Common use of Commercialization Plan Clause in Contracts

Commercialization Plan. Abbott shall use Commercially Reasonable Efforts to make the Diagnostic Test commercially available in each country in which Regulatory Approval is obtained pursuant to the Regulatory Plan and, with Epizyme’s cooperation as appropriate and agreed by Epizyme in Epizyme’s reasonable discretion, shall commercialize the Diagnostic Test pursuant to the provisions of a joint commercialization plan (the “Commercialization Plan”), which shall include the following: (a) the activities to be performed by each Party (and, in the case of Epizyme, if Epizyme has licensed to or is otherwise collaborating with a Third Party with respect to the development or commercialization of the Epizyme Product in any country or territory, the activities 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 is 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 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 Team Lead shall suggest appropriate revisions to the Commercialization Plan to the JSC for its prior written review and approval. If the JSC approves such revisions, and the Parties consent in writing to such revisions, then the JSC shall revise the Commercialization Plan accordingly without need for amending this Agreement. The Parties shall not unreasonably withhold their consent to appropriate Commercialization Plan revisions. The revised Commercialization Plan shall thereafter be the Commercialization Plan for all purposes of 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, best sales and marketing practices and in compliance with Applicable Law.

Appears in 2 contracts

Samples: Development and Commercialization Agreement (Epizyme, Inc.), Development and Commercialization Agreement (Epizyme, Inc.)

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Commercialization Plan. Abbott shall use Commercially Reasonable Efforts The JCC will oversee the Commercialization of Shared Products by the Parties in the Field in the Territory. No later than [***] prior to make the Diagnostic Test commercially available anticipated launch of the Shared Product in each the first country in which Regulatory Approval is obtained pursuant the Territory, the JCC will develop and submit to the Regulatory Plan andJSC for approval, with Epizyme’s cooperation as appropriate and agreed by Epizyme in Epizyme’s reasonable discretion, shall commercialize the Diagnostic Test pursuant to the provisions of a joint commercialization 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, which shall 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 the following: (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 performed by each Party (and, conducted in connection with the Commercialization of the Shared Product in the case 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 Epizymethe United States. The Commercializing lead, if Epizyme has licensed to or is otherwise collaborating with a Third Party with respect to the development United States or commercialization outside of the Epizyme Product in any country or territoryUnited 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 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 determined 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 is 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 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 Team Lead shall suggest appropriate revisions to the Commercialization Plan to the JSC for its prior written review and approval. If the JSC approves such revisions, and the Parties consent in writing to such revisions, then the JSC shall revise the Commercialization Plan accordingly without need for amending this Agreement. The Parties shall not unreasonably withhold their consent to appropriate Commercialization Plan revisions. The revised Commercialization Plan shall thereafter be the Commercialization Plan for all purposes of 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, best sales and marketing practices and in compliance with Applicable LawJSC.

Appears in 2 contracts

Samples: Strategic Collaboration, Option and License Agreement (CRISPR Therapeutics AG), Strategic Collaboration, Option and License Agreement (CRISPR Therapeutics AG)

Commercialization Plan. Abbott The Commercialization of the Licensed Products shall use Commercially Reasonable Efforts to make the Diagnostic Test commercially available in each country in which Regulatory Approval is obtained be conducted pursuant to the Regulatory Plan and, an annual plan and budget to be prepared by Licensee with Epizyme’s cooperation as appropriate and agreed by Epizyme in Epizyme’s reasonable discretion, shall commercialize the Diagnostic Test pursuant respect to the provisions of a joint commercialization plan 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 include the following: (a) the activities to be performed consistent with Licensee’s obligations set forth in Section 4.1. The Commercialization Plans shall include, when and as formulated by each Party (and, in the case of Epizyme, if Epizyme has licensed to or is otherwise collaborating with a Third Party Licensee: with respect to the development Americas/Europe Territory or commercialization of the Epizyme Product in any country or territoryAsia/ROW Territory, the activities to be performed by such Third Partyas applicable, (i) and the deliverables related thereto; (b) the timelines for each activity under the Commercialization Plan; (c) the overarching commercialization strategy and commercial goals general strategies for the Diagnostic Testpromoting, including the availability Detailing, marketing, sales and distribution of the Diagnostic Test 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 for which Regulatory Approval is sought pursuant to within the Regulatory Plan; Licensee Territory, (diii) customer service; product positioning and promotional plans (eincluding examples of planned Promotional Materials), (iv) 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 PartyPhase 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 teams force size and scientific teams; allocation throughout the Licensee Territory and, during the Co-Promotion Period, (gxi) forecasting a detailed budget for the Commercialization Costs to be incurred in connection with performing such Americas/Europe Commercialization Plan and measurement (xii) an allocation of sales and distribution dataspecific responsibilities of each of the Parties with respect to Commercialization objectives, including reporting a specification of sales units of the Diagnostic Test to Epizyme target market segments 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 Detailing requirements and strategy to be performed post-launch achieved during the calendar year 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 is 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 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, which the Commercialization Team Lead shall suggest appropriate revisions to the Commercialization Plan to the JSC for its prior written review and approval. If the JSC approves such revisions, and the Parties consent in writing to such revisions, then the JSC shall revise the Commercialization Plan accordingly without need for amending this AgreementPlans relate. The Parties agree that any forecasts provided by Licensee as part of the Commercialization Plans shall be regarded as Licensee’s good faith estimates based upon conditions then existing and shall not unreasonably withhold their consent to appropriate Commercialization Plan revisionsbe binding upon Licensee. The revised first such Commercialization Plan Plans shall be prepared by Licensee and furnished to Licensor through the JSC by no later than twelve months before the anticipated launch of the first Licensed Product in each of the Americas/Europe Territory and Asia/ROW Territory, respectively, and shall thereafter be updated annually, with delivery of draft Commercialization Plans to Licensor by no later than November 1 of each successive Calendar Year and delivery of the final Commercialization Plan for all purposes Plans following the approval of this Agreement. The Parties shall each use their Commercially Reasonable Efforts to perform all such Commercialization Plans by the board of their obligations under the Commercialization Plan in accordance with generally accepted ethical, best sales and marketing practices and in compliance with Applicable Lawdirectors of Licensee.

Appears in 1 contract

Samples: License Agreement (Clovis Oncology, Inc.)

Commercialization Plan. Abbott shall use Commercially Reasonable Efforts to make (a) As further described in this section 7.4, the Diagnostic Test commercially available strategy for the commercial launch of, and subsequent Commercialization of, each Joint Product in each country Commercialization Territory shall be described in which Regulatory Approval is obtained pursuant to the Regulatory Plan and, with Epizyme’s cooperation as appropriate and agreed by Epizyme in Epizyme’s reasonable discretion, shall commercialize the Diagnostic Test pursuant to the provisions of a joint commercialization comprehensive plan (the each such plan, and any revisions thereto, a “Commercialization Plan”), which shall include the following: ) 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 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 each Party (and, applicable country in the case of EpizymeCommercialization 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, if Epizyme has licensed including the applicable key distinctive colors, logos, images, and symbols, and Trademarks (including the Product Trademarks) to or is otherwise collaborating be used in connection therewith (consistent with Section 7.9); and (g) a Third Party with respect to the development or commercialization comprehensive budget of the Epizyme 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). 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 country other information the JMC believes is necessary or territoryuseful 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 activities Parties shall amend such plan pursuant to be performed by Section 7.4(b) to include such Third Party) items when appropriate. In the event of any inconsistency between a Commercialization Plan and this Agreement, the deliverables related thereto;terms of this Agreement shall control. (b) The applicable JMC shall develop for approval by the timelines JEC a proposed Commercialization Plan for each activity under Joint Product for each Commercialization Territory at least [***] months prior to the then-current date of expected First Commercial Sale for such Joint Product in the Commercialization Territory as determined by such JMC (such date, the “Anticipated Launch Date” for such Joint Product). In addition, the JMC shall prepare and provide to the JEC for approval by [***] of each year an updated Commercialization Plan for the following Calendar Year. The JMC may also prepare amendments to the Commercialization Plan from time to time during the Calendar Year. If the JMC or JEC cannot agree on any amendment to any such Commercialization Plan;, the matter shall be resolved [***]. (c) In the overarching commercialization strategy and commercial goals for event the Diagnostic TestJMC cannot agree on a Commercialization Plan (or any amendment thereto, including each annual update) to be submitted to the availability and distribution 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 any amendment thereto, including each annual update) within [***] days after consideration thereof, then such matter shall be referred to the Senior Officers of the Diagnostic Test in each country Parties 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 is 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 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 Team Lead shall suggest appropriate revisions to the Commercialization Plan to the JSC for its prior written review and approvalresolution. If such Senior Officers cannot reach resolution on the JSC approves such revisions, and the Parties consent in writing to such revisions, then the JSC shall revise the Commercialization Plan accordingly without need for amending this Agreement. The Parties shall not unreasonably withhold their consent to appropriate Commercialization Plan revisions. The revised Commercialization Plan shall thereafter be the Commercialization Plan for all purposes of 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, best sales and marketing practices and in compliance with Applicable Lawmatter within a [***]-day period [***].

Appears in 1 contract

Samples: Collaboration Agreement (Reata Pharmaceuticals Inc)

Commercialization Plan. Abbott shall use Commercially Reasonable Efforts to make 3.6.1 An initial version of the Diagnostic Test commercially available plan for the Commercialization of the Licensed Product in each country in which Regulatory Approval the US Territory is obtained pursuant to the Regulatory Plan and, with Epizyme’s cooperation attached as appropriate and agreed by Epizyme in Epizyme’s reasonable discretion, shall commercialize the Diagnostic Test pursuant to the provisions of a joint commercialization plan Schedule 1 (the “Commercialization Plan”), which shall as such Commercialization Plan may be updated from time to time by the JCC. The Parties acknowledge and agree that the initial version of the Commercialization Plan is consistent with MedImmune and Innate’s obligations under the [***]. 3.6.2 The Commercialization Plan must include until the followingend of the US Transition Period: (a) general strategies for Promoting, marketing and distributing the activities to be performed by each Party (and, Licensed Product in the case of Epizyme, if Epizyme has licensed to or is otherwise collaborating with a Third Party with respect to the development or commercialization of the Epizyme Product in any country or territory, the activities to be performed by such Third Party) and the deliverables related theretoUS Territory; (b) numbers of Full Time Sales Representatives, field based supervisory sales managers and medical/scientific liaisons (expressed in FTEs) for the timelines for each activity under the Commercialization PlanLicensed Product; (c) the overarching commercialization strategy Promotional activities and commercial goals for the Diagnostic TestDetailing plans, including the availability target prescribers and distribution of the Diagnostic Test in each country for which Regulatory Approval is sought pursuant to the Regulatory Planfrequency and coverage metrics; (d) customer servicebudgeted expenditure for sales and marketing; (e) responsibilities summary-level market and sales forecasts for and restrictions on public relations activity/Direct-To-Consumer and other promotional advertising activitythe Licensed Product; (f) coordination a projection of Net Sales for the pre-launch/launch and post launch of Abbott/Epizyme (and Third Party, if applicable) sales teams and scientific teamsLicensed Product; (g) forecasting and measurement SOV (share of sales and distribution data, including reporting of sales units of the Diagnostic Test to Epizyme and the Epizyme Product to Abbottvoice) objectives; (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;plans regarding distribution; and (i) activities Innate’s strategy with respect to be performed post-launch to ensure ongoing alignment of the Diagnostic Test Intended Use pricing and Epizyme Product Indicationreimbursement, including fulfilling any commitment(s) imposed by Regulatory Authorities;managed care and discounts. (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 is 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 soon as practicable following 3.6.3 Following the Effective Date, each Party, through its representatives on the initial Joint Commercialization Plan will be modified and made more comprehensive pursuant to the provisions of this Agreement. ThereafterCommittee, 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 propose amendments to the Commercialization Plan to the JSC for its prior written review and approval. If the JSC approves such revisions, at any time and the Parties consent in writing to such revisions, then the JSC Joint Commercialization Committee shall revise review the Commercialization Plan accordingly without need at least quarterly for amending this Agreementthe purpose of considering appropriate amendments with the objective of optimising the Commercialization of the Licensed Product in the US Territory. The Parties Provided they are consistent with the content principles set forth in clause 3.6.2, each Party shall not unreasonably withhold their consent to appropriate Commercialization Plan revisions. The revised Commercialization Plan shall thereafter be consider all comments made by the other on the Commercialization Plan for all purposes of this Agreement. The Parties and any proposed amendments thereto in good faith. 3.6.4 During the US Transition Period, the Joint Commercialization Committee shall each use their Commercially Reasonable Efforts review and agree any proposed amendments to perform all of their obligations under the Commercialization Plan with the objective of optimising the Commercialization of the Licensed Product in accordance the US Territory, and transitioning its Commercialization to Innate, and complying with generally accepted ethical, best sales and marketing practices and in compliance with Applicable Lawthe provisions of the [***].

Appears in 1 contract

Samples: License Agreement (Innate Pharma SA)

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Commercialization Plan. Abbott shall use Commercially Reasonable Efforts to make At least [***] before the Diagnostic Test commercially available anticipated First Commercial Sale of the Product in each the Field in a country in which Regulatory Approval is obtained pursuant to the Regulatory Plan andTerritory, with Epizyme’s cooperation as appropriate and agreed by Epizyme in Epizyme’s reasonable discretion, shall commercialize the Diagnostic Test pursuant to the provisions of MTPC will provide a joint strategic commercialization plan (for the “Commercialization Plan”), which shall include the following: (a) the activities to be performed by each Party (and, Products in the case of Epizyme, if Epizyme has licensed to or is otherwise collaborating with a Third Party with respect to Field in the development or commercialization of the Epizyme Product in any country or territory, the activities to be performed by such Third Party) Territory for review 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 approval by the Parties prior to JSC (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 timesuch approved plan, the “Commercialization Plan”). The initial Commercialization Plan is 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 soon as practicable following the Effective Date, the initial Commercialization Plan will set forth, among other things, (a) [***] marketing strategy that includes plans for market research, health economics, pricing and reimbursement, medical affairs and value added initiatives; (b) [***] communications strategy that includes plans for public relations, conferences and exhibitions and other external meetings and communications, publications and symposia, and internet activities; (c) a high level operating plan for the implementation of such strategies on [***] basis, including, without limitation, information related to product positioning, core messages to be modified communicated, and made more comprehensive pursuant pricing strategies; (d) revenue targets and unit forecasts, planned for Products in the Territory and the timelines for achieving such activities; and (e) all other activities to the provisions of this Agreement. Thereafter, as may be necessary from time-to-time, conducted by MTPC in particular as the Diagnostic Test gets closer to commercialization, connection with the Commercialization Team Lead shall suggest appropriate revisions to of Products in the Territory. During the 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 JSC, and any amendments required to comply with Applicable Laws or written requirements imposed by Regulatory Authorities being subject to report to the JSC for its prior written review and approvalJSC. If the JSC approves such revisions, and the Parties consent in writing to such revisions, then the JSC shall revise the The Commercialization Plan accordingly without need for amending this Agreement. The Parties shall not unreasonably withhold their consent to appropriate Commercialization Plan revisions. The revised Commercialization Plan shall thereafter be must at all times contain terms that reflect the Commercialization Plan for all purposes use of this Agreement. The Parties shall each use their Commercially Reasonable Efforts to perform Commercialize all of their obligations under Products that have Regulatory Approval in the Territory and, except as otherwise expressly allocated to Viela in this Agreement, including in Section 4.6.3 (Commercialization Plan in accordance with generally accepted ethicalCooperation), best sales and marketing practices and in compliance with Applicable Lawmay not include any activities to be conducted by Viela, without Viela’s prior consent, which shall not be unreasonably withheld.

Appears in 1 contract

Samples: License Agreement (Viela Bio, Inc.)

Commercialization Plan. Abbott shall use Commercially Reasonable Efforts to make (a) As further described in this section 7.4, the Diagnostic Test commercially available strategy for the commercial launch of, and subsequent Commercialization of, each Joint Product in each country Commercialization Territory shall be described in which Regulatory Approval is obtained pursuant to the Regulatory Plan and, with Epizyme’s cooperation as appropriate and agreed by Epizyme in Epizyme’s reasonable discretion, shall commercialize the Diagnostic Test pursuant to the provisions of a joint commercialization comprehensive plan (the each such plan, and any revisions thereto, a “Commercialization Plan”), which shall include the following: ) 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 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 each Party (and, applicable country in the case of EpizymeCommercialization 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, if Epizyme has licensed including the applicable key distinctive colors, logos, images, and symbols, and Trademarks (including the Product Trademarks) to or is otherwise collaborating be used in connection therewith (consistent with Section 7.9); and (g) a Third Party with respect to the development or commercialization comprehensive budget of the Epizyme 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). 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 country other information the JMC believes is necessary or territoryuseful 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 activities Parties shall amend such plan pursuant to be performed by Section 7.4(b) to include such Third Party) items when appropriate. In the event of any inconsistency between a Commercialization Plan and this Agreement, the deliverables related thereto;terms of this Agreement shall control. (b) The applicable JMC shall develop for approval by the timelines JEC a proposed Commercialization Plan for each activity under Joint Product for each Commercialization Territory at least [***] months prior to the then-current date of expected First Commercial Sale for such Joint Product in the Commercialization Territory as determined by such JMC (such date, the “Anticipated Launch Date” for such Joint Product). In addition, the JMC shall prepare and provide to the JEC for approval by [***]of each year an updated Commercialization Plan for the following Calendar Year. The JMC may also prepare amendments to the Commercialization Plan from time to time during the Calendar Year. If the JMC or JEC cannot agree on any amendment to any such Commercialization Plan;, the matter shall be resolved [***]. (c) In the overarching commercialization strategy and commercial goals for event the Diagnostic TestJMC cannot agree on a Commercialization Plan (or any amendment thereto, including each annual update) to be submitted to the availability and distribution 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 any amendment thereto, including each annual update) within [***] days after consideration thereof, then such matter shall be referred to the Senior Officers of the Diagnostic Test in each country Parties 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 is 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 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 Team Lead shall suggest appropriate revisions to the Commercialization Plan to the JSC for its prior written review and approvalresolution. If such Senior Officers cannot reach resolution on the JSC approves such revisions, and the Parties consent in writing to such revisions, then the JSC shall revise the Commercialization Plan accordingly without need for amending this Agreement. The Parties shall not unreasonably withhold their consent to appropriate Commercialization Plan revisions. The revised Commercialization Plan shall thereafter be the Commercialization Plan for all purposes of 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, best sales and marketing practices and in compliance with Applicable Lawmatter within a [***])-day period [***].

Appears in 1 contract

Samples: Collaboration Agreement (Reata Pharmaceuticals Inc)

Commercialization Plan. Abbott shall use Commercially Reasonable Efforts to make the Diagnostic Test commercially available in each country in which Regulatory Approval is obtained pursuant to the Regulatory Plan andAbbott, with EpizymeIdera’s cooperation as appropriate and agreed by Epizyme in Epizyme’s reasonable discretioncooperation, shall commercialize the Diagnostic Test for the Diagnostic Test Intended Use pursuant to the provisions of a joint commercialization plan (the “Commercialization Plan”)plan, which shall include the following: (a) the activities to be performed by each Party (and, in the case of Epizyme, if Epizyme has licensed to or is otherwise collaborating with a Third Party with respect to the development or commercialization of the Epizyme Product in any country or territory, the activities 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 PlanTest; (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) 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 Epizyme Idera and the Epizyme 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 prior to any launch; (i) activities to be performed post-launch with respect to ensure ongoing alignment of the Diagnostic Test Intended Use and Epizyme Product IndicationUse, 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. , including responsibility for timely and comprehensive resolution of any compliance findings or actions of Regulatory Authorities during audits (pre and post-approval) (as amended from time to time, the “Commercialization Plan”). The initial Commercialization Plan is 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 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 Team Lead shall suggest appropriate revisions to the Commercialization Plan to the JSC for its prior written review and approval. If the JSC approves such revisions, and the Parties consent in writing to such revisions, then the JSC shall revise the Commercialization Plan accordingly without need for amending this Agreement. The Parties shall not unreasonably withhold their consent to appropriate Commercialization Plan revisions. The revised Commercialization Plan shall thereafter be the Commercialization Plan for all purposes of 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, best good sales and marketing practices and in compliance with Applicable Law, provided however that Abbott shall have the right to delay First Commercial Sale in accordance with Section 7.9.

Appears in 1 contract

Samples: Development and Commercialization Agreement (Idera Pharmaceuticals, Inc.)

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