Common use of Commercialization Plan Clause in Contracts

Commercialization Plan. (a) Not later than three [***] after submission of Regulatory Filings for each Product in each country of the Territory, Licensee will provide to the JCC for review its initial Commercialization Plan for each Product for each country in the Territory. Such initial Commercialization Plan will describe Licensee’s plans for activities to be conducted for such Product for such country. Each Commercialization Plan shall include the details of obligations to be performed by Licensee to achieve the specific activities that are applicable to the stage of [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. Commercialization (e.g., pre-launch, launch planning, launch, or post-launch) of the applicable Product during the time period covered by such Commercialization Plan and subsequent time periods. (b) Prior to the First Commercial Sale for such Product in such country, Licensee will provide to the JCC for review an updated Commercialization Plan for such Product for such country. Such updated Commercialization Plan will include, but not be limited to, Licensee’s updated plans for activities to be conducted for such Product for such country prior to launch as well as activities to be conducted in connection with such launch. (c) Promptly after each anniversary of the First Commercial Sale of such Product during the Term, Licensee will provide to the JCC for review updated Commercialization Plans for such Product for such country. Such further updated Commercialization Plan will include, but not be limited to, Licensee’s plans for Commercialization activities for such Product and such country for the twelve (12) month period following the date of delivery of such Commercialization Plan. No Commercialization Plan may be implemented by Licensee if [***]. Each Commercialization Plan shall be consistent with and shall not contradict the terms of this Agreement [***], and in the event of any inconsistency between the Commercialization Plan and this Agreement, the terms of this Agreement shall prevail. Notwithstanding the foregoing, if a [***], Licensee shall [***] and shall promptly [***].

Appears in 3 contracts

Samples: License Agreement (Coherus BioSciences, Inc.), License Agreement (Coherus BioSciences, Inc.), License Agreement (Coherus BioSciences, Inc.)

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Commercialization Plan. At such times as the JGC will deem appropriate, the JGC will direct the Parties to mutually prepare a Worldwide Commercialization Plan, and the JGC will review and approve such initial Worldwide Commercialization Plan. Thereafter, the JGC will have one or the other Party (or both) update the Worldwide Commercialization Plan each calendar year, and the JGC will review and approve any such update or any other amendment to the Worldwide Commercialization Plan. Notwithstanding anything in this CCPS Agreement to the contrary, the Parties acknowledge and agree that (i) Bluebird may decline to perform any Commercialization activity proposed to be conducted by Bluebird in the Worldwide Commercialization Plan (other than Manufacturing of Vectors and associated Payloads), and (ii) the Worldwide Commercialization Plan will not include, and Bluebird will have no obligation to perform, any such Commercialization activity that Bluebird has declined to perform, provided that once Bluebird has agreed to perform a Commercialization activity, it will be obligated to perform, and cannot decline to perform, such activity. In addition, either Party may request at any time that the JGC consider and approve other updates to the Worldwide Commercialization Plan. Further: (a) Not later than three The JGC will set the required form and contents of the Worldwide Commercialization Plan. The Worldwide Commercialization Plan will reflect a singular marketing and sales approach worldwide, and will specify, among other things, the number of sales reps in the U.S. for each Party, allocation of regions in the U.S. for each Parties’ sales force, creation of marketing materials, planning for conferences, and other marketing activities. CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***] after submission of Regulatory Filings for each Product in each country of the Territory]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, Licensee will provide to the JCC for review its initial Commercialization Plan for each Product for each country in the Territory. Such initial Commercialization Plan will describe Licensee’s plans for activities to be conducted for such Product for such country. Each Commercialization Plan shall include the details of obligations to be performed by Licensee to achieve the specific activities that are applicable to the stage of [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. Commercialization (e.g., pre-launch, launch planning, launch, or post-launch) of the applicable Product during the time period covered by such Commercialization Plan and subsequent time periodsAS AMENDED. (b) Prior to Neither Party (itself or by or through any others, including any Affiliates or Sublicensees) will take any material action regarding the First Commercial Sale for such Commercialization of Licensed Product unless described in such country, Licensee will provide to the JCC for review an updated Worldwide Commercialization Plan for such Product for such country. Such updated Commercialization Plan will include, but not be limited to, Licensee’s updated plans for activities to be conducted for such Product for such country prior to launch as well as activities to be conducted in connection with such launchor approved by the JGC. (c) Promptly after each anniversary All Commercialization of Licensed Product for U.S. Administration will be conducted under the supervision of the First Commercial Sale JGC and as part of such Product during the Term, Licensee U.S. Development & Commercialization Program. (d) Celgene will provide to the JCC have final decision making authority for review updated Commercialization Plans for such Product for such country. Such further updated Commercialization Plan will include, but not be limited to, Licensee’s plans for all Commercialization activities for such Product worldwide, including timing of launch and such country for pricing and the twelve (12) month period following the date of delivery of such Commercialization Worldwide Development Plan. No Commercialization Plan may be implemented by Licensee if [***]. Each Commercialization Plan shall be consistent with and shall not contradict the terms of this Agreement [***], and in the event of any inconsistency between the Commercialization Plan and this Agreement, the terms of this Agreement shall prevail. Notwithstanding the foregoing, if a [***], Licensee shall [***] and shall promptly [***].

Appears in 3 contracts

Samples: Master Collaboration Agreement (Bluebird Bio, Inc.), Master Collaboration Agreement (Bluebird Bio, Inc.), Master Collaboration Agreement (Bluebird Bio, Inc.)

Commercialization Plan. In accordance with the Commercialization Plan (including the Launch Plan), Hutchmed (itself or through any other Hutchmed Entities) shall have the sole discretion and right to, and shall use Commercially Reasonable Efforts to, Commercialize (including booking sales, establishing pricing and related interactions with Governmental Authorities to be listed on the central or provincial reimbursement list, warehousing, commercial distribution, order processing, invoicing and collection) the Licensed Products in the Field in the Territory at its sole expense in each of (a) Not later than three Mainland China, (b) Taiwan and (c) Hong Kong and Macau (it being understood that, if Hutchmed Commercializes Licensed Products in Hong Kong, it may be commercially reasonable to not separately also Commercialize Licensed Products in Macau). The Commercialization Plan will be developed on a [**] rolling basis and include the then-current [**] after submission and the following [**]. At least [**] prior to anticipated approval of Regulatory Filings the first Drug Approval Application for each a Licensed Product in each country of the Field in the Territory, Licensee will provide Hutchmed shall present the draft Commercialization Plan (including the Launch Plan) to the JCC for review its initial Commercialization Plan for each Product for each country in the Territory. Such initial Commercialization Plan will describe Licensee’s plans for activities to be conducted for such Product for such country. Each Commercialization Plan shall include the details of obligations to be performed by Licensee to achieve the specific activities that are applicable to the stage of [***] Certain information in this document has been omitted review, discussion and filed separately approval (so long as it is consistent with the Securities terms and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. Commercialization (e.g., pre-launch, launch planning, launch, or post-launch) of the applicable Product during the time period covered by such Commercialization Plan and subsequent time periods. (b) Prior to the First Commercial Sale for such Product in such country, Licensee will provide to the JCC for review an updated Commercialization Plan for such Product for such country. Such updated Commercialization Plan will include, but not be limited to, Licensee’s updated plans for activities to be conducted for such Product for such country prior to launch as well as activities to be conducted in connection with such launch. (c) Promptly after each anniversary of the First Commercial Sale of such Product during the Term, Licensee will provide to the JCC for review updated Commercialization Plans for such Product for such country. Such further updated Commercialization Plan will include, but not be limited to, Licensee’s plans for Commercialization activities for such Product and such country for the twelve (12) month period following the date of delivery of such Commercialization Plan. No Commercialization Plan may be implemented by Licensee if [***]. Each Commercialization Plan shall be consistent with and shall not contradict the terms conditions of this Agreement [***], and Hutchmed has taken into consideration in good faith the event of any inconsistency between the Commercialization Plan and this Agreement, the terms of this Agreement shall prevailGlobal Brand Strategy). Notwithstanding the foregoing, if the first approval of the first Drug Approval Application for a Licensed Product in the Field in the Territory may be obtained such that is not possible for Hutchmed to present a draft Commercialization Plan [***]] in advance, Licensee Hutchmed shall present such draft Commercialization Plan as soon as possible. Within [***] prior to the anticipated approval of the first Drug Approval Application for a Licensed Product in the Field in the Territory, Hutchmed shall submit to the JCC the final Commercialization Plan (including the Launch Plan) for review, discussion, and shall promptly approval. Each [***]] after the approval of the first Drug Approval Application for a Licensed Product in the Field in the Territory, Hutchmed shall submit to the JCC the Commercialization Plan for review, discussion, and approval. The Parties shall ensure at all times that the Commercialization Plan is consistent with the terms and conditions of this Agreement, and Hutchmed shall consider in good faith the Global Brand Strategy and the Global Medical Affairs Strategy.

Appears in 2 contracts

Samples: License Agreement (HUTCHMED (China) LTD), License Agreement (Epizyme, Inc.)

Commercialization Plan. (ai) Not later than three [***] after submission The initial plan for the Commercialization of Regulatory Filings for each the Product in each country of the Territory, Licensee will provide to the JCC for review its initial Commercialization Plan for each Product for each country Field in the Territory. Such initial Partner Territory is attached to this Agreement as Exhibit 5.1 (the “Initial Commercialization Plan will describe Licensee’s plans for activities Plan”), and includes in reasonable detail: the number of sales representatives to be conducted deployed, an account/physician target-specific detail and coverage plan (including, “call points”), the dollar amount and allocation of planned promotional and marketing expenses, the projected dates for such Product for such country. Each Commercialization Plan shall include the details of obligations to be performed by Licensee to achieve the specific activities that are applicable to the stage of [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. Commercialization (e.g., pre-launch, launch planning, launch, or post-launch) of the applicable Product during the time period covered by such Commercialization Plan and subsequent time periods. (b) Prior to the First Commercial Sale for such Product in such country, Licensee will provide to the JCC for review an updated Commercialization Plan for such Product for such country. Such updated Commercialization Plan will include, but not be limited to, Licensee’s updated plans for activities to be conducted for such Product for such country prior to launch as well as activities to be conducted in connection with such launch. (c) Promptly after each anniversary of the First Commercial Sale of such the Product during in the TermPartner Territory, Licensee will provide as well as an outline regarding the price and brand positioning of the Product, which shall be consistent with the minimum commercial diligences set forth in Section 5.2(b). The Initial Commercialization Plan can be adjusted by the JSC. (ii) Partner shall prepare for the JSC’s review updates of the Commercialization Plan on an ongoing basis, and in any event, the JSC shall review the then-current Commercialization Plan in the sixth (6th) and twelfth (12th) month of each calendar year. (iii) Partner shall carry out and manage, and shall cause its Affiliates and Sublicensees to carry out and manage, the Commercialization of the Product in the Partner Territory in material accordance with the then-current Commercialization Plan and the provisions of this Agreement. (iv) If, after taking into account all potential opportunities with respect to the JCC Product in a comprehensive analysis of the relevant clinical science, clinical need, published data and commercial considerations, the JSC determines that Partner should develop and present to Bioprojet a go-to-market Commercialization plan for review updated the OSA Target Indication (the “OSA Proposal”), then Partner shall do so within ninety (90) days of such determination. The OSA Proposal shall take into account the Parties’ mutual agreement that the Product’s optimal brand positioning and pricing strategy in the Partner Territory are the Narcolepsy with Cataplexy and EDS Target Indications and include, among other things, (i) analysis of potential regulatory options for the Product in the Partner Territory for the Narcolepsy with Cataplexy, EDT and OSA Target Indications, including an assessment of the viability of different brand names, and simultaneous Commercialization Plans of the same compound, for such Product three (3) Target Indications, (ii) commercial payor/pricing analysis for such country. Such further updated Commercialization Plan will include, but not be limited to, Licensee’s plans for Commercialization activities for such Product and such country potential managed care contracting strategies for the twelve OSA Target Indication and (12iii) month period following a full medical affairs development program to support the date OSA Target Indication. The Parties shall discuss the OSA Proposal in good faith and, if the Parties mutually agree upon a go-to-market Commercialization plan for the OSA Target Indications (whether incorporating, in whole or in part, the elements of delivery of such Commercialization Plan. No Commercialization Plan may be implemented by Licensee if [***]. Each the OSA Proposal or otherwise), the Initial Commercialization Plan shall be consistent with and shall not contradict amended by mutual written agreement of the terms of this Agreement [***], and in the event of any inconsistency between the Parties to reflect such mutually agreed upon go-to-market Commercialization Plan and this Agreement, the terms of this Agreement shall prevail. Notwithstanding the foregoing, if a [***], Licensee shall [***] and shall promptly [***]plan.

Appears in 2 contracts

Samples: License and Commercialization Agreement (Harmony Biosciences Holdings, Inc.), License and Commercialization Agreement (Harmony Biosciences Holdings, Inc.)

Commercialization Plan. On a Product by Product basis, not later than sixty (a60) days after the filing of the first application for Regulatory Approval of a Product in the Copromotion Territory, the MSC shall prepare and approve a rolling multiyear (not less than three (3) years) plan for Commercializing such Product in the Copromotion Territory (the "Copromotion Territory Commercialization Plan"), which plan includes a comprehensive market development, marketing, sales, supply and distribution strategy for such Product in the Copromotion Territory. The Copromotion Territory Commercialization Plan shall be updated by the MSC at least once each calendar year such that it addresses no less than the three (3) upcoming years. Not later than three [***] thirty (30) days after submission the filing of the first application for Regulatory Filings Approval of a Product in the Copromotion Territory and thereafter on or before September 30 of each calendar year, the MSC shall prepare an annual commercialization plan and budget (the "Annual Commercialization Plan and Budget"), which plan is based on the then current Copromotion Territory Commercialization Plan and includes a comprehensive market development, marketing, sales, supply and distribution strategy, including an overall budget for anticipated marketing, promotion and sales efforts in the upcoming calendar year (the first such Annual Development Plan and Budget shall cover the remainder of the calendar year in which such Product is anticipated to be approved plus the first full calendar year thereafter). The Annual Commercialization Plan and Budget will specify which Target Markets and distribution channels each Party shall devote its respective Promotion efforts towards, the personnel and other resources to be devoted by each Party to such efforts, the number and positioning of Details to be performed by each Party, as well as market and sales forecasts and related operating expenses, for the Product in each country of the Copromotion Territory, Licensee will provide to and budgets for projected Pre-Marketing Expenses, Sales and Marketing Expenses and Post-Approval Research and Regulatory Expenses. In preparing and updating the JCC for review its initial Commercialization Plan for each Product for each country in the Territory. Such initial Commercialization Plan will describe Licensee’s plans for activities to be conducted for such Product for such country. Each Commercialization Plan shall include the details of obligations to be performed by Licensee to achieve the specific activities that are applicable to the stage of [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. Commercialization (e.g., pre-launch, launch planning, launch, or post-launch) of the applicable Product during the time period covered by such Copromotion Territory Commercialization Plan and subsequent time periods. (b) Prior to the First Commercial Sale for such Product in such country, Licensee will provide to the JCC for review an updated Commercialization Plan for such Product for such country. Such updated Commercialization Plan will include, but not be limited to, Licensee’s updated plans for activities to be conducted for such Product for such country prior to launch as well as activities to be conducted in connection with such launch. (c) Promptly after each anniversary of the First Commercial Sale of such Product during the Term, Licensee will provide to the JCC for review updated Commercialization Plans for such Product for such country. Such further updated Commercialization Plan will include, but not be limited to, Licensee’s plans for Commercialization activities for such Product and such country for the twelve (12) month period following the date of delivery of such Commercialization Plan. No Commercialization Plan may be implemented by Licensee if [***]. Each Commercialization Plan shall be consistent with and shall not contradict the terms of this Agreement [***], and in the event of any inconsistency between the Annual Commercialization Plan and this AgreementBudget, the terms of this Agreement shall prevail. Notwithstanding the foregoingMSC will take into consideration factors such as market conditions, if a [***], Licensee shall [***] regulatory issues and shall promptly [***]competition.

Appears in 2 contracts

Samples: Collaboration and License Agreement (Viropharma Inc), Collaboration and License Agreement (Viropharma Inc)

Commercialization Plan. (a) Not later than three [***] after submission of Regulatory Filings for each Product in each country The Commercialization of the Territory, Licensee will provide to Product under this Agreement in Cytokinetics Territory and Astellas Territory shall be coordinated under a Commercialization plan (the JCC for review its initial Commercialization Plan for each Product for each country in the TerritoryPlan”). Such initial Commercialization Plan will describe Licensee’s plans for activities to be conducted for such Product for such country. Each The Commercialization Plan shall include a reasonably detailed description of and anticipated timeline for the details of obligations to be performed by Licensee to achieve the specific Parties’, their respective Affiliates’ and sublicensees’ Commercialization activities that are applicable to the stage of [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. Commercialization (e.g.Product in their respective territory, including pre-launchlaunch plans, launch planningplans, launchmarket analytics, or post-launch) of the applicable Product during the time period covered by such Commercialization Plan product forecasts, pricing assumptions and subsequent time periodscompetitive intelligence. (b) Prior No later than [*], or promptly following the Effective Date (if the Effective Date occurs during such [*] period), the JCC shall prepare and approve the initial Commercialization Plan. Thereafter, from time to time during the Term (but no less than annually), the JCC shall prepare and approve updates and amendments, as appropriate, to the First Commercial Sale then-current Commercialization Plan to reflect changes in its plans, including in response to changes in the marketplaces and related product forecasts, relative success of the Product and other relevant factors influencing such plans and activities. The JCC shall agree on the costs to be reimbursed in accordance with requests made under Section [*] (if any) and shared costs (if any) to be included in the Commercialization Plan with appropriate lead times for such Product in such countryplanning purposes, Licensee will provide including budgeting and a mechanism for payment from one Party to the other Party. By [*] of each calendar year starting on [*] or the Effective Date whichever is later, the JCC shall agree upon a proposed budget for review an updated reimbursable and/or shared costs (if any) for the following Astellas fiscal year. Astellas shall use good faith efforts to [*]. Annual updates shall be finally approved no later than [*] before the beginning of next calendar year. Once approved by the JCC, such revised Commercialization Plan for such Product for such country. Such updated shall replace the prior Commercialization Plan will include, but not be limited to, Licensee’s updated plans for activities to be conducted for such Product for such country prior to launch as well as activities to be conducted in connection with such launchPlan. (c) Promptly after each anniversary If the terms of the First Commercial Sale of such Product during the Term, Licensee will provide to the JCC for review updated Commercialization Plans for such Product for such country. Such further updated Commercialization Plan will includecontradict, but not be limited toor create inconsistencies or ambiguities with, Licensee’s plans for Commercialization activities for such Product and such country for the twelve (12) month period following the date of delivery of such Commercialization Plan. No Commercialization Plan may be implemented by Licensee if [***]. Each Commercialization Plan shall be consistent with and shall not contradict the terms of this Agreement [***], and in the event of any inconsistency between the Commercialization Plan and this Agreement, then the terms of this Agreement shall prevail. Notwithstanding the foregoing, if a [***], Licensee shall [***] and shall promptly [***]govern.

Appears in 2 contracts

Samples: License and Collaboration Agreement (Cytokinetics Inc), License and Collaboration Agreement (Cytokinetics Inc)

Commercialization Plan. At such times as the JGC will deem appropriate, the JGC will direct the Parties to mutually prepare a Worldwide Commercialization Plan, and the JGC will review and approve such initial Worldwide Commercialization Plan. Thereafter, the JGC will have one or the other Party (or both) update the Worldwide Commercialization Plan each calendar year, and the JGC will review and approve any such update or any other amendment to the Worldwide Commercialization Plan. Notwithstanding anything in this CCPS Agreement to the contrary, the Parties acknowledge and agree that (i) Bluebird may decline to perform any Commercialization activity proposed to be conducted by Bluebird in the Worldwide Commercialization Plan (other than Manufacturing of Vectors and associated Payloads), and (ii) the Worldwide Commercialization Plan will not include, and Bluebird will have no obligation to perform, any such Commercialization activity that Bluebird has declined to perform, provided that once Bluebird has agreed to perform a Commercialization activity, it will be obligated to perform, and cannot decline to perform, such activity. In addition, either Party may request at any time that the JGC consider and approve other updates to the Worldwide Commercialization Plan. Further: (a) Not later than three [***] after submission of Regulatory Filings for each Product in each country The JGC will set the required form and contents of the Territory, Licensee will provide to the JCC for review its initial Worldwide Commercialization Plan for each Product for each country in the TerritoryPlan. Such initial The Worldwide Commercialization Plan will describe Licensee’s plans reflect a singular marketing and sales approach worldwide, and will specify, among other things, the number of sales reps in the U.S. for activities to be conducted each Party, allocation of regions in the U.S. for such Product each Parties’ sales force, creation of marketing materials, planning for such country. Each Commercialization Plan shall include the details of obligations to be performed by Licensee to achieve the specific activities that are applicable to the stage of [***] Certain information in this document has been omitted conferences, and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. Commercialization (e.g., pre-launch, launch planning, launch, or post-launch) of the applicable Product during the time period covered by such Commercialization Plan and subsequent time periodsother marketing activities. (b) Prior to Neither Party (itself or by or through any others, including any Affiliates or Sublicensees) will take any material action regarding the First Commercial Sale for such Commercialization of Licensed Product unless described in such country, Licensee will provide to the JCC for review an updated Worldwide Commercialization Plan for such Product for such country. Such updated Commercialization Plan will include, but not be limited to, Licensee’s updated plans for activities to be conducted for such Product for such country prior to launch as well as activities to be conducted in connection with such launchor approved by the JGC. (c) Promptly after each anniversary All Commercialization of Licensed Product for U.S. Administration will be conducted under the supervision of the First Commercial Sale JGC and as part of such Product during the Term, Licensee U.S. Development & Commercialization Program. (d) Celgene will provide to the JCC have final decision making authority for review updated Commercialization Plans for such Product for such country. Such further updated Commercialization Plan will include, but not be limited to, Licensee’s plans for all Commercialization activities for such Product worldwide, including timing of launch and such country for pricing and the twelve (12) month period following the date of delivery of such Commercialization Worldwide Development Plan. No Commercialization Plan may be implemented by Licensee if [***]. Each Commercialization Plan shall be consistent with and shall not contradict the terms of this Agreement [***], and in the event of any inconsistency between the Commercialization Plan and this Agreement, the terms of this Agreement shall prevail. Notwithstanding the foregoing, if a [***], Licensee shall [***] and shall promptly [***].

Appears in 2 contracts

Samples: Master Collaboration Agreement (2seventy Bio, Inc.), Master Collaboration Agreement (Bluebird Bio, Inc.)

Commercialization Plan. (a) Not Unless and until either Party has exercised its Opt-Out Right, commencing no later than three [***] after submission of Regulatory Filings for each Product in each country prior to the anticipated launch of the Territoryfirst Licensed Product, Licensee will provide the Parties shall prepare and deliver to the JCC for JCT an initial written plan and budget that describes in detail the Commercialization activities (including pre-launch and launch activities, if applicable, but excluding Manufacturing activities which shall be addressed as set forth in Article VI) to be undertaken with respect to Licensed Product(s) in the United States in the next Calendar Year and the dates by which such activities are targeted to be accomplished (as such plan may be updated or amended from time to time in accordance with this Agreement, the “Commercialization Plan”). The Commercialization Plan (including the budget) shall allocate activities between the Parties, and shall contain sufficient detail with respect to Commercialization tactics and other matters to enable the JCT to conduct a meaningful review its of the Commercialization Plan. The Parties shall seek to finalize the initial Commercialization Plan for each the United States no later than [**] prior to launch of the first Licensed Product for each country in the TerritoryUnited States. Such initial It is intended that the Commercialization Plan will describe Licensee’s plans contemplate that the Parties will co-promote Licensed Product in the United States in a manner that reflects each Parties’ capabilities and that is consistent with each Parties’ promotional efforts for activities to be conducted for such Product for such countryits own products of similar market potential. Each Commercialization Plan The Parties shall include the details of obligations to be performed by Licensee to achieve the specific activities negotiate in good faith a co-promotion agreement that are applicable to the stage of [***] Certain information in this document has been omitted and filed separately is consistent with the Securities terms of this Agreement, taking into account the Parties’ respective capabilities, including terms related to term of co-promotion activities, auditing of sales details, mechanisms to address underperformance and Exchange Commission. Confidential treatment has been requested failure to perform details at agreed upon levels, sales force training, and other customary terms, with respect a view to the omitted portions. Commercialization (e.g., prefinalizing and entering into such co-launch, launch planning, launch, or post-launch) of the applicable Product during the time period covered by such Commercialization Plan and subsequent time periodspromotion agreement as soon as reasonably practicable. (b) Prior In addition to annual updates or modifications to the First Commercial Sale for such Product in such countryCommercialization Plan decided by the JCT pursuant to Section 2.2(c), Licensee will provide either Party may develop and submit to the JCC for review an updated JCT from time to time proposed amendments to the Commercialization Plan for such Product for such country(excluding any amendment to the budget, which amendment shall require the approval of both Parties outside the JCT). Such updated Commercialization Plan will include, but not be limited to, Licensee’s updated plans for activities to be conducted for such Product for such country prior to launch as well as activities to be conducted in connection with such launch. (c) Promptly after each anniversary of the First Commercial Sale Upon approval of such Product during proposed amendments by the Term, Licensee will provide JCT (subject to the JCC for review updated Commercialization Plans for such Product for such country. Such further updated Commercialization Plan will includelimitations set forth in Section 2.2(d)), but not be limited to, Licensee’s plans for Commercialization activities for such Product and such country for the twelve (12) month period following the date of delivery of such Commercialization Plan. No Commercialization Plan may be implemented by Licensee if [***]. Each Commercialization Plan shall be consistent with and shall not contradict the terms of this Agreement [***], and in the event of any inconsistency between the Commercialization Plan and this Agreement, the terms of this Agreement shall prevail. Notwithstanding the foregoing, if a [***], Licensee shall [***] and shall promptly [***]amended accordingly.

Appears in 2 contracts

Samples: Collaboration Agreement (Arrowhead Research Corp), Collaboration Agreement (Alnylam Pharmaceuticals, Inc.)

Commercialization Plan. (a) Not Commencing no later than three [**] prior to the anticipated launch of the first Licensed Product, Cubist shall prepare and deliver to the JCT, by no later than [**] after submission of Regulatory Filings for each Calendar Year, a written plan and budget that describes in detail the Commercialization activities (including pre-launch and launch activities, if applicable) to be undertaken with respect to Licensed Product in each country the Profit-Share Territory in the next Calendar Year and the dates by which such activities are targeted to be accomplished (each, a “Commercialization Plan”). The Commercialization Plan (including the budget) shall contain sufficient detail with respect to Commercialization tactics and other matters to enable the JCT to conduct a meaningful review of the TerritoryCommercialization Plan, Licensee will provide to and the JCC for review its initial JCT shall approve the first Commercialization Plan for each Product for each country in the Territory. Such initial Commercialization Plan will describe Licensee’s plans for activities to be conducted for such Product for such country. Each Commercialization Plan shall include the details of obligations to be performed by Licensee to achieve the specific activities that are applicable to the stage of Profit-Share Territory no later than [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. Commercialization (e.g., pre-launch, launch planning, launch, or post-launch) of the applicable Product during the time period covered by such Commercialization Plan and subsequent time periods. (b) Prior to the First Commercial Sale for such Product in such country, Licensee will provide to the JCC for review an updated Commercialization Plan for such Product for such country. Such updated Commercialization Plan will include, but not be limited to, Licensee’s updated plans for activities to be conducted for such Product for such country prior to launch as well as activities to be conducted in connection with such launch. (c) Promptly after each anniversary of the First Commercial Sale of such first Licensed Product during in the TermProfit-Share Territory. Thereafter, Licensee will provide the JCT shall review the Commercialization Plan not less frequently than annually and shall develop Commercialization Plan updates, which shall include updated budgets for the Profit-Share Territory, for each Calendar Year. Cubist may also develop and submit to the JCC JCT for review updated Commercialization Plans for such Product for such country. Such further updated Commercialization Plan will include, but not be limited to, Licensee’s plans for Commercialization activities for such Product and such country for from time to time other proposed substantive amendments to the twelve (12) month period following the date of delivery of such Commercialization Plan. No Amendments and updates to the Commercialization Plan may be implemented by Licensee if [***]. Each Plan, including any budgets for the Profit-Share Territory contained in the Commercialization Plan shall be consistent with and Plan, shall not contradict be effective without the terms approval of the JCT. Notwithstanding anything in this Agreement [***]to the contrary, and if Cubist engages or uses a Third Party to perform any Commercialization activities in the event of any inconsistency between the Commercialization Plan and this AgreementProfit-Share Territory under circumstances where such Third Party will be granted a sublicense under Alnylam Technology or where there will be a material penalty for early termination that is inconsistent with industry standards, the terms of this Agreement shall prevail. Notwithstanding the foregoing, if a [***], Licensee shall [***] and shall promptly [***].

Appears in 1 contract

Samples: License and Collaboration Agreement (Alnylam Pharmaceuticals, Inc.)

Commercialization Plan. All Commercialization with respect to a Product under this Agreement shall be conducted pursuant to a Commercialization Plan, which shall set forth the plan for the Commercialization of such Product and the activities to be carried out with respect thereto, together with a proposed budget for such activities (a) Not later than three [***] after submission of Regulatory Filings for each Product in each country of each, a “Commercialization Plan”). The Parties, through the TerritoryJSC, Licensee will provide to the JCC for review its initial shall agree upon a preliminary Commercialization Plan for each Product for each country in the Territory. Such initial Commercialization Plan will describe Licensee’s plans for activities at least ************ prior to be conducted anticipated Regulatory Approval for such Product for such countryProduct. Each A copy of each Commercialization Plan shall include be attached hereto as part of Exhibit C. During the details of obligations Commercialization Phase with respect to be performed by Licensee each Product, the Parties, through the JSC, shall update the Commercialization Plan with respect to achieve the specific activities that are applicable such Product on an annual basis prior to the stage commencement of [the next calendar year, or more often as determined by the JSC. Each updated Commercialization Plan shall include, for the subsequent ***] Certain information *********, the projection of the plan for Commercialization Activities for the Product in this document has been omitted each Territory and filed separately timelines for performing such activities, the projected Net Sales and other revenues from the sale of the Product, together with an updated Commercialization budget. The Commercialization Plan shall contain an estimation of the resources that each Party intends to employ in connection with the Securities Commercialization of the relevant Product. In addition, the JSC will review performance against the Commercialization Plan for each Product on a quarterly basis, and Exchange Commission. Confidential treatment has been requested with respect will report any variations to the omitted portionsParties in writing. If, in any quarter, there is a variation of ************ or greater from the budget or from projected Net Sales and other revenues, the JSC will revise the Commercialization (e.g., pre-launch, launch planning, launch, or post-launch) of Plan and budget for the applicable Product during ************ prior to the time period covered by such commencement of the second quarter following the quarter in which the variation occurred. For example, if a ************ variation is reported in quarter one of a calendar year, a revised Commercialization Plan and subsequent time periods. (b) Prior budget must be prepared at least ************ prior to the First Commercial Sale for commencement of quarter three of such Product in calendar year. Until such country, Licensee will provide to the JCC for review time as an updated Commercialization Plan for such Product for such country. Such updated is approved in accordance with this Section 6.1, the preceding Commercialization Plan will include(including, but without limitation, all budget projections therein) shall remain in effect. The JSC shall not be limited to, Licensee’s updated plans for activities to be conducted for such Product for such country prior to launch as well as activities to be conducted in connection with such launch. (c) Promptly after each anniversary of the First Commercial Sale of such Product during the Term, Licensee will provide to the JCC for review updated Commercialization Plans for such Product for such country. Such further updated approve any Commercialization Plan will include, but not be limited to, Licensee’s plans for Commercialization activities for such Product and such country for the twelve (12) month period following the date of delivery of such Commercialization Plan. No Commercialization Plan may be implemented by Licensee if [***]. Each Commercialization Plan shall be consistent that is inconsistent with and shall not contradict or contradicts the terms of this Agreement [***], and in the event of any inconsistency between the Commercialization Plan and this Agreement, the terms of this Agreement shall prevail. Notwithstanding the foregoing, if a [***], Licensee shall [***] and shall promptly [***].

Appears in 1 contract

Samples: Joint Development and Commercialization Agreement (GTC Biotherapeutics Inc)

Commercialization Plan. (a) Not later than three [***] after submission The commercialization of Regulatory Filings each Collaboration Product shall be governed by a Commercialization Plan which shall describe the overall plan for each commercializing such Collaboration Product, including (i) a comprehensive marketing, sales, pricing, distribution and licensing strategy for such Collaboration Product in each country of all applicable countries, including the Territory, Licensee will provide to the JCC for review its initial Commercialization Plan for each Product for each country in the Territory. Such initial Commercialization Plan will describe Licensee’s plans for activities Third Parties to be conducted utilized and the arrangements with them that have been or are proposed to be agreed upon (including policies and procedures for adjustments, rebates, bundling and the like), (ii) estimated launch date, market and sales forecasts, in numbers of devices to be sold and local currency issues, and competitive analysis for such Product Collaboration Product, and (iii) a budget for such country. Each the Commercialization Plan shall include the details of obligations Costs to be performed by Licensee to achieve the specific activities that are applicable to the stage of [***] Certain information incurred in this document has been omitted and filed separately connection with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. Commercialization (e.g., pre-launch, launch planning, launch, or post-launch) of the applicable Product during the time period covered by performing such Commercialization Plan and subsequent time periodsPlan. (b) Prior Upon the submission of all Regulatory Approval filings for a Collaboration Product in any given country, NEUROMetrix shall develop and submit to the First Commercial Sale for such Product in such country, Licensee will provide to the JCC Steering Committee for review and approval an updated initial Commercialization Plan taking into consideration factors such as market conditions, regulatory factors, competition and the costs and profits of such Collaboration Product. NEUROMetrix shall be primarily responsible for such Product for such country. Such updated developing each Commercialization Plan will includeand, but not be limited to, Licensee’s updated plans for activities to be conducted for such Product for such country prior to launch as well as activities to be conducted in connection therewith, shall consult with such launch. (c) Promptly after each anniversary Cyberkinetics regarding the identification, timing and execution of the First Commercial Sale of such Product during the Term, Licensee will provide to the JCC for review updated Commercialization Plans for such Product for such country. Such further updated Commercialization Plan will include, but not be limited to, Licensee’s plans for Commercialization activities for such Product and such country budget for the twelve (12) month period following major commercialization tasks required to perform the date Commercialization Plan, including without limitation the coordination of delivery of such manufacturing with sales and marketing. Cyberkinetics shall be primarily responsible for developing a detailed manufacturing plan for each Collaboration Product, which plan shall be reviewed and approved by the Steering Committee and included within each Commercialization Plan. No Cyberkinetics shall deliver such plan to NEUROMetrix within a reasonable period of time prior to the date NEUROMetrix expects to submit the overall Commercialization Plan may be implemented by Licensee if [***]to the Steering Committee. Each Commercialization Plan shall be updated annually by NEUROMetrix, in consultation with Cyberkinetics, and shall be submitted to the Steering Committee for approval not later than sixty (60) days prior to January 1 of each year. Each Commercialization Plan approved by the Steering Committee shall be signed by an authorized representative of each of Cyberkinetics and NEUROMetrix. (c) NEUROMetrix shall be primarily responsible for the implementation of each Commercialization Plan, including without limitation, setting all terms of sale, including establishing pricing policies, credit terms and cash discounts and allowances, formulating marketing plans, providing patient information, providing customer support services, providing reimbursement counseling services and sales force training; provided that NEUROMetrix's execution and performance in respect of its marketing and sale of Collaboration Products shall be consistent with the strategy, policies and procedures established by each Commercialization Plan. NEUROMetrix shall not contradict act as an agent of the terms Company in connection with the sale of this Agreement [***], Collaboration Products and all revenues from such sales shall be booked by the Company. NEUROMetrix shall use Commercially Reasonable and Diligent Efforts to conduct the activities described in the event of each Commercialization Plan. Cyberkinetics shall use Commercially Reasonable and Diligent Efforts to perform any inconsistency between the activities allocated to it under a Commercialization Plan and this Agreement, the terms of this Agreement shall prevail. Notwithstanding the foregoing, if a [***], Licensee shall [***] and shall promptly [***]to provide such additional marketing support services as NEUROMetrix may from time to time reasonably request.

Appears in 1 contract

Samples: Collaboration Agreement (Cyberkinetics Neurotechnology Systems, Inc.)

Commercialization Plan. (a) Not On an annual basis, ACADIA shall prepare a Commercialization plan with respect to the Commercialization of each Product in the Field in the Territory pursuant to this Agreement (as may be amended by ACADIA, the “Commercialization Plan”). The Commercialization Plan for the first full year following commercial launch of the first Product for which an NDA is filed with the FDA will be provided to Neuren by ACADIA as soon as it is available but, in any event, no later than three [***] days after submission of Regulatory Filings for each Product in each country the filing of the Territory, Licensee will provide to NDA for such Product with the JCC for review its initial Commercialization Plan for each Product for each country in the TerritoryFDA. Such initial Commercialization Plan will describe shall provide a reasonably detailed plan for ACADIA’s (or its Affiliate’s or Sub-Licensee’s plans for ’s) Commercialization activities to be conducted for such Product for such country. Each Commercialization Plan shall include the details of obligations to be performed by Licensee to achieve the specific activities that are applicable to the stage of [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. Commercialization (e.g.such Product, including pre-launchlaunch plans and launch plans, launch planningpricing, launch, or post-launch) of label expansion and market positioning (which information may be preliminary). ACADIA may amend the applicable Product during the time period covered by such Commercialization Plan and subsequent from time periodsto time in its discretion. (b) Prior Throughout the Term, at each JSC meeting pursuant to clause 4.4, ACADIA shall update the First Commercial Sale for such JSC of progress in the Marketing Authorisations of the Product in such countrythe Territory, Licensee will and Neuren shall provide to the JCC for review an updated Commercialization Plan for such JSC updates of progress in the Marketing Authorisations of the Product for such country. Such updated Commercialization Plan will include, but not be limited to, Licensee’s updated plans for activities to be conducted for such Product for such country prior to launch as well as activities to be conducted in connection with such launchoutside the Territory. (c) Promptly after each anniversary of During the First Commercial Sale of such Product during the Term, Licensee will provide to the JCC for review updated Commercialization Plans for such Product for such country. Such further updated Commercialization Plan will include, but not be limited to, Licensee’s plans for Commercialization activities for such Product and such country for the twelve (12) month period following the date of delivery of such Commercialization Plan. No Commercialization Plan may be implemented by Licensee if first [***]. Each Commercialization Plan …] years after launch, appropriate executives of Neuren and ACADIA shall be consistent with and shall not contradict the terms of this Agreement meet at least [***]…] per calendar year to discuss and review the Commercialization Plan, if provided, and in the event ACADIA’s progress towards achievement of any inconsistency between the Commercialization Plan and this Agreementto discuss and review the marketing and sales of each Product in the Territory. Unless the parties otherwise agree, the terms of this Agreement shall prevail. Notwithstanding the foregoing, if a [***], Licensee shall [***] and shall promptly [***]meetings will take place in San Diego.

Appears in 1 contract

Samples: Licence Agreement (Acadia Pharmaceuticals Inc)

Commercialization Plan. (a) Not later than three [***] after submission Without limiting the generality of Regulatory Filings Auxilium’s sole responsibility and decision-making authority for each Commercializing the Product in each country the Field in the Auxilium Territory as set forth in Section 4.2, Auxilium will use its Commercially Reasonable Efforts to carry out the Commercialization of the TerritoryProduct in accordance with a written Commercialization Plan, Licensee will provide as such may be amended or revised by Auxilium from time to time, that describes the JCC for review its initial anticipated Commercialization Plan for each Product for each country in the Territory. Such initial Commercialization Plan will describe Licensee’s plans for activities to be conducted for such performed with respect to Product for such countryin the Auxilium Territory by Auxilium or on its behalf by permitted Third Parties (the “Commercialization Plan”). Each Commercialization Plan shall include the details of obligations to be performed by Licensee to achieve the specific activities that are applicable address, in reasonable detail, to the stage extent applicable, call plans for Detailing of [***] Certain information in this document has been omitted Product, Sales Force training, Product sampling strategies and filed separately with the Securities quantities, Product positioning and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. Commercialization (e.g.scientific communication strategy, preand DTC and non-launch, launch planning, launch, or post-launch) of the applicable Product during the time period covered by such Commercialization Plan and subsequent time periodsDTC advertising. (b) Prior to the First Commercial Sale for such Product in such country, Licensee will provide to the JCC for review an updated Attached hereto as Exhibit A is a Commercialization Plan for such Product for such country. Such updated Commercialization Plan will include, but not be limited to, Licensee’s updated plans for activities to be conducted for such Product for such country prior to launch as well as covering activities to be conducted in connection with such launchpreparation of Product Launch in the Auxilium Territory and during the first full calendar year following the Product Launch. (c) Promptly after each anniversary Auxilium shall thereafter update the Commercialization Plan (together with the Medical Affairs Plan described in Section 4.7) on an annual basis as follows: Auxilium shall provide the JSC with preliminary drafts of the First Commercial Sale of such Product during the Term, Licensee will provide to the JCC for review updated Commercialization Plans for such Product for such country. Such further updated Commercialization Plan will include, but not be limited to, Licensee’s plans for Commercialization activities for such Product and such country Medical Affairs Plan no later than *** of each year for the twelve (12) month period JSC’s review and comment and Auxilium shall provide the JSC with the final Commercialization Plan and Medical Affairs Plan no later than *** of the year immediately following such year. In preparing the date updated versions of delivery the Commercialization Plan and Medical Affairs Plan, Auxilium shall analyze the effectiveness of such the elements of the prior year Commercialization Plan and Medical Affairs Plan and shall use updated sales forecasts to develop the new Commercialization Plan. No Auxilium agrees to give due consideration to the input provided by the JSC but Auxilium at all times will retain responsibility and decision-making authority for the Commercialization of the Product in the Field in the Auxilium Territory. Auxilium may, at its election, update the Commercialization Plan may be implemented and Medical Affairs Plan between annual updates by Licensee if [***]. following this same procedure. (d) Each Party shall use Commercially Reasonable Efforts in performing its obligations under this Section 4.3 concerning (as applicable) the Commercialization Plan shall be consistent with and shall not contradict the terms of this Agreement [***], and in Medical Affairs Plan. (e) In the event of any inconsistency between between, on the one hand, the Commercialization Plan and or Medical Affairs Plan and, on the other hand, this Agreement, the terms of this Agreement shall prevail. Notwithstanding the foregoing, if a [***], Licensee shall [***] and shall promptly [***].

Appears in 1 contract

Samples: License and Commercialization Agreement (Vivus Inc)

Commercialization Plan. Commercialization of the Licensed Product under this Agreement shall be governed by a written Commercialization plan that describes the anticipated Commercialization activities to be performed with respect to Licensed Product in the Territory by Licensee, its Affiliates, or it permitted sublicensees, as well as projected timelines and lineitem quarterly budgets for such activities (a) Not the “Commercialization Plan”). Each Commercialization Plan shall address, in reasonable detail, call plans for detailing of Licensed Product, sales force training, sample distribution strategies and quantities, product positioning and communication strategy, and advertising. Licensee shall prepare and present to the JSC for review the initial Commercialization Plan no later than three [***] after submission months prior to the first anticipated Marketing Approval in the Territory; provided, however, that for clarity, the JSC shall not have the right to approve the Commercialization Plan. As often as Licensee deems appropriate, Licensee shall, update or amend the then-current Commercialization Plan; provided, however, that Licensee shall submit to the JSC an updated or amended Commercialization Plan on at least a semi-annual basis. Once presented to the JSC, such updated or amended Commercialization Plan shall become effective immediately and supersede the then-current Commercialization Plan immediately prior to such presentation. Licensee shall use Commercially Reasonable Efforts to perform the tasks and obligations set forth in the Commercialization Plan in accordance with the projected timelines set forth therein and in accordance with the terms and conditions of Regulatory Filings this Agreement. At Licensee’s request, Company shall provide additional Commercialization support for each the Commercialization of the Licensed Product in each country of the Territory, Licensee will provide to the JCC for review its initial Commercialization Plan for each Product for each country in the Territory. Such initial Commercialization Plan will describe Licensee’s plans for activities to be conducted for such Product for such country. Each Commercialization Plan shall include the details of obligations to be performed by Licensee to achieve the specific activities that are applicable to the stage of [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. Commercialization (e.g., pre-launch, launch planning, launch, or post-launch) of the applicable Product during the time period covered by such Commercialization Plan and subsequent time periods. (b) Prior to the First Commercial Sale for such Product in such country, Licensee will provide to the JCC for review an updated Commercialization Plan for such Product for such country. Such updated Commercialization Plan will includeincluding, but not be limited to, Licensee’s updated plans training, travel for activities to be conducted for such Product for such country prior to training, global market research, global launch as well as activities to be conducted in connection with such launch. (c) Promptly after each anniversary of the First Commercial Sale of such Product during the Term, Licensee will provide to the JCC for review updated Commercialization Plans for such Product for such country. Such further updated Commercialization Plan will include, but not be limited to, Licensee’s plans for Commercialization activities for such Product and such country for the twelve (12) month period following the date of delivery of such Commercialization Plan. No Commercialization Plan may be implemented by Licensee if [***]. Each Commercialization Plan shall be consistent with and shall not contradict the terms of this Agreement [***]readiness, and in other related Commercialization activities; provided, however, that Licensee shall reimburse Company for any reasonable costs and expenses incurred thereof. In the event of any inconsistency between the Commercialization Plan and this Agreement, the terms of this Agreement shall prevail. Notwithstanding the foregoing, if a [***], Licensee shall [***] and shall promptly [***].

Appears in 1 contract

Samples: License Agreement (Immunomedics Inc)

Commercialization Plan. (a) Not No later than three [***] after submission * prior to the anticipated filing of an application for Regulatory Filings Approval for each Product in each country of the TerritoryU.S., Licensee will provide Endo shall deliver to the JCC a draft written commercialization plan setting forth anticipated material commercialization activities to be performed with respect to such Product in the U.S. by Endo or on its behalf (which shall include development of all marketing and promotional material and training of all sales personnel), as well as projected timelines for such activities (the “Commercialization Plan”). The JCC shall promptly review its such draft initial Commercialization Plan and may provide commercially reasonable comments to Endo for each Product for each country its consideration. Endo shall give good faith consideration to such comments and may revise such draft Commercialization Plan to implement such of the JCC’s comments that it shall deem necessary or advisable to include in the Territorydraft. Such initial Endo shall, thereafter, submit the Commercialization Plan will describe Licensee’s plans for activities to be conducted for with such Product for such country. Each Commercialization Plan changes, revisions and modifications that it shall include the details of obligations to be performed by Licensee to achieve the specific activities that are applicable deem advisable to the stage of [***] Certain information in this document has been omitted JCC, and filed separately the Commercialization Plan, together with the Securities such changes, revisions and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. Commercialization (e.g.modifications, pre-launchas applicable, launch planning, launch, or post-launch) of the applicable Product during the time period covered by such Commercialization Plan and subsequent time periodsshall be deemed final. (b) Prior No later than *** prior to the First Commercial Sale for such anticipated launch of Product in such countrythe U.S., Licensee will Endo shall update the Commercialization Plan, and shall thereafter update the Commercialization Plan on an annual basis as follows: Endo shall provide the JCC with a draft update to the Commercialization Plan no later than *** of each year. Endo shall give good faith consideration to any comments provided by the JCC for review an and may revise such Commercialization Plan to implement such of the JCC’s comments that it shall deem necessary or advisable to include in the Commercialization Plan, after which the update to the Commercialization Plan shall be deemed to be finalized. Endo shall deliver a final version of the updated Commercialization Plan for such Product for such country. Such updated Commercialization Plan will include, but not be limited to, Licensee’s updated plans for activities to be conducted for such Product for such country prior to launch as well as activities to be conducted in connection with such launchno later than *** of the following year. (c) Promptly after each anniversary of the First Commercial Sale of such Product during the Term, Licensee will provide to the JCC for review updated Commercialization Plans for such Product for such country. Such further updated The Commercialization Plan will include, but not be limited to, Licensee’s plans for Commercialization activities for such Product and such country for the twelve (12) month period following the date of delivery of such Commercialization Plan. No Commercialization Plan may be implemented by Licensee if [shall include ***]. Each Commercialization Plan shall be consistent with and shall not contradict the terms of this Agreement [***], and in the event of any inconsistency between the Commercialization Plan and this Agreement, the terms of this Agreement shall prevail. Notwithstanding the foregoing, if a [***], Licensee shall [***] and shall promptly [***].

Appears in 1 contract

Samples: License and Development Agreement (Biodelivery Sciences International Inc)

Commercialization Plan. (a) Not later than three [***] after submission of Regulatory Filings With respect to the initial Indication for each which a BLA for the Licensed Product is filed in each country of the TerritoryUnited States, Licensee Novartis will prepare and provide to the JCC for review its initial Commercialization Plan for each Product for each country in the Territory. Such initial Commercialization Plan will describe Licensee’s plans for activities to be conducted for such Product for such country. Each Commercialization Plan shall include the details of obligations to be performed by Licensee to achieve the specific activities that are applicable to the stage of [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested review, with respect to the omitted portions. Commercialization Plan, (e.g., pre-launch, launch planning, launch, or post-launcha) of the applicable Product during the time period covered by Strategy comprising such Commercialization Plan no earlier than […***…] or later than […***…] prior to the expected date of First Commercial Sale of such Licensed Product in the United States and subsequent time periods. (b) Prior the Tactical Plan comprising such Commercialization Plan no earlier than […***…] or later than […***…] prior to the expected date of First Commercial Sale for of such Licensed Product in such countrythe United States. With respect to each future Indication for which the Licensed Product is being Commercialized by Novartis in the Novartis Territory, Licensee Novartis will prepare and provide to the JCC for its review an updated a Commercialization Plan for the Licensed Product and such Product for such country. Such updated Commercialization Plan will include, but not be limited to, Licensee’s updated plans for activities to be conducted for such Product for such country Indication no later than […***…] prior to launch as well as activities to be conducted in connection with such launch. (c) Promptly after each anniversary the expected date of the First Commercial Sale of such Product during the TermLicensed Product. For […***…], Licensee will Novartis shall provide to JCC a […***…] written report that provides an overview of the JCC for review updated Commercialization Plans for such Product for such country. Such further updated Commercialization Plan will include, but not be limited to, Licensee’s plans for global Commercialization activities for such the Licensed Product performed by Novartis and such its Affiliates and Sublicensees in each country for since the twelve prior report provided by Novartis, which written report will include (12i) month period following the date an overview of delivery of such Commercialization Plan. No Commercialization Plan may be implemented by Licensee if Novartis’s [***]. Each Commercialization Plan shall be consistent with …] in the Novartis Territory and shall not contradict (ii) Novartis’ estimates for sales on a rolling basis of the terms of this Agreement Licensed Product for the subsequent [***]…] period; provided, that, (y) Novartis shall have no obligation under this Section 5.2.2 to prepare any such estimates that do not otherwise exist and (z) such estimates shall not be binding upon Novartis in the event of any inconsistency between way. Any material amendments or modifications to the Commercialization Plan for any Licensed Product shall be prepared by Novartis and this Agreement, delivered promptly to the terms of this Agreement shall prevail. Notwithstanding the foregoing, if a [***], Licensee shall [***] and shall promptly [***]JCC.

Appears in 1 contract

Samples: Option, Collaboration and License Agreement (BeiGene, Ltd.)

Commercialization Plan. While Vifor shall be responsible for preparing the Commercialization Plan, the JCC (ausing appropriate experts within each Party’s organization) Not later than three [***] after submission of Regulatory Filings shall have the right and be responsible for each discussing and approving the initial Commercialization Plan, which sets forth in reasonable detail the tasks, timeline and budget for Commercialization activities for the Licensed Product in each country 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 this Agreement. Vifor (and its applicable Affiliates and Sublicensees) shall conduct Commercialization activities for the Licensed Product in the Field in the United States in accordance with the approved Commercialization Plan. The Commercialization Plan shall set 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), including budgets for all such Commercialization activities, the marketing and advertising plans, the specific commitments for the numbers of “Primary Detail Equivalents” for the Vifor (or VFMCRP, as applicable) sales representatives to conduct on Licensed Product in the applicable calendar year, and annual projections for Net Sales of Licensed Products in the U.S. for the coming year. From time to time, either Party may propose amendments or modifications to the Commercialization Plan as needed based on the progress or results of the TerritoryCommercialization of Licensed Products, Licensee will provide and/or changes in the U.S. market for Licensed Products in the Field, and in such case the JCC shall review in good ​ ​ faith and comment on the proposed amendments or modifications, and if the JCC agrees, shall subject the agreed amendments or modifications to the JCC for review its initial Commercialization Plan for each Product for each country in the Territory. Such initial Commercialization Plan will describe Licensee’s plans for activities to be conducted for such Product for such country. Each Commercialization Plan shall include the details of obligations to be performed by Licensee to achieve the specific activities that are applicable to the stage of [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. Commercialization (e.g., pre-launch, launch planning, launch, or post-launch) of the applicable Product during the time period covered by such Commercialization Plan and subsequent time periods. (b) Prior to the First Commercial Sale for such Product in such country, Licensee will provide to the JCC for review an updated Commercialization Plan for such Product for such country. Such updated Commercialization Plan will include, but not be limited to, Licensee’s updated plans for activities to be conducted for such Product for such country prior to launch as well as activities to be conducted in connection with such launch. (c) Promptly after each anniversary of the First Commercial Sale of such Product during the Term, Licensee will provide to the JCC for review updated Commercialization Plans for such Product for such country. Such further updated Commercialization Plan will include, but not be limited to, Licensee’s plans for Commercialization activities for such Product and such country for the twelve (12) month period following the date of delivery of such Commercialization Plan. No Commercialization Plan may be implemented by Licensee if [***]. Each Commercialization Plan shall be consistent with and shall not contradict the terms of this Agreement [***], and in the event of any inconsistency between the Commercialization Plan and this Agreement, the terms of this Agreement shall prevail. Notwithstanding the foregoingcomment and, if a [***]acceptable, Licensee shall [***] and shall promptly [***]approval.

Appears in 1 contract

Samples: License Agreement (Cara Therapeutics, Inc.)

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Commercialization Plan. Cipla will be responsible for preparing and presenting to the JSC a Commercialization Plan twelve (a12) Not later than three [***] after submission of months prior to the anticipated Regulatory Filings for each Product in each country Approval of the TerritoryProduct for marketing in the U.S. or in any other country in the Territory in connection with the Pulmonary Indication. Following JSC review and approval of such Commercialization Plan, Licensee the JSC shall review the implementation and execution of the Commercialization Plan on at least a quarterly basis; provided, that if any unexpected circumstance occurs that would result in a variation from the Commercialization budget set forth in such Commercialization Plan of fifteen percentage (15%) or greater, then the JSC shall promptly convene a special meeting to review the causes for such variation and establish a plan for remediation. For clarity, in no event, will provide either Party be required to incur Commercialization Costs in excess of one hundred and fifteen percentage (115%) of the JCC for review its amount set forth in the budget and/or Commercialization Costs contained in the Commercialization Plan unless such costs are pre-approved by JSC. By the June 30th following the date of the initial Commercialization Plan for and each Product for each country in the Territory. Such initial Commercialization Plan June 30th thereafter, Cipla, will describe Licensee’s plans for activities to be conducted for such Product for such country. Each Commercialization Plan shall include the details of obligations to be performed by Licensee to achieve the specific activities that are applicable prepare and present to the stage of [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. Commercialization (e.g., pre-launch, launch planning, launch, or post-launch) of the applicable Product during the time period covered by such Commercialization Plan and subsequent time periods. (b) Prior to the First Commercial Sale for such Product in such country, Licensee will provide to the JCC for review JSC an updated Commercialization Plan for the immediately following Calendar Year (e.g., Cipla will prepare and present to the JSC the Calendar Year 2021 Commercialization Plan by September 3, 2020). In the event that the Product receives Regulatory Approval for a Pulmonary Indication in any country other than the U.S., the JSC shall make a determination if the Product will be Commercialized in such jurisdiction within thirty (30) days of such Regulatory Approval and, if the JSC so determines to Commercialize the Product in such jurisdiction, then Cipla shall prepare and present Commercialization Plans (including annually updated Commercialization Plans) for such country. Such updated Commercialization Plan will include, but not be limited to, Licensee’s updated plans for activities to be conducted for such Product for such country prior to launch as well as activities to be conducted in connection with such launch. (c) Promptly after each anniversary of jurisdiction following the First Commercial Sale of such Product during the Term, Licensee will provide to the JCC for review updated Commercialization Plans for such Product for such country. Such further updated Commercialization Plan will include, but not be limited to, Licensee’s plans for Commercialization activities for such Product and such country same procedure set forth above for the twelve (12) month period following the date of delivery of such Commercialization Plan. No Commercialization Plan may be implemented by Licensee if [***]. Each Commercialization Plan shall be consistent with and shall not contradict the terms of this Agreement [***], and in the event of any inconsistency between the Commercialization Plan and this Agreement, the terms of this Agreement shall prevail. Notwithstanding the foregoing, if a [***], Licensee shall [***] and shall promptly [***].U.S.

Appears in 1 contract

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

Commercialization Plan. (a) Not later than three Within [***] after submission of Regulatory Filings the first Approval Application for each a Product in each country the Co-Promote Territory is filed, the Steering Committee, or appropriate JPT, shall meet to discus the strategy for commercialization of the Territory, Licensee will provide to the JCC for review its initial Commercialization Plan for each Product for each country in the Co-Promote Territory. Such initial Commercialization Plan will describe Licensee’s plans for activities to be conducted for such Product for such country. Each Commercialization Plan shall include the details of obligations to be performed by Licensee to achieve the specific activities that are applicable to the stage of Within [***] Certain information the foregoing meeting of the Steering Committee or appropriate JPT, Genentech PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE BEEN FILED SEPARATELY WITH THE SECRETARY OF THE COMMISSION PURSUANT TO THE COMPANY'S APPLICATION REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24B-2 OF THE EXCHANGE ACT. shall submit to the Steering Committee, or appropriate JPT, an annual plan for the commercialization of such Product in this document has been omitted 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 filed separately with the Securities and Exchange Commission. Confidential treatment has been requested Genentech shall reasonably consider Altus's comments with respect to the omitted portions. Commercialization (e.g., pre-launch, launch planning, launch, or post-launch) of the applicable Product during the time period covered by such Commercialization Plan and subsequent time periods. (b) Prior to the First Commercial Sale for such Product in such country, Licensee will provide to the JCC for review an updated Commercialization Plan for such Product for such country. Such updated Commercialization Plan will include, but not be limited to, Licensee’s updated plans for activities to be conducted for such Product for such country prior to launch as well as activities to be conducted in connection with such launch. (c) Promptly after each anniversary of the First Commercial Sale of such Product during the Term, Licensee will provide to the JCC for review updated Commercialization Plans for such Product for such country. Such further updated Commercialization Plan will include, but not be limited to, Licensee’s plans for Commercialization activities for such Product and such country for the twelve (12) month period following the date of delivery of such Commercialization Plan. No Genentech shall update the Commercialization Plan may be implemented by Licensee if on [***]. Each Commercialization Plan shall be consistent with and shall not contradict the terms of this Agreement [***], and in the event of any inconsistency between the Commercialization Plan and this Agreement, the terms of this Agreement shall prevail. Notwithstanding the foregoing, if a [***], Licensee shall Prior to each [***] of the Commercialization Plan, the 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 promptly [***]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 marketing and sales of Products in the Co-Promote Territory.

Appears in 1 contract

Samples: Collaboration and License Agreement (Altus Pharmaceuticals Inc.)

Commercialization Plan. (a) Not later than three [***] after submission The strategy for the Commercialization of Regulatory Filings for each Licensed Product shall be described in each country of a comprehensive plan that describes the Territory, Licensee will provide to the JCC for review its initial Commercialization Plan for each Product for each country in the Territory. Such initial Commercialization Plan will describe Licensee’s plans for activities to be conducted for such Product for such country. Each Commercialization Plan shall include the details of obligations to be performed by Licensee to achieve the specific activities that are applicable to the stage of [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. Commercialization (e.g., pre-launch, launch and subsequent Commercialization activities for such Licensed Product in the Territory, which shall include, without limitation, (i) the annual anticipated number of details to be conducted in each country within the Territory, (ii) the annual anticipated marketing expenses to be incurred in each of the countries within the Territory, (iii) the annual anticipated number of FTEs to be assigned to Commercialize in each of the countries within the Territory, and (iv) a report on pricing, advertising, education, planning, launchmarketing, or post-launchand sales force training (the “Commercialization Plan”). An initial Commercialization Plan for Biovance shall be prepared by Alliqua and presented to the JSC as soon as practicable, but in any event, within ninety (90) days of the applicable Product during Effective Date or such other time agreed to by the time period covered by such JSC. In addition, Alliqua shall submit an initial Commercialization Plan and subsequent time periods. (b) Prior for ECMs to the First Commercial Sale JSC no later than ninety (90) days prior to anticipated 510(k) or other Regulatory Clearance and/or Approval in each relevant jurisdiction within the Territory. The Parties shall, and shall cause their respective members of the JSC to, cooperate with each other in good faith to promptly finalize a mutually acceptable Commercialization Plan for such Product in such country, Licensee will provide to the JCC for review each Licensed Product. Alliqua shall deliver an updated Commercialization Plan for such Product for such country. Such updated Commercialization Plan will includeeach Licensed Product, but not be limited toas applicable, Licensee’s updated plans for activities to be conducted for such Product for such country prior to launch as well as activities to be conducted in connection with such launch. (c) Promptly after at each anniversary meeting of the First Commercial Sale of JSC or at such Product during times as agreed to by the TermJSC. 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, Licensee will provide to the JCC for review updated Commercialization Plans for such Product for such countryAS AMENDED, GRANTING CONFIDENTIAL TREATMENT TO SELECTED PORTIONS. Such further updated Commercialization Plan will includeACCORDINGLY, but not be limited toTHE CONFIDENTIAL PORTIONS HAVE BEEN OMITTED FROM THIS EXHIBIT, Licensee’s plans for Commercialization activities for such Product and such country for the twelve (12) month period following the date of delivery of such Commercialization PlanAND HAVE BEEN FILED SEPARATELY WITH THE COMMISSION. No Commercialization Plan may be implemented by Licensee if [OMITTED PORTIONS ARE INDICATED IN THIS EXHIBIT WITH “***]. Each Commercialization Plan shall be consistent with and shall not contradict the terms of this Agreement [***], and in the event of any inconsistency between the Commercialization Plan and this Agreement, the terms of this Agreement shall prevail. Notwithstanding the foregoing, if a [***], Licensee shall [***] and shall promptly [***].

Appears in 1 contract

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

Commercialization Plan. (a) Not No later than three [***] after submission prior to the anticipated First Commercial Sale of Regulatory Filings for each a DT Co-Co Product in each country of the Territory, Licensee will provide Moderna and Metagenomi shall prepare and submit to the JCC for review its 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 Plan shall also contain a [***] rolling annual plan for the global Commercialization activities for the DT Co-Co Product in the Territory and the Commercialization Budget shall include a [***] financial forecast reflecting reasonably anticipated Commercialization Costs in accordance with the Commercialization Plan. Subject to comments and proposed changes by the other Party, each Party will be responsible for the Commercialization Plan for 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 address (to the extent applicable given the stage of Commercialization and estimated anticipated First Commercial Sale) (a) the Product Marks, global usage guidelines for the Product Marks, global key positioning, and messaging strategy for such DT Co-Co Product in such Indication, and guidelines for the 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 country in the Territory. Such initial The JCC shall prepare, review, and discuss, and the JSC shall review, discuss, and determine whether to approve, each Commercialization Plan will describe Licensee’s plans for activities a DT Co-Co Product. Moderna shall have the sole right to select the Product Marks for each DT Co-Co Product to be conducted for such Product for such country. Each Commercialization Plan shall include the details of obligations to be performed by Licensee to achieve the specific activities that are applicable to the stage of [***] Certain information used in this document has been omitted Moderna’s Region and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. Commercialization (e.g., pre-launch, launch planning, launch, or post-launch) of included in the applicable Product during the time period covered by such Commercialization Plan and subsequent time periods. may decide to develop and adopt certain distinctive colors, logos, images, symbols, and trade dress to be used (b) Prior in addition to the First Commercial Sale for such Product Marks) in connection with the Commercialization of each DT Co-Co Product in such countryModerna’s Region. The Parties shall jointly select the Product Marks for each DT Co-Co Product to be used in Metagenomi’s Region and included in the applicable Commercialization Plan and may jointly decide to develop and adopt certain distinctive colors, Licensee will provide logos, images, symbols, and trade dress to be used (in addition to the Product Marks) in connection with 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 (or more frequently as may be required), the JCC shall review and update each Commercialization Plan and Commercialization Budget based on the currently available information and data, including for review an updated any applicable new formulations or Indications that that were added to a Development Plan pursuant to Section 6.4.7(b) (JDC and JSC Decision Regarding New Development Activities) or new Combination Products approved by the JSC in accordance with Section 6.4.8 (Combination Products), in each case, that are not included in the then-current Commercialization Plan for the applicable DT Co-Co Product. The JSC shall review, discuss, and determine whether to approve any such Product for such country. Such updated Commercialization Plan will include, but not be limited to, Licensee’s updated plans for activities to be conducted for such Product for such country prior to launch as well as activities to be conducted in connection with such launch. (c) Promptly after each anniversary of the First Commercial Sale of such Product during the Term, Licensee will provide update to the JCC for review updated Commercialization Plans for such Product for such country. Such further updated Commercialization Plan will include, but not be limited to, Licensee’s plans for Commercialization activities for such Product and such country for the twelve (12) month period following the date of delivery of such Commercialization Plan. No Commercialization Plan may be implemented by Licensee if [***]. Each Commercialization Plan shall be consistent with and shall not contradict the terms of this Agreement [***], and in the event of any inconsistency between the applicable Commercialization Plan and this Agreement, the terms of this Agreement corresponding Commercialization Budget. Each such update to a Commercialization Plan and corresponding Commercialization Budget shall prevail. Notwithstanding the foregoing, if a [***], Licensee shall [***] become effective and shall promptly [***]supersede the previous Commercialization Plan and corresponding Commercialization Budget upon approval thereof by the JSC.

Appears in 1 contract

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

Commercialization Plan. (a) Not No later than three [***] after submission of Regulatory Filings for each Product in each country of the Territory[ * ], Licensee will subject to Sections 9.3(d) and 9.3(e), Astellas shall prepare and provide to the JCC for review its initial and discussion a written plan for the Commercialization Plan for each of such Collaboration Product for each country in an Astellas’ fiscal year (the Territory“Commercialization Plan”). Such initial Commercialization Plan will describe Licensee’s plans for activities to be conducted for such Product for such country. Each The Commercialization Plan shall include a reasonably detailed description of and anticipated timeline for the details of obligations to be performed by Licensee to achieve the specific Parties’, their respective Affiliates’ and sublicensees’ Commercialization activities that are applicable to the stage of [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. Commercialization (e.g.such Collaboration Product, including pre-launchlaunch plans, launch planningplans, launchmarket analytics, or post-launch) product forecasts, pricing assumptions and competitive intelligence. It is the Parties’ understanding that, [ * ] Astellas will be the Party primarily responsible for the conduct of the applicable Product during Commercialization activities under the time period covered by such Commercialization Plan. Each Party shall use Diligent Efforts to [ * ] of the collaboration under the Commercialization Plan (including [ * ]). The Parties agree that the Commercialization Plan and subsequent time periodsthe applicable Commercialization strategy shall be consistent. (b) Prior If Cytokinetics exercises its Co-Promotion option for a Collaboration Product, the Commercialization Plan shall also include a reasonably detailed description of and anticipated timeline for Cytokinetics’ Co-Promotion activities as well as a budget therefor, which shall be consistent with Section 9.6 below. (c) Subject to Sections 9.3(d) and 9.3(e)(ii), Astellas shall periodically (at least on an annual basis) prepare updates and amendments to its Commercialization Plan to reflect changes in its plans, including in response to changes in the First Commercial Sale for marketplaces and related product forecasts, relative success of the Collaboration Products and other relevant factors influencing such Product in such countryplans and activities. Subject to Sections 9.3(d) and 9.3(e)(ii), Licensee will provide Astellas shall submit all updates and amendments to its Commercialization Plan to the JCC for review and discussion. For clarity, the Commercialization budget is subject to the final determination by the JCC, subject to [ * ], subject to Section 9.8. Cytokinetics may perform [ * ] activities within the scope of its responsibilities under the Commercialization Plan, [ * ]. (d) The Commercialization Plan (and any amendment thereto) for any Collaboration Product (i) for a [ * ] Indication, (ii) for [ * ] Indication for which Cytokinetics exercises the Cytokinetics Co-Funding Option [ * ], and (iii) subject to Section 9.3(e) and Section 9.8, for [ * ] Indication, must be agreed by the JCC by [ * ]. Neither Party shall conduct any Commercialization activities that are inconsistent with such agreed-upon Commercialization Plan and any Co-Promotion Agreement. (e) With respect to the Commercialization of a Collaboration Product in [ * ] Indication, subject to Section 9.8, then: (i) If Cytokinetics has an updated Established Commercial Infrastructure, Cytokinetics shall have [ * ] for the Commercialization strategy for such Collaboration Product for such Indication in the Shared Territory (but not for the Commercialization strategies with respect to such Collaboration Product as a whole), provided however, such Commercialization strategy and the overall Commercialization Plan shall be consistent. [ * ] = Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) would likely cause competitive harm if publicly disclosed. (ii) Regardless of [ * ] as relates to the portions of the Commercialization Plan for such Collaboration Product that are specific to such Indication for the Shared Territory, as well as any update and/or amendment thereof. The Commercialization strategy with respect to [ * ] Indications includes the following [ * ]. (iii) [ * ] the Shared Territory and the [ * ] Astellas and Cytokinetics as well as the [ * ] such Collaboration Product for such country. Such updated Commercialization Plan will includeIndication, but not be limited tosubject to the discussion and final determination by the JCC, Licensee’s updated plans for activities to be conducted for such Product for such country prior to launch as well as activities to be conducted in connection with such launchtaking into account [ * ]. (civ) Promptly after each anniversary of the First Commercial Sale of such Product during the Term, Licensee will provide Notwithstanding anything to the JCC for review updated Commercialization Plans contrary, the [ * ] for such Collaboration Product in such Indication in a particular country will have the decision making authority with respect [ * ] and other terms of sale for such Collaboration Product in such Indication for such country. Such further updated Commercialization Plan will include, provided that the other Party may conduct, [ * ]. (v) If [ * ] the Collaboration Product(s) in such [ * ] Indication, but the Parties have not determined which Party will [ * ] for the Collaboration Product(s) in such [ * ] Indication under Section 9.8(b), then [ * ] shall be limited to, Licensee’s plans responsible for Commercialization the pre-commercialization activities for the Collaboration Product in such Product and such country for the twelve [ * ] Indication. (12f) month period following the date of delivery of such Commercialization Plan. No Commercialization Plan may be implemented by Licensee if [***]. Each Commercialization Plan Subject to Section 9.3(c), Astellas shall be consistent with and shall not contradict the terms solely responsible for all costs incurred by or on behalf of this Agreement [***], and either Party in the event of any inconsistency between performing their respective obligations under the Commercialization Plan except [ * ] (or [ * ] determined by the JCC), which shall be agreed between the Parties acting reasonably and this Agreement, the terms of this Agreement shall prevail. Notwithstanding the foregoing, if a [***in good faith [ * ], Licensee shall [***] and shall promptly [***]for its Co-Promotion activities as set forth in the Co-Promotion Agreement.

Appears in 1 contract

Samples: License and Collaboration Agreement (Cytokinetics Inc)

Commercialization Plan. (a) Not later than three [***] after submission All Commercialization of Regulatory Filings for each the Product in each country the Field in the Territory shall be conducted pursuant to a commercialization plan, which shall set forth the plan for the Detailing and Promotion of the Territory, Licensee will provide to the JCC for review its initial Commercialization Plan for each Product for each country in the Territory. Such initial Commercialization Plan will describe Licensee’s plans for Field in the Territory in accordance with Applicable Laws and the activities to be conducted for such Product for such countrycarried out related thereto (the “Commercialization Plan”). Each The Parties have agreed upon a high-level outline of the Commercialization Plan Plan, as further described on Exhibit 6.2. No later than ninety (90) days after the Effective Date, and prior to January 1 of each and every Calendar Year after the first Calendar Year, United Therapeutics shall include the details of obligations to be performed by Licensee to achieve the specific activities that are applicable submit to the stage of [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. Commercialization (e.g., pre-launch, launch planning, launch, or post-launch) of the applicable Product during the time period covered by such Commercialization Plan and subsequent time periods. (b) Prior to the First Commercial Sale for such Product in such country, Licensee will provide to the JCC JSC for review an updated Commercialization Plan for such Product for such countryPlan. Such For purposes of clarification, after submission of the first updated Commercialization Plan will includeand not later than ninety (90) days after the Effective Date, but not be limited to, Licensee’s United Therapeutics shall submit the first annual updated plans for activities Commercialization Plan to be conducted for such Product for such country the JSC prior to launch the start of the second Calendar Year (i.e., prior to January 1, 2010). If Lilly determines that such updated Commercialization Plan does not comply with Applicable Laws, including laws relating to promotional and advertising materials as well as activities to be conducted accepted industry standards and Lilly’s ethical policies, in connection each case with such launch. (c) Promptly after each anniversary of the First Commercial Sale of such Product during the Term, Licensee will provide respect to the JCC for review updated Commercialization Plans for Product in the Field in the Territory, or that the activities conducted under such Product for such country. Such further updated Commercialization Plan will includeare reasonably likely to materially adversely affect products in Lilly’s Domain, but not Lilly shall be limited topermitted to propose, Licensee’s plans for in good faith, revisions to such updated Commercialization activities for such Product Plan, and such country for the twelve (12) month period following the date of delivery of United Therapeutics shall revise such Commercialization Plan. No Commercialization Plan may be implemented by Licensee if [***]. Each Commercialization Plan shall be consistent with and shall not contradict the terms of this Agreement [***], and in In the event of any inconsistency between the Commercialization Plan and this Agreement, the terms of this Agreement shall prevail. Notwithstanding the foregoing, if a [***], Licensee shall [***] and shall promptly [***].

Appears in 1 contract

Samples: License Agreement (United Therapeutics Corp)

Commercialization Plan. (a) Not No later than three [***] following Evelo notifying ALJ in writing that the first dose in the first patient of any Phase III Clinical Trial for a Product has occurred anywhere in the world after submission of Regulatory Filings for each Product in each country the Effective Date, ALJ will prepare: (a) a reasonably detailed written plan of the Territory, Licensee will provide to the JCC for review its initial Commercialization Plan for each Product for each country in the Territory. Such initial Commercialization Plan will describe Licensee’s plans for activities to be conducted for such Product for such country. Each Commercialization Plan shall include the details of obligations to be performed by Licensee to achieve the specific activities that are applicable to the stage of [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. Commercialization (e.g., pre-launch, launch planning, launch, or post-launch) of the applicable Product during the time period covered by such Commercialization Plan and subsequent time periods. (b) Prior to the First Commercial Sale for such Product in such country, Licensee will provide to the JCC for review an updated Commercialization Plan for such Product for such country. Such updated Commercialization Plan will include, but not be limited to, Licensee’s updated plans for activities to be conducted for such Product for such country prior to launch as well as activities to be conducted in connection with such launch. (c) Promptly after each anniversary of the First Commercial Sale of such Product during the Term, Licensee will provide to the JCC for review updated Commercialization Plans for such Product for such country. Such further updated Commercialization Plan will include, but not be limited to, Licensee’s plans for Commercialization activities for such Product in the Territory and submit such country for plan to the twelve PCC to review, discuss, and determine whether to approve (12as such plan may be updated as set forth below in this Section 6.1 (Commercialization Plan), a “Commercialization Plan”); and (b) month period following a detailed, written budget of the date Distribution Costs and other FTE Costs, Out-of-Pocket Expenses, Manufacturing Costs, and Other Operating Expenses expected to be incurred by or on behalf of delivery each Party in the performance of such Commercialization activities on a Calendar Year basis (as may be updated pursuant to this Section 6.1 (Commercialization Plan), the “Commercialization Budget”). No The Commercialization Plan may will include all Commercialization activities to be implemented undertaken by Licensee if [***]each Party for the Products in the Territory and an allocation between the Parties for all such activities (including, in the case of Evelo, manufacturing of the API for each Product). Each At least once each Calendar Year, ALJ will provide to the PCC an update to the then-current Commercialization Plan and Commercialization Budget, and may provide additional updates thereto from time to time, and the PCC will review, discuss, and determine whether to approve any proposed amendments or updates to the Commercialization Plan (including any amendments to the Commercialization Budget) in accordance with Section 3.3 (Decision-Making). If an amendment to the Commercialization Budget is required for the completion of a Commercialization activity already contemplated in the Commercialization Plan, and the PCC does not agree to such amendment to the Commercialization Budget for such Commercialization activity, each Party shall be relieved of its obligations under Section 6.2 to the extent directly relating to the specific Commercialization activity or portion of such Commercialization activity for which the increased budget was required. The Commercialization Plan for a Product (including each update thereto) must be consistent with Evelo’s global brand strategy and shall global key messaging for such Product (each, a “Global Commercialization Plan”), if and as provided to ALJ in writing by Evelo from time to time during the Term. ALJ will not contradict perform any Commercialization activities for the terms of this Agreement [***], and Products for the Territory other than in the event of any inconsistency between accordance with the Commercialization Plan and this Agreement, the terms of this Agreement shall prevail. Notwithstanding the foregoing, if a [***], Licensee shall [***] and shall promptly [***]Plan.

Appears in 1 contract

Samples: Commercialization and License Agreement (Evelo Biosciences, Inc.)

Commercialization Plan. (a) Not Commencing no later than three [***] after submission ]* prior to the anticipated launch of Regulatory Filings for the first Licensed Product, Cubist shall prepare and deliver to the JCT, by no later than []* of each Calendar Year, a written plan and budget that describes in detail the Commercialization activities (including pre-launch and launch activities, if applicable) to be undertaken with respect to Licensed Product in each country the Profit-Share Territory in the next Calendar Year and the dates by which such activities are targeted to be accomplished (each, a “Commercialization Plan”). The Commercialization Plan (including the budget) shall contain sufficient detail with respect to Commercialization tactics and other matters to enable the JCT to conduct a meaningful review of the TerritoryCommercialization Plan, Licensee will provide to and the JCC for review its initial JCT shall approve the first Commercialization Plan for each the Profit-Share Territory no later than []* prior to launch of the first Licensed Product in the Profit-Share Territory. Thereafter, the JCT shall review the Commercialization Plan not less frequently than annually and shall develop Commercialization Plan updates, which shall include updated budgets for the Profit-Share Territory, for each country in the TerritoryCalendar Year. Such initial Commercialization Plan will describe Licensee’s plans for activities to be conducted for such Product for such countryCubist may also develop and *Confidential Treatment Requested. Each Commercialization Plan shall include the details of obligations to be performed by Licensee to achieve the specific activities that are applicable to the stage of [***] Certain information in this document has been omitted and Omitted portions filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect submit to the omitted portions. Commercialization (e.g., pre-launch, launch planning, launch, or post-launch) of the applicable Product during the JCT for review from time period covered by such Commercialization Plan and subsequent to time periods. (b) Prior other proposed substantive amendments to the First Commercial Sale for such Product in such country, Licensee will provide to the JCC for review an updated Commercialization Plan for such Product for such country. Such updated Commercialization Plan will include, but not be limited to, Licensee’s updated plans for activities to be conducted for such Product for such country prior to launch as well as activities to be conducted in connection with such launch. (c) Promptly after each anniversary of the First Commercial Sale of such Product during the Term, Licensee will provide to the JCC for review updated Commercialization Plans for such Product for such country. Such further updated Commercialization Plan will include, but not be limited to, Licensee’s plans for Commercialization activities for such Product and such country for the twelve (12) month period following the date of delivery of such Commercialization Plan. No Amendments and updates to the Commercialization Plan may be implemented by Licensee if [***]. Each Plan, including any budgets for the Profit-Share Territory contained in the Commercialization Plan shall be consistent with and Plan, shall not contradict be effective without the terms approval of the JCT. Notwithstanding anything in this Agreement [***]to the contrary, and if Cubist engages or uses a Third Party to perform any Commercialization activities in the event of any inconsistency between the Commercialization Plan and this AgreementProfit-Share Territory under circumstances where such Third Party will be granted a sublicense under Alnylam Technology or where there will be a material penalty for early termination that is inconsistent with industry standards, the terms of this Agreement shall prevail. Notwithstanding the foregoing, if a []***], Licensee shall [***] and shall promptly [***].

Appears in 1 contract

Samples: License and Collaboration Agreement (Cubist Pharmaceuticals Inc)

Commercialization Plan. All Commercialization with respect to a Product under this Agreement shall be conducted pursuant to a Commercialization Plan, which shall set forth the plan for the Commercialization of such Product and the activities to be carried out with respect thereto, together with a proposed budget for such activities (a) Not later than three [***] after submission of Regulatory Filings for each Product in each country of each, a “Commercialization Plan”). The Operating Parties, through the TerritoryJSC, Licensee will provide to the JCC for review its initial shall agree upon a preliminary Commercialization Plan for each Product at least ************ prior to the anticipated Regulatory Approval for such Product. During the Commercialization Phase with respect to each country in Product, the Territory. Such initial Operating Parties, through the JSC, shall update the Commercialization Plan will describe Licensee’s plans for activities with respect to be conducted for such Product for such countryon an annual basis prior to the commencement of the next calendar year, or more often as determined by the JSC. Each updated Commercialization Plan shall include include, for the details of obligations to be performed by Licensee to achieve the specific activities that are applicable to the stage of [subsequent ***] Certain information *********, the projection of the plan for Commercialization Activities for the Product in this document has been omitted each Territory and filed separately timelines for performing such activities, the projected Net Sales and other revenues from the sale of the Product, together with an updated Commercialization budget. The Commercialization Plan shall contain an estimation of the resources that each Operating Party intends to employ in connection with the Securities Commercialization of the relevant Product. In addition, the JSC will review performance against the Commercialization Plan for each Product on a quarterly basis, and Exchange Commission. Confidential treatment has been requested with respect will report any variations to the omitted portionsOperating Parties in writing. If, in any quarter, there is a variation of ************ or greater from the budget or from projected Net Sales and other revenues, the JSC will revise the Commercialization (e.g., pre-launch, launch planning, launch, or post-launch) of Plan and budget for the applicable Product during ************ prior to the time period covered by such commencement of the second quarter following the quarter in which the variation occurred. For example, if a ************ variation is reported in quarter one of a calendar year, a revised Commercialization Plan and subsequent time periods. (b) Prior budget must be prepared at least ************ prior to the First Commercial Sale for commencement of quarter three of such Product in calendar year. Until such country, Licensee will provide to the JCC for review time as an updated Commercialization Plan for such Product for such country. Such updated is approved in accordance with this Section 6.1, the preceding Commercialization Plan will include(including, but without limitation, all budget projections therein) shall remain in effect. The JSC shall not be limited to, Licensee’s updated plans for activities to be conducted for such Product for such country prior to launch as well as activities to be conducted in connection with such launch. (c) Promptly after each anniversary of the First Commercial Sale of such Product during the Term, Licensee will provide to the JCC for review updated Commercialization Plans for such Product for such country. Such further updated approve any Commercialization Plan will include, but not be limited to, Licensee’s plans for Commercialization activities for such Product and such country for the twelve (12) month period following the date of delivery of such Commercialization Plan. No Commercialization Plan may be implemented by Licensee if [***]. Each Commercialization Plan shall be consistent that is inconsistent with and shall not contradict or contradicts the terms of this Agreement [***], and in the event of any inconsistency between the Commercialization Plan and this Agreement, the terms of this Agreement shall prevail. Notwithstanding the foregoing, if a [***], Licensee shall [***] and shall promptly [***].

Appears in 1 contract

Samples: Joint Development and Commercialization Agreement (GTC Biotherapeutics Inc)

Commercialization Plan. (a) Not later than three [***] after submission Without limiting the generality of Regulatory Filings Licensee’s sole responsibility and decision-making authority for each Commercializing the Product in each country of the TerritoryField in the Licensee Territory as set forth in Section 4.2, Licensee will provide use its Commercially Reasonable Efforts to carry out the JCC for review its initial Commercialization Plan for each of the Product for each country in accordance with a written Commercialization Plan, as such may be amended or revised by Licensee from time to time, that describes the Territory. Such initial anticipated Commercialization Plan will describe Licensee’s plans for activities to be conducted for such performed with respect to Product for such countryin the Licensee Territory by Licensee or on its behalf by permitted Third Parties (the “Commercialization Plan”). Each Commercialization Plan shall include the details of obligations to be performed by Licensee to achieve the specific activities that are applicable address, in reasonable detail, to the stage extent applicable, call plans for Detailing of [***] Certain information in this document has been omitted Product, Sales Force training, Product sampling strategies and filed separately with the Securities quantities, Product positioning and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. Commercialization (e.g.scientific communication strategy, preand DTC and non-launch, launch planning, launch, or post-launch) of the applicable Product during the time period covered by such Commercialization Plan and subsequent time periodsDTC advertising. (b) Prior to Within thirty (30) days of the First Commercial Sale for such Product in such countryEffective Date, Licensee will provide shall deliver to the JCC for review an updated VIVUS a Commercialization Plan for such Product for such country. Such updated Commercialization Plan will include, but not be limited to, Licensee’s updated plans for activities to be conducted for such Product for such country prior to launch as well as covering activities to be conducted in connection with preparation of any Product Launch in the Licensee Territory on a country-by-country basis and during the first full calendar year following such launchProduct Launch. (c) Promptly after each anniversary Licensee shall thereafter update the Commercialization Plan (together with the Medical Affairs Plan described in Section 4.7) on an annual basis as follows: Licensee shall provide the JSC (or VIVUS in the absence of a JSC) with preliminary drafts of the First Commercial Sale Commercialization Plan and Medical Affairs Plan no later than November 15 of each year for the JSC’s (or VIVUS’ in the absence of a JSC) review and comment and Licensee shall provide the JSC (or VIVUS in the absence of a JSC) with the final Commercialization Plan and Medical Affairs Plan no later than January 31 of the year immediately following such Product during year. In preparing the Termupdated versions of the Commercialization Plan and Medical Affairs Plan, Licensee will provide to shall analyze the JCC for review updated Commercialization Plans for such Product for such country. Such further updated effectiveness of the elements of the prior year Commercialization Plan will include, but not be limited to, Licensee’s plans for Commercialization activities for such Product and such country for Medical Affairs Plan and shall use updated sales forecasts to develop the twelve (12) month period following the date of delivery of such new Commercialization Plan. No Licensee agrees to give due consideration to the input provided by the JSC (or VIVUS in the absence of a JSC) but Licensee at all times will retain responsibility and decision-making authority for the Commercialization of the Product in the Field in the Licensee Territory. Licensee may, at its election, update the Commercialization Plan may be implemented and Medical Affairs Plan between annual updates by Licensee if [***]. following this same procedure. (d) Each Party shall use Commercially Reasonable Efforts in performing its obligations under this Section 4.3 concerning (as applicable) the Commercialization Plan shall be consistent with and shall not contradict the terms of this Agreement [***], and in Medical Affairs Plan. (e) In the event of any inconsistency between between, on the one hand, the Commercialization Plan and or Medical Affairs Plan and, on the other hand, this Agreement, the terms of this Agreement shall prevail. Notwithstanding the foregoing, if a [***], Licensee shall [***] and shall promptly [***].

Appears in 1 contract

Samples: License and Commercialization Agreement (Petros Pharmaceuticals, Inc.)

Commercialization Plan. (a) Not No later than three [***] after submission of Regulatory Filings for each Product in each country of the Territory], Licensee will Astellas shall prepare and provide to the JCC for review its initial and discussion a written plan for the Commercialization Plan for each of such Collaboration Product for each country in an Astellas’ fiscal year (the Territory“Commercialization Plan”). Such initial Commercialization Plan will describe Licensee’s plans for activities to be conducted for such Product for such country. Each The Commercialization Plan shall include the details a reasonably detailed description of obligations to be performed by Licensee to achieve the specific and anticipated timeline for Astellas’, its Affiliates’ and sublicensees’ Commercialization activities that are applicable to the stage of [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. Commercialization (e.g.such Collaboration Product, including, without limitation pre-launchlaunch plans, launch planningplans, launchmarket analytics, or postproduct forecasts, pricing assumptions and competitive intelligence. If Cytokinetics exercises its Co-launchPromotion option for a Collaboration Product, the Commercialization Plan shall also include a reasonably detailed description of and anticipated timeline for Cytokinetics’ Co-Promotion activities as well as a budget therefor, which shall be consistent with Section 8.6 below. Astellas shall periodically (at least on an annual basis) prepare updates and amendments to its Commercialization Plan to reflect changes in its plans, including in response to changes in the marketplaces and related product forecasts, relative success of the applicable Product during the time period covered by Collaboration Products and other relevant factors influencing such plans and activities. Astellas shall submit all updates and amendments to its Commercialization Plan and subsequent time periods. (b) Prior to the First Commercial Sale for such Product in such country, Licensee will provide to the JCC for review an updated and discussion. The Commercialization Plan for such any Collaboration Product for such country. Such updated Commercialization Plan will include, but not be limited to, Licensee’s updated plans for activities to be conducted for such Product for such country prior to launch as well as activities to be conducted in connection with such launch. (c) Promptly after each anniversary of the First Commercial Sale of such Product during the Term, Licensee will provide to the JCC for review updated Commercialization Plans for such Product for such country. Such further updated Commercialization Plan will include, but not be limited to, Licensee’s plans for Commercialization activities for such Product and such country for the twelve (12) month period following the date of delivery of such Commercialization Plan. No Commercialization Plan may be implemented by Licensee if [***]] must be agreed by the Parties. Each Commercialization Plan Astellas shall be consistent with and shall not contradict the terms solely responsible for all costs incurred by or on behalf of this Agreement [***], and either Party in the event of any inconsistency between performing their respective obligations under the Commercialization Plan and this Agreement, the terms of this Agreement shall prevail. Notwithstanding the foregoingand, if a Cytokinetics exercises its Co-Promotion option, shall pay Cytokinetics [***], Licensee shall [***] and shall promptly [***]determined by the JCC) for its Co-Promotion activities as set forth in the Co-Promotion Agreement.

Appears in 1 contract

Samples: License and Collaboration Agreement (Cytokinetics Inc)

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