Product Development Plans Sample Clauses

Product Development Plans. A Product Development Plan for each Collaboration Compound for which AstraZeneca elects to commence GLP Toxicology Studies shall be prepared and approved as provided in Section 5.1.2. Each Product Development Plan shall: (a) set forth (i) the Development objectives and activities to be performed to progress to the next AstraZeneca development tollgate with reasonable specificity, (ii) a timeline for such activities, (iii) which activities, if any, are Targacept Development Activities, (iv) with respect to any such Targacept Development Activities, the number of FTEs estimated to be required to perform such activities, the corresponding FTE Cost, and the estimated External Targacept R&D Costs for such activities (if any), broken down on a Calendar Quarter basis (collectively, a “Targacept Development Budget”), and (v) the decision points and criteria required to pass the next AstraZeneca development tollgate; and (b) be consistent with the other terms of this Agreement. References in this Agreement to AstraZeneca development tollgates mean development tollgates that apply across its internal development programs and not solely to Development Programs hereunder. Each such Product Development Plan shall be reviewed from time to time by the JDC in accordance with AstraZeneca’s internal milestones and tollgates and may be updated and amended from time to time by the JDC pursuant to Section 2.3.4, with any disputes with respect thereto submitted to the ESC for resolution in accordance with Section 2.1.5; provided, however, that in the event that such an update or amendment would change or otherwise increase Targacept’s activities under the applicable plan (as distinguished from an update or amendment that modifies the objectives of a plan but not Targacept’s activities), resulting in an expense to Targacept not contemplated in the applicable then-current Targacept Development Budget, which additional expense is [********], Targacept shall advise AstraZeneca in good faith of the aggregate additional cost of such activities and the Parties through the JDC shall agree on a corresponding amendment to the applicable Targacept Development Budget to reflect the commercially reasonable costs of such activities, [********], such matter shall promptly be referred to an Expert in accordance with Section 14.4 (expedited arbitration). Targacept shall have the right to contract with Third Parties for the conduct of any Targacept Development Activities solely to the extent pro...
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Product Development Plans. FOR NEXT 2 YEARS Product development plans are included below.
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Product Development Plans. 2.1 The Parties have agreed an initial programme of work as described in Schedule 1 (the "Initial Product Development Plan").
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Product Development Plans. From time to time during the Term of this Agreement, Toshiba and Vital Images may enter into Product Development * * * Confidential Treatment has been requested, the portion indicated has been redacted and the redacted portion has been separately filed with the Securities and Exchange Commission. Plans with respect to Project Software. Upon the execution of a Product Development Plan, Vital Images shall begin developing the Project Software described in such Product Development Plan in accordance with the schedule and other terms set forth in such Product Development Plan and the other terms and conditions set forth in this Agreement.
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Product Development Plans. The First Product Development Plan (hereinafter defined) and any Subsequent Product Development Plan (hereinafter defined) shall include the following: Neos shall use its commercially reasonable efforts to develop (and validate a method for the testing of) a commercially viable subject Product (the “Development”) starting upon Cornerstone’s request. Contingent upon the successful completion of the Development, Neos will produce an exhibit batch (each, the “Exhibit Batch”) of the greater of a 1/10 scale of a batch of the Product or 200 liters of the subject Product and place the Exhibit Batch on stability (the “Stability Work”). Neos will use its commercially reasonable efforts to complete adequate Stability Work on the applicable Product. If adequate Stability Work is completed successfully in accordance with Neos’ stability protocol, Neos will manufacture a reasonable amount of the Product designated by Cornerstone to be used in the Clinical Studies (defined below). If the Clinical Studies are successfully completed for a Product, Neos shall use its commercially reasonable efforts to validate its process for manufacturing the Product (the “Process Validation Work”), including the manufacture of any lots reasonably necessary to complete the Process Validation Work.
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Product Development Plans. Following the exercise of the Option with respect to a Program, Novartis shall provide TScan with a high-level development plan covering Novartis’ Development activities through its first filing of an NDA for the first Product associated with such Optioned Program with any Regulatory Authority and annual (or more frequently as Novartis may determine) updates thereto (each, a “Product Development Plan”). Novartis may modify each Product Development Plan at any time in its sole discretion.
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Product Development Plans. (a) Attached hereto as Schedule 3.1.3 (Product Development Plan) is the initial product-specific plan for the Development of Licensed Products in the Territory (“Product Development Plan”).
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Related to Product Development Plans

  • Product Development SB shall have responsibility for, and control of, the development and commercialization of each Product arising from this Agreement, including process development, delivery system and formulation development, preclinical studies, clinical studies, sales and marketing.

  • 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 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 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 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.

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

  • Marketing Plans 1. The MCO shall develop a marketing plan that meets SDOH guidelines and any local requirements as approved by the State Department of Health (SDOH).

  • 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).

  • Research Neither the Investor nor any Affiliate of the Investor shall have, in the prior thirty (30) days, published or distributed any research report (as such term is defined in Rule 500 of Regulation AC) concerning the Company.

  • 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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