U.S. Commercialization Budget Sample Clauses

U.S. Commercialization Budget. At such times as the JGC will deem appropriate, and concurrently with the preparation of the initial Worldwide Commercialization Plan, Celgene will prepare an initial U.S. Commercialization Budget, and the JGC will review and approve such initial U.S. Commercialization Budget. [***]
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U.S. Commercialization Budget. At such times as the JCC will deem appropriate, and concurrently with the preparation of the initial U.S. Commercialization Plan, Celgene (after good faith consultation with Jounce) will prepare an initial U.S. Commercialization Budget, and the JCC will review and approve such initial U.S. Commercialization Budget. Thereafter, Celgene (after good faith consultation with Jounce) will update the U.S. Commercialization Budget at least once in each Calendar Year, (but in any event no later than November 30 of each Calendar Year during the Co-Co Term) and the JCC will review and approve any such update or any other amendment to the U.S. Commercialization Budget. In addition, either Party may request at any time that the JCC consider and approve other updates to the U.S. Commercialization Budget.
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U.S. Commercialization Budget. At such times as the JCC will deem appropriate, and concurrently with the preparation of the initial U.S. Commercialization Plan, Jounce (after good faith consultation with Celgene) will prepare an initial U.S. Commercialization Budget, and the JCC will review and approve such initial U.S. Commercialization Budget. Thereafter, Jounce (after good faith consultation with Celgene) will update the U.S. Commercialization Budget at least once in each Calendar Year, (but in any event no later than November 30 of each Calendar Year during the Co-Co Term) and the JCC will CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. 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, AS AMENDED. review and approve any such update or any other amendment to the U.S. Commercialization Budget. In addition, either Party may request at any time that the JCC consider and approve other updates to the U.S. Commercialization Budget.
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U.S. Commercialization Budget. (a) The U.S. Commercialization Budget included in the U.S. Commercialization Plan shall be a [**] budget setting forth the budgeted amounts for costs with respect to activities allocated to the Parties under the U.S. Commercialization Plan during the then-current Calendar Year and the successive two Calendar Years thereafter, and shall include for both Parties a budget for FTE Costs and Out-of-Pocket Costs, broken down by Calendar Quarter for the then-current Calendar Year. The U.S. Commercialization Budget shall also include a breakout of costs by functional area or category as determined by the JCC in conjunction with the Finance Working Group. Concurrently with the annual preparation of the U.S. Commercialization Budget in accordance with Section 5.3.5(a), the JCC shall also prepare, and the JSC shall review to approve, an updated [**] U.S. Commercialization Budget covering the next Calendar Year and the succeeding two Calendar Years.
Sample 1
U.S. Commercialization Budget. The US Commercialization Budget shall set forth the budgeted amounts for costs with respect to activities allocated to the Parties under such US Commercialization Plan [**] thereafter, and shall include for both Parties a budget for applicable Commercialization FTE Costs and Out-of-Pocket Costs for such period, broken down by Calendar Quarter for the then-current Calendar Year. The US Commercialization Budget shall also include a breakout of costs by functional area or category as determined by the JCC with input and support from the Finance Working Group. Concurrently with the annual update of the US Commercialization Plan in accordance with Section 5.3.1, the JCC will prepare, and the JSC will review and approve an updated US Commercialization Budget for the US Commercialization Plan. The US Commercialization Budget shall be binding unless and until amended in accordance with Section 5.3.1.
Sample 1
U.S. Commercialization Budget. The Commercialization budget for the Product in the United States shall be (a) set forth in and comprise part of the U.S. Commercialization Plan and (b) divided as between the Marketing Plan and the Medical Affairs Plan. Unless otherwise agreed by the Parties without resort to the dispute resolution procedures of Section 16.2 [***]
Sample 1
U.S. Commercialization Budget. The U.S. Commercialization Plan shall include a [***] rolling budget for Allowable Expenses to be incurred by the Parties in conducting Commercialization activities for the Profit Share Product in the U.S. pursuant to the U.S. Commercialization Plan during [***] the “U.S. Commercialization Budget”). The U.S. Commercialization Budget shall include budgeted amounts for Commercial FTE Costs and Out-of-Pocket Expenses, broken down by Calendar Quarter for [***], for Commercialization activities in the U.S. and a breakout of costs by functional area or category, as determined by the USJCC in conjunction with the JFC. The [***] of the U.S. Commercialization Budget [***] to the extent provided in the Financial Exhibit, and the [***] shall serve as [***] (subject to any other applicable restrictions in this Exhibit). Each U.S. Commercialization Budget shall also include an annual amount for strategic commercial efforts that will be undertaken by Xxxxxxx and its Affiliates at the global team level in accordance with the global commercialization strategy described in Section 5.1.2(e), of which [***] percent ([***]%) shall be allocable to the U.S. (the “Allocable Global Costs”).
Sample 1
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U.S. Commercialization Budget. The U.S. Commercialization Budget associated with a U.S. Commercialization Plan shall set forth the budgeted amounts for costs with respect to activities allocated to the Parties under such U.S. Commercialization Plan, and shall include for both Parties a budget for applicable Commercial FTE Costs and Out-of-Pocket Costs, broken down by Calendar Quarter for the then-current Calendar Year. The Commercialization Budget shall also include a breakout of costs by functional area or category as determined by the JCC.
Sample 1
U.S. Commercialization Budget. At such times as the JCC will deem appropriate, and concurrently with the preparation of the initial U.S. Commercialization Plan, [***] will prepare an initial U.S. Commercialization Budget, and the JCC will review and approve such initial U.S. Commercialization Budget. Thereafter, [***] will update the U.S. Commercialization Budget at least once in each Calendar Year, (but in any event no later than [*** ]of each Calendar Year during the Co-Co Term) and the JCC will review and approve any such update or any other amendment to the U.S. Commercialization Budget. In addition, either Party may request at any time that the JCC consider and approve other updates to the U.S. Commercialization Budget. Notwithstanding the foregoing, the terms of Section 6.4 shall apply.
Sample 1

Related to U.S. Commercialization Budget

  • Development Plan As defined in Section 3.2(a).

  • Development Budget Attached hereto as Exhibit "B" and incorporated herein by this reference is the Development Budget in an amount equal to $_____________. Owner acknowledges and represents that the attached Development Budget includes the total costs and expenses to acquire, develop, renovate and construct the Real Property and the Apartment Housing.

  • Commercialization Plan On a Product by Product basis, not later than sixty (60) 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 thirty (30) days after the filing of the first application for Regulatory 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, and budgets for projected Pre-Marketing Expenses, Sales and Marketing Expenses and Post-Approval Research and Regulatory Expenses. In preparing and updating the Copromotion Territory Commercialization Plan and each Annual Commercialization Plan and Budget, the MSC will take into consideration factors such as market conditions, regulatory issues and competition.

  • 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 Indication Product), including:

  • Development and Commercialization Subject to Sections 4.6 and 4.7, Fibrocell shall be solely responsible for the development and Commercialization of Fibrocell Products and Improved Products. Fibrocell shall be responsible for all costs incurred in connection with the Fibroblast Program except that Intrexon shall be responsible for the following: (a) costs of establishing manufacturing capabilities and facilities in connection with Intrexon’s manufacturing obligation under Section 4.6 (provided, however, that Intrexon may include an allocable portion of such costs, through depreciation and amortization, when calculating the Fully Loaded Cost of manufacturing a Fibrocell Product, to the extent such allocation, depreciation, and amortization is permitted by US GAAP, it being recognized that the majority of non-facilities scale-up costs cannot be capitalized and amortized under US GAAP); (b) costs of basic research with respect to the Intrexon Channel Technology and Intrexon Materials (i.e., platform improvements) but, for clarity, excluding research described in Section 4.7 or research requested by the JSC for the development of a Fibrocell Product or an Improved Product (which research costs shall be reimbursed by Fibrocell); (c) [*****]; and (d) costs of filing, prosecution and maintenance of Intrexon Patents. The costs encompassed within subsection (a) above shall include the scale-up of Intrexon Materials and related active pharmaceutical ingredients for clinical trials and Commercialization of Fibrocell Products undertaken pursuant to Section 4.6, which shall be at Intrexon’s cost whether it elects to conduct such efforts internally or through Third Party contractors retained by either Intrexon or Fibrocell (with Intrexon’s consent).

  • Development Plans 4.3.1 For each Licensed Indication and corresponding Licensed Product in the Field, Licensee will prepare and deliver to Licensor a development plan and budget (each a “Development Plan”). The initial Development Plans for each Licensed Indication will be delivered within […***…] after the Grant Date for such Licensed Indication.

  • Commercialization Intrexon shall have the right to develop and Commercialize the Reverted Products itself or with one or more Third Parties, and shall have the right, without obligation to Fibrocell, to take any such actions in connection with such activities as Intrexon (or its designee), at its discretion, deems appropriate.

  • Research Plan The Parties recognize that the Research Plan describes the collaborative research and development activities they will undertake and that interim research goals set forth in the Research Plan are good faith guidelines. Should events occur that require modification of these goals, then by mutual agreement the Parties can modify them through an amendment, according to Paragraph 13.6.

  • Development Activities NovaDel shall not be required to commence any Development Activities until Licensee has paid at least twenty-five percent (25%) of the non-refundable License Fee described in Section 4.4.

  • Commercialization Activities Within North America, the Parties will use Commercially Reasonable Efforts to Commercialize Licensed Products in the Field. In addition, within North America and subject to Section 2.7.6, the Parties will use Commercially Reasonable Efforts to conduct the Commercialization activities assigned to them pursuant to the Commercialization Plan/Budget, including the performance of detailing in accordance therewith. In conducting the Commercialization activities, the Parties will comply with all Applicable Laws, applicable industry professional standards and compliance policies of Celgene which have been previously furnished to Acceleron, as the same may be updated from time to time and provided to Acceleron. Neither Party shall make any claims or statements with respect to the Licensed Products that are not strictly consistent with the product labeling and the sales and marketing materials approved for use pursuant to the Commercialization Plan/Budget.

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