Development and Commercialization of Licensed Product Sample Clauses

Development and Commercialization of Licensed Product. 4.1. Subject to Teva exercising the License Option by serving the License Notice on Cell Cure pursuant to Section 2.2.2, Teva undertakes at its own expense to make such commercially reasonable efforts, throughout the terms of this Agreement, to further develop, register, manufacture, have manufactured, commence commercial sales, make ongoing sales and otherwise commercialize Licensed Product [*Certain information has been omitted under a request for confidential treatment, and the omitted information has been filed with the Commission].
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Development and Commercialization of Licensed Product. Within [* * *] days of the Effective Date, Company shall present to Novavax for its written approval Development plans for the Licensed Product which shall specify preclinical studies (including a toxicology program and other preclinical testing), human clinical trials, manufacturing scale up, Regulatory Approval strategy and any other significant Development activities, that Company plans to perform to obtain Regulatory Approval of such Licensed Product in the Territory (the THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. “Development Plans”). Novavax may reasonably request adjustments to activities described in such Development plans as a condition to granting its approval. In no event shall Company materially alter a Development Plan without Novavax’s prior written consent. Company shall conduct Development of such Licensed Product in a manner that is materially consistent with the Development Plans. All clinical trial protocols for Licensed Product conducted by Company shall require the prior written approval of Novavax. At least [* * *] prior to anticipated commercial launch, Company shall present to Novavax for its written approval a plan to Commercialize the Licensed Product which shall specify a multi-year marketing and public relations strategy, operational plans to implement such strategies and any other significant Commercialization activities (the “Commercialization Plan”). Novavax may reasonably request adjustments to the Commercialization plan as a condition to granting its approval. In no event shall Company materially alter the Commercialization Plan without Novavax’s prior written consent. Company shall conduct Commercialization of such Licensed Product in a manner that is materially consistent with the Commercialization Plan. Novavax acknowledges that the Licensed Product is being contributed by Novavax to the Company in accordance with the Joint Venture Agreement and that if the Company cannot Develop and Commercialize such Licensed Product it will not obtain the value of such contribution. Company acknowledges that Novavax (or its affiliates or licensees) are Developing and Commercializing Licensed Product outside the Territory and Company’s activities could raise safety concerns and have an impact on Novavax’s activities including the Regulatory Approval and regulatory profile of an ...
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Development and Commercialization of Licensed Product. (a) As between the parties, B&C shall retain all development and commercialization rights to the B&C Compounds in Korea and shall be solely responsible for all costs associated with any such efforts; provided that (i) all clinical studies conducted by B&C or its Affiliates of products incorporating B&C Compounds shall be designed by B&C in collaboration with XTL, (ii) B&C shall keep XTL informed of the ongoing progress of all such clinical studies on a current basis, (iii) B&C shall promptly provide XTL with complete data from such clinical studies and (iv) upon the written request of XTL, B&C shall promptly provide XTL with all data from pre-clinical studies of B&C Compounds which XTL has chosen for clinical development, including, without limitation, toxicity, pharmacokinetics and biological activity data. XTL shall have the right to use such data solely for its submissions seeking regulatory or marketing approval of B&C Compounds outside of Korea.
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Development and Commercialization of Licensed Product. 4.1PMDA Consultation. Within [***] after Saxx’x receipt of Novan Scientific Information pursuant to Section 6.1, Saxx xhall use Commercially Reasonable Efforts to visit and start consultation with PMDA with respect to development of and obtainment of the Marketing Approval for the Licensed Product in the Licensed Field in the Licensed Territory. Novan shall, at Saxx’x request, reasonably cooperate with Saxx xn such PMDA consultation (including but not limited to by attending such PMDA consultation) at Novan’s expense.
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Development and Commercialization of Licensed Product 
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Related to Development and Commercialization of Licensed Product

  • 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).

  • 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.

  • Commercialization License Subject to the terms of this Agreement, including without limitation Section 2.2 and Theravance's Co-Promotion rights in Section 5.3.2, Theravance hereby grants to GSK, and GSK accepts, an exclusive license under the Theravance Patents and Theravance Know-How to make, have made, use, sell, offer for sale and import Alliance Products in the Territory.

  • Licensed Product “Licensed Product” shall mean any article, composition, apparatus, substance, chemical material, method, process or service whose manufacture, use, or sale is covered or claimed by a Valid Claim within the Patent Rights. For clarity, a “Licensed Product” shall not include other product or material that (a) is used in combination with Licensed Product, and (b) does not constitute an article, composition, apparatus, substance, chemical material, method, process or service whose manufacture, use, or sale is covered or claimed by a Valid Claim within the Patent Rights.

  • Licensed Products Lessee will obtain no title to Licensed Products which will at all times remain the property of the owner of the Licensed Products. A license from the owner may be required and it is Lessee's responsibility to obtain any required license before the use of the Licensed Products. Lessee agrees to treat the Licensed Products as confidential information of the owner, to observe all copyright restrictions, and not to reproduce or sell the Licensed Products.

  • Marking of Licensed Products To the extent commercially feasible and consistent with prevailing business practices, Company shall xxxx, and shall cause its Affiliates and Sublicensees to xxxx, all Licensed Products that are manufactured or sold under this Agreement with the number of each issued patent under the Patent Rights that applies to such Licensed Product.

  • 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.

  • 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 Efforts The RECIPIENT shall, including whether through its own efforts or the efforts of a licensee under a License Agreement allowed by the terms of this Attachment, use diligent and commercially reasonable efforts to commercialize at least one Commercial Product or Commercial Service or otherwise bring to practical application the Project Results in accordance with the commercial development plan submitted with the Application and including any changes to such commercial development plan in accordance with Section D3.01. For the avoidance of doubt, partnering or licensing activities shall be considered to be efforts to commercialize.

  • 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.

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