The Strategic Plan for Licensed Product(s) Sample Clauses

The Strategic Plan for Licensed Product(s). Subject to and in accordance with the terms of this Agreement, for each Product licensed to Novartis under Section 5.1, Novartis will use Commercially Reasonable Efforts to Develop and Commercialize such Product in accordance with a global strategic development and commercialization plan to be defined by Novartis (the “Strategic Plan”). The Strategic Plan will cover both the long-term global strategy for each Product and, on a rolling [***]-month basis, the more detailed activities Novartis will perform over the course of the next [***] months, including overview and timing of the CVOT Novartis will conduct for the CVRR Indication Novartis will pursue for each Product. As determined by [***], the activities and strategy in the Strategic Plan will be driven by emerging data, the shifting competitive landscape over time, and scientific, reimbursement environment, and medical factors that impact regulatory, development and commercialization strategies. The Strategic Plan will contain the global strategy and launch planning and sequence in Major Markets as determined by [***]. When materially updating the Strategic Plan, Novartis will include the following components: (i) The objectives of the Strategic Plan and estimated timelines; (ii) The estimated timing and launch sequence per Indication for each Product; (iii) The key global Clinical Studies (including the CVOT Novartis will conduct), including estimated timelines for the key milestones associated with such studies, the primary and secondary endpoints, * ***Confidential Treatment Requested approximate size and duration of such studies, and patient populations, in reasonable detail as determined by Novartis, that Novartis will conduct for each Product; and (iv) Key elements of the planning and strategy to support Development, Manufacturing, Regulatory Approvals and Commercialization (including [***] and [***]). Each time Novartis exercises its Option to a Product, such Product will be included in the Strategic Plan in accordance with the principles set forth in this Section 6.1.
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The Strategic Plan for Licensed Product(s). Subject to and in accordance with the terms of this Agreement, for each Product licensed to Novartis under Section 5.1, Novartis will use Commercially Reasonable Efforts to Develop and Commercialize such Product in accordance with a global strategic development and commercialization plan to be defined by Novartis (the “Strategic Plan”).
Sample 1
The Strategic Plan for Licensed Product(s). 6.2.1. Scope. Novartis will adopt a [***] global strategic development and commercialization plan to Develop and Commercialize the Licensed Products (the “Strategic Plan”). The Strategic Plan will cover both the long-term global strategy for each Licensed Product and, on a rolling [***] basis, the material Development and Commercialization activities Novartis plans to perform over the course of the next [***].
Sample 1

Related to The Strategic Plan for Licensed Product(s)

  • 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 Plan (a) Not later than three [***] after submission of Regulatory Filings for each Product in each country of the Territory, Licensee will provide to the JCC for review its initial Commercialization Plan for each Product for each country in the Territory. Such initial Commercialization Plan will describe Licensee’s plans for activities to be conducted for such Product for such country. Each Commercialization Plan shall include the details of obligations to be performed by Licensee to achieve the specific activities that are applicable to the stage of [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. Commercialization (e.g., pre-launch, launch planning, launch, or post-launch) of the applicable Product during the time period covered by such Commercialization Plan and subsequent time periods. (b) Prior to the First Commercial Sale for such Product in such country, Licensee will provide to the JCC for review an updated Commercialization Plan for such Product for such country. Such updated Commercialization Plan will include, but not be limited to, Licensee’s updated plans for activities to be conducted for such Product for such country prior to launch as well as activities to be conducted in connection with such launch. (c) Promptly after each anniversary of the First Commercial Sale of such Product during the Term, Licensee will provide to the JCC for review updated Commercialization Plans for such Product for such country. Such further updated Commercialization Plan will include, but not be limited to, Licensee’s plans for Commercialization activities for such Product and such country for the twelve (12) month period following the date of delivery of such Commercialization Plan. No Commercialization Plan may be implemented by Licensee if [***]. Each Commercialization Plan shall be consistent with and shall not contradict the terms of this Agreement [***], and in the event of any inconsistency between the Commercialization Plan and this Agreement, the terms of this Agreement shall prevail. Notwithstanding the foregoing, if a [***], Licensee shall [***] and shall promptly [***].

  • 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.

  • 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).

  • 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.

  • Marketing Plan The MCOP shall submit an annual marketing plan to ODM including all planned activities for promoting membership in or increasing awareness of the MCOP. The marketing plan submission shall include an attestation by the MCOP that the plan is accurate and is not intended to mislead, confuse, or defraud the eligible individuals or ODM.

  • Licensed Product The term “Licensed Product” shall mean any product (a) the manufacture, use, importation, sale or offer for sale of which would, in the absence of the license granted by this Agreement, infringe a Valid Claim of any of the Licensed Patent Rights, or (b) that is comprised of, utilizes or incorporates Licensed Biological Materials, or (c) that is discovered, developed or made using a Licensed Process.

  • Program Development NWESD agrees that priority in the development of new applications services by XXXXX shall be in accordance with the expressed direction of the XXXXX Board of Directors operating under their bylaws.

  • 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.

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

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