Development of the Licensed Product Sample Clauses

Development of the Licensed Product. Threshold and Merck shall jointly and collaboratively Develop the Licensed Product in the Territory and conduct (either by themselves or through their respective Affiliates, agents or Third Party subcontractors) all Development activities (including Clinical Trials and non-clinical studies) to obtain Regulatory Approval for any Licensed Product in any Indication in the Territory in accordance with the Development Plan and the other terms of this Agreement. The Parties shall use Commercially Reasonable Efforts to diligently Develop the Licensed Product in accordance with the Development Plan and the other terms of this Agreement, it being understood that Threshold will be responsible for the Sarcoma Program as set forth in Article 4.6.
Sample 1Sample 2
AutoNDA by SimpleDocs
Development of the Licensed Product. Subject to the terms and conditions of this Agreement, Licensee shall use its Commercially Reasonable Efforts to Develop, and to obtain Regulatory Approval for, at least one Licensed Product in the Territory. Attached to this Agreement as Exhibit is an abbreviated Development Plan containing the anticipated and required studies and the timelines for the same, believed by Licensee to be reasonably necessary to support the submission of a NDA to the FDA for the first Licensed Product. Within ninety (90) days after the Effective Date, Licensee shall provide Forendo with a true and correct copy of its comprehensive Development Plan for the first Licensed Product, which Development Plan shall be consistent with the Development Plan attached to this Agreement as Exhibit 5.1. The Development Plan shall cover the material Development activities and estimated timelines believed by Licensee to be reasonably necessary to support the submission of a NDA to the FDA for the Licensed Product. The Development Plan, and any updates thereto, shall contain in reasonable detail the Development objectives to be achieved during the then-current Contract Year, the Development activities to be performed and estimated timeline for performing such Development activities. Licensee’s achievement, by itself or through its Affiliates or Sublicensees, of any objectives set forth in the Development Plan by the date set forth therein shall be deemed sufficient to satisfy the requirement to use Commercially Reasonable Efforts under this Section 5.1 as of such date; provided, however, the failure to meet such objectives shall not in and of itself be deemed to be a breach of Licensee’s Commercially Reasonable Efforts, though it may be a factor in such determination.
Sample 1
Development of the Licensed Product. Subject to the terms and conditions of this Agreement, OnCore shall for each Licensed Product use its Commercially Reasonable Efforts to Develop, obtain Regulatory Approval for, and Commercialize each such Licensed Product in the Field in the United States, the European Union and Asia pursuant to the Development Plan. Within [***] after the Effective Date, OnCore shall submit to the JSC for review and discussion an initial Development Plan that covers all material Development activities and their timelines believed by OnCore, as of the date of submission, to be reasonably necessary to support the submission of a Regulatory Approval Application for the Licensed Product in the Field. The Development Plan, and any updates thereto, shall contain in reasonable detail the Development objectives to be achieved during the then-current Contract Year, the Development activities to be performed and a timeline for performing such Development activities.
Sample 1
Development of the Licensed Product. Meda shall use Commercially Reasonable Efforts to Develop and Commercialize the Licensed Products for use in the Field in accordance with a development plan prepared by Meda, which plan shall be modified and updated from time to time in consultation with Pipex (and Meda will consider in good faith all comments provided by Pipex) and, to the extent required to comply with the XxXxxx License, XxXxxx (the “Development Plan”). Meda shall report to Pipex, in writing and on a quarterly basis, Meda’s efforts to comply with the Development Plan, including progress on research and Development of the Licensed Product, the status of the NDA and other applications for Regulatory Approvals. Meda agrees to pay Pipex XXX% of any amounts paid to XxXxxx as consideration for future amendments of the development obligations under the XxXxxx License or any new agreement with XxXxxx regarding the Licensed Patent that amends such development obligations.
Sample 1
Development of the Licensed Product 
Sample 1Sample 2Sample 3See All (5)

Related to Development of the Licensed Product

  • 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 Territory Worldwide NIH Patent License Agreement—Exclusive APPENDIX C – ROYALTIES Royalties:

  • 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.

  • 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.

  • 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 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. [***].

  • 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.

  • Research Collaboration (a) GSK hereby grants to Anacor a non-exclusive, non-royalty bearing license under the GSK IP, solely as and to the extent necessary or important to conduct activities for which Anacor is responsible under the Research Plans during the Research Collaboration Term.

  • Development of Products (a) During the term of this Agreement, ViewRay may from time to time seek services from PEKO with respect to the development of certain Products that can be incorporated into the ViewRay Renaissance™ MRI-guided radiation therapy system. For each Program to be undertaken by PEKO pursuant to this Agreement, the parties will prepare a “Work Statement” and agree to said “Work Statement” in substantially the form attached as Attachment 1. Each Work Statement will describe: (i) the (i) services that PEKO will be responsible for providing to ViewRay and the deliverables that PEKO will be responsible for delivering to ViewRay (“Deliverable(s)”), (ii) delivery schedule for the Deliverables, (iii) pricing terms, (iv) work plan for the Program, and (v) ViewRay’s responsibilities in connection with the Program. Each Work Statement will be prepared based upon the requirements and information provided to PEKO by ViewRay. A separate Work Statement will be required for each Program; and each Work Statement will become subject to this Agreement only when mutually agreed and signed by ViewRay and PEKO.

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