GSK Development Activities Sample Clauses

GSK Development Activities. At each meeting of the Joint Project Team, GSK will make a presentation summarizing the results of the GSK Development Activities. During the period between Joint Project Team meetings, POZEN may reasonably request additional information and materials from GSK reasonably related to the content of such presentations, including the underlying data for such results and to consult with GSK regarding the implementation of the GSK Development Activities and the Formulation Development Timeline. In addition, when the GSK Development Activities have been completed, GSK will provide POZEN with a complete copy of the results of the GSK Development Activities, any final reports describing such results, as well as the underlying data including a copy of the final authorized dataset including all data listings and tables. In order to facilitate the flow of information, GSK will permit one employee of POZEN to attend one scheduled meeting of the project team that is performing the GSK Development Activities per month.
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GSK Development Activities. GSK, at its sole discretion and expense, will be solely responsible for, using Commercially Reasonable Efforts, conducting all aspects of the development of the Program other than the Eurand Development Activities (the “GSK Development Activities”), including, without limitation, determining the clinical, regulatory and *** strategy (in accordance with the terms of the Clinical Supply Agreement and Commercial Supply Agreement) for the Product, the conduct of *** and *** Clinical Studies, and liaising and managing *** interactions with Regulatory Authorities, with the exception of the filing and maintenance of the DMF.
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GSK Development Activities. Except as set forth in this Section ‎4.1, and subject to the terms and conditions of this Agreement, including the Scynexis Retained Rights, GSK shall have the exclusive right, and sole responsibility and decision-making authority, to Develop any Compound and any Product in the Field for the GSK Territory and to conduct (either itself or through one or more Affiliates, Sublicensees or other Third Parties selected by GSK) all CMC activities, non-clinical studies and Clinical Trials that GSK believes appropriate to obtain, expand or maintain Regulatory Approval for any Product in the Field for the GSK Territory, as well as any Clinical Trial (whether required or optional) commenced after Regulatory Approval.
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GSK Development Activities. During the Collaboration Term, as between the Parties, GSK will be solely responsible for the conduct of all Development activities (including all non-clinical or pre-clinical studies or Clinical Trials and all activities related to value-evidence outcomes, patient-focused outcomes and epidemiology) for the Licensed Compound and all Licensed Products (including any Combination Products or Combination Therapies) in the Territory, in each case, other than the Shared Global Development Activities, including any Independent Registration Studies conducted pursuant to Section 5.3.2 (Independent Registration Studies) (the “GSK Development Activities”). Notwithstanding the foregoing, from time to time during the Development Term, GSK shall keep the JDC reasonably informed with respect to any material GSK Development Activities, including providing periodic updates with respect thereto.
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GSK Development Activities. 2.1 Formulation GSK will develop [***] formulation containing [***] Relevant studies to the formulation work will include [***]
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Related to GSK Development Activities

  • 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.

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

  • 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.

  • Clinical Development (a) Stellartech shall design, develop and construct a Clinical Unit for each of the Thermage Disposable Device and the Thermage Generator, and any required component or subassembly thereof and shall deliver such Clinical Units to Thermage in accordance with the Development Program; (b) Stellartech shall deliver to Thermage such other Deliverables as are contemplated by the Development Program in accordance with the Development Program; and (c) as requested by Thermage and automatically at the conclusion of the Development Program, Stellartech, so long as Thermage is not in breach of its material obligation hereunder, shall deliver in writing to Thermage any and all data and information held by or in the control of Stellartech which is necessary or useful to obtain regulatory approval of the Products in the United States or any foreign country.

  • 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 Diligence Upon receipt of the Marketing Authorization for a Licensed Product in the Field in a given Region in the Territory, Lian (directly, or through its Affiliates, Sublicensees or contractors) will use Commercially Reasonable Efforts to Commercialize such Licensed Product in the Field in such Region in the Territory. Lian will have sole decision-making authority and discretion with respect to Commercializing the Licensed Product in the Field in the Territory. [***].

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

  • Development Work Do, or cause to be done, such development and other work as may be reasonably necessary to protect from diminution and production capacity of the Mortgaged Property and each producing well thereon.

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