialization Plan, which shall set forth the plan for the Commercialization of Shared Products by such Product and the Parties in activities to be carried out with respect thereto, together with a proposed budget for such activities (each, a “Commercialization Plan”). The Operating Parties, through the Field in the Territory. No later than [JSC, shall agree upon a preliminary Commercialization Plan for each Product at least ***] ********* prior to the anticipated launch of the Shared Product in the first country in the Territory, the JCC will develop and submit to the JSC Regulatory Approval for approval, a Commercialization plan (the “Commercialization Plan”) that sets forth such Product. During the Commercialization activities to be undertaken by the Parties Phase with respect to each Product, the Operating Parties, through the JSC, shall update the Commercialization Plan with respect to such Product on an annual basis prior to the commencement of the Shared next calendar year, or more often as determined by the JSC. Each updated Commercialization Plan shall include, for the subsequent ************, the projection of the plan for Commercialization Activities for the Product in each Territory and timelines for performing such activities, the Territoryprojected Net Sales and other revenues from the sale of the Product, together with an updated Commercialization budget. The Commercialization Plan may include activities on a region-by-region or country-by-country basis, as determined by shall contain an estimation of the JCC. The JCC will update the Commercialization Plan on [***] (or more frequently as needed) and submit it resources that each Operating Party intends to the JSC for approval. The Commercialization Plan 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 strategies on [***], including information related to Shared Product positioning, core messages to be communicated and pricing strategies, (e) a detailing strategy, (f) a pricing strategy, (g) all other material activities to be conducted employ in connection with the Commercialization of the Shared Product in relevant Product. In addition, the Field in the Territory and (h) a budget for activities conducted under JSC will review performance against the Commercialization Plan for each Product on a quarterly basis, and will report any variations to the Operating Parties in writing. If, in any quarter, there is a variation of ************ or greater from the budget or from projected Net Sales and other revenues, the JSC will revise the Commercialization Plan and budget for the applicable Product ************ prior to the commencement of the second quarter following the quarter in which the variation occurred. For example, if a ************ variation is reported in quarter one of a calendar year, a revised Commercialization Plan and budget must be prepared at least ************ prior to the commencement of quarter three of such calendar year. Until such time as an updated Commercialization Plan is approved in accordance with this Section 6.1, the preceding Commercialization Plan (the “Commercialization Budget”)including, without limitation, all budget projections therein) shall remain in effect. The JSC shall not approve any Commercialization Plan will include a meaningful role for both Parties. In allocating responsibilities between that is inconsistent with or contradicts the Parties, the JCC will take into consideration each Party’s expertise, capabilities, staffing and available resources to take on such activities, as well as the Parties’ intention to provide CRISPR an opportunity to build and expand its expertise, capabilities, staffing and available resources in connection with performing Commercialization activities allocated to it. CRISPR shall be the Commercializing lead for Shared Products in the United States and Vertex shall be the Commercializing lead for Shared Products outside terms of the United States. The Commercializing lead, with respect to the United States or outside of the United States, respectively, shall be referred to herein as the “Lead Commercialization Party” for such jurisdiction (as applicable, the “Lead Commercialization Party” Unless otherwise specified in the Commercialization Plan, the Parties will jointly be responsible for conducting all Commercialization activities outside of the United States, such activities to be determined by the JSCthis Agreement.
Appears in 1 contract
Sources: Joint Development and Commercialization Agreement (GTC Biotherapeutics Inc)
Commercialization Plan. The JCC will oversee (a) Without limiting the Commercialization generality of Shared Products by Licensee’s sole responsibility and decision-making authority for Commercializing the Parties Product in the Field in the Territory. No later than [***] prior Licensee Territory as set forth in Section 4.2, Licensee will use its Commercially Reasonable Efforts to carry out the Commercialization of the Product in accordance with a written Commercialization Plan, as such may be amended or revised by Licensee from time to time, that describes the anticipated launch of the Shared Commercialization activities to be performed with respect to Product in the first country in the Territory, the JCC will develop and submit to the JSC for approval, a Commercialization plan Licensee Territory by Licensee or on its behalf by permitted Third Parties (the “Commercialization Plan”). Each Commercialization Plan shall address, in reasonable detail, to the extent applicable, call plans for Detailing of Product, Sales Force training, Product sampling strategies and quantities, Product positioning and scientific communication strategy, and DTC and non-DTC advertising.
(b) that sets forth Within thirty (30) days of the Effective Date, Licensee shall deliver to VIVUS a Commercialization Plan covering activities to be undertaken by the Parties with respect to the Commercialization conducted in preparation of the Shared any Product Launch in the Territory. The Commercialization Plan may include activities Licensee Territory on a region-by-region or country-by-country basis, as determined by basis and during the JCC. The JCC will first full calendar year following such Product Launch.
(c) Licensee shall thereafter update the Commercialization Plan (together with the Medical Affairs Plan described in Section 4.7) on [***] an annual basis as follows: Licensee shall provide the JSC (or more frequently as neededVIVUS in the absence of a JSC) with preliminary drafts of the Commercialization Plan and submit it Medical Affairs Plan no later than November 15 of each year for the JSC’s (or VIVUS’ in the absence of a JSC) review and comment and Licensee shall provide the JSC (or VIVUS in the absence of a JSC) with the final Commercialization Plan and Medical Affairs Plan no later than January 31 of the year immediately following such year. In preparing the updated versions of the Commercialization Plan and Medical Affairs Plan, Licensee shall analyze the effectiveness of the elements of the prior year Commercialization Plan and Medical Affairs Plan and shall use updated sales forecasts to develop the new Commercialization Plan. Licensee agrees to give due consideration to the input provided by the JSC (or VIVUS in the absence of a JSC) but Licensee at all times will retain responsibility and decision-making authority for approval. The Commercialization Plan 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 strategies on [***], including information related to Shared Product positioning, core messages to be communicated and pricing strategies, (e) a detailing strategy, (f) a pricing strategy, (g) all other material activities to be conducted in connection with the Commercialization of the Shared Product in the Field in the Territory and (h) a budget for activities conducted under Licensee Territory. Licensee may, at its election, update the Commercialization Plan and Medical Affairs Plan between annual updates by following this same procedure.
(the “Commercialization Budget”). The Commercialization Plan will include a meaningful role for both Parties. In allocating responsibilities between the Parties, the JCC will take into consideration each Party’s expertise, capabilities, staffing and available resources to take on such activities, as well as the Parties’ intention to provide CRISPR an opportunity to build and expand d) Each Party shall use Commercially Reasonable Efforts in performing its expertise, capabilities, staffing and available resources in connection with performing Commercialization activities allocated to it. CRISPR shall be the Commercializing lead for Shared Products in the United States and Vertex shall be the Commercializing lead for Shared Products outside of the United States. The Commercializing lead, with respect to the United States or outside of the United States, respectively, shall be referred to herein as the “Lead Commercialization Party” for such jurisdiction obligations under this Section 4.3 concerning (as applicable) the Commercialization Plan and Medical Affairs Plan.
(e) In the event of any inconsistency between, on the one hand, the “Lead Commercialization Party” Unless otherwise specified in Plan or Medical Affairs Plan and, on the Commercialization Planother hand, this Agreement, the Parties will jointly be responsible for conducting all Commercialization activities outside terms of the United States, such activities to be determined by the JSCthis Agreement shall prevail.
Appears in 1 contract
Sources: License and Commercialization Agreement (Petros Pharmaceuticals, Inc.)
Commercialization Plan. The JCC will oversee the Commercialization of Shared Products by the Parties in the Field in the Territory. No later than [***] prior to before the anticipated launch date of the Shared submission of the first MAA for a Product in the first country in the its Territory, the JCC will develop and each Party shall submit to the JSC (or a joint Commercialization subcommittee established by the JSC) for approval, review and discussion a written Commercialization plan (the “Commercialization Plan”) that sets forth the timeline and details of all major Commercialization activities to be undertaken by the Parties with respect to the Commercialization of the Shared planned for such Product in such Party’s Territory for the Territory. 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 next [***] (or more frequently as needed) and submit it to the JSC for approvaleach, a “Commercialization Plan”). The Each Commercialization Plan will include shall include, without limitation, pricing and market access strategy (a) “Pricing and Access Strategy”). EpimAb shall not, directly or indirectly, Commercialize any Compounds or Products except in a manner consistent with the Global Branding StrategyPricing and Access Strategy portion of its Commercialization Plan. Thereafter, (b) a marketing strategyfrom time to time, (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 strategies on but at least [***], EpimAb shall prepare updates or amendments to its Commercialization Plan to reflect changes in such plans, including information related those in response to Shared Product positioningchanges in the marketplace, core messages relative success of the Products, and other relevant factors influencing such plan and activities, and submit such update or amendment to JSC for review and discussion. NEWCO shall submit material updates or amendments to its Commercialization Plan the JSC for review, provided, however, that such updates or amendments may be communicated submitted after NEWCO implements and pricing strategies, (e) a detailing strategy, (f) a pricing strategy, (g) all other material starts conducting the activities to be conducted contemplated in connection with the such updates or amendments. The Commercialization of the Shared Product in the Field in the Territory and (h) a budget for activities conducted under the Commercialization Plan (the “Commercialization Budget”). The Commercialization Plan will include a meaningful role for both Parties. In allocating responsibilities between the Parties, the JCC will take into consideration each Party’s expertise, capabilities, staffing and available resources to take on such activities, as well as the Parties’ intention to provide CRISPR an opportunity to build and expand its expertise, capabilities, staffing and available resources in connection with performing Commercialization activities allocated to it. CRISPR shall be the Commercializing lead for Shared Products in the United States and Vertex shall be the Commercializing lead for Shared Products outside of the United States. The Commercializing lead, with respect conducted pursuant to the United States or outside of the United States, respectively, shall be referred to herein as the “Lead Commercialization Party” for such jurisdiction (as applicable, the “Lead Commercialization Party” Unless otherwise specified in the Commercialization Plan. Notwithstanding the foregoing or anything to the contrary, after NEWCO undergoes a Change of Control to an Acquirer (or NEWCO exclusively licenses all or substantially all its rights in the Parties will jointly be responsible for conducting all Commercialization activities outside Licensed Technology under this Agreement to a Person) that, collectively with its Affiliates, has a market capitalization of greater than [***] at the United Statestime of such Change of Control (or exclusive license, such activities to be determined by the JSCas applicable), NEWCO shall have no obligation to: [***].
Appears in 1 contract
Sources: License and Collaboration Agreement (Rallybio Corp)
Commercialization Plan. The JCC will oversee the Commercialization of Shared Products by the Parties in the Field in the Territory. No On a Collaboration Product-by-Collaboration Product basis, not later than [***] prior to the anticipated launch after commencement of the Shared Product in the first country Phase III Clinical Trial of a R&D Candidate in the Territory, the JCC will develop ELAN shall prepare and submit to the JSC shall review, and after due consideration by ELAN of any suggestions or comments, accept ELAN's rolling multi-year (being not less than[***]) plan for approval, a Commercialization plan (Commercializing the “Commercialization Plan”) that sets forth the Commercialization activities to be undertaken by the Parties with respect to the Commercialization of the Shared Collaboration Product in the TerritoryTerritory (the "Commercialization Plan"), which plan shall include without limitation [***]. The Commercialization Plan may include activities on a region-by-region or country-by-country basis, as determined shall be updated by the JCCELAN at least once each calendar year. Not later than [***] after the filing of the first BLA for an R&D Candidate in the Territory and thereafter on or before August 31 of each calen dar year, ELAN shall prepare and the JSC shall review, and after due consideration by ELAN of any suggestions or comments, accept a long term plan (the "Post BLA Filing Plan"), which plan shall be based on and shall supersede the then current Commercialization Plan and which shall include [***]. The JCC Post BLA Filing Budget shall be based on and shall supersede the relevant Commercialization Budget. The Post BLA Filing Plan will update specify [***]. In preparing and updating the Commercialization Plan, Commercialization Budget, each Post BLA Filing Plan on and each Post BLA Filing Budget, ELAN will take into consideration factors such as market conditions, regulatory issues and competition. If in any year of a Post BLA Filing Plan the aggregate expenses incurred by the Parties are in excess of [***] of the amounts set out in the Post BLA Filing Budget for that year (a "Post BLA Excess Year") then each Party shall charge to its R&D Account [***] of such [***] and, in addition, ELAN shall charge to its R&D Account any amounts in excess of such [***] (or more frequently as needed) the "Post BLA Excess Charge"). All expenses incurred by the Parties in respect of any Post BLA Filing Budget and submit it charged to their respective R&D Accounts shall be shared equally by the JSC Parties in accordance with Section 5.3.1 and Section 5.3.4; provided, however, in any years following a Post BLA Excess Year CAT shall, in addition to any sums which may be due to ELAN under Section 5.3.4 for approval. The Commercialization Plan will include (a) that year in respect of the Global Branding Strategythen current Post BLA Filing Budget, (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 strategies on pay to ELAN [***], including information related ] of any Post BLA Excess Charges charged by ELAN to Shared Product positioning, core messages to be communicated and pricing strategies, (e) a detailing strategy, (f) a pricing strategy, (g) all other material activities to be conducted is R&D Account in connection with the Commercialization each Post BLA Excess Year provided always that CAT's liability hereunder in any year shall not exceed [***] of [***] of the Shared Product relevant Post BLA Filing Budget. If CAT's liability hereunder in the Field in the Territory and (h) a budget for activities conducted under the Commercialization Plan (the “Commercialization Budget”). The Commercialization Plan will include a meaningful role for both Parties. In allocating responsibilities between the Parties, the JCC will take into consideration each Party’s expertise, capabilities, staffing and available resources to take on such activities, as well as the Parties’ intention to provide CRISPR an opportunity to build and expand its expertise, capabilities, staffing and available resources in connection with performing Commercialization activities allocated to it. CRISPR shall be the Commercializing lead for Shared Products in the United States and Vertex shall be the Commercializing lead for Shared Products outside any year does exceed [***] of [***] of the United States. The Commercializing lead, with respect to the United States or outside of the United States, respectively, relevant Post BLA Filing Budget then this Section shall be referred to herein as the “Lead Commercialization Party” for such jurisdiction (as applicable, the “Lead Commercialization Party” Unless otherwise specified in the Commercialization Plan, the Parties will jointly be responsible for conducting all Commercialization activities outside of the United States, such activities to be determined by the JSCapply mutatis mutandis thereto.
Appears in 1 contract
Sources: Research and Development (Cambridge Antibody Technology Group PLC)
Commercialization Plan. The JCC will oversee the Commercialization of Shared Products by the Parties in the Field in the Territory. (a) No later than [***[ * ] prior to the anticipated filing of an application for Regulatory Approval for a Product in the U.S., Endo shall deliver to the JSC a draft written commercialization plan setting forth anticipated material commercialization activities to be performed with respect to such Product in the U.S. by Endo or on its behalf, as well as projected timelines for such activities (the “Commercialization Plan”). The JSC shall promptly review such draft initial Commercialization Plan and may provide commercially reasonable comments to Endo for its consideration. Endo shall give good faith consideration to such comments and may revise such draft Commercialization Plan to implement such of the JSC’s comments that it shall deem necessary or advisable to include in the draft. Endo shall, thereafter, submit the Commercialization Plan with such changes, revisions and modifications that it shall deem advisable to the JSC, and the Commercialization Plan, together with such changes, revisions and modifications, as applicable, shall be deemed final.
(b) No later than [ * ] prior to the anticipated launch of the Shared a Product in the first country in U.S., Endo shall update the Territory, the JCC will develop and submit to the JSC for approval, a Commercialization plan (the “Commercialization Plan”) that sets forth the Commercialization activities to be undertaken by the Parties with respect to the Commercialization of the Shared Product in the Territory. The Commercialization Plan may include activities on a region-by-region or country-by-country basis, as determined by the JCC. The JCC will and shall thereafter update the Commercialization Plan on [***] (or more frequently an annual basis as needed) and submit it to follows: Endo shall provide the JSC for approval. The Commercialization Plan will include (a) the Global Branding Strategy, (b) with 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 strategies on [***], including information related draft update to Shared Product positioning, core messages to be communicated and pricing strategies, (e) a detailing strategy, (f) a pricing strategy, (g) all other material activities to be conducted in connection with the Commercialization of the Shared Product in the Field in the Territory and (h) a budget for activities conducted under the Commercialization Plan (no later than December 1 of each year. Endo shall give good faith consideration to any comments provided by the “Commercialization Budget”). The JSC and may revise such Commercialization Plan will include a meaningful role for both Parties. In allocating responsibilities between the Parties, the JCC will take into consideration each Party’s expertise, capabilities, staffing and available resources to take on implement such activities, as well as the Parties’ intention to provide CRISPR an opportunity to build and expand its expertise, capabilities, staffing and available resources in connection with performing Commercialization activities allocated to it. CRISPR shall be the Commercializing lead for Shared Products in the United States and Vertex shall be the Commercializing lead for Shared Products outside of the United States. The Commercializing lead, with respect JSC’s comments that it shall deem necessary or advisable to the United States or outside of the United States, respectively, shall be referred to herein as the “Lead Commercialization Party” for such jurisdiction (as applicable, the “Lead Commercialization Party” Unless otherwise specified include in the Commercialization Plan, after which the Parties will jointly update to the Commercialization Plan shall be responsible for conducting all Commercialization activities outside deemed to be finalized. Endo shall deliver a final version of the United Statesupdated Commercialization Plan no later than January 31 of the following year.
(c) The Commercialization Plan shall include a marketing plan for the Product for which Regulatory Approval is being sought or obtained in the U.S. that includes plans related to the anticipated promotion and sale of such Product in the U.S., such activities competitive analysis, including information regarding actions intended to mitigate competitive threats, a non-binding sales forecast for the following year and the marketing, promotion and advertising campaigns proposed to be determined by conducted, including the JSCnumber of detailing representatives, level of promotion and Endo’s medical education activities.
Appears in 1 contract
Sources: License, Development and Supply Agreement (Alexza Pharmaceuticals Inc.)
Commercialization Plan. The JCC Cipla will oversee be responsible for preparing and presenting to the JSC a Commercialization of Shared Products by the Parties in the Field in the Territory. No later than [***] Plan twelve (12) months prior to the anticipated launch Regulatory Approval of the Shared Product for marketing in the first U.S. or in any other country in the TerritoryTerritory in connection with the Pulmonary Indication. Following JSC review and approval of such Commercialization Plan, the JCC will develop JSC shall review the implementation and submit to the JSC for approval, a Commercialization plan (the “Commercialization Plan”) that sets forth the Commercialization activities to be undertaken by the Parties with respect to the Commercialization execution of the Shared Product in the Territory. 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 [***] at least a quarterly basis; provided, that if any unexpected circumstance occurs that would result in a variation from the Commercialization budget set forth in such Commercialization Plan of fifteen percentage (15%) or more frequently as neededgreater, then the JSC shall promptly convene a special meeting to review the causes for such variation and establish a plan for remediation. For clarity, in no event, will either Party be required to incur Commercialization Costs in excess of one hundred and fifteen percentage (115%) of the amount set forth in the budget and/or Commercialization Costs contained in the Commercialization Plan unless such costs are pre-approved by JSC. By the June 30th following the date of the initial Commercialization Plan and submit it each June 30th thereafter, Cipla, will prepare and present to the JSC for approval. The an updated Commercialization Plan 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 immediately following Calendar Year (e.g., Cipla will prepare and present to the JSC the Calendar Year 2021 Commercialization Plan by September 3, 2020). In the event that the Product receives Regulatory Approval for a Pulmonary Indication in any country other than the U.S., the JSC shall make a determination if the Product will be Commercialized in such jurisdiction within thirty (30) days of such strategies on [***]Regulatory Approval and, including information related if the JSC so determines to Shared Product positioning, core messages to be communicated and pricing strategies, (e) a detailing strategy, (f) a pricing strategy, (g) all other material activities to be conducted in connection with Commercialize the Commercialization of the Shared Product in the Field in the Territory such jurisdiction, then Cipla shall prepare and present Commercialization Plans (hincluding annually updated Commercialization Plans) a budget for activities conducted under the Commercialization Plan (the “Commercialization Budget”). The Commercialization Plan will include a meaningful role for both Parties. In allocating responsibilities between the Parties, the JCC will take into consideration each Party’s expertise, capabilities, staffing and available resources to take on such activities, as well as the Parties’ intention to provide CRISPR an opportunity to build and expand its expertise, capabilities, staffing and available resources in connection with performing Commercialization activities allocated to it. CRISPR shall be the Commercializing lead for Shared Products in the United States and Vertex shall be the Commercializing lead for Shared Products outside of the United States. The Commercializing lead, with respect to the United States or outside of the United States, respectively, shall be referred to herein as the “Lead Commercialization Party” for such jurisdiction (as applicable, following the “Lead Commercialization Party” Unless otherwise specified in same procedure set forth above for the Commercialization Plan, the Parties will jointly be responsible for conducting all Commercialization activities outside of the United States, such activities to be determined by the JSC.U.S.
Appears in 1 contract
Sources: Development and Commercialization Agreement (Pulmatrix, Inc.)
Commercialization Plan. The JCC will oversee the Commercialization of Shared Products the Licensed Product under this Agreement shall be governed by a written Commercialization plan that describes the Parties anticipated Commercialization activities to be performed with respect to Licensed Product in the Field Territory by Licensee, its Affiliates, or it permitted sublicensees, as well as projected timelines and lineitem quarterly budgets for such activities (the “Commercialization Plan”). Each Commercialization Plan shall address, in reasonable detail, call plans for detailing of Licensed Product, sales force training, sample distribution strategies and quantities, product positioning and communication strategy, and advertising. Licensee shall prepare and present to the Territory. No JSC for review the initial Commercialization Plan no later than [***] months prior to the first anticipated launch Marketing Approval in the Territory; provided, however, that for clarity, the JSC shall not have the right to approve the Commercialization Plan. As often as Licensee deems appropriate, Licensee shall, update or amend the then-current Commercialization Plan; provided, however, that Licensee shall submit to the JSC an updated or amended Commercialization Plan on at least a semi-annual basis. Once presented to the JSC, such updated or amended Commercialization Plan shall become effective immediately and supersede the then-current Commercialization Plan immediately prior to such presentation. Licensee shall use Commercially Reasonable Efforts to perform the tasks and obligations set forth in the Commercialization Plan in accordance with the projected timelines set forth therein and in accordance with the terms and conditions of this Agreement. At Licensee’s request, Company shall provide additional Commercialization support for the Commercialization of the Shared Licensed Product in the first country in the Territory, including, but not limited to, training, travel for training, global market research, global launch readiness, and other related Commercialization activities; provided, however, that Licensee shall reimburse Company for any reasonable costs and expenses incurred thereof. In the JCC will develop and submit to the JSC for approval, a Commercialization plan (the “Commercialization Plan”) that sets forth the Commercialization activities to be undertaken by the Parties with respect to the Commercialization event of the Shared Product in the Territory. 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 any inconsistency between the Commercialization Plan on [***] (or more frequently as needed) and submit it to the JSC for approval. The Commercialization Plan 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 strategies on [***], including information related to Shared Product positioning, core messages to be communicated and pricing strategies, (e) a detailing strategy, (f) a pricing strategy, (g) all other material activities to be conducted in connection with the Commercialization of the Shared Product in the Field in the Territory and (h) a budget for activities conducted under the Commercialization Plan (the “Commercialization Budget”). The Commercialization Plan will include a meaningful role for both Parties. In allocating responsibilities between the Partiesthis Agreement, the JCC will take into consideration each Party’s expertise, capabilities, staffing and available resources to take on such activities, as well as the Parties’ intention to provide CRISPR an opportunity to build and expand its expertise, capabilities, staffing and available resources in connection with performing Commercialization activities allocated to it. CRISPR terms of this Agreement shall be the Commercializing lead for Shared Products in the United States and Vertex shall be the Commercializing lead for Shared Products outside of the United States. The Commercializing lead, with respect to the United States or outside of the United States, respectively, shall be referred to herein as the “Lead Commercialization Party” for such jurisdiction (as applicable, the “Lead Commercialization Party” Unless otherwise specified in the Commercialization Plan, the Parties will jointly be responsible for conducting all Commercialization activities outside of the United States, such activities to be determined by the JSCprevail.
Appears in 1 contract
Sources: License Agreement (Immunomedics Inc)
Commercialization Plan. The JCC will oversee 7.2.1 With respect to each Collaboration Product, in connection with the Commercialization of Shared Products by determination to file the Parties in first Drug Approval Application for such Collaboration Product, the Field in the Territory. No later than [***] prior LCP shall prepare and provide to the anticipated launch of the Shared Product in the first country in the Territory, the JCC will develop and submit to the JSC for approval, a Commercialization commercialization plan (the “Commercialization Plan”) that sets forth for such Collaboration Product. The LCP shall provide the initial Commercialization activities to be undertaken by the Parties with respect Plan for each Collaboration Product to the Commercialization of the Shared Product in the Territory. 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 [***] (or more frequently as needed) and submit it to the JSC for approval]. The Each such initial Commercialization Plan will include shall include, (a) the Global Branding Strategy, [***]; (b) a marketing strategy, [***]; (c) a communications strategy that includes plans for public relations, conferences [***]; (e) [***]; and exhibitions and other external meetings, internal meetings and communications, publications and symposia, internet activities and core brand package, (df) a high level operating plan for [***].
(a) With respect to the implementation of such strategies on initial Commercialization Plan (including the associated Commercialization Budget) [***], including information related the JCC shall review and approve such Commercialization Plan and shall submit such Commercialization Plan to Shared Product positioningthe JSC for the JSC to review and approve, core messages to be communicated and pricing strategies, (e) a detailing strategy, (f) a pricing strategy, (g) all other material activities to be conducted in connection with the Commercialization exception of the Shared Product portion relating to plans for Commercial Manufacture and supply for Commercialization, which shall be submitted to the JMC for review and approval prior to submission to the JSC for review and approval. If the JSC cannot agree on the Commercialization Plan submitted by the JCC within [***] after being submitted by the JCC or the JMC, whichever is later, then such dispute shall be resolved in accordance with Section 3.9.2. Each initial Commercialization Plan and associated Commercialization Budget [***] will go into effect once approved by the Field JSC in accordance with Section 3.9.
(b) With respect to the Territory initial Commercialization Plan (including the associated Commercialization Budget) [***], the JCC and the JSC shall review and discuss, and [***].
7.2.2 The LCP shall prepare and submit to the JCC for review and approval, on an annual basis, any material changes to each Commercialization Plan, including any updates to the Commercialization Budget for each Collaboration Product, no later than [***] of each Calendar Year.
(ha) a budget for activities conducted under With respect to the Commercialization Plan (including the “associated Commercialization Budget”). The Commercialization Plan will include a meaningful role for both Parties. In allocating responsibilities between the Parties) [***], the JCC will take into consideration each Party’s expertise, capabilities, staffing shall review and available resources approve such annual updates and shall submit such updates to take the JSC for review and approval. If the JSC cannot agree on such activitiesupdates submitted by the JCC within [***], as well as the Parties’ intention to provide CRISPR an opportunity to build and expand its expertise, capabilities, staffing and available resources in connection with performing Commercialization activities allocated to it. CRISPR then such dispute shall be resolved in accordance with Section 3.9.2. Upon the Commercializing lead for Shared Products in the United States and Vertex JSC’s preliminary approval, such updates shall be submitted to each Party for its internal budgeting process with a target for final approval no later than [***] of each Calendar Year, at which time any such approved update shall be appended to the Commercializing lead Commercialization Plan [***], provided that, [***]. Any material updates to the Commercialization Plans, including any updates to the associated Commercialization Budgets, for Shared the Antibody Products outside and Functional Genomics Products shall not be effective without the approval of the United States. The Commercializing leadJSC, with subject to the terms and conditions of Section 3.9.
(b) With respect to the United States or outside of Commercialization Plan (including the United States, respectively, shall be referred to herein as the “Lead associated Commercialization Party” for such jurisdiction (as applicableBudget) [***], the “Lead JCC and the JSC shall review and discuss all annual updates to such Commercialization Party” Unless otherwise specified in the Commercialization PlanPlans, the Parties will jointly be responsible for conducting all Commercialization activities outside of the United States, such activities to be determined by the JSCand [***].
Appears in 1 contract
Commercialization Plan. The JCC will oversee the Commercialization of Shared Products by the Parties in the Field in the Territory. (a) No later than [***] prior ], subject to Sections 9.3(d) and 9.3(e), Astellas shall prepare and provide to the anticipated launch JCC for review and discussion a written plan for the Commercialization of the Shared such Collaboration Product in the first country in the Territory, the JCC will develop and submit to the JSC for approval, a Commercialization plan an Astellas’ fiscal year (the “Commercialization Plan”) that sets forth ). The Commercialization Plan shall include a reasonably detailed description of and anticipated timeline for the Parties’, their respective Affiliates’ and sublicensees’ Commercialization activities with respect to such Collaboration Product, including pre-launch plans, launch plans, market analytics, product forecasts, pricing assumptions and competitive intelligence. It is the Parties’ understanding that, [*] Astellas will be the Party primarily responsible for the conduct of the Commercialization activities under the Commercialization Plan. Each Party shall use Diligent Efforts to [*] of the collaboration under the Commercialization Plan (including [*]). The Parties agree that the Commercialization Plan and the applicable Commercialization strategy shall be undertaken consistent.
(b) If Cytokinetics exercises its Co-Promotion option for a Collaboration Product, the Commercialization Plan shall also include a reasonably detailed description of and anticipated timeline for Cytokinetics’ Co-Promotion activities as well as a budget therefor, which shall be consistent with Section 9.6 below.
(c) Subject to Sections 9.3(d) and 9.3(e)(ii), Astellas shall periodically (at least on an annual basis) prepare updates and amendments to its Commercialization Plan to reflect changes in its plans, including in response to changes in the marketplaces and related product forecasts, relative success of the Collaboration Products and other relevant factors influencing such plans and activities. Subject to Sections 9.3(d) and 9.3(e)(ii), Astellas shall submit all updates and amendments to its Commercialization Plan to the JCC for review and discussion. For clarity, the Commercialization budget is subject to the final determination by the Parties JCC, subject to [*], subject to Section 9.8. Cytokinetics may perform [*] activities within the scope of its responsibilities under the Commercialization Plan, [*].
(d) The Commercialization Plan (and any amendment thereto) for any Collaboration Product (i) for a [*] Indication, (ii) for [*] Indication for which Cytokinetics exercises the Cytokinetics Co-Funding Option [*], and (iii) subject to Section 9.3(e) and Section 9.8, for [*] Indication, must be agreed by the JCC by [*]. Neither Party shall conduct any Commercialization activities that are inconsistent with such agreed-upon Commercialization Plan and any Co-Promotion Agreement.
(e) With respect to the Commercialization of a Collaboration Product in [*] Indication, subject to Section 9.8, then:
(i) If Cytokinetics has an Established Commercial Infrastructure, Cytokinetics shall have [*] for the Commercialization strategy for such Collaboration Product for such Indication in the Shared Territory (but not for the Commercialization strategies with respect to such Collaboration Product in as a whole), provided however, such Commercialization strategy and the overall Commercialization Plan shall be consistent.
(ii) Regardless of [*] as relates to the portions of the Commercialization Plan for such Collaboration Product that are specific to such Indication for the Shared Territory, as well as any update and/or amendment thereof. The Commercialization strategy with respect to [*] Indications includes the following [*].
(iii) [*] the Shared Territory and the [*] Astellas and Cytokinetics as well as the [*] such Collaboration Product for such Indication, subject to the discussion and final determination by the JCC, taking into account [*].
(iv) Notwithstanding anything to the contrary, the [*] for such Collaboration Product in such Indication in a particular country will have the decision making authority with respect [*] and other terms of sale for such Collaboration Product in such Indication for such country, provided that the other Party may conduct, [*].
(v) If [*] the Collaboration Product(s) in such [*] Indication, but the Parties have not determined which Party will [*] for the Collaboration Product(s) in such [*] Indication under Section 9.8(b), then [*] shall be responsible for the pre-commercialization activities for the Collaboration Product in such [*] Indication.
(f) Subject to Section 9.3(c), Astellas shall be solely responsible for all costs incurred by or on behalf of either Party in performing their respective obligations under the Commercialization Plan may include activities on a region-by-region except [*] (or country-by-country basis, as [*] determined by the JCC. The JCC will update ), which shall be agreed between the Commercialization Plan on Parties acting reasonably and in good faith and [***] (or more frequently as needed) and submit it to the JSC for approval. The Commercialization Plan 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 strategies on [***], including information related to Shared Product positioning, core messages to be communicated and pricing strategies, (e) a detailing strategy, (f) a pricing strategy, (g) all other material for its Co-Promotion activities to be conducted in connection with the Commercialization of the Shared Product as set forth in the Field in the Territory and (h) a budget for activities conducted under the Commercialization Plan (the “Commercialization Budget”). The Commercialization Plan will include a meaningful role for both Parties. In allocating responsibilities between the Parties, the JCC will take into consideration each Party’s expertise, capabilities, staffing and available resources to take on such activities, as well as the Parties’ intention to provide CRISPR an opportunity to build and expand its expertise, capabilities, staffing and available resources in connection with performing Commercialization activities allocated to it. CRISPR shall be the Commercializing lead for Shared Products in the United States and Vertex shall be the Commercializing lead for Shared Products outside of the United States. The Commercializing lead, with respect to the United States or outside of the United States, respectively, shall be referred to herein as the “Lead Commercialization Party” for such jurisdiction (as applicable, the “Lead Commercialization Party” Unless otherwise specified in the Commercialization Plan, the Parties will jointly be responsible for conducting all Commercialization activities outside of the United States, such activities to be determined by the JSCCo-Promotion Agreement.
Appears in 1 contract
Sources: License and Collaboration Agreement (Cytokinetics Inc)
Commercialization Plan. The JCC will oversee strategy and budget for the Commercialization of Shared Products by of, the Parties in the Field in the Territory. No later than [***] prior to the anticipated launch of the Shared Product in the first country Territory will be described in the Territory, the JCC will develop and submit to the JSC for approval, a Commercialization comprehensive plan (the “Commercialization Plan”) and in a budget (the “Incremental Cost Budget”), each developed by EPI Health based on good faith assumptions regarding the then-current forecast for the Product in the Field in the Territory, in consultation with MC2, and each shall be subject to final approval by MC2, such approval not to be unreasonably withheld; provided that, notwithstanding the foregoing or anything to the contrary herein, (i) the Incremental Cost Budget as it pertains to the EPI Health Sales Representatives must be mutually agreed by MC2 and EPI Health; (ii) neither Party shall be permitted to decrease the number of EPI Health Sales Representatives to less than [***] or increase the number of EPI Health Sales Representatives to more than [***], and (iii) MC2 may, in its sole discretion and acting in good faith, increase the Incremental Cost Budget relative to the then-current Incremental Cost Budget by no more than ten percent (10%) or decrease the Incremental Cost Budget relative to the then-current Incremental Cost Budget by no more than fifty percent (50%) solely with respect to increases or decreases in the Incremental Costs for non-inventory and non-personnel costs, provided that sets forth MC2 may not reduce the Incremental Cost Budget for noncancellable expenses so long as EPI Health uses Commercially Reasonable Efforts to cancel or reduce such expenses (including in accordance with the terms of any contract therefor) as soon as practicable following a request to do so by MC2 ((i) through (iii), the “Agreed Budget Limitations”). The Commercialization Plan for Calendar Year 2022 is attached hereto as Exhibit 7.2 A, and the Incremental Cost Budget for Calendar Year 2022 (including the Incremental Costs actually incurred by EPI Health since the Amendment Effective Date until the date on which the Condition Precedent is satisfied) is attached hereto as Exhibit 7.2 B. The Commercialization Plan and Incremental Cost Budget shall be updated and may be amended during the Term in accordance with Section 7.3 and Section 9.3. The Commercialization Plan will be used as the basis for the Commercialization activities to be undertaken by under this Agreement and shall specifically describe the Parties with respect to (a) Commercialization activities for the Commercialization of the Shared Product in the Territory. The Commercialization Plan may include activities on a region-by-region or country-by-country basisTerritory (including messaging, as determined by the JCC. The JCC will update the Commercialization Plan on [***] (or more frequently as needed) branding, list price and submit it to the JSC for approval. The Commercialization Plan will include (a) the Global Branding Strategyrebating strategy, pricing, advertising, education, planning, marketing, promotion, product sampling and sales force training and allocation), (b) a marketing strategykey tactics for implementing those activities, (c) a communications strategy that includes plans for public relationsspecific resource commitments required of the Parties, conferences including number and exhibitions location of EPI Sales Territories, number of EPI Health Sales Representatives, number of Details by position, and other external meetings, internal meetings and communications, publications and symposia, internet activities and core brand packagemarketing spend, (d) a high level operating plan for the implementation of such strategies on [***], including information related to Shared Product positioning, core messages to be communicated and pricing strategiesField Force Detailing Plan, (e) a detailing strategy, three (3)-year sales forecast and (f) a pricing strategy, (g) all any other material activities to be conducted in connection with information necessary or useful for the successful Commercialization of the Shared Product in the Field in the Territory and (h) a budget for activities conducted under Territory. In the event of any inconsistency between either the Commercialization Plan (or Incremental Cost Budget, on the “Commercialization Budget”)one hand, and this Agreement, on the other hand, the terms of this Agreement shall govern and control. The Notwithstanding anything to the contrary in this Agreement, the Commercialization Plan will include a meaningful role shall specify and account for both Partiesthe performance of EPI Commercialization Activities by EPI Health and MC2 Commercialization Activities by MC2. In allocating responsibilities between the Parties, the JCC will take into consideration each Party’s expertise, capabilities, staffing and available resources no event shall EPI Health be required to take on such activities, as well as the Parties’ intention perform any function or activity or to provide CRISPR an opportunity to build and expand its expertise, capabilities, staffing and available resources in connection with performing Commercialization activities allocated to it. CRISPR shall be the Commercializing lead for Shared Products in the United States and Vertex shall be the Commercializing lead for Shared Products outside of the United States. The Commercializing lead, with respect to the United States or outside of the United States, respectively, shall be referred to herein as the “Lead Commercialization Party” for such jurisdiction (as applicable, the “Lead Commercialization Party” Unless otherwise specified purchase inventory set forth in the Commercialization Plan, Plan the Parties will jointly be responsible for conducting all Commercialization activities outside cost of the United States, such activities to be determined which is not covered by the JSCthen-current Incremental Cost Budget.
Appears in 1 contract
Sources: Promotion and Collaboration Agreement (Novan, Inc.)
Commercialization Plan. The JCC will oversee the Commercialization of Shared Products by the Parties in the Field in the Territory. No On a Collaboration Product-by-Collaboration Product basis, not later than [***] prior to the anticipated launch after commencement of the Shared Product in the first country Phase III Clinical Trial of a R&D Candidate in the Territory, the JCC will develop ELAN shall prepare and submit to the JSC shall review, and after due consideration by ELAN of any suggestions or comments, accept ELAN's rolling multi-year (being not less than[***]) plan for approval, a Commercialization plan (Commercializing the “Commercialization Plan”) that sets forth the Commercialization activities to be undertaken by the Parties with respect to the Commercialization of the Shared Collaboration Product in the TerritoryTerritory (the "Commercialization Plan"), which plan shall include without limitation [***]. The Commercialization Plan may include activities on a region-by-region or country-by-country basis, as determined shall be updated by the JCCELAN at least once each calendar year. Not later than [***] after the filing of the first BLA for an R&D Candidate in the Territory and thereafter on or before August 31 of each calendar year, ELAN shall prepare and the JSC shall review, and after due consideration by ELAN of any suggestions or comments, accept a long term plan (the "Post BLA Filing Plan"), which plan shall be based on and shall supersede the then current Commercialization Plan and which shall include [***]. The JCC Post BLA Filing Budget shall be based on and shall supersede the relevant Commercialization Budget. The Post BLA Filing Plan will update specify [***]. In preparing and updating the Commercialization Plan, Commercialization Budget, each Post BLA Filing Plan on and each Post BLA Filing Budget, ELAN will take into consideration factors such as market conditions, regulatory issues and competition. If in any year of a Post BLA Filing Plan the aggregate expenses incurred by the Parties are in excess of [***] of the amounts set out in the Post BLA Filing Budget for that year (a "Post BLA Excess Year") then each Party shall charge to its R&D Account [***] of such [***] and, in addition, ELAN shall charge to its R&D Account any amounts in excess of such [***] (or more frequently as needed) the "Post BLA Excess Charge"). All expenses incurred by the Parties in respect of any Post BLA Filing Budget and submit it charged to their respective R&D Accounts shall be shared equally by the JSC Parties in accordance with Section 5.3.1 and Section 5.3.4; provided, however, in any years following a Post BLA Excess Year CAT shall, in addition to any sums which may be due to ELAN under Section 5.3.4 for approval. The Commercialization Plan will include (a) that year in respect of the Global Branding Strategythen current Post BLA Filing Budget, (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 strategies on pay to ELAN [***], including information related ] of any Post BLA Excess Charges charged by ELAN to Shared Product positioning, core messages to be communicated and pricing strategies, (e) a detailing strategy, (f) a pricing strategy, (g) all other material activities to be conducted is R&D Account in connection with the Commercialization each Post BLA Excess Year provided always that CAT's liability hereunder in any year shall not exceed [***] of [***] of the Shared Product relevant Post BLA Filing Budget. If CAT's liability hereunder in the Field in the Territory and (h) a budget for activities conducted under the Commercialization Plan (the “Commercialization Budget”). The Commercialization Plan will include a meaningful role for both Parties. In allocating responsibilities between the Parties, the JCC will take into consideration each Party’s expertise, capabilities, staffing and available resources to take on such activities, as well as the Parties’ intention to provide CRISPR an opportunity to build and expand its expertise, capabilities, staffing and available resources in connection with performing Commercialization activities allocated to it. CRISPR shall be the Commercializing lead for Shared Products in the United States and Vertex shall be the Commercializing lead for Shared Products outside any year does exceed [***] of [***] of the United States. The Commercializing lead, with respect to the United States or outside of the United States, respectively, relevant Post BLA Filing Budget then this Section shall be referred to herein as the “Lead Commercialization Party” for such jurisdiction (as applicable, the “Lead Commercialization Party” Unless otherwise specified in the Commercialization Plan, the Parties will jointly be responsible for conducting all Commercialization activities outside of the United States, such activities to be determined by the JSCapply mutatis mutandis thereto.
Appears in 1 contract
Sources: Research, Development and Commercialization Agreement (Cambridge Antibody Technology Group PLC)
Commercialization Plan. The JCC will oversee the Commercialization of Shared Products by the Parties in the Field in the Territory. No later than [***] 12 months prior to the anticipated launch Launch Date, Cardiome shall prepare and deliver to SteadyMed for review a reasonably detailed written plan for the Commercialization of the Shared Product in the first country in Territory during the Territory, the JCC will develop and submit period beginning six (6) months prior to the JSC for approval, a Commercialization plan anticipated Launch Date and ending on the fifth (5th) anniversary thereof (the “Commercialization Plan”) that sets forth the Commercialization activities to be undertaken by the Parties with respect to the Commercialization of the Shared Product in the Territory. 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 [***] (or more frequently as needed) and submit it to the JSC for approval. The Commercialization Plan 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 strategies on [***], including information related to Shared Product positioning, core messages to be communicated and pricing strategies, (e) a detailing strategy, (f) a pricing strategy, (g) all other material activities to be conducted in connection with the Commercialization of the Shared Product in the Field in the Territory and (h) a budget for activities conducted under the Commercialization Plan (the “Commercialization Budget”). The Commercialization Plan will shall include a meaningful role information regarding planned Commercialization activities for both Parties. In allocating responsibilities between Supplied Item in the PartiesTerritory, the JCC will take into consideration each Party’s expertiseincluding, without limitation, pre-launch activities, establishment of government or private payor and reimbursement capabilities and pharmaceutical logistics capabilities, staffing supply and available resources to take on such inventory-related activities, Promotion, anticipated number and geographic distribution/coverage of Sales Representatives by country, and Sales Force and tactical marketing activities (such as well as market research to develop Product positioning key messages). Cardiome may amend or update the Parties’ intention Commercialization Plan from time to time to reflect changes in Cardiome’s Commercialization plans, and shall in any event provide CRISPR an opportunity SteadyMed with annual updates to build and expand its expertise, capabilities, staffing and available resources in connection with performing Commercialization activities allocated to it. CRISPR shall be the Commercializing lead for Shared Products in the United States and Vertex shall be the Commercializing lead for Shared Products outside of the United States. The Commercializing lead, with respect to the United States or outside of the United States, respectively, shall be referred to herein as the “Lead Commercialization Party” for such jurisdiction (as applicable, the “Lead Commercialization Party” Unless otherwise specified in the Commercialization Plan, in each case, subject to the Parties will jointly be responsible for conducting all requirements of this Article 6. SteadyMed may provide comments and suggestions regarding the Commercialization Plan and any amendment or update thereto to Cardiome, and C▇▇▇▇▇▇▇ agrees to consider such comments and suggestions in good faith. As used herein, the term “Commercialization Plan” means the version of the Commercialization Plan most recently provided by Cardiome to SteadyMed. Cardiome shall deliver annual written reports to SteadyMed of the Commercialization activities outside and efforts conducted by or on behalf of Cardiome and its Affiliates for Supplied Item in the United StatesTerritory during each Quarter, which shall include such activities detail regarding the matters described in Sections 3.2(c), and Sections 3.2(c) through 3.2(g), as the JSC may request or require or as may be reasonably required for SteadyMed to be determined by the JSCassess Cardiome’s compliance with its obligations under Sections 6.3 and 6.4.
Appears in 1 contract
Sources: Exclusive License and Supply Agreement (Correvio Pharma Corp.)
Commercialization Plan. The JCC will oversee the Commercialization of Shared Products by the Parties in the Field in the Territory. No later than [***] 12 months prior to the anticipated launch Launch Date, Cardiome shall prepare and deliver to SteadyMed for review a reasonably detailed written plan for the Commercialization of the Shared Product in the first country in Territory during the Territory, the JCC will develop and submit period beginning six (6) months prior to the JSC for approval, a Commercialization plan anticipated Launch Date and ending on the fifth (5th) anniversary thereof (the “Commercialization Plan”) that sets forth the Commercialization activities to be undertaken by the Parties with respect to the Commercialization of the Shared Product in the Territory. 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 [***] (or more frequently as needed) and submit it to the JSC for approval. The Commercialization Plan 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 strategies on [***], including information related to Shared Product positioning, core messages to be communicated and pricing strategies, (e) a detailing strategy, (f) a pricing strategy, (g) all other material activities to be conducted in connection with the Commercialization of the Shared Product in the Field in the Territory and (h) a budget for activities conducted under the Commercialization Plan (the “Commercialization Budget”). The Commercialization Plan will shall include a meaningful role information regarding planned Commercialization activities for both Parties. In allocating responsibilities between Supplied Item in the PartiesTerritory, the JCC will take into consideration each Party’s expertiseincluding, without limitation, pre-launch activities, establishment of government or private payor and reimbursement capabilities and pharmaceutical logistics capabilities, staffing supply and available resources to take on such inventory-related activities, Promotion, anticipated number and geographic distribution/coverage of Sales Representatives by country, and Sales Force and tactical marketing activities (such as well as market research to develop Product positioning key messages). Cardiome may amend or update the Parties’ intention Commercialization Plan from time to time to reflect changes in Cardiome’s Commercialization plans, and shall in any event provide CRISPR an opportunity SteadyMed with annual updates to build and expand its expertise, capabilities, staffing and available resources in connection with performing Commercialization activities allocated to it. CRISPR shall be the Commercializing lead for Shared Products in the United States and Vertex shall be the Commercializing lead for Shared Products outside of the United States. The Commercializing lead, with respect to the United States or outside of the United States, respectively, shall be referred to herein as the “Lead Commercialization Party” for such jurisdiction (as applicable, the “Lead Commercialization Party” Unless otherwise specified in the Commercialization Plan, in each case, subject to the Parties will jointly be responsible for conducting all requirements of this Article 6. SteadyMed may provide comments and suggestions regarding the Commercialization Plan and any amendment or update thereto to Cardiome, and Cardiome agrees to consider such comments and suggestions in good faith. As used herein, the term “Commercialization Plan” means the version of the Commercialization Plan most recently provided by Cardiome to SteadyMed. Cardiome shall deliver annual written reports to SteadyMed of the Commercialization activities outside and efforts conducted by or on behalf of Cardiome and its Affiliates for Supplied Item in the United StatesTerritory during each Quarter, which shall include such activities detail regarding the matters described in Sections 3.2(c), and Sections 3.2(c) through 3.2(g), as the JSC may request or require or as may be reasonably required for SteadyMed to be determined by the JSCassess Cardiome’s compliance with its obligations under Sections 6.3 and 6.4.
Appears in 1 contract
Sources: Exclusive License and Supply Agreement (Cardiome Pharma Corp)
Commercialization Plan. The JCC will oversee the Commercialization of Shared Products by the Parties in the Field in the Territory. No later than Within [***] prior to the anticipated launch of the Shared first Approval Application for a Product in the first country Co-Promote Territory is filed, the 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, the JCC will develop and 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 JSC Steering Committee, or appropriate JPT, an annual plan for approval, a Commercialization plan the commercialization of such Product in the Co-Promote Territory (the “"Commercialization Plan”) that sets forth "). Although Genentech shall be responsible for the creation of the Commercialization activities Plan, Altus, through the Steering Committee, or appropriate JPT, shall have the opportunity to be undertaken by comment on the Parties Commercialization Plan, and Genentech shall reasonably consider Altus's comments with respect to the Commercialization of the Shared Product in the TerritoryPlan. The Commercialization Plan may include activities on a region-by-region or country-by-country basis, as determined by the JCC. The JCC will Genentech shall update the Commercialization Plan on [***] (or more frequently as needed) and submit it ]. Prior to the JSC for approval. The Commercialization Plan 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 strategies on each [***], including information related to Shared Product positioning, core messages to be communicated and pricing strategies, (e) a detailing strategy, (f) a pricing strategy, (g) all other material activities to be conducted in connection with the Commercialization ] of the Shared Product in the Field in the Territory and (h) a budget for activities conducted under the Commercialization Plan (the “Commercialization Budget”). The Commercialization Plan will include a meaningful role for both Parties. In allocating responsibilities between the Parties, the JCC will take into consideration each Party’s expertise, capabilities, staffing and available resources to take on such activities, as well as the Parties’ intention to provide CRISPR an opportunity to build and expand its expertise, capabilities, staffing and available resources in connection with performing Commercialization activities allocated to it. CRISPR shall be the Commercializing lead for Shared Products in the United States and Vertex shall be the Commercializing lead for Shared Products outside of the United States. The Commercializing lead, with respect to the United States or outside of the United States, respectively, shall be referred to herein as the “Lead Commercialization Party” for such jurisdiction (as applicable, the “Lead Commercialization Party” Unless otherwise specified in the Commercialization Plan, the Parties will jointly Steering Committee, or appropriate JPT, shall meet to broadly review the past year's commercialization of Products in the Co-Promote Territory and discuss plans for commercialization of Products in the Co-Promote Territory in the upcoming year. Altus shall be responsible for conducting all Commercialization activities outside kept apprised of the United Statescommercialization activity by and through the Steering Committee, such activities 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 be determined by the JSCCommercialization Plan and any material events in the marketing and sales of Products in the Co-Promote Territory.
Appears in 1 contract
Sources: Collaboration and License Agreement (Altus Pharmaceuticals Inc.)
Commercialization Plan. The JCC will oversee the Commercialization of Shared Products by the Parties in the Field in the Territory. No later than [***] prior to following Evelo notifying ALJ in writing that the anticipated launch first dose in the first patient of any Phase III Clinical Trial for a Product has occurred anywhere in the world after the Effective Date, ALJ will prepare: (a) a reasonably detailed written plan of the Shared Commercialization activities for such Product in the first country in the Territory, the JCC will develop Territory and submit such plan to the JSC for approvalPCC to review, discuss, and determine whether to approve (as such plan may be updated as set forth below in this Section 6.1 (Commercialization Plan), a Commercialization plan (the “Commercialization Plan”) that sets forth the Commercialization activities to be undertaken by the Parties with respect to the Commercialization of the Shared Product in the Territory. 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 [***] (or more frequently as needed) ); and submit it to the JSC for approval. The Commercialization Plan will include (a) the Global Branding Strategy, (b) a marketing strategydetailed, (c) a communications strategy that includes plans for public relations, conferences and exhibitions written budget of the Distribution Costs and other external meetingsFTE Costs, internal meetings Out-of-Pocket Expenses, Manufacturing Costs, and communications, publications and symposia, internet activities and core brand package, (d) a high level operating plan for Other Operating Expenses expected to be incurred by or on behalf of each Party in the implementation performance of such strategies Commercialization activities on [***]a Calendar Year basis (as may be updated pursuant to this Section 6.1 (Commercialization Plan), including information related to Shared Product positioning, core messages to be communicated and pricing strategies, (e) a detailing strategy, (f) a pricing strategy, (g) all other material activities to be conducted in connection with the Commercialization of the Shared Product in the Field in the Territory and (h) a budget for activities conducted under the Commercialization Plan (the “Commercialization Budget”). The Commercialization Plan will include a meaningful role for both Parties. In allocating responsibilities between the Parties, the JCC will take into consideration each Party’s expertise, capabilities, staffing and available resources to take on such activities, as well as the Parties’ intention to provide CRISPR an opportunity to build and expand its expertise, capabilities, staffing and available resources in connection with performing all Commercialization activities allocated to it. CRISPR shall be undertaken by each Party for the Commercializing lead for Shared Products in the United States Territory and Vertex shall be an allocation between the Commercializing lead Parties for Shared Products outside all such activities (including, in the case of Evelo, manufacturing of the United StatesAPI for each Product). The Commercializing leadAt least once each Calendar Year, with respect ALJ will provide to the United States PCC an update to the then-current Commercialization Plan and Commercialization Budget, and may provide additional updates thereto from time to time, and the PCC will review, discuss, and determine whether to approve any proposed amendments or outside updates to the Commercialization Plan (including any amendments to the Commercialization Budget) in accordance with Section 3.3 (Decision-Making). If an amendment to the Commercialization Budget is required for the completion of the United States, respectively, shall be referred to herein as the “Lead a Commercialization Party” for such jurisdiction (as applicable, the “Lead Commercialization Party” Unless otherwise specified activity already contemplated in the Commercialization Plan, and the Parties PCC does not agree to such amendment to the Commercialization Budget for such Commercialization activity, each Party shall be relieved of its obligations under Section 6.2 to the extent directly relating to the specific Commercialization activity or portion of such Commercialization activity for which the increased budget was required. The Commercialization Plan for a Product (including each update thereto) must be consistent with Evelo’s global brand strategy and global key messaging for such Product (each, a “Global Commercialization Plan”), if and as provided to ALJ in writing by Evelo from time to time during the Term. ALJ will jointly be responsible for conducting all not perform any Commercialization activities outside of for the United States, such activities to be determined by Products for the JSCTerritory other than in accordance with the Commercialization Plan.
Appears in 1 contract
Sources: Commercialization and License Agreement (Evelo Biosciences, Inc.)
Commercialization Plan. The JCC will oversee While Vifor shall be responsible for preparing the Commercialization of Shared Products by the Parties in the Field in the Territory. No later than [***] prior to the anticipated launch of the Shared Product in the first country in the TerritoryPlan, the JCC will develop (using appropriate experts within each Party’s organization) shall have the right and submit to be responsible for discussing and approving the JSC for approval, a Commercialization plan (the “initial Commercialization Plan”) that , which sets forth in reasonable detail the tasks, timeline and budget for Commercialization activities to be undertaken by the Parties with respect to the Commercialization of the Shared Product in the Territory. 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 [***] (or more frequently as needed) and submit it to the JSC for approval. The Commercialization Plan 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 strategies on [***], including information related to Shared Product positioning, core messages to be communicated and pricing strategies, (e) a detailing strategy, (f) a pricing strategy, (g) all other material activities to be conducted in connection with the Commercialization of the Shared Licensed Product in the Field in the Territory United States, and for discussing, and approving on an annual basis (hor, if needed, on an interim basis) a budget for activities conducted under all subsequent updates, amendments and modifications to the Commercialization Plan Plan, as reasonably needed or appropriate for the Commercialization of Licensed Product in the Field in the United States consistent with this Agreement. Vifor (and its applicable Affiliates and Sublicensees) shall conduct Commercialization activities for the “Licensed Product in the Field in the United States in accordance with the approved Commercialization Budget”)Plan. The Commercialization Plan will include a meaningful role shall set forth the tasks to be undertaken by (or on behalf of) Vifor for both Parties. In allocating responsibilities between the Parties, the JCC will take into consideration each Party’s expertise, capabilities, staffing and available resources to take on such activities, as well as the Parties’ intention to provide CRISPR an opportunity to build and expand its expertise, capabilities, staffing and available resources in connection with performing Commercialization activities allocated to it. CRISPR shall be for the Commercializing lead for Shared Products Licensed Product in the Field in the United States (including coordination with VFMCFP promotional activities to FMC US Dialysis Clinics), including budgets for all such Commercialization activities, the marketing and Vertex shall be advertising plans, the Commercializing lead specific commitments for Shared the numbers of “Primary Detail Equivalents” for the Vifor (or VFMCRP, as applicable) sales representatives to conduct on Licensed Product in the applicable calendar year, and annual projections for Net Sales of Licensed Products outside in the U.S. for the coming year. From time to time, either Party may propose amendments or modifications to the Commercialization Plan as needed based on the progress or results of the United States. The Commercializing leadCommercialization of Licensed Products, with respect and/or changes in the U.S. market for Licensed Products in the Field, and in such case the JCC shall review in good faith and comment on the proposed amendments or modifications, and if the JCC agrees, shall subject the agreed amendments or modifications to the United States or outside of the United StatesJCC for review and comment and, respectivelyif acceptable, shall be referred to herein as the “Lead Commercialization Party” for such jurisdiction (as applicable, the “Lead Commercialization Party” Unless otherwise specified in the Commercialization Plan, the Parties will jointly be responsible for conducting all Commercialization activities outside of the United States, such activities to be determined by the JSCapproval.
Appears in 1 contract
Commercialization Plan. The JCC will oversee the Commercialization of Shared Products by the Parties in the Field in the Territory. No Commencing no later than [***] prior to the anticipated launch of the Shared first Licensed Product, Cubist shall prepare and deliver to the JCT, by no later than [**] of each Calendar Year, a written plan and budget that describes in detail the Commercialization activities (including pre-launch and launch activities, if applicable) to be undertaken with respect to Licensed Product in the first country Profit-Share Territory in the Territory, next Calendar Year and the JCC will develop and submit dates by which such activities are targeted to the JSC for approvalbe accomplished (each, a Commercialization plan (the “Commercialization Plan”) that sets forth the Commercialization activities to be undertaken by the Parties with respect to the Commercialization of the Shared Product in the Territory. 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 [***] (or more frequently as needed) and submit it to the JSC for approval. The Commercialization Plan 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 strategies on [***], including information related to Shared Product positioning, core messages to be communicated and pricing strategies, (e) a detailing strategy, (f) a pricing strategy, (g) all other material activities to be conducted in connection with the Commercialization of the Shared Product in the Field in the Territory and (h) a budget for activities conducted under the Commercialization Plan (the “Commercialization Budget”). The Commercialization Plan will include a meaningful role for both Parties. In allocating responsibilities between (including the Parties, the JCC will take into consideration each Party’s expertise, capabilities, staffing and available resources to take on such activities, as well as the Parties’ intention to provide CRISPR an opportunity to build and expand its expertise, capabilities, staffing and available resources in connection with performing Commercialization activities allocated to it. CRISPR budget) shall be the Commercializing lead for Shared Products in the United States and Vertex shall be the Commercializing lead for Shared Products outside of the United States. The Commercializing lead, contain sufficient detail with respect to Commercialization tactics and other matters to enable the United States or outside JCT to conduct a meaningful review of the United StatesCommercialization Plan, respectively, and the JCT shall be referred approve the first Commercialization Plan for the Profit-Share Territory no later than [**] prior to herein as launch of the “Lead Commercialization Party” for such jurisdiction (as applicablefirst Licensed Product in the Profit-Share Territory. Thereafter, the “Lead JCT shall review the Commercialization Party” Unless otherwise specified Plan not less frequently than annually and shall develop Commercialization Plan updates, which shall include updated budgets for the Profit-Share Territory, for each Calendar Year. Cubist may also develop and submit to the JCT for review from time to time other proposed substantive amendments to the Commercialization Plan. Amendments and updates to the Commercialization Plan, including any budgets for the Profit-Share Territory contained in the Commercialization Plan, shall not be effective without the Parties will jointly be responsible for conducting all approval of the JCT. Notwithstanding anything in this Agreement to the contrary, if Cubist engages or uses a Third Party to perform any Commercialization activities outside of in the United StatesProfit-Share Territory under circumstances where such Third Party will be granted a sublicense under Alnylam Technology or where there will be a material penalty for early termination that is inconsistent with industry standards, such activities to be determined by the JSC[**].
Appears in 1 contract
Sources: License and Collaboration Agreement (Alnylam Pharmaceuticals, Inc.)
Commercialization Plan. The JCC will oversee the Commercialization of Shared Products by the Parties in the Field in the Territory. No ADCT shall present, no later than [***] days prior to the anticipated launch date of the Shared first MAA approval of the Product in the first country in the Sobi Territory, to the JCC will develop JSC a global sales and marketing strategy for the worldwide sales of Products by ADCT and its Affiliates (such strategy, as may be amended by ADCT from time to time in accordance with this Section 7.3 (Commercialization Plan)) (the “Global Commercialization Strategy”). If from time to time ADCT wishes to amend the Global Commercialization Strategy, ADCT shall prepare and present the revised strategy at a JSC meeting for review and discussion. ADCT shall have the final decision with respect to the Global Commercialization Strategy and any amendments thereto; provided that ADCT shall consider in good faith any comments from Sobi on the Global Commercialization Strategy. Sobi shall submit to the JSC for approvalreview and approval a plan containing strategy, a activities and timelines for Commercialization plan of Products in the Sobi Territory, including planned marketing activities for the Sobi Territory (such plan, as may be amended with approval of the JSC during the Term, the “Sobi Commercialization Plan”) that sets forth ). Sobi shall use reasonable efforts to materially align the Commercialization activities to be undertaken by the Parties with respect to the Commercialization of the Shared Product in the Territory. The Sobi Commercialization Plan may include activities on a region-by-region or country-by-country basis, with the Global Commercialization Strategy as determined notified to Sobi by ADCT in accordance with the JCCforegoing. The JCC will Sobi shall update the Sobi Commercialization Plan on [***] (or more frequently as needed) and submit it present such updates to the JSC for approval. The Commercialization Plan 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 at least annually for the implementation of such strategies on [***], including information related to Shared Product positioning, core messages to be communicated JSC’s review and pricing strategies, (e) a detailing strategy, (f) a pricing strategy, (g) all other material activities to be conducted in connection with the Commercialization of the Shared Product in the Field in the Territory and (h) a budget for activities conducted under the Commercialization Plan (the “Commercialization Budget”). The Commercialization Plan will include a meaningful role for both Parties. In allocating responsibilities between the Parties, the JCC will take into consideration each Party’s expertise, capabilities, staffing and available resources to take on such activities, as well as the Parties’ intention to provide CRISPR an opportunity to build and expand its expertise, capabilities, staffing and available resources in connection with performing Commercialization activities allocated to it. CRISPR shall be the Commercializing lead for Shared Products in the United States and Vertex shall be the Commercializing lead for Shared Products outside of the United States. The Commercializing lead, with respect to the United States or outside of the United States, respectively, shall be referred to herein as the “Lead Commercialization Party” for such jurisdiction (as applicable, the “Lead Commercialization Party” Unless otherwise specified in the Commercialization Plan, the Parties will jointly be responsible for conducting all Commercialization activities outside of the United States, such activities to be determined by the JSCapproval.
Appears in 1 contract
Commercialization Plan. The JCC will oversee (a) Without limiting the Commercialization generality of Shared Products by Auxilium’s sole responsibility and decision-making authority for Commercializing the Parties Product in the Field in the Territory. No later than [***] prior Auxilium Territory as set forth in Section 4.2, Auxilium will use its Commercially Reasonable Efforts to carry out the Commercialization of the Product in accordance with a written Commercialization Plan, as such may be amended or revised by Auxilium from time to time, that describes the anticipated launch of the Shared Commercialization activities to be performed with respect to Product in the first country in the Territory, the JCC will develop and submit to the JSC for approval, a Commercialization plan Auxilium Territory by Auxilium or on its behalf by permitted Third Parties (the “Commercialization Plan”) that sets forth the ). Each Commercialization activities to be undertaken by the Parties with respect Plan shall address, in reasonable detail, to the Commercialization extent applicable, call plans for Detailing of the Shared Product, Sales Force training, Product in the Territory. The Commercialization Plan may include activities on a regionsampling strategies and quantities, Product positioning and scientific communication strategy, and DTC and non-by-region or country-by-country basis, as determined by the JCC. The JCC will update the Commercialization Plan on [***] (or more frequently as needed) and submit it to the JSC for approval. The Commercialization Plan will include (a) the Global Branding Strategy, DTC advertising.
(b) Attached hereto as Exhibit A is 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 strategies on [***], including information related to Shared Product positioning, core messages to be communicated and pricing strategies, (e) a detailing strategy, (f) a pricing strategy, (g) all other material Commercialization Plan covering activities to be conducted in connection preparation of Product Launch in the Auxilium Territory and during the first full calendar year following the Product Launch.
(c) Auxilium shall thereafter update the Commercialization Plan (together with the Medical Affairs Plan described in Section 4.7) on an annual basis as follows: Auxilium shall provide the JSC with preliminary drafts of the Commercialization Plan and Medical Affairs Plan no later than *** of each year for the JSC’s review and comment and Auxilium shall provide the JSC with the final Commercialization Plan and Medical Affairs Plan no later than *** of the year immediately following such year. In preparing the updated versions of the Commercialization Plan and Medical Affairs Plan, Auxilium shall analyze the effectiveness of the elements of the prior year Commercialization Plan and Medical Affairs Plan and shall use updated sales forecasts to develop the new Commercialization Plan. Auxilium agrees to give due consideration to the input provided by the JSC but Auxilium at all times will retain responsibility and decision-making authority for the Commercialization of the Shared Product in the Field in the Territory and (h) a budget for activities conducted under Auxilium Territory. Auxilium may, at its election, update the Commercialization Plan and Medical Affairs Plan between annual updates by following this same procedure.
(the “Commercialization Budget”). The Commercialization Plan will include a meaningful role for both Parties. In allocating responsibilities between the Parties, the JCC will take into consideration each Party’s expertise, capabilities, staffing and available resources to take on such activities, as well as the Parties’ intention to provide CRISPR an opportunity to build and expand d) Each Party shall use Commercially Reasonable Efforts in performing its expertise, capabilities, staffing and available resources in connection with performing Commercialization activities allocated to it. CRISPR shall be the Commercializing lead for Shared Products in the United States and Vertex shall be the Commercializing lead for Shared Products outside of the United States. The Commercializing lead, with respect to the United States or outside of the United States, respectively, shall be referred to herein as the “Lead Commercialization Party” for such jurisdiction obligations under this Section 4.3 concerning (as applicable) the Commercialization Plan and Medical Affairs Plan.
(e) In the event of any inconsistency between, on the one hand, the “Lead Commercialization Party” Unless otherwise specified in Plan or Medical Affairs Plan and, on the Commercialization Planother hand, this Agreement, the Parties will jointly be responsible for conducting all Commercialization activities outside terms of the United States, such activities to be determined by the JSCthis Agreement shall prevail.
Appears in 1 contract
Sources: License and Commercialization Agreement (Vivus Inc)
Commercialization Plan. The JCC will oversee strategy for the Commercialization of Shared Products by each Licensed Product shall be described in a comprehensive plan that describes the Parties in the Field in the Territory. No later than [***] prior to the anticipated pre-launch, launch of the Shared and subsequent Commercialization activities for such Licensed Product in the first country in the Territory, which shall include, without limitation, (i) the JCC will develop annual anticipated number of details to be conducted in each country within the Territory, (ii) the annual anticipated marketing expenses to be incurred in each of the countries within the Territory, (iii) the annual anticipated number of FTEs to be assigned to Commercialize in each of the countries within the Territory, and submit to the JSC for approval(iv) a report on pricing, a Commercialization plan advertising, education, planning, marketing, and sales force training (the “Commercialization Plan”). An initial Commercialization Plan for Biovance shall be prepared by Alliqua and presented to the JSC as soon as practicable, but in any event, within ninety (90) that sets forth days of the Commercialization activities Effective Date or such other time agreed to be undertaken by the Parties with respect JSC. In addition, Alliqua shall submit an initial Commercialization Plan for ECMs to the Commercialization of the Shared Product JSC no later than ninety (90) days prior to anticipated 510(k) or other Regulatory Clearance and/or Approval in each relevant jurisdiction within the Territory. The Parties shall, and shall cause their respective members of the JSC to, cooperate with each other in good faith to promptly finalize a mutually acceptable Commercialization Plan may include activities on a region-by-region or country-by-country basisfor each Licensed Product. Alliqua shall deliver an updated Commercialization Plan for each Licensed Product, as determined applicable, at each meeting of the JSC or at such times as agreed to by the JCCJSC. The JCC will update the Commercialization Plan on [THE COMPANY HAS REQUESTED AN ORDER FROM THE SECURITIES AND EXCHANGE COMMISSION (THE “COMMISSION”) PURSUANT TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED, GRANTING CONFIDENTIAL TREATMENT TO SELECTED PORTIONS. ACCORDINGLY, THE CONFIDENTIAL PORTIONS HAVE BEEN OMITTED FROM THIS EXHIBIT, AND HAVE BEEN FILED SEPARATELY WITH THE COMMISSION. OMITTED PORTIONS ARE INDICATED IN THIS EXHIBIT WITH “***] (or more frequently as needed) and submit it to the JSC for approval. The Commercialization Plan 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 strategies on [***], including information related to Shared Product positioning, core messages to be communicated and pricing strategies, (e) a detailing strategy, (f) a pricing strategy, (g) all other material activities to be conducted in connection with the Commercialization of the Shared Product in the Field in the Territory and (h) a budget for activities conducted under the Commercialization Plan (the “Commercialization Budget”). The Commercialization Plan will include a meaningful role for both Parties. In allocating responsibilities between the Parties, the JCC will take into consideration each Party’s expertise, capabilities, staffing and available resources to take on such activities, as well as the Parties’ intention to provide CRISPR an opportunity to build and expand its expertise, capabilities, staffing and available resources in connection with performing Commercialization activities allocated to it. CRISPR shall be the Commercializing lead for Shared Products in the United States and Vertex shall be the Commercializing lead for Shared Products outside of the United States. The Commercializing lead, with respect to the United States or outside of the United States, respectively, shall be referred to herein as the “Lead Commercialization Party” for such jurisdiction (as applicable, the “Lead Commercialization Party” Unless otherwise specified in the Commercialization Plan, the Parties will jointly be responsible for conducting all Commercialization activities outside of the United States, such activities to be determined by the JSC.
Appears in 1 contract
Sources: License, Marketing and Development Agreement (Alliqua, Inc.)
Commercialization Plan. The (a) No later than [ * ], subject to Sections 9.3(d) and 9.3(e), Astellas shall prepare and provide to the JCC will oversee for review and discussion a written plan for the Commercialization of Shared Products by the Parties in the Field in the Territory. No later than [***] prior to the anticipated launch of the Shared such Collaboration Product in the first country in the Territory, the JCC will develop and submit to the JSC for approval, a Commercialization plan an Astellas’ fiscal year (the “Commercialization Plan”) that sets forth ). The Commercialization Plan shall include a reasonably detailed description of and anticipated timeline for the Parties’, their respective Affiliates’ and sublicensees’ Commercialization activities with respect to such Collaboration Product, including pre-launch plans, launch plans, market analytics, product forecasts, pricing assumptions and competitive intelligence. It is the Parties’ understanding that, [ * ] Astellas will be the Party primarily responsible for the conduct of the Commercialization activities under the Commercialization Plan. Each Party shall use Diligent Efforts to [ * ] of the collaboration under the Commercialization Plan (including [ * ]). The Parties agree that the Commercialization Plan and the applicable Commercialization strategy shall be undertaken consistent.
(b) If Cytokinetics exercises its Co-Promotion option for a Collaboration Product, the Commercialization Plan shall also include a reasonably detailed description of and anticipated timeline for Cytokinetics’ Co-Promotion activities as well as a budget therefor, which shall be consistent with Section 9.6 below.
(c) Subject to Sections 9.3(d) and 9.3(e)(ii), Astellas shall periodically (at least on an annual basis) prepare updates and amendments to its Commercialization Plan to reflect changes in its plans, including in response to changes in the marketplaces and related product forecasts, relative success of the Collaboration Products and other relevant factors influencing such plans and activities. Subject to Sections 9.3(d) and 9.3(e)(ii), Astellas shall submit all updates and amendments to its Commercialization Plan to the JCC for review and discussion. For clarity, the Commercialization budget is subject to the final determination by the Parties JCC, subject to [ * ], subject to Section 9.8. Cytokinetics may perform [ * ] activities within the scope of its responsibilities under the Commercialization Plan, [ * ].
(d) The Commercialization Plan (and any amendment thereto) for any Collaboration Product (i) for a [ * ] Indication, (ii) for [ * ] Indication for which Cytokinetics exercises the Cytokinetics Co-Funding Option [ * ], and (iii) subject to Section 9.3(e) and Section 9.8, for [ * ] Indication, must be agreed by the JCC by [ * ]. Neither Party shall conduct any Commercialization activities that are inconsistent with such agreed-upon Commercialization Plan and any Co-Promotion Agreement.
(e) With respect to the Commercialization of a Collaboration Product in [ * ] Indication, subject to Section 9.8, then:
(i) If Cytokinetics has an Established Commercial Infrastructure, Cytokinetics shall have [ * ] for the Commercialization strategy for such Collaboration Product for such Indication in the Shared Territory (but not for the Commercialization strategies with respect to such Collaboration Product as a whole), provided however, such Commercialization strategy and the overall Commercialization Plan shall be consistent. [ * ] = Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) would likely cause competitive harm if publicly disclosed.
(ii) Regardless of [ * ] as relates to the portions of the Commercialization Plan for such Collaboration Product that are specific to such Indication for the Shared Territory, as well as any update and/or amendment thereof. The Commercialization strategy with respect to [ * ] Indications includes the following [ * ].
(iii) [ * ] the Shared Territory and the [ * ] Astellas and Cytokinetics as well as the [ * ] such Collaboration Product for such Indication, subject to the discussion and final determination by the JCC, taking into account [ * ].
(iv) Notwithstanding anything to the contrary, the [ * ] for such Collaboration Product in such Indication in a particular country will have the decision making authority with respect [ * ] and other terms of sale for such Collaboration Product in such Indication for such country, provided that the other Party may conduct, [ * ].
(v) If [ * ] the Collaboration Product(s) in such [ * ] Indication, but the Parties have not determined which Party will [ * ] for the Collaboration Product(s) in such [ * ] Indication under Section 9.8(b), then [ * ] shall be responsible for the pre-commercialization activities for the Collaboration Product in such [ * ] Indication.
(f) Subject to Section 9.3(c), Astellas shall be solely responsible for all costs incurred by or on behalf of either Party in performing their respective obligations under the Commercialization Plan may include activities on a region-by-region except [ * ] (or country-by-country basis, as [ * ] determined by the JCC. The JCC will update ), which shall be agreed between the Commercialization Plan on [***] (or more frequently as needed) Parties acting reasonably and submit it to the JSC for approval. The Commercialization Plan 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 strategies on [***in good faith [ * ], including information related to Shared Product positioning, core messages to be communicated and pricing strategies, (e) a detailing strategy, (f) a pricing strategy, (g) all other material for its Co-Promotion activities to be conducted in connection with the Commercialization of the Shared Product as set forth in the Field in the Territory and (h) a budget for activities conducted under the Commercialization Plan (the “Commercialization Budget”). The Commercialization Plan will include a meaningful role for both Parties. In allocating responsibilities between the Parties, the JCC will take into consideration each Party’s expertise, capabilities, staffing and available resources to take on such activities, as well as the Parties’ intention to provide CRISPR an opportunity to build and expand its expertise, capabilities, staffing and available resources in connection with performing Commercialization activities allocated to it. CRISPR shall be the Commercializing lead for Shared Products in the United States and Vertex shall be the Commercializing lead for Shared Products outside of the United States. The Commercializing lead, with respect to the United States or outside of the United States, respectively, shall be referred to herein as the “Lead Commercialization Party” for such jurisdiction (as applicable, the “Lead Commercialization Party” Unless otherwise specified in the Commercialization Plan, the Parties will jointly be responsible for conducting all Commercialization activities outside of the United States, such activities to be determined by the JSCCo-Promotion Agreement.
Appears in 1 contract
Sources: License and Collaboration Agreement (Cytokinetics Inc)
Commercialization Plan. (a) The JCC will oversee commercialization of each Collaboration Product shall be governed by a Commercialization Plan which shall describe the overall plan for commercializing such Collaboration Product, including (i) a comprehensive marketing, sales, pricing, distribution and licensing strategy for such Collaboration Product in all applicable countries, including the Third Parties to be utilized 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 devices to be sold and local currency issues, and competitive analysis for such Collaboration Product, and (iii) a budget for the Commercialization Costs to be incurred in connection with performing such Commercialization Plan.
(b) Upon the submission of Shared Products by the Parties in the Field in the Territory. No later than [***] prior to the anticipated launch of the Shared all Regulatory Approval filings for a Collaboration Product in the first country in the Territoryany given country, the JCC will NEUROMetrix shall develop and submit to the JSC Steering Committee for approvalreview and approval an initial Commercialization Plan taking into consideration factors such as market conditions, a regulatory factors, competition and the costs and profits of such Collaboration Product. NEUROMetrix shall be primarily responsible for developing each Commercialization plan (Plan and, in connection therewith, shall consult with Cyberkinetics regarding the “identification, timing and execution of and budget for the major commercialization tasks required to perform the Commercialization Plan”) that sets forth , including without limitation the Commercialization activities to coordination of manufacturing with sales and marketing. Cyberkinetics shall be undertaken primarily responsible for developing a detailed manufacturing plan for each Collaboration Product, which plan shall be reviewed and approved by the Parties with respect Steering Committee and included within each Commercialization Plan. Cyberkinetics shall deliver such plan to NEUROMetrix within a reasonable period of time prior to the Commercialization of date NEUROMetrix expects to submit the Shared Product in the Territory. The overall Commercialization Plan may include activities on a region-by-region or country-by-country basisto the Steering Committee. Each Commercialization Plan shall be updated annually by NEUROMetrix, as determined in consultation with Cyberkinetics, and shall be submitted to the Steering Committee for approval not later than sixty (60) days prior to January 1 of each year. Each Commercialization Plan approved by the JCC. The JCC will update the Commercialization Plan on [***] (or more frequently as needed) Steering Committee shall be signed by an authorized representative of each of Cyberkinetics and submit it to the JSC for approval. The Commercialization Plan will include (a) the Global Branding Strategy, (b) a marketing strategy, NEUROMetrix.
(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 NEUROMetrix shall be primarily responsible for the implementation of such strategies on [***]each Commercialization Plan, including information related to Shared Product positioningwithout limitation, core messages to setting all terms of sale, including establishing pricing policies, credit terms and cash discounts and allowances, formulating marketing plans, providing patient information, providing customer support services, providing reimbursement counseling services and sales force training; provided that NEUROMetrix's execution and performance in respect of its marketing and sale of Collaboration Products shall be communicated and pricing strategies, (e) a detailing consistent with the strategy, (f) a pricing strategy, (g) all other material activities to be conducted policies and procedures established by each Commercialization Plan. NEUROMetrix shall act as an agent of the Company in connection with the sale of Collaboration Products and all revenues from such sales shall be booked by the Company. NEUROMetrix shall use Commercially Reasonable and Diligent Efforts to conduct the activities described in each Commercialization of the Shared Product in the Field in the Territory Plan. Cyberkinetics shall use Commercially Reasonable and (h) a budget for activities conducted under the Commercialization Plan (the “Commercialization Budget”). The Commercialization Plan will include a meaningful role for both Parties. In allocating responsibilities between the Parties, the JCC will take into consideration each Party’s expertise, capabilities, staffing and available resources Diligent Efforts to take on such activities, as well as the Parties’ intention to provide CRISPR an opportunity to build and expand its expertise, capabilities, staffing and available resources in connection with performing Commercialization perform any activities allocated to it. CRISPR shall be the Commercializing lead for Shared Products in the United States it under a Commercialization Plan and Vertex shall be the Commercializing lead for Shared Products outside of the United States. The Commercializing lead, with respect to the United States or outside of the United States, respectively, shall be referred provide such additional marketing support services as NEUROMetrix may from time to herein as the “Lead Commercialization Party” for such jurisdiction (as applicable, the “Lead Commercialization Party” Unless otherwise specified in the Commercialization Plan, the Parties will jointly be responsible for conducting all Commercialization activities outside of the United States, such activities to be determined by the JSCtime reasonably request.
Appears in 1 contract
Sources: Collaboration Agreement (Cyberkinetics Neurotechnology Systems, Inc.)
Commercialization Plan. The JCC will oversee the Commercialization of Shared Products by the Parties in the Field in the Territory. (a) No later than [*** prior to the anticipated filing of an application for Regulatory Approval for Product in the U.S., Endo shall deliver to the JCC a draft written commercialization plan setting forth anticipated material commercialization activities to be performed with respect to such Product in the U.S. by Endo or on its behalf (which shall include development of all marketing and promotional material and training of all sales personnel), as well as projected timelines for such activities (the “Commercialization Plan”). The JCC shall promptly review such draft initial Commercialization Plan and may provide commercially reasonable comments to Endo for its consideration. Endo shall give good faith consideration to such comments and may revise such draft Commercialization Plan to implement such of the JCC’s comments that it shall deem necessary or advisable to include in the draft. Endo shall, thereafter, submit the Commercialization Plan with such changes, revisions and modifications that it shall deem advisable to the JCC, and the Commercialization Plan, together with such changes, revisions and modifications, as applicable, shall be deemed final.
(b) No later than *] ** prior to the anticipated launch of the Shared Product in the first country in U.S., Endo shall update the Territory, the JCC will develop and submit to the JSC for approval, a Commercialization plan (the “Commercialization Plan”) that sets forth the Commercialization activities to be undertaken by the Parties with respect to the Commercialization of the Shared Product in the Territory. The Commercialization Plan may include activities on a region-by-region or country-by-country basis, as determined by the JCC. The JCC will and shall thereafter update the Commercialization Plan on [***] (or more frequently an annual basis as needed) and submit it follows: Endo shall provide the JCC with a draft update to the JSC for approval. The Commercialization Plan 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 strategies on [***], including information related to Shared Product positioning, core messages to be communicated and pricing strategies, (e) a detailing strategy, (f) a pricing strategy, (g) all other material activities to be conducted in connection with the Commercialization of the Shared Product in the Field in the Territory and (h) a budget for activities conducted under the Commercialization Plan (no later than *** of each year. Endo shall give good faith consideration to any comments provided by the “Commercialization Budget”). The JCC and may revise such Commercialization Plan will include a meaningful role for both Parties. In allocating responsibilities between the Parties, the JCC will take into consideration each Party’s expertise, capabilities, staffing and available resources to take on implement such activities, as well as the Parties’ intention to provide CRISPR an opportunity to build and expand its expertise, capabilities, staffing and available resources in connection with performing Commercialization activities allocated to it. CRISPR shall be the Commercializing lead for Shared Products in the United States and Vertex shall be the Commercializing lead for Shared Products outside of the United States. The Commercializing lead, with respect JCC’s comments that it shall deem necessary or advisable to the United States or outside of the United States, respectively, shall be referred to herein as the “Lead Commercialization Party” for such jurisdiction (as applicable, the “Lead Commercialization Party” Unless otherwise specified include in the Commercialization Plan, after which the Parties will jointly update to the Commercialization Plan shall be responsible for conducting all Commercialization activities outside deemed to be finalized. Endo shall deliver a final version of the United States, such activities to be determined by updated Commercialization Plan no later than *** of the JSCfollowing year.
(c) The Commercialization Plan shall include ***.
Appears in 1 contract
Sources: License and Development Agreement (Biodelivery Sciences International Inc)
Commercialization Plan. The JCC will oversee the Commercialization of Shared Products by the Parties in the Field in the Territory. No later than [***] prior to the anticipated launch of the Shared Product in the first country in the Territory, the JCC will develop and submit to the JSC for approval, a Commercialization plan (the “Commercialization Plan”) that sets forth the Commercialization activities to be undertaken by the Parties with respect to the All Commercialization of the Shared Product in the Territory. 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 [***] (or more frequently as needed) and submit it to the JSC for approval. The Commercialization Plan 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 strategies on [***], including information related to Shared Product positioning, core messages to be communicated and pricing strategies, (e) a detailing strategy, (f) a pricing strategy, (g) all other material activities to be conducted in connection with the Commercialization of the Shared Product in the Field in the Territory shall be conducted pursuant to a commercialization plan, which shall set forth the plan for the Detailing and (h) a budget for Promotion of the Product in the Field in the Territory in accordance with Applicable Laws and the activities conducted under the Commercialization Plan to be carried out related thereto (the “Commercialization BudgetPlan”). The Parties have agreed upon a high-level outline of the Commercialization Plan, as further described on Exhibit 6.2. No later than ninety (90) days after the Effective Date, and prior to January 1 of each and every Calendar Year after the first Calendar Year, United Therapeutics shall submit to the JSC for review an updated Commercialization Plan. For purposes of clarification, after submission of the first updated Commercialization Plan will include a meaningful role for both Partiesand not later than ninety (90) days after the Effective Date, United Therapeutics shall submit the first annual updated Commercialization Plan to the JSC prior to the start of the second Calendar Year (i.e., prior to January 1, 2010). In allocating responsibilities between the PartiesIf Lilly determines that such updated Commercialization Plan does not comply with Applicable Laws, the JCC will take into consideration each Party’s expertise, capabilities, staffing including laws relating to promotional and available resources to take on such activities, advertising materials as well as the Parties’ intention to provide CRISPR an opportunity to build accepted industry standards and expand its expertiseLilly’s ethical policies, capabilities, staffing and available resources in connection with performing Commercialization activities allocated to it. CRISPR shall be the Commercializing lead for Shared Products in the United States and Vertex shall be the Commercializing lead for Shared Products outside of the United States. The Commercializing lead, each case with respect to the United States Product in the Field in the Territory, or outside of that the United Statesactivities conducted under such updated Commercialization Plan are reasonably likely to materially adversely affect products in Lilly’s Domain, respectively, Lilly shall be referred permitted to herein as the “Lead Commercialization Party” for propose, in good faith, revisions to such jurisdiction (as applicable, the “Lead Commercialization Party” Unless otherwise specified in the updated Commercialization Plan, and United Therapeutics shall revise such Commercialization Plan. In the Parties will jointly be responsible for conducting all event of any inconsistency between the Commercialization activities outside Plan and this Agreement, the terms of the United States, such activities to be determined by the JSCthis Agreement shall prevail.
Appears in 1 contract
Commercialization Plan. (a) The JCC will oversee the Commercialization of Shared Products by the Parties in the Field in the Territory. No later than [***] prior to the anticipated launch of the Shared Product in the first country in the Territory, the JCC will shall develop and submit to approve a rolling multi-year plan and budget for commercializing the JSC for approval, a Commercialization plan Product (the “"Commercialization Plan”) that sets forth the Commercialization activities to be undertaken by the Parties with respect to the Commercialization of the Shared Product in the Territory"). The Commercialization Plan may shall include activities on a region-by-region or country-by-country basiscomprehensive market development, as determined by marketing, sales, supply and distribution strategy, including an overall budget for anticipated marketing, promotion and sales efforts in the JCC. The JCC will update the Commercialization Plan on [***] (or more frequently as needed) and submit it to the JSC for approvalcalendar year. The Commercialization Plan will include (a) specify which Target Populations and distribution channels each Party shall devote its Co-Promotion efforts towards, the Global Branding Strategy, (b) a marketing strategy, (c) a communications strategy that includes plans for public relations, conferences and exhibitions personnel and other external meetingsresources to be devoted by each Party to such efforts, internal meetings the number and communicationspositioning of details to be performed by each Party, publications as well as market and symposiasales forecasts and related operating expenses, internet activities and core brand package, (d) a high level operating plan for the implementation of such strategies on [***], including information related to Shared Product positioning, core messages to be communicated and pricing strategies, (e) a detailing strategy, (f) a pricing strategy, (g) all other material activities to be conducted in connection with the Commercialization of the Shared Product in the Field in the Territory Territory, and (h) a budget budgets for activities conducted under projected Commercialization Expenses and Sales and Marketing Expenses. In preparing the Commercialization Plan (the “Commercialization Budget”). The Commercialization Plan will include a meaningful role for both Parties. In allocating responsibilities between the PartiesPlan, the JCC will take into consideration each Party’s expertisefactors such as market conditions, capabilities, staffing regulatory issues and available resources to take on such activities, as well as competition. The Commercialization Plan will include the Parties’ intention to provide CRISPR an opportunity to build general strategy and expand its expertise, capabilities, staffing and available resources in connection with performing Commercialization activities allocated to it. CRISPR shall be operating guidelines for the Commercializing lead for Shared Products in the United States and Vertex shall be the Commercializing lead for Shared Products outside commercialization of the United StatesProduct.
(b) It is the intention of the Parties that Aviron's sales and marketing organization shall concentrate on a specific market segment or segments, to be agreed upon by the JCC, and that Aviron's marketing efforts shall include the development of an electronic-based selling infrastructure to support sales of the Product. The Commercializing leadIt is also the intention of the Parties that, with respect assuming regulatory approval therefor, Wyeth-Ayerst shall focus its initial sales and marketing efforts of the Product to the United States or outside of healthy pediatric Target Population, giving the United States, respectively, shall be referred to herein as Product first detail position for the “Lead Commercialization Party” for such jurisdiction (as applicable, Flu Season in which occurs the “Lead Commercialization Party” Unless otherwise specified in the Commercialization PlanLaunch Date. Further, the Parties will jointly intend that, if the Product is approved in the Field in the Territory for the adult Target Population, then Wyeth-Ayerst shall provide (including hiring, if necessary) sufficient personnel in its sales and marketing organization to market and sell the Product to such adult Target Population.
(c) The first Commercialization Plan shall be responsible for conducting all prepared and approved as promptly as possible after the Effective Date and shall thereafter be immediately in effect. Annually thereafter, the JCC shall update and amend the Commercialization activities outside of Plan with such process as the United States, such activities to be determined by the JSCJCC shall determine. [***] = CONFIDENTIAL TREATMENT REQUESTED.
Appears in 1 contract