Commercialization of Collaboration Products Sample Clauses

Commercialization of Collaboration Products. Commercialization of a Collaboration Product may not occur until the JSC agrees in writing that the Collaboration Product is ready for Commercialization. Furthermore, upon the commencement of the [***], whichever is occurs first, for any Collaboration Product, the Parties shall amend the respective Development and Commercialization Plan for such Collaboration Product in good faith by adding a Commercialization addendum that shall: [***]. The JSC shall amend each Commercialization addendum to the respective Development and Commercialization Plan at least [***], or more frequently if agreed to by the JSC.
AutoNDA by SimpleDocs
Commercialization of Collaboration Products. If the Parties agree to seek a contract manufacturer, the Lead Party for such Collaboration Program will be the lead contracting party for the applicable drug substance or drug product. To the extent one Party supplies the other with drug substance or drug product for such Collaboration Program the costs to supply such drug substance or drug product shall be deemed part of the overall Development Costs, or commercial costs, as the case may be, as they are incurred. Any supply agreement for commercial supply during the Term shall include [***]. With respect to [***]. Unless a Party has opted-out prior to such time, the Parties will share in all profits and losses arising from any Collaboration Product in the same ratios in which the Parties bore Development Costs for such Collaboration Program. In general, except for the Antibody Program, as set forth below, the Lead Party for Development will continue to act as the “Lead Commercialization Party” or “LCP” for such Collaboration Program. The LCP will conduct its activities in accordance with an agreed upon commercialization plan (the “Commercial Plan”) and budget (“Commercial Budget”) (with a [***] overage provision) for such countries. For each Antibody Product, following the filing for Regulatory Approval (i.e. an NDA or MAA, as applicable), GSK will assume the role of LCP for the Commercialization of each such Antibody Product, and will be responsible for booking all sales of such Antibody Product. GSK will be responsible for all Commercialization activities worldwide with respect to each Collaboration Product, except (a) for detailing conducted by Vir in the US Territory under the Co-Promotion Agreement, if agreed by the Parties, for so long as the Co-Promotion Agreement is in effect, and (b) in connection with sales in the WuXi Territory for Antibody Products arising or licensed to WuXi under the WuXi Agreement and directed to SARs-COV-2. GSK will be required to use commercially reasonable efforts to Commercialize each Collaboration Product in the US following regulatory approval in the US, in [***] following regulatory approval in the European Union, and the United Kingdom, following regulatory approval in the United Kingdom. Except in the case of an Opt-Out, for each Collaboration Product, Vir and GSK will share net profits and net losses, to be defined in the Definitive Collaboration Agreement from commercialization of any Collaboration Product worldwide.
Commercialization of Collaboration Products. Wyeth-Ayerst in its sole discretion will make all decisions regarding the commercialization and sales and marketing of Collaboration Products and will use Commercially Reasonable Efforts to commercialize Collaboration Products in those countries of the world where such Collaboration Products have received Regulatory Approval. The use of Commercially Reasonable Efforts by any Affiliate or sublicensee of Wyeth-Ayerst to commercialize Collaboration Products in a country shall satisfy Wyeth-Ayerst's obligation to use Commercially Reasonable Efforts to commercialize such Collaboration Product in such country.
Commercialization of Collaboration Products. GSK in its sole discretion will make all decisions regarding the commercialization and sales and marketing of Collaboration Products in the Territory and will book all sales of Collaboration Products. GSK will use Commercially Reasonable Efforts to commercialize Collaboration Products in all countries of the Territory.
Commercialization of Collaboration Products 

Related to Commercialization of Collaboration Products

  • 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.

  • Research Collaboration Upon FibroGen’s request, the Parties will discuss conducting a research program funded by AstraZeneca and directed toward franchise enhancement and lifecycle management for HIF Compounds or other topics that the Parties determine relevant to the Products and the Field. Upon agreement on the terms of such research program, the Parties will enter into a separate agreement or amend this Agreement accordingly.

  • 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 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.

  • New Products You agree to comply with NASD Notice to Members 5-26 recommending best practices for reviewing new products.

  • Commercialization Reports Throughout the term of this Agreement and during the Sell-Off Period, and within thirty (30) days of December 31st of each year, Company will deliver to University written reports of Company’s and Sublicensees’ efforts and plans to develop and commercialize the innovations covered by the Licensed Rights and to make and sell Licensed Products. Company will have no obligation to prepare commercialization reports in years where (a) Company delivers to University a written Sales Report with active sales, and (b) Company has fulfilled all Performance Milestones. In relation to each of the Performance Milestones each commercialization report will include sufficient information to demonstrate achievement of those Performance Milestones and will set out timeframes and plans for achieving those Performance Milestones which have not yet been met.

Time is Money Join Law Insider Premium to draft better contracts faster.