Common use of Commercialization Plan Clause in Contracts

Commercialization Plan. The 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 specific responsibilities of each of the Parties with respect to Commercialization objectives, including a specification of target market segments and Detailing requirements and strategy to be achieved during the calendar year to which the Commercialization Plans relate. The Parties agree that any forecasts provided by Licensee as part of the Commercialization Plans shall be regarded as Licensee’s good faith estimates based upon conditions then existing and shall not be binding upon Licensee. The first such Commercialization Plans shall be prepared by Licensee and furnished to Licensor through the JSC by no later than twelve months before the anticipated launch of the first Licensed Product in 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 Plans following the approval of such Commercialization Plans by the board of directors of Licensee.

Appears in 1 contract

Samples: License Agreement (Clovis Oncology, Inc.)

AutoNDA by SimpleDocs

Commercialization Plan. The Commercialization of the Licensed Products While Vifor shall be conducted pursuant to an annual plan and budget to be prepared by Licensee with respect to responsible for preparing 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 JCC (using appropriate experts within each Party’s organization) shall have the right and be responsible for discussing and approving the initial Commercialization Plans”)Plan, which plans sets forth in reasonable detail the tasks, timeline and budgets shall be budget for Commercialization activities for the Licensed Product in the Field in the United States, and for discussing, and approving on an annual basis (or, if needed, on an interim basis) all subsequent updates, amendments and modifications to the Commercialization Plan, as reasonably needed or appropriate for the Commercialization of Licensed Product in the Field in the United States consistent with Licensee’s obligations set forth this Agreement. Vifor (and its applicable Affiliates and Sublicensees) shall conduct Commercialization activities for the Licensed Product in Section 4.1the Field in the United States in accordance with the approved Commercialization Plan. The Commercialization Plans Plan shall includeset forth the tasks to be undertaken by (or on behalf of) Vifor for Commercialization activities for the Licensed Product in the Field in the United States (including coordination with VFMCFP promotional activities to FMC US Dialysis Clinics), when including budgets for all such Commercialization activities, the marketing and as formulated by Licensee: with respect to advertising plans, the Americas/Europe Territory specific commitments for the numbers of “Primary Detail Equivalents” for the Vifor (or the Asia/ROW TerritoryVFMCRP, as applicable) sales representatives to conduct on Licensed Product in the applicable calendar year, (i) general strategies and annual projections for the promoting, Detailing, marketing, sales and distribution Net Sales 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 U.S. for the Licensed Products for the Licensee Territory and for each country within the Licensee Territorycoming year. From time to time, (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 either Party may propose amendments or modifications to the Commercialization Costs to be incurred in connection with performing such Americas/Europe Commercialization Plan and (xii) an allocation of specific responsibilities of each of as needed based on the Parties with respect to Commercialization objectives, including a specification of target market segments and Detailing requirements and strategy to be achieved during the calendar year to which the Commercialization Plans relate. The Parties agree that any forecasts provided by Licensee as part progress or results 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 of Licensed Products, and/or changes in the JSC by no later than twelve months before U.S. market for Licensed Products in the anticipated launch of the first Licensed Product in each of the Americas/Europe Territory and Asia/ROW Territory, respectivelyField, and in such case the JCC shall thereafter be updated annuallyreview in good ​ CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, with delivery of draft Commercialization Plans MARKED BY [***], HAS BEEN OMITTED BECAUSE CARA THERAPEUTICS, INC. HAS DETERMINED THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO CARA THERAPEUTICS, INC. IF PUBLICLY DISCLOSED. ​ faith and comment on the proposed amendments or modifications, and if the JCC agrees, shall subject the agreed amendments or modifications to Licensor by no later than November 1 of each successive Calendar Year the JCC for review and delivery of the final Commercialization Plans following the approval of such Commercialization Plans by the board of directors of Licenseecomment and, if acceptable, approval.

Appears in 1 contract

Samples: License Agreement (Cara Therapeutics, Inc.)

Commercialization Plan. No later than [***] prior to the anticipated First Commercial Sale of a DT Co-Co Product in the Territory, Moderna and Metagenomi shall prepare and submit to the JCC, an initial Commercialization Plan for such DT Co-Co Product, which will set forth a reasonably detailed description of anticipated Commercialization activities for the applicable DT Co-Co Products in the Territory, including the corresponding Commercialization Budget. The Commercialization of the Licensed Products Plan shall be conducted pursuant to an also contain a [***] rolling annual plan for the global Commercialization activities for the DT Co-Co Product in the Territory and budget to be prepared by Licensee the Commercialization Budget shall include a [***] financial forecast reflecting reasonably anticipated Commercialization Costs in accordance with respect to the Americas/Europe Territory (the “Americas/Europe Commercialization Plan”) . Subject to comments and proposed changes by the Asia/ROW Territory (other Party, each Party will be responsible for 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 4.1for its respective Region. The Commercialization Plans for each Region will be incorporated into the overall Commercialization Plan. The Commercialization Plan may discuss certain matters on an Indication-by-Indication basis and shall include, when and as formulated by Licensee: with respect address (to the Americas/Europe Territory or extent applicable given the Asia/ROW Territorystage of Commercialization and estimated anticipated First Commercial Sale) (a) the Product Marks, as applicable, (i) general strategies global usage guidelines for the promotingProduct Marks, Detailingglobal key positioning, marketingand messaging strategy for such DT Co-Co Product in such Indication, sales and distribution of guidelines for the Licensed Products Product Materials prepared in accordance with Section 6.7.9 (Product Materials) and (b) the general pricing and market access strategy (including discounts, rebates and other price reductions) globally and for each DT Co-Co Product for such Indication in each applicable countriescountry in the Territory. The JCC shall prepare, including review, and discuss, and the identification of any Third Parties engaged or JSC shall review, discuss, and determine whether to approve, each Commercialization Plan for a DT Co-Co Product. Moderna shall have the sole right to select the Product Marks for each DT Co-Co Product to be engaged used in Moderna’s Region and included in the applicable Commercialization Plan and may decide to develop and adopt certain distinctive colors, logos, images, symbols, and trade dress to be used (in addition to the Product Marks) in connection with such activities and the arrangements with them that have been or are proposed Commercialization of each DT Co-Co Product in Moderna’s Region. The Parties shall jointly select the Product Marks for each DT Co-Co Product to be agreed upon (including policies used in Metagenomi’s Region and procedures for adjustmentsincluded in the applicable Commercialization Plan and may jointly decide to develop and adopt certain distinctive colors, rebateslogos, bundling and the like)images, (ii) estimated launch date, market and sales forecasts, in numbers of patients and local currencysymbols, 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 trade dress to be incurred used (in addition to the Product Marks) in connection with performing such Americas/Europe the Commercialization of each DT Co-Co Product in Metagenomi’s Region. The JCC shall prepare, review, and discuss, and the JSC shall review, discuss, and determine whether to approve, each Commercialization Plan and Commercialization Budget. On an annual basis during the Term (xii) an allocation of specific responsibilities of or more frequently as may be required), the JCC shall review and update each of Commercialization Plan and Commercialization Budget based on the Parties with respect to Commercialization objectivescurrently available information and data, including for any applicable new formulations or Indications that that were added to a specification of target market segments Development Plan pursuant to Section 6.4.7(b) (JDC and Detailing requirements and strategy to be achieved during JSC Decision Regarding New Development Activities) or new Combination Products approved by the calendar year to which JSC in accordance with Section 6.4.8 (Combination Products), in each case, that are not included in the then-current Commercialization Plans relatePlan for the applicable DT Co-Co Product. The Parties agree that JSC shall review, discuss, and determine whether to approve any forecasts provided by Licensee as part of such update to the applicable Commercialization Plans Plan and corresponding Commercialization Budget. Each such update to a Commercialization Plan and corresponding Commercialization Budget shall be regarded as Licensee’s good faith estimates based upon conditions then existing become effective and shall not be binding supersede the previous Commercialization Plan and corresponding Commercialization Budget upon Licensee. The first such Commercialization Plans shall be prepared by Licensee and furnished to Licensor through the JSC by no later than twelve months before the anticipated launch of the first Licensed Product in 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 Plans following the approval of such Commercialization Plans thereof by the board of directors of LicenseeJSC.

Appears in 1 contract

Samples: Collaboration and License Agreement (Metagenomi Technologies, LLC)

Commercialization Plan. The (a) As further described in this section 7.4, the strategy for the commercial launch of, and subsequent Commercialization of the Licensed Products of, each Joint Product in each Commercialization Territory shall be conducted pursuant to an annual described in a comprehensive plan (each such plan, and budget to be prepared by Licensee with respect to the Americas/Europe Territory (the any revisions thereto, a Americas/Europe Commercialization Plan”) for such Commercialization Territory that describes: (a) the pre-launch, launch and subsequent Commercialization activities for such Joint Product in the Asia/ROW Commercialization Territory (including promotional messaging, branding (including Product Specific terms in this exhibit have been redacted because confidential treatment for those terms has been requested. These redacted terms have been marked in this exhibit with three asterisks [***]. An unredacted version of this exhibit has been separately filed with the “Asia/ROW Commercialization Plan”) (the Americas/Europe Commercialization Plan Securities and the Asia/ROW Commercialization Plan, collectively the “Commercialization Plans”Exchange Commission. Trademarks), which plans and budgets shall be consistent with Licensee’s obligations set forth in Section 4.1. The Commercialization Plans shall includepricing, when and as formulated by Licensee: with respect to the Americas/Europe Territory or the Asia/ROW Territoryadvertising, as applicable, (i) general strategies for the promoting, Detailingplanning, marketing, sales and distribution force training); (b) key tactics for implementing those activities; (c) the responsibilities for implementing those activities assigned to each of the Licensed Products 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 applicable countriescountry in the Commercialization 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 identification of any Third Parties engaged or applicable key distinctive colors, logos, images, and symbols, and Trademarks (including the Product Trademarks) to be engaged used in connection therewith (consistent with Section 7.9); and (g) a comprehensive budget of the projected costs for executing such activities and for such Joint Product in the arrangements with them that have been or are proposed Commercialization Territory (which budget shall include required amounts of promotional funds to be agreed upon (including policies and procedures for adjustments, rebates, bundling and expended by the likeParties), (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) . The Parties may agree on 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 single Commercialization Costs Plan to be incurred in connection with performing such Americas/Europe cover multiple Joint Products. Each Commercialization Plan and (xiiall subsequent revisions thereto shall contain the information described above in this Section 7.4(a) an allocation and any other information the JMC believes is necessary or useful for the successful commercial launch and subsequent Commercialization of specific responsibilities of each of the Parties with respect to Commercialization objectives, including a specification of target market segments and Detailing requirements and strategy to be achieved during the calendar year to which the Commercialization Plans relatesuch Joint Product. The Parties agree acknowledge that any forecasts provided by Licensee as part certain items of the Commercialization Plans shall be regarded as Licensee’s good faith estimates based upon conditions then existing and shall Plan may not be binding upon Licenseeamenable to determination at the time the Commercialization Plan is initially drafted. The first 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 Plans Plan and this Agreement, the terms of this Agreement 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 Plans following the approval of such Commercialization Plans by the board of directors of Licenseecontrol.

Appears in 1 contract

Samples: Collaboration Agreement (Reata Pharmaceuticals Inc)

Commercialization Plan. The Commercialization of the Licensed Products Compounds and the Licensed Product for the Territory shall be conducted pursuant to an annual a comprehensive, Territory-wide commercialization plan approved by the JSC (which shall be broken down by region, including, at a minimum, for the SeaGen Territory, Merck Territory and budget to be prepared by Licensee Collaboration Territory) (each, a “Commercialization Plan”); provided that with respect to the Americas/Europe SeaGen Territory (the “Americas/Europe Commercialization Plan”) and the Asia/ROW Territory (Merck 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 a higher level plan (with Licensee’s obligations more specific details to be set forth in the applicable Regional Commercialization Sub-Plans as set forth in Section 4.16.2.4). The Each Commercialization Plans Plan shall include, when and as formulated by Licensee: with respect to the Americas/Europe Territory or the Asia/ROW Territory, as applicable, include (i) general strategies a Commercialization Budget (which shall be further broken down by region, including, at a minimum, for the promotingSeaGen Territory, Detailing, marketing, sales Merck Territory 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 likeCollaboration Territory), (ii) estimated launch date, market and sales forecasts, in numbers of patients and local currency, and competitive analysis for the Licensed Products Product forecast for the Licensee Territory Commercialization purposes and for each country within the Licensee Territory, (iii) product positioning and promotional plans a plan for the launch sequence of the Licensed Product in the applicable countries in the Territory. The Commercialization Plan shall (a) subject to Section 4.1.2, allocate Commercialization activities between the Parties in the Collaboration Territory (including examples the Promotion of planned the Licensed Product in and the preparation of the Promotional MaterialsMaterials and Other Field-Based Materials for, in each case, the applicable countries or regions in the Collaboration Territory), (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) including an allocation of specific responsibilities of each the Commercialization Budget for such activities, (b) unless otherwise agreed to by the Parties in writing, allocate all Commercialization activities in the SeaGen Territory (including the Promotion of the Parties with respect to Commercialization objectives, including a specification of target market segments and Detailing requirements and strategy to be achieved during the calendar year to which the Commercialization Plans relate. The Parties agree that any forecasts provided by Licensee as part of the Commercialization Plans shall be regarded as Licensee’s good faith estimates based upon conditions then existing and shall not be binding upon Licensee. The first such Commercialization Plans shall be prepared by Licensee and furnished to Licensor through the JSC by no later than twelve months before the anticipated launch of the first Licensed Product in each and the preparation of the Americas/Europe Territory Promotional Materials and Asia/ROW Other Field-Based Materials for, in each case, the SeaGen Territory, respectively) to SeaGen, and shall thereafter be updated annually(c) unless otherwise agreed to by the Parties in writing, with delivery of draft allocate all Commercialization Plans to Licensor by no later than November 1 of each successive Calendar Year and delivery activities in the Merck Territory (including the Promotion of the final Licensed Product in and the preparation of the Promotional Materials and Other Field-Based Materials for, in each case, the Merck Territory) to Merck, but in all cases, the Commercialization Plans following the approval of such Commercialization Plans by the board of directors of Licensee.Plan shall be -73- [ * ] = 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

Appears in 1 contract

Samples: License and Collaboration Agreement (Seagen Inc.)

AutoNDA by SimpleDocs

Commercialization Plan. The Commercialization Within [***] the first Approval Application for a Product in the 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 Licensed Products Steering Committee or appropriate JPT, Genentech PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE BEEN FILED SEPARATELY WITH THE SECRETARY OF THE COMMISSION PURSUANT TO THE COMPANY'S APPLICATION REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24B-2 OF THE EXCHANGE ACT. shall be conducted pursuant submit to the Steering Committee, or appropriate JPT, an annual plan for the commercialization of such Product in the Co-Promote Territory (the "Commercialization Plan"). Although Genentech shall be responsible for the creation of the Commercialization Plan, Altus, through the Steering Committee, or appropriate JPT, shall have the opportunity to comment on the Commercialization Plan, and budget to be prepared by Licensee Genentech shall reasonably consider Altus's comments with respect to the Americas/Europe Territory (the “Americas/Europe Commercialization Plan”) and . Genentech shall update the Asia/ROW Territory (Commercialization Plan on [***]. Prior to each [***] of the “Asia/ROW Commercialization Plan”) (, the Americas/Europe 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 kept apprised of the commercialization activity by and through the Steering Committee, or appropriate JPT. In addition, Genentech shall, as reasonably practicable, inform Altus between meetings of the Steering Committee, or appropriate JPT, of significant changes to the Commercialization Plan and any material events in the Asia/ROW Commercialization Plan, collectively the “Commercialization Plans”), which plans marketing 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 specific responsibilities of each of the Parties with respect to Commercialization objectives, including a specification of target market segments and Detailing requirements and strategy to be achieved during the calendar year to which the Commercialization Plans relate. The Parties agree that any forecasts provided by Licensee as part of the Commercialization Plans shall be regarded as Licensee’s good faith estimates based upon conditions then existing and shall not be binding upon Licensee. The first such Commercialization Plans shall be prepared by Licensee and furnished to Licensor through the JSC by no later than twelve months before the anticipated launch of the first Licensed Product in each of the Americas/Europe Territory and Asia/ROW Promote 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 Plans following the approval of such Commercialization Plans by the board of directors of Licensee.

Appears in 1 contract

Samples: Country Serial (Altus Pharmaceuticals Inc.)

Commercialization Plan. The strategy for the Commercialization of the each Licensed Products Product shall be conducted pursuant to an annual described in a comprehensive plan that describes the pre-launch, launch and budget to be prepared by Licensee with respect to subsequent Commercialization activities for such Licensed Product in 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”)Territory, 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 applicablewithout limitation, (i) general strategies for the promoting, Detailing, marketing, sales and distribution annual anticipated number of the Licensed Products details to be conducted in each applicable countries, including country within 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)Territory, (ii) estimated launch date, market and sales forecasts, the annual anticipated marketing expenses to be incurred in numbers each of patients and local currency, and competitive analysis for the Licensed Products for the Licensee Territory and for each country countries within the Licensee Territory, (iii) product positioning the annual anticipated number of FTEs to be assigned to Commercialize in each of the countries within the Territory, and promotional plans (including examples of planned Promotional Materials), (iv) Phase IV clinical trial supporta report on pricing, if applicableadvertising, (v) managed care contracting strategyeducation, (vi) conduct of Licensed Product-specific training programs for sales representativesplanning, (viii) a detailed manufacturing planmarketing, (ix) pre-launch commercialization activities and the expected date of launch, (x) sales force size and allocation throughout training (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 Plan”). An initial Commercialization Plan and (xii) an allocation of specific responsibilities of each of the Parties with respect to Commercialization objectives, including a specification of target market segments and Detailing requirements and strategy to be achieved during the calendar year to which the Commercialization Plans relate. The Parties agree that any forecasts provided by Licensee as part of the Commercialization Plans shall be regarded as Licensee’s good faith estimates based upon conditions then existing and shall not be binding upon Licensee. The first such Commercialization Plans for Biovance shall be prepared by Licensee Alliqua and furnished presented to Licensor through the JSC as soon as practicable, but in any event, within ninety (90) days of the Effective Date or such other time agreed to by the JSC. In addition, Alliqua shall submit an initial Commercialization Plan for ECMs to the JSC no later than twelve months before the ninety (90) days prior to anticipated launch of the first Licensed Product 510(k) or other Regulatory Clearance and/or Approval in each of relevant jurisdiction within the Americas/Europe Territory and Asia/ROW Territory, respectively. The Parties shall, 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 cause their respective members of the final JSC to, cooperate with each other in good faith to promptly finalize a mutually acceptable Commercialization Plans following Plan for each Licensed Product. Alliqua shall deliver an updated Commercialization Plan for each Licensed Product, as applicable, at each meeting of the approval of JSC or at such Commercialization Plans times as agreed to by the board of directors of LicenseeJSC. 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 “*****”.

Appears in 1 contract

Samples: License, Marketing and Development Agreement (Alliqua, Inc.)

Commercialization Plan. The Commercialization of the Licensed Products Partner shall be conducted pursuant to responsible for the creation and implementation of an annual plan and budget to be prepared by Licensee with respect to for the Americas/Europe commercialization of Products in the Field in the Territory, which will include any Post Marketing Studies (as defined below) of Products in the Field in the 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 Plan shall include, when without limitation, identification of, and as formulated by Licensee: proposed plans to address, potential challenges 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 commercialization of the Licensed Products in each applicable countries, including the identification of any Third Parties engaged or Field in the Territory. Partner shall prepare and submit to be engaged in connection with such activities and Optimer 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 initial Commercialization Plan no later than […***…] after the first submission of a MAA for Product in the Territory for review and (xii) an allocation of specific responsibilities of each of discussion through the Parties with respect to Commercialization objectives, including a specification of target market segments and Detailing requirements and strategy to be achieved during the calendar year to which the Commercialization Plans relateJSC. The Parties agree that any forecasts provided by Licensee as part of the Subsequent updated Commercialization Plans shall be regarded as Licensee’s submitted by Partner to Optimer on an annual basis on or before the end of February each Calendar Year for review and discussion through the JSC. Through the JSC, Partner shall regularly consult with and provide ***Confidential Treatment Requested updates to Optimer regarding the commercialization strategy and the commercialization of Products in the Field in the Territory. Partner shall consider in good faith estimates based upon conditions then existing Optimer’s input regarding such commercialization strategy and the Commercialization Plan; provided, however, that Partner shall not have final decision-making authority with respect to commercialization of Products in the Field in the Territory, including the right to set the terms of sales and book all sales of Products in the Field in the Territory, subject to Section 5.1(c) below. Partner shall provide Optimer with access to KOLs as may reasonably be binding upon Licensee. The first such Commercialization Plans shall be prepared requested by Licensee and furnished to Licensor through Optimer, where “KOLs” means all healthcare providers in the JSC by no later than twelve months before the anticipated launch of the first Licensed Territory that have administered a Product in each of clinical trials, have published academic articles relating to a Product, or are otherwise regarded by Partner, its Affiliates and Sublicensees, as the Americas/Europe case may be, as a key opinion leader for a Product in the Territory. Optimer shall provide Partner with access to KOLs as may reasonably be requested by Partner, where “KOLs” means all healthcare providers outside the Territory and Asia/ROW XXXX Territory that have administered a Product in clinical trials, have published academic articles relating to a Product, or are otherwise regarded by Optimer, its Affiliates and Sublicensees, as the case may be, as a key opinion leader for a Product outside the Territory and XXXX 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 Plans following the approval of such Commercialization Plans by the board of directors of Licensee.

Appears in 1 contract

Samples: Collaboration and License Agreement (Optimer Pharmaceuticals Inc)

Time is Money Join Law Insider Premium to draft better contracts faster.