Companion Diagnostic and Biomarkers Sample Clauses

Companion Diagnostic and Biomarkers. To the extent that biomarker analysis or a companion diagnostic will be required as per the Research Plan or the Development Plan, the Joint Research Committee or the Joint Steering Committee, as applicable, will consider Biontech’s capabilities for biomarker testing and diagnostic development as well as alternative proposals and will make the decision as to whether Biontech in the sole interest of the applicable Collaboration Product shall be the preferred choice to determine biomarkers and develop a companion diagnostic. If Biontech is selected by the Joint Steering Committee to determine biomarkers and develop a companion diagnostic for the applicable Collaboration Product, Biontech will use Commercially Reasonable Efforts to develop a companion diagnostic to be tested in clinical trials and shall have the exclusive right to manufacture and commercialize such companion diagnostic. The costs incurred by Biontech in developing such a companion diagnostic shall be considered Shared Costs for the purposes of this Agreement and shall be included in the then current Budget. However, any costs incurred or profit obtained during the commercial manufacturing or commercialization of any such companion diagnostic by Biontech shall be incurred and obtained at Biontech’s sole expense and benefit, and shall not be considered Shared Costs nor Shared Profits.
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Companion Diagnostic and Biomarkers. To the extent that biomarker analysis or a companion diagnostic will be required as per the Research Plan or the Development Plan, the Joint Research Committee or the Joint Steering Committee, as applicable, will consider Biontech’s capabilities for biomarker testing and diagnostic development as well as alternative proposals and will make the decision as to whether Biontech in the sole interest of the applicable LCA Product shall be the preferred choice to determine biomarkers and develop a companion diagnostic. If Biontech is selected by the Joint Steering Committee to determine biomarkers and develop a companion diagnostic for the applicable LCA Product, Biontech will use Commercially Reasonable Efforts to develop a companion diagnostic to be tested in clinical trials and shall have the exclusive right to manufacture and commercialize such companion diagnostic. The costs incurred by Biontech in developing such a companion diagnostic shall be considered Shared Costs for the purposes of this Agreement and shall be included in the then current Budget. However, any costs incurred or profit obtained during the commercial manufacturing or commercialization of any such companion diagnostic by Biontech shall be incurred and obtained at Biontech’s sole expense and benefit, and shall not be considered Shared Costs nor Shared Profits. Notwithstanding the foregoing or any other provision in this Agreement, the Parties acknowledge and agree that Xxxxxx has the right to appoint and enter into arrangements with [***] to develop companion or other diagnostics relating to LCA Products pursuant to and in accordance with the terms of a side letter no. 5 to the Prior Collaboration Agreement dated 12 August 2021 (as amended by amendment no. 1 to side letter no. 5 dated 23 September 2021), which is appended to this Agreement in Exhibit 8, and the terms of which the Parties agree shall apply mutatis mutandis to this Agreement (with references to the Prior Collaboration Agreement therein being read as references to this Agreement). Confidential
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Related to Companion Diagnostic and Biomarkers

  • 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.

  • 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.

  • 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.

  • 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).

  • 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. [***].

  • Collaboration Each Party shall provide to the enforcing Party reasonable assistance in such enforcement, at such enforcing Party’s request and expense, including to be named in such action if required by Applicable Laws to pursue such action. The enforcing Party shall keep the other Party regularly informed of the status and progress of such enforcement efforts, shall reasonably consider the other Party’s comments on any such efforts, including determination of litigation strategy and filing of material papers to the competent court. The non-enforcing Party shall be entitled to separate representation in such matter by counsel of its own choice and at its own expense, but such Party shall at all times cooperate fully with the enforcing Party.

  • Research Program The term “Research Program” shall mean the research program to be undertaken by TSRI under the direction and control of the Principal Investigator as expressly set forth on Exhibit A hereto.

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

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