Development Timelines Sample Clauses

Development Timelines. It is hereby acknowledged that the Parties' mutual strategic objective is to move Alliance Products into Development and subsequent Commercialization at the earliest opportunity. GSK will consult with the Joint Program Committee and will share, modify and further develop all applicable Development Plans and timelines in that forum. GSK will use Diligent Efforts to secure the necessary resources and will keep the Joint Program Committee informed on the progress of individual studies and activities relating to Alliance Products in accordance with Section 3.2.3. [*]=CERTAIN INFORMATION ON THIS PAGE HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.
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Development Timelines. The development timeline will be developed and agreed to by the Abbott and Epizyme Project Timeline Leads.
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Development Timelines. It is hereby acknowledged that GSK's strategic objective is [*]. GSK will consult with the Joint Project Committee and will share, modify and further develop all applicable Development Plans and timelines in that forum. It is recognised that success can be optimised [*]. At a strategic level, GSK is committed to this objective. However, at an operational level it is recognised that [*]. GSK will use Diligent Efforts to secure the necessary resource and will keep the Joint Project Committee informed on the progress of individual studies and activities relating to Collaboration Products as part of any changes to Development Plans and timelines. The current objective of the Collaboration is to achieve Marketing Authorization Approval in the US and other Major Markets for a Collaboration Product from one of the eight Pooled Compounds which can be used as a single agent and/or in combination with other therapeutically active components (including but not limited to a Long Acting Inhaled Corticosteroid) for the treatment and/or prophylaxis of one or more respiratory diseases [*] and Development Plans and timelines will be developed and/or refined in an effort to achieve this objective.
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Development Timelines. It is hereby acknowledged that the Parties’ mutual strategic objective is to move one Supplemental MABA Alliance Product into Development at the earliest opportunity ([***]), to initiate and undertake clinical Development of at least one Supplemental MABA Alliance Product having regard to progress made with respect to the MABA Alliance Product currently in clinical Development and to move at least one MABA Alliance Product or one Supplemental MABA Alliance Product into subsequent Commercialization at the earliest opportunity. GSK will consult with the Joint Program Committee and will share, modify and further develop all applicable Development Plans and timelines in that forum. GSK will use Diligent Efforts to secure the necessary resources and will keep the Joint Program Committee informed on the progress of individual studies and activities relating to Supplemental MABA Alliance Products in accordance with Section 3.2.3 of the Agreement as amended by this Amendment.
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Development Timelines. MPP will require any Sublicensee that intends to further develop the Compound into one or more Product(s) to agree upon reasonable diligence requirements and development milestones. MPP will require any Sublicensee that intends to commercialize the Product(s) to agree upon reasonable registration and commercialization timelines.
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Development Timelines. It is hereby acknowledged that GSK’s strategic objective is to move one or more of the Collaboration Products into Development at the earliest opportunity. GSK will consult with the Joint Project Committee and will share, modify and further develop all applicable Development Plans and timelines in that forum. It is recognised that success can be optimised by pursuing a number of Collaboration Products through various phases of clinical Development up to the point of Technical or Commercial Failure, and/or until the first Collaboration Product for both single agent and combination therapy achieves regulatory agency approval. At a strategic level, GSK is committed to this objective. However, at an operational level it is recognised that internal and external resources will be constrained from time to time, resulting in the need to prioritise individual studies and activities relating to Collaboration Products. GSK will use Diligent Efforts to secure the necessary resource and will keep the Joint Project Committee informed on the progress of individual studies and activities relating to Collaboration Products as part of any changes to Development Plans and timelines. The current objective of the Collaboration is to achieve Marketing Authorization Approval in the US and other Major Markets for a Collaboration Product from one of the eight Pooled Compounds which can be used as a single agent and/or in combination with other therapeutically active components (including but not limited to a Long Acting Inhaled Corticosteroid) for the treatment and/or prophylaxis of one or more respiratory diseases by end 2009 for the single agent and 2010 for the first combination product and Development Plans and timelines will be developed and/or refined in an effort to achieve this objective.
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Development Timelines. Licensee will use reasonable efforts to research and develop the Licensed Product through Phase 2 and, if the Licensed Product is determined to meet Licensee’s target regimen profile (“TRP”) and strategic objectives and receives marketing approval, help facilitate the distribution of the Licensed Products in the Field in the Target Countries (which Target Countries will be prioritized by Licensee based on cost- effectiveness, impact and other relevant factors) and in accordance with Licensee’s charitable mission, strategies, and priorities. In conducting its research, development, and other activities for the Licensed Product, Licensee will adhere with the then-current open access policy and Global Access objectives of the Xxxx & Xxxxxxx Xxxxx Foundation (see xxxxx://xxx.xxxxxxxxxxxxxxx.xxx/How-We-Work/General-Information/Open-Access- Policy and xxxxx://xxx.xxxxxxxxxxxxxxx.xxx/How-We-Work/General-Information/Global- Access-Statement). In addition, subject to applicable laws and regulations, Licensee will broadly share data and results of its research and development of the Licensed Product, including with other collaborations and public-private partnerships working to develop new TB drugs and drug regimens. Licensee will be presumed to be in noncompliance of its diligence obligations hereunder if it fails to reach the milestones at the time points as defined in Exhibit C unless Licensee can demonstrate that its failure to achieve a particular milestone was caused by scientific or clinical findings, delays caused by ethics committees or regulatory authorities, third party claims, the inability to obtain access to other compositions or compounds on appropriate terms as needed for the intended drug regimen, the lack of late stage development partners or funding, or other similar unexpected events or delays, including events beyond its reasonable control. If it is determined that a failure of due diligence has occurred and is not reasonably cured or adequately rebutted within thirty (30) days of MPP’s written notice to Licensee of such failure, MPP will have the right to terminate the licenses granted to Licensee pursuant to Section 6.3 hereof. Such termination is MPP’s sole and exclusive remedy for failure to satisfy any of the requirements of this Section 3.1.
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Development Timelines. ProQR will perform the following Development activities for the Licensed Product on the following timelines:
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Related to Development Timelines

  • 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.

  • 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.

  • Development Activities The Development activities referred to in item “b” of paragraph 3.1 include: studies and projects of implementation of the Production facilities; drilling and completion of the Producing and injection xxxxx; and installation of equipment and vessels for extraction, collection, Treatment, storage, and transfer of Oil and Gas. The installation referred to in item “c” includes, but is not limited to, offshore platforms, pipelines, Oil and Gas Treatment plants, equipment and facilities for measurement of the inspected Production, wellhead equipment, production pipes, flow lines, tanks, and other facilities exclusively intended for extraction, as well as oil and gas pipelines for Production Outflow and their respective compressor and pumping stations.

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

  • Development Work The Support Standards do not include development work either (i) on software not licensed from CentralSquare or (ii) development work for enhancements or features that are outside the documented functionality of the Solutions, except such work as may be specifically purchased and outlined in Exhibit 1. CentralSquare retains all Intellectual Property Rights in development work performed and Customer may request consulting and development work from CentralSquare as a separate billable service.

  • Development Schedule The Project shall substantially comply with the specific timetables and triggers for action set forth in Article 5 of this Agreement. The parties acknowledge that, as provided in G.S. 160A-400.25(b), the failure to meet a commencement or completion date shall not, in and of itself, constitute a material breach of this Agreement pursuant to G.S. 160A-400.27 but must be judged based upon the totality of the circumstances.

  • 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.

  • 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:

  • Research Plans The Research Plan for the [***] Designated Target is attached as Schedule 2.2.3-1. Subsequent Research Plans agreed upon in accordance with Section 2.4.2.4 will be attached as additional sequentially numbered schedules (Schedule 2.2.3-2, Schedule 2.2.3-3, etc.).

  • 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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