Commercialization Plans Sample Clauses
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Commercialization Plans. The JCC will review and discuss the Territory Commercialization Plan and the North American Commercialization Plan, each of which will be provided to the JCC by ▇▇▇▇▇▇▇ or Vertex, respectively, no later than [***] prior to the projected commercial launch for the Product in the United States (with respect to the North American Commercialization Plan) or the European Union (with respect to the Territory Commercialization Plan). [***] The responsible Party will also provide to the JCC, for review and discussion, any subsequent material amendments to the most recent Commercialization Plan that it provided to the JCC and in any event shall submit an updated plan on an annual basis. [***] prior to the projected commercial launch for the Product in either the United States or the European Union, the JCC will consider plans for sharing certain global Commercialization activities (i.e., activities that benefit the Product in both the Vertex’ and ▇▇▇▇▇▇▇’▇ territories, including without limitation such activities that relate to [***] and the appropriate allocation of responsibilities and budget for such activities. Any such plan (including the allocation of responsibilities and budget) recommended by the JCC will be referred to the JSC for approval and if approved, will be reviewed and updated annually thereafter by the JSC upon referral from the JCC. The Territory Commercialization Plan will contain the annual Commercialization plans and budgets for [***] with sufficient detail with respect to Commercialization, including but not limited to details [***] to enable the JCC to conduct a meaningful review of such plans. Comparable information will be provided for the Territory as a whole and on a regional basis. Amendments and updates to the Territory Commercialization Plan and particularly the Commercialization plans for [***] shall not be effective without review and discussion by the JCC. Notwithstanding the foregoing, ▇▇▇▇▇▇▇ shall be solely responsible for all decisions regarding the prices charged for the Product in the Territory, as well as discounts, rebates and all other deductions from Net Sales allowed under Section 1.77.
Commercialization Plans. As soon as practicable after formation of the JCC (following Acucela’s exercise of an Opt-In Right under Section 3.1), the JCC shall prepare and approve the initial Commercialization Plan for Commercialization of the Licensed Product for the Initial Indication in the Initial Formulation (and, if applicable, any New Formulation or Other Indication Product) in the Territory. The Parties shall use Commercially Reasonable Efforts to ensure that such initial Commercialization Plan for Commercialization of the Licensed Product for the Initial Indication in the Initial Formulation is consistent with the general Commercialization Plan outline set forth in Exhibit C attached hereto and incorporated herein (the “General Commercialization Plan Outline”). The JCC shall prepare and approve a separate Commercialization Plan for Commercialization of Licensed Product for the Initial Indication in the Initial Formulation in the Territory and for Commercialization of each Other Indication Product and New Formulation (if any) in the Territory, and shall update and amend each Commercialization Plan not less than annually or more frequently as needed to take into account changed circumstances or completion, commencement or cessation of Commercialization activities not contemplated by the then-current Commercialization Plan. Amendments and revisions to the Commercialization Plan shall be reviewed and discussed, in advance, by the JCC, and Otsuka agrees to consider proposals and suggestions made by Acucela regarding amendments and revisions to the Commercialization Plan. Any amendment or revision to the Commercialization Plan that provides for an increase or decrease in the number of FTEs for any Phase 3b Clinical Trials or Post-Approval Studies as compared to the previous version of the Commercialization Plan, or that provides for addition or discontinuation of tasks or activities as compared to the previous version of the Commercialization Plan, or that moves forward the timetable for activities reflected in the Commercialization Plan, shall provide for a reasonable ramp-up or wind-down period, as applicable, to accommodate a smooth and orderly transition of Commercialization activities to the amended or revised Commercialization Plan. Each Commercialization Plan shall identify the goals of Commercialization contemplated thereunder and shall address Commercialization (including Co-Promotion) activities related to the Licensed Product (including, if applicable, any Other Indica...
Commercialization Plans. 10.3.1 In-Vivo [***] Commercialization Plans. Subject to Applicable Law, NVS will prepare and provide to HMI (through the JSC): (a) an initial high-level summary of the anticipated Commercialization strategy and activities to be conducted for an In-Vivo [***] Product; and (b) an associated budget, no later than [***] for such In-Vivo [***] Product. In addition, NVS will prepare and provide to the JSC a Commercialization plan for each In-Vivo [***] Product that contemplates the commercial launch of, and the Commercialization activities to be taken in the first [***] after the First Commercial Sale of, such In-Vivo [***] Product in the Territory excluding the U.S. if HMI is the Commercializing Party and including the U.S. if NVS is the Commercializing Party (the “Global In-Vivo [***] Commercialization Plan”). If HMI is the Commercializing Party, then HMI will prepare and provide to the JSC a Commercialization plan for each In-Vivo [***] Product that contemplates the commercial launch of, and the Commercialization activities to be taken in the first [***] after the First Commercial Sale of, such In-Vivo [***] Product in the U.S. (the “U.S. In-Vivo [***] Commercialization Plan”). If HMI is the Commercializing Party, then each Party will provide the applicable Commercialization plan to the other Party no later than [***] such In-Vivo [***] Product in such Party’s territory. Subject to Applicable Law, (i) the strategic objectives and activities in the U.S. In-Vivo [***] Commercialization Plan will be consistent with the strategic objectives and activities in the Global In-Vivo [***] Commercialization Plan, unless otherwise agreed by the Parties; and (ii) the Global In-Vivo [***] Commercialization Plan and the U.S. In-Vivo [***] Commercialization Plan will each be reviewed, discussed, and approved by the JSC. Thereafter, at least once each [***], NVS will submit an updated Global In-Vivo [***] Commercialization Plan for each In-Vivo [***] Product, and HMI will submit an updated U.S. In-Vivo [***] Commercialization Plan, in each case, to the JSC for review, discussion, and approval.
Commercialization Plans. Each Party shall submit a Commercialization Plan to the JSC for discussion no less [***] prior to the anticipated date of such Party obtaining Regulatory Approval for a Licensed Product. Thereafter, each Party shall provide a copy of the then-current Commercialization Plan to the JSC at least once each Calendar Year during the Licensed Product Royalty Term and Takeda Royalty Term, as applicable.
Commercialization Plans. Licensee shall provide ARCH with its ----------------------- strategic and detailed plans for the commercialization of the Licensed Products. Such plans shall include research and development plans, product milestones and related timetable schedules, government or regulatory timetables and sales and marketing plans. Licensee will update these plans at least on an annual basis.
Commercialization Plans. Each Party shall use Diligent Efforts to prepare annual marketing plans for each Product, such plans shall contain the details contained in the marketing plans regularly prepared by such Party for its other products and shall include plans related to the pre-launch, launch, promotion and sale of the Product, and the general nature of the marketing, promotion and advertising campaigns proposed to be conducted, including, in the case of Enzon, the number of sales representatives proposed to detail the Product (each such plan a “Commercialization Plan”). Each Party shall provide the other Party a copy of all Commercialization Plans for each Product as soon as practicable after such plan is completed.
Commercialization Plans. Activities to be undertaken before the next annual report including, but not limited to, the type and objective of any necessary efforts and their projected starting and completion dates.
Commercialization Plans. During the Royalty Term with respect to each Product, at least thirty (30) days prior to the commencement of each Calendar Year, Processa shall provide Ocuphire, for information purposes only, a summary of the planned Commercialization activities to be conducted by or on behalf of Processa and its Affiliates and Sublicensees with respect to such Product in each country in the Territory during such Calendar Year (each such plan, a “Commercialization Plan”).
Commercialization Plans. Astellas shall keep Pandion reasonably well informed of Astellas’ Commercialization activities.
Commercialization Plans. The Parties shall cooperate to develop each Commercialization Plan setting forth the Promotion activities and other Commercialization activities to be conducted by Spectrum in the Territory with respect to each Product.