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. The JCC will oversee Abbott shall use Commercially Reasonable Efforts to make the Commercialization of Shared Products by the Parties Diagnostic Test commercially available in the Field each country in the Territory. No later than [***] prior which Regulatory Approval is obtained pursuant to the anticipated launch of Regulatory Plan and, with Epizyme’s cooperation as appropriate and agreed by Epizyme in Epizyme’s reasonable discretion, shall commercialize the Shared Product in the first country in the Territory, the JCC will develop and submit Diagnostic Test pursuant to the JSC for approval, provisions of a Commercialization joint commercialization plan (the “Commercialization Plan”), which shall include the following:
(a) that sets forth the Commercialization activities to be undertaken performed by each Party (and, in the Parties case of Epizyme, if Epizyme has licensed to or is otherwise collaborating with a Third Party with respect to the Commercialization development or commercialization of the Shared Epizyme Product in any country or territory, the Territoryactivities to be performed by such Third Party) and the deliverables related thereto;
(b) the timelines for each activity under the Commercialization Plan;
(c) the overarching commercialization strategy and commercial goals for the Diagnostic Test, including the availability and distribution of the Diagnostic Test in each country for which Regulatory Approval is sought pursuant to the Regulatory Plan;
(d) customer service;
(e) responsibilities for and restrictions on public relations activity/Direct-To-Consumer and other promotional advertising activity;
(f) coordination of the pre-launch/launch and post launch of Abbott/Epizyme (and Third Party, if applicable) sales teams and scientific teams;
(g) forecasting and measurement of sales and distribution data, including reporting of sales units of the Diagnostic Test to Epizyme and the Epizyme Product to Abbott;
(h) the establishment of “launch success factors” for each market. Such launch success factors shall be agreed upon by the Parties prior to any launch;
(i) activities to be performed post-launch to ensure ongoing alignment of the Diagnostic Test Intended Use and Epizyme Product Indication, including fulfilling any commitment(s) imposed by Regulatory Authorities;
(j) plans for manufacturing and supplying the Diagnostic Test; and
(k) plans for maintaining acceptable levels of regulatory and GMP/GLP compliance during development, manufacture and marketing of the Diagnostic Test. (as amended from time to time, the “Commercialization Plan”). The initial Commercialization Plan may include activities on a region-by-region or country-by-country basisis attached hereto as Exhibit D. The Parties acknowledge that the initial Commercialization Plan does not address all of the items set forth above, but the Parties agree that, as determined by soon as practicable following the JCCEffective Date, the initial Commercialization Plan will be modified and made more comprehensive pursuant to the provisions of this Agreement. The JCC will update Thereafter, as may be necessary from time-to-time, in particular as the Diagnostic Test gets closer to commercialization, the Commercialization Team Lead shall suggest appropriate revisions to the Commercialization Plan on [***] (or more frequently as needed) and submit it to the JSC for its prior written review and approval. The If the JSC approves such revisions, and the Parties consent in writing to such revisions, then the JSC shall revise the Commercialization Plan will include (a) the Global Branding Strategy, (b) a marketing strategy, (c) a communications strategy that includes plans accordingly without need 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 amending this Agreement. The Parties shall not unreasonably withhold their consent to Shared Product positioning, core messages to appropriate Commercialization Plan revisions. The revised Commercialization Plan shall thereafter 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 Plan for all purposes of the Shared Product in the Field in the Territory and (h) a budget for activities conducted this Agreement. The Parties shall each use their Commercially Reasonable Efforts to perform all of their obligations under the Commercialization Plan (the “Commercialization Budget”). The Commercialization Plan will include a meaningful role for both Parties. In allocating responsibilities between the Partiesin accordance with generally accepted ethical, the JCC will take into consideration each Party’s expertise, capabilities, staffing best sales and available resources to take on such activities, as well as the Parties’ intention to provide CRISPR an opportunity to build marketing practices and expand its expertise, capabilities, staffing and available resources in connection compliance 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 JSCApplicable Law.
Appears in 2 contracts
Sources: Development and Commercialization Agreement (Epizyme, Inc.), Development and Commercialization Agreement (Epizyme, Inc.)
Commercialization Plan. The JCC At least [***] before the anticipated First Commercial Sale of the Product in the Field in a country in the Territory, MTPC will oversee provide a strategic commercialization plan for the Commercialization of Shared Products by the Parties in the Field in the TerritoryTerritory for review and approval by the JSC (any such approved plan, the “Commercialization Plan”). No later than The Commercialization Plan will set forth, among other things, (a) [***] prior to the anticipated launch of the Shared Product in the first country in the Territorymarketing strategy that includes plans for market research, the JCC will develop health economics, pricing and submit to the JSC for approvalreimbursement, a Commercialization plan medical affairs and value added initiatives; (the “Commercialization Plan”b) 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, and internet activities and core brand package, activities; (dc) a high level operating plan for the implementation of such strategies on [***]] basis, including including, without limitation, information related to Shared Product product positioning, core messages to be communicated communicated, and pricing strategies; (d) revenue targets and unit forecasts, planned for Products in the Territory and the timelines for achieving such activities; and (e) a detailing strategy, (f) a pricing strategy, (g) all other material activities to be conducted by MTPC in connection with the Commercialization of the Shared Product Products in the Field in Territory. During the Territory and (h) a budget for activities conducted under Term, MTPC will amend the Commercialization Plan on an ongoing basis as necessary, any amendments (other than amendments required to comply with Applicable Laws or written requirements imposed by Regulatory Authorities) being subject to review and approval by the “Commercialization Budget”)JSC, and any amendments required to comply with Applicable Laws or written requirements imposed by Regulatory Authorities being subject to report to the JSC. The Commercialization Plan will include a meaningful role for both Parties. In allocating responsibilities between must at all times contain terms that reflect the Partiesuse of Commercially Reasonable Efforts to Commercialize all Products that have Regulatory Approval in the Territory and, the JCC will take into consideration each Party’s expertise, capabilities, staffing and available resources to take on such activities, except 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 otherwise expressly allocated to it. CRISPR shall be the Commercializing lead for Shared Products Viela in the United States and Vertex shall be the Commercializing lead for Shared Products outside of the United States. The Commercializing leadthis Agreement, with respect to the United States or outside of the United Statesincluding in Section 4.6.3 (Commercialization Cooperation), 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 may not include any activities to be determined conducted by the JSCViela, without Viela’s prior consent, which shall not be unreasonably withheld.
Appears in 1 contract
Sources: License Agreement (Viela Bio, Inc.)
Commercialization Plan. The JCC will oversee Abbott, with Idera’s cooperation, shall commercialize the Diagnostic Test for the Diagnostic Test Intended Use pursuant to the provisions of a commercialization plan, which shall include the following:
(a) the activities to be performed by each Party and the deliverables related thereto;
(b) the timelines for each activity under the Commercialization Plan;
(c) the overarching commercial goals including the availability and distribution of Shared Products the Diagnostic Test;
(d) customer service;
(e) responsibilities for and restrictions on public relations activity/Direct-To-Consumer and other promotional advertising activity;
(f) coordination of the pre-launch/launch and post launch of Abbott/Idera sales teams and scientific teams;
(g) forecasting and measurement of sales and distribution data, including reporting of sales units of the Diagnostic Test to Idera and the Idera Product to Abbott;
(h) the establishment of “launch success factors” for each market. Such launch success factors shall be agreed upon by the Parties in the Field in the Territory. No later than [***] prior to any launch;
(i) activities to be performed post-launch with respect to the anticipated launch Diagnostic Test Intended Use, including fulfilling any commitment(s) imposed by Regulatory Authorities;
(j) plans for manufacturing and supplying the Diagnostic Test; and
(k) plans for maintaining acceptable levels of regulatory and GMP/GLP compliance during development, manufacture and marketing of the Shared Product in the first country in the TerritoryDiagnostic Test, the JCC will develop including responsibility for timely and submit comprehensive resolution of any compliance findings or actions of Regulatory Authorities during audits (pre and post-approval) (as amended from time to the JSC for approvaltime, a Commercialization plan (the “Commercialization Plan”) ). The initial Commercialization Plan is attached hereto as Exhibit D. The Parties acknowledge that sets the initial Commercialization Plan does not address all of the items set forth above, but the Parties agree that, as soon as practicable following the Effective Date, the initial Commercialization Plan will be modified and made more comprehensive pursuant to the provisions of this Agreement. Thereafter, as may be necessary from time-to-time, in particular as the Diagnostic Test gets closer to commercialization, the Commercialization activities to be undertaken by the Parties with respect Team Lead shall suggest appropriate revisions 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 its prior written review and approval. The If the JSC approves such revisions, and the Parties consent in writing to such revisions, then the JSC shall revise the Commercialization Plan will include (a) the Global Branding Strategy, (b) a marketing strategy, (c) a communications strategy that includes plans accordingly without need 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 amending this Agreement. The revised Commercialization Plan shall thereafter 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 Plan for all purposes of the Shared Product in the Field in the Territory and (h) a budget for activities conducted this Agreement. The Parties shall each use their Commercially Reasonable Efforts to perform all of their obligations under the Commercialization Plan (in accordance with generally accepted ethical, good sales and marketing practices and in compliance with Applicable Law, provided however that Abbott shall have 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 right 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 delay First Commercial Sale in connection accordance 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 JSCSection 7.9.
Appears in 1 contract
Sources: Development and Commercialization Agreement (Idera Pharmaceuticals, Inc.)
Commercialization Plan. The JCC will oversee (a) As further described in this section 7.4, the strategy for the commercial launch of, and subsequent Commercialization of, each Joint Product in each Commercialization Territory shall be described in a comprehensive plan (each such plan, and any revisions thereto, a “Commercialization Plan”) for such Commercialization Territory that describes: (a) the pre-launch, launch and subsequent Commercialization activities for such Joint Product in the Commercialization Territory (including promotional messaging, branding (including Product Trademarks), pricing, advertising, planning, marketing, sales force training); (b) key tactics for implementing those activities; (c) the responsibilities for implementing those activities assigned to each of Shared Products the Parties; (d) the Detailing plan (including the number of Sales Representatives to be provided by the Parties and the number of PDEs required to be performed by the Parties in the Field each applicable country in the TerritoryCommercialization Territory during each Calendar Quarter); (e) Phase IV Studies and Medical Affairs Activities; (f) the brand elements for such Joint Product throughout the Profit Share Region, including the applicable key distinctive colors, logos, images, and symbols, and Trademarks (including the Product Trademarks) to be used in connection therewith (consistent with Section 7.9); and (g) a comprehensive budget of the projected costs for executing such activities for such Joint Product in the Commercialization Territory (which budget shall include required amounts of promotional funds to be expended by the Parties). No later than The Parties may agree on a single Commercialization Plan to cover multiple Joint Products. Each Commercialization Plan and all subsequent revisions thereto shall contain the information described above in this Section 7.4(a) and any other information the JMC believes is necessary or useful for the successful commercial launch and subsequent Commercialization of such Joint Product. The Parties acknowledge that certain items of the Commercialization Plan may not be amenable to determination at the time the Commercialization Plan is initially drafted. In such event, the Parties shall amend such plan pursuant to Section 7.4(b) to include such items when appropriate. In the event of any inconsistency between a Commercialization Plan and this Agreement, the terms of this Agreement shall control.
(b) The applicable JMC shall develop for approval by the JEC a proposed Commercialization Plan for each Joint Product for each Commercialization Territory at least [***] months prior to the anticipated launch then-current date of the Shared expected First Commercial Sale for such Joint 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, Territory as determined by such JMC (such date, the JCC“Anticipated Launch Date” for such Joint Product). The JCC will update In addition, the Commercialization Plan on JMC shall prepare and provide to the JEC for approval by [***] (or more frequently as needed) and submit it of each year an updated Commercialization Plan for the following Calendar Year. The JMC may also prepare amendments to the JSC for approval. The Commercialization Plan will include (a) from time to time during the Global Branding StrategyCalendar Year. If the JMC or JEC cannot agree on any amendment to any such Commercialization Plan, (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 matter shall be resolved [***], including information related to Shared Product positioning, core messages to be communicated and pricing strategies, .
(ec) In the event the JMC cannot agree on 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 Partiesor any amendment thereto, the JCC will take into consideration including each Party’s expertise, capabilities, staffing and available resources annual update) 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 submitted to the United States or outside of the United StatesJEC within [***] days after consideration thereof, respectively, then such matter shall be referred to herein as the “Lead JEC for resolution. In the event the JEC cannot agree on a Commercialization Party” for Plan (or any amendment thereto, including each annual update) within [***] days after consideration thereof, then such jurisdiction (as applicable, matter shall be referred to the “Lead Commercialization Party” Unless otherwise specified in the Commercialization Plan, Senior Officers of the Parties will jointly be responsible for conducting all Commercialization activities outside of resolution. If such Senior Officers cannot reach resolution on the United States, such activities to be determined by the JSCmatter within a [***]-day period [***].
Appears in 1 contract
Sources: Collaboration Agreement (Reata Pharmaceuticals Inc)
Commercialization Plan. The JCC will oversee Commercialization of the Licensed Products shall be conducted pursuant to an annual plan and budget to be prepared by Licensee with respect to the Americas/Europe Territory (the “Americas/Europe Commercialization Plan”) and the Asia/ROW Territory (the “Asia/ROW Commercialization Plan”) (the Americas/Europe Commercialization Plan and the Asia/ROW Commercialization Plan, collectively the “Commercialization Plans”), which plans and budgets shall be consistent with Licensee’s obligations set forth in Section 4.1. The Commercialization Plans shall include, when and as formulated by Licensee: with respect to the Americas/Europe Territory or the Asia/ROW Territory, as applicable, (i) general strategies for the promoting, Detailing, marketing, sales and distribution of the Licensed Products in each applicable countries, including the identification of any Third Parties engaged or to be engaged in connection with such activities and the arrangements with them that have been or are proposed to be agreed upon (including policies and procedures for adjustments, rebates, bundling and the like), (ii) estimated launch date, market and sales forecasts, in numbers of patients and local currency, and competitive analysis for the Licensed Products for the Licensee Territory and for each country within the Licensee Territory, (iii) product positioning and promotional plans (including examples of planned Promotional Materials), (iv) Phase IV clinical trial support, if applicable, (v) managed care contracting strategy, (vi) conduct of Licensed Product-specific training programs for sales representatives, (viii) a detailed manufacturing plan, (ix) pre-launch commercialization activities and the expected date of launch, (x) sales force size and allocation throughout the Licensee Territory and, during the Co-Promotion Period, (xi) a detailed budget for the Commercialization Costs to be incurred in connection with performing such Americas/Europe Commercialization Plan and (xii) an allocation of Shared Products by specific responsibilities of each of the Parties in with respect to Commercialization objectives, including a specification of target market segments and Detailing requirements and strategy to be achieved during the Field in calendar year to which the TerritoryCommercialization Plans relate. No The Parties agree that any forecasts provided by Licensee as part of the Commercialization Plans shall be regarded as Licensee’s good faith estimates based upon conditions then existing and shall not be binding upon Licensee. The first such Commercialization Plans shall be prepared by Licensee and furnished to Licensor through the JSC by no later than [***] prior to twelve months before the anticipated launch of the Shared first Licensed 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 each 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 Americas/Europe 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 StatesAsia/ROW Territory, respectively, and shall thereafter be referred updated annually, with delivery of draft Commercialization Plans 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 Licensor by no later than November 1 of each successive Calendar Year and delivery of the United States, final Commercialization Plans following the approval of such activities to be determined Commercialization Plans by the JSCboard of directors of Licensee.
Appears in 1 contract
Commercialization Plan. The JCC will oversee (a) As further described in this section 7.4, the strategy for the commercial launch of, and subsequent Commercialization of, each Joint Product in each Commercialization Territory shall be described in a comprehensive plan (each such plan, and any revisions thereto, a “Commercialization Plan”) for such Commercialization Territory that describes: (a) the pre-launch, launch and subsequent Commercialization activities for such Joint Product in the Commercialization Territory (including promotional messaging, branding (including Product Trademarks), pricing, advertising, planning, marketing, sales force training); (b) key tactics for implementing those activities; (c) the responsibilities for implementing those activities assigned to each of Shared Products the Parties; (d) the Detailing plan (including the number of Sales Representatives to be provided by the Parties and the number of PDEs required to be performed by the Parties in the Field each applicable country in the TerritoryCommercialization Territory during each Calendar Quarter); (e) Phase IV Studies and Medical Affairs Activities; (f) the brand elements for such Joint Product throughout the Profit Share Region, including the applicable key distinctive colors, logos, images, and symbols, and Trademarks (including the Product Trademarks) to be used in connection therewith (consistent with Section 7.9); and (g) a comprehensive budget of the projected costs for executing such activities for such Joint Product in the Commercialization Territory (which budget shall include required amounts of promotional funds to be expended by the Parties). No later than The Parties may agree on a single Commercialization Plan to cover multiple Joint Products. Each Commercialization Plan and all subsequent revisions thereto shall contain the information described above in this Section 7.4(a) and any other information the JMC believes is necessary or useful for the successful commercial launch and subsequent Commercialization of such Joint Product. The Parties acknowledge that certain items of the Commercialization Plan may not be amenable to determination at the time the Commercialization Plan is initially drafted. In such event, the Parties shall amend such plan pursuant to Section 7.4(b) to include such items when appropriate. In the event of any inconsistency between a Commercialization Plan and this Agreement, the terms of this Agreement shall control.
(b) The applicable JMC shall develop for approval by the JEC a proposed Commercialization Plan for each Joint Product for each Commercialization Territory at least [***] months prior to the anticipated launch then-current date of the Shared expected First Commercial Sale for such Joint Product in the first country in the TerritoryCommercialization Territory as determined by such JMC (such date, the JCC will develop “Anticipated Launch Date” for such Joint Product). In addition, the JMC shall prepare and submit provide to the JSC JEC for approval, a approval by [***]of each year an updated Commercialization plan (Plan for the “Commercialization Plan”) that sets forth the Commercialization activities to be undertaken by the Parties with respect following Calendar Year. The JMC may also prepare amendments to the Commercialization of Plan from time to time during the Shared Product in Calendar Year. If the Territory. The JMC or JEC cannot agree on any amendment to any such Commercialization Plan, the matter shall be resolved [***].
(c) In the event the JMC cannot agree on a Commercialization Plan may include activities on a region-by-region (or country-by-country basisany amendment thereto, as determined by including each annual update) to be submitted to the JCC. The JCC will update the Commercialization Plan on JEC within [***] days after consideration thereof, then such matter shall be referred to the JEC for resolution. In the event the JEC cannot agree on a Commercialization Plan (or more frequently as neededany amendment thereto, including each annual update) and submit it within [***] days after consideration thereof, then such matter shall be referred to the JSC Senior Officers of the Parties for approvalresolution. The Commercialization Plan will include (a) If such Senior Officers cannot reach resolution on the Global Branding Strategy, (b) matter within 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-day period [***].
Appears in 1 contract
Sources: Collaboration Agreement (Reata Pharmaceuticals Inc)
Commercialization Plan. The JCC will oversee 3.6.1 An initial version of the 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 Licensed Product in the first country in the Territory, the JCC will develop and submit to the JSC for approval, a Commercialization plan US Territory is attached as Schedule 1 (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 ), as such Commercialization Plan may include activities on a region-by-region or country-by-country basis, as determined be updated from time to time by the JCC. The JCC will update Parties acknowledge and agree that the initial version of the Commercialization Plan on [***] (or more frequently as needed) is consistent with MedImmune and submit it to Innate’s obligations under 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 [***].
3.6.2 The Commercialization Plan must include until the end of the US Transition Period:
(a) general strategies for Promoting, marketing and distributing the Licensed Product in the US Territory;
(b) numbers of Full Time Sales Representatives, field based supervisory sales managers and medical/scientific liaisons (expressed in FTEs) for the Licensed Product;
(c) Promotional activities and Detailing plans, including information related to Shared Product positioning, core messages to be communicated target prescribers and pricing strategies, frequency and coverage metrics;
(d) budgeted expenditure for sales and marketing;
(e) a detailing strategy, summary-level market and sales forecasts for the Licensed Product;
(f) a pricing strategy, projection of Net Sales for the Licensed Product;
(g) all other material activities SOV (share of voice) objectives;
(h) plans regarding distribution; and
(i) Innate’s strategy with respect to be conducted in connection pricing and reimbursement, managed care and discounts.
3.6.3 Following the Effective Date, each Party, through its representatives on the Joint Commercialization Committee, may propose amendments to the Commercialization Plan at any time and the Joint Commercialization Committee shall review the Commercialization Plan at least quarterly for the purpose of considering appropriate amendments with the objective of optimising the Commercialization of the Shared Licensed Product in the Field US Territory. Provided they are consistent with the content principles set forth in clause 3.6.2, each Party shall consider all comments made by the Territory and (h) a budget for activities conducted under other on the Commercialization Plan (and any proposed amendments thereto in good faith.
3.6.4 During the “US Transition Period, the Joint Commercialization Budget”). The Committee shall review and agree any proposed amendments to the Commercialization Plan will include a meaningful role for both Parties. In allocating responsibilities between with the Parties, objective of optimising the JCC will take into consideration each Party’s expertise, capabilities, staffing and available resources to take on such activities, as well as Commercialization of 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 Licensed Product in the United States US Territory, and Vertex shall be transitioning its Commercialization to Innate, and complying with the Commercializing lead for Shared Products outside provisions 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 Agreement (Innate Pharma SA)