Commercialization Plans and Budgets Sample Clauses

Commercialization Plans and Budgets. (a) Attached hereto as Exhibit D is a plan setting forth the activities to be completed in furtherance of preparing for Commercialization of SER-109 in the United States (the “Pre-Launch Plan”). Each Party shall use Commercially Reasonable Efforts to carry out its activities in the Pre-Launch Plan in accordance with the Pre-Launch Plan, which activities shall be conducted at Seres’ sole cost and expense, subject to the Pre-Launch Cap in Section 7.4(a). For the sake of clarity, no costs and expenses of Seres in carrying out activities contemplated in the Pre-Launch Plan shall constitute Allowable Expenses and, to the extent applicable, Seres shall reimburse Licensee for the costs and expenses incurred by Licensee and its Affiliates in carrying out any activities contemplated in the Pre-Launch Plan to be conducted by Licensee or any of its Affiliates, subject to the Pre-Launch Cap in Section 7.4(a).
Sample 1
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Commercialization Plans and Budgets. (a) The Commercialization Plan for a country in the Territory shall cover only activities for commercialization of the Combination Product in such country that shall be conducted by a single Member Party or that must be coordinated between the Member Parties, which activities shall conform to the Collaboration Principles and the provisions of this Section 5. [ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
Sample 1
Commercialization Plans and Budgets. Within (***) after finalization thereof, AEVI will submit a commercialization plan (“Commercialization Plan”) to KKC for information only. After the launch of such Licensed Product, no later than (***) prior to the beginning of the next Contract Year, AEVI will update the Commercialization Plan for the Field in the Territory for such Licensed Product and submit such updates to KKC for information only. KKC may provide input on Commercialization strategies for the Field in the Territory. AEVI will give reasonable consideration to KKC’s input, but KKC acknowledges that AEVI has the final decision-making authority over Commercialization activities in Field in the Territory.
Sample 1
Commercialization Plans and Budgets. (a) In General. Except in the limited case of certain Additional Products as provided in Section 5.2.2(c), the Commercialization of each Product and MDX-1379 shall be governed by a comprehensive, multi-year, worldwide Commercialization plan and budget for such Product and MDX-1379 covering both the United States and the Royalty Territory (the “Global Commercialization Plan and Budget”), and by detailed Commercialization plans and budgets covering the Commercialization activities to be performed for a particular calendar Year for each Co-Promotion Product in the United States (each, an “Annual US Commercialization Plan and Budget,” and, together with the applicable Annual RT Commercialization Plan and Budget, an “Annual Commercialization Plan and Budget”). In addition, the Commercialization of each such Co-Promotion Product shall be governed by a pre-Launch Commercialization plan for the United States covering the period from the date such plan is adopted by the JEC (generally, upon commencement of the first Phase III Clinical Trials for such Co-Promotion Product) through the end of the second (2nd) full calendar Year following Launch of such Co-Promotion Product in the United States (the “Pre-Launch US Commercialization Plan and Budget,” and, together with the applicable Pre-Launch RT Commercialization Plan and Budget, a “Pre-Launch Commercialization Plan and Budget”); provided that once an Annual US Commercialization Plan and Budget is adopted for a given Co-Promotion Product for a Year, any Pre-Launch US Commercialization Plan and Budget for such Co-Promotion Product that covers the same calendar Year as the Annual US Commercialization Plan and Budget shall have no further effect for such overlapping calendar Year.
Sample 1
Commercialization Plans and Budgets. Commencing at least ***** prior to the projected First Commercial Sale of a Licensed Product in the Field in the Territory, Medgenics will commence preparing a commercialization plan (each, a “Commercialization Plan”) for such Licensed Product in the Field in the Territory, including but not limited to marketing strategies and materials, and patient advocacy, and its planned annual budget estimating with reasonable detail Allowable Expenses expected to be incurred by Medgenics in connection with the Commercialization of Profit-Share Products. No later than ***** prior to the projected First Commercial Sale of such Licensed Product in the Territory, Medgenics will submit a Commercialization Plan to KHK for information only. After the launch of such Licensed Product, no later than ***** prior to the beginning of the next Contract Year, Medgenics will update the Commercialization Plan for the Field in the Territory for such Licensed Product and submit such updates to KHK for information only. During the course of Medgenics’ initial preparation of the Commercialization Plan and any subsequent updates, KHK may provide input on Commercialization strategies for Field for the Territory. Medgenics will give reasonable consideration to KHK’s input, but KHK acknowledges that Medgenics has the final decision-making authority over Commercialization activities in Field in the Territory.
Sample 1
Commercialization Plans and Budgets. Subject to Section 10.2 and to applicable terms in Article 14 of this Agreement:
Sample 1
Commercialization Plans and Budgets 
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Related to Commercialization Plans and Budgets

  • 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 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:

  • 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.

  • 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.

  • Business Plan and Budget To the extent requested by any Initial Lender, as soon as available, but in any event within thirty (30) days after the end of each fiscal year of the Borrower, an annual business plan and budget of the Borrower and its Subsidiaries on a Consolidated basis, including forecasts prepared by management of the Borrower, in form satisfactory to such Lender, of Consolidated balance sheets and statements of income or operations and cash flows of the Borrower and its Subsidiaries on a monthly basis for the immediately following fiscal year. As to any information contained in materials filed with the SEC or furnished pursuant to Section 6.2(f), the Borrower shall not be separately required to furnish such information under Section 6.1(a) or (b) above, but the foregoing shall not be in derogation of the obligation of the Borrower to furnish the information and materials described in Sections 6.1(a) and (b) above at the times specified therein.

  • Annual Business Plan and Budgets As soon as available but in any event no later than 45 days following the end of each fiscal year of the Borrower, an annual business plan and budget of the Consolidated Parties containing, among other things, pro forma financial statements for the next four fiscal quarters and the next fiscal year.

  • 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.

  • 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).

  • Annual Business Plan and Budget As soon as practicable and in any event not later than thirty (30) days after the end of each Fiscal Year, a business plan and operating and capital budget of the Borrower and its Subsidiaries for the ensuing four (4) fiscal quarters, such plan to be prepared in accordance with GAAP and to include, on a quarterly basis, the following: a quarterly operating and capital budget, a projected income statement, statement of cash flows and balance sheet, calculations demonstrating projected compliance with the financial covenants set forth in Section 9.15 and a report containing management’s discussion and analysis of such budget with a reasonable disclosure of the key assumptions and drivers with respect to such budget, accompanied by a certificate from a Responsible Officer of the Borrower to the effect that such budget contains good faith estimates (utilizing assumptions believed to be reasonable at the time of delivery of such budget) of the financial condition and operations of the Borrower and its Subsidiaries for such period.

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