Research and Development Plans Sample Clauses

Research and Development Plans. The Research and Development Plans, subject to Sections 4.6 and 13.2, for each Product (including tasks, allocation of responsibilities, and estimated development timelines) shall be set forth in the form attached hereto as Exhibit C. The Parties may periodically modify the Research and Development Plans, within the scope of and in a manner consistent with this Agreement, further detail the responsibilities of each Party within the general scope of responsibilities set forth herein, and revise the Research and Development Plans accordingly. The Parties acknowledge that the timelines and dates set forth in the Research and Development Plans are good faith estimates. However, in the event that an estimated development timeline will not be met, the Party with responsibility for meeting that timeline shall notify the other Party and the Parties shall work together in good faith to bring the project back on schedule. Each Party shall be responsible for its own costs except the raw material and certain high value consumables and out of pocket expenses will be paid by Citius.
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Research and Development Plans. All Research and Development activities occurring during the R&D Collaboration Term and the timelines and budget for all Collaboration Targets and Products therefor shall be set forth in one or more mutually agreed upon research plans (each, a “Research Plan”) or Development Plans, copies of which will be signed and furnished to each Party, subject to Section 4.1.3, as may be amended from time to time in accordance with the terms of this Agreement. Once agreed upon, the first Research Plan hereunder shall be attached hereto as Exhibit B. For clarity, subject to Section 4.1.3, the budgets to be set forth in the Research Plan(s) shall be construed only as guidelines and shall not in any way limit a Party’s obligations to use Commercially Reasonable Efforts to perform all activities specified in the Research Plan, subject to the rights of reimbursement and any limitations on responsibilities or their costs as expressly set forth in this Article 4. Each Target and Compound shall have a separate Research Plan and Development Plan associated with it unless otherwise agreed to by the Parties (e.g. because a Target is dual or Targets are interdependent). For the avoidance of doubt, Novo’s Research and Development activities shall not be constrained by the contents of any Research Plan or Development Plan.
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Research and Development Plans. The Research and Development Plan and associated budget for Heptares’ activities under the Research and Development Plan and plan for Neurocrine's activities in relation to [***] at the Execution Date is attached at Schedule 1. The Parties have agreed to the initial budget for Heptares’ activities under the Research and Development Plan set out in Schedule 1 for the Development Costs for the Development activities planned in the first [***] months following the Effective Date. Within [***] days following the Effective Date, the Parties will mutually agree, through the JSC (and during such [***] day period [***] shall not have final decision making authority with regard to any proposed amendment), on an amendment to such initial Research and Development Plan and budget so that such Research and Development Plan and budget shall be divided into separate sections one for each of [***] (and each such section shall be considered a separate Research and Development Plan for the purposes of this Agreement). Such final Research and Development Plans shall cover Heptares’ activities and budgets; and Neurocrine's activities under the Research and Development Plans for the remaining period of the Research Term. If a Party believes that the Research and Development Plans (including the budget included therein) should be amended, that Party shall propose such amendment to the other Party and the matter shall be discussed at the JSC. The terms of, and activities set forth in, the Research and Development Plans shall at all times be conducted in compliance with all applicable Laws and in accordance with professional and ethical standards customary in the pharmaceutical and biotechnology industry, taking into account, where applicable, each Party’s health care compliance policies and applicable standard operating procedures.
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Research and Development Plans. Each Licensed Program will have a plan for the conduct of Research and Development through Completion of the first Phase 1 Clinical Trial for the applicable Licensed Product, with such plan satisfying the requirements of this Section 2.6 (each, a “Research and Development Plan”); provided, however, that the Parties may mutually agree to add additional activities to a Research and Development Plan (including further Phase 1 Clinical Trials). Each Party shall use Commercially Reasonable Efforts to perform those obligations assigned to it under each Research and Development Plan. Each Research and Development Plan shall include: (a) [**], (b) [**], (c) [**], (d) [**], (e) [**], (f) [**], and (g) [**].
Sample 1
Research and Development Plans. Metra will prepare the research and development plan for the Tests and Sumitomo will prepare the development plan for the Tests for the Japanese market promptly after signing this Agreement. Preliminary version of such a plan for IGF-BP3 is attached to this Agreement as Exhibits B and C. Both companies will use reasonable diligence to accomplish such a plan. The plan may be modified at any time by Sumitomo and Metra. Both companies will meet at least semi-annually to discuss such plans and to exchange information.
Sample 1
Research and Development Plans 
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Related to Research and Development Plans

  • Research and Development (i) Advice and assistance in relation to research and development of Party B;

  • Initial Development Plan Not later than the Effective Date, Licensee shall have provided Merck with an initial Development plan for the Licensed Product in the Field in the Territory, which shall be incorporated as part of this Agreement as Attachment 3.02(a) (as may be amended in accordance with this Agreement, the “Development Plan”). **CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND WILL BE FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO A CONFIDENTIAL TREATMENT REQUEST.

  • Clinical Development Licensee will have sole responsibility for and sole decision making over the clinical development of any Product arising from the Research Program in the Field. Notwithstanding the foregoing, if Licensee wishes to conduct clinical development of a Development Candidate at Penn and Penn has the clinical expertise, interest and ability to run such a trial as assessed at Penn’s sole discretion, such a study will be conducted under a separate Clinical Trial Agreement to be negotiated by the Parties prior to initiation of such study. Such separate clinical trial agreement will include a detailed clinical development plan, including costs and time lines for conducting the Clinical Trial.

  • 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 document specifying the work program, schedule, and relevant investments required for the Development and the Production of a Discovery or set of Discoveries of Oil and Gas in the Contract Area, including its abandonment.

  • Joint Development If joint development is involved, the Recipient agrees to follow the latest edition of FTA Circular 7050.1, “Federal Transit Administration Guidance on Joint Development.”

  • Development Program A. Development activities to be undertaken (Please break activities into subunits with the date of completion of major milestones)

  • 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).

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