Companion Diagnostic Sample Clauses

Companion Diagnostic. The term
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Companion Diagnostic. Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission. Patient Screening Assays V1.5 - Immunohistochemistry · Contract Laboratory Selection *** · Timeline for Development *** · Adoption and Comparability for Clinical use *** Analytical Development V1.5 — Addition of Flow Cytometry for Clinical Correlates · Contract Laboratory Selection *** · Timeline for Development *** ***Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission. · Adoption and Comparability for Clinical use *** Release/Potency Assay Development · Assay Development Required: *** · Timeline for Development *** CMC, Analytical and Diagnostic Regulatory: *** ***Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission. Initial Target Program Generation 2 *** · Project Selection: *** . · Timeline: ***. · Acceptance criteria/milestones: *** ***Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission. · Clinical Phase 1/2a Studies: *** . · Operational activities: *** Maximum Resource/Costs (£) Generation 1 Clinical: *** *** ***Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission. 91 *** *** CMC: *** *** *** *** *** *** *** *** *** *** *** *** *** *** *** *** *** *** *** *** *** Generation 2: *** *** *** *** *** *** TOTAL *** Further details of the above costs are provided in the attached Exhibit A to Schedule 1 ***Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission. *** ***Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission. SCHEDULE 2
Companion Diagnostic. For any jointly-developed therapeutics arising under this Collaboration Agreement, Xxxxx will have the sole and exclusive right to develop any companion diagnostic for the therapeutic and retain sole and exclusive ownership of any companion diagnostic related IP. Notwithstanding the foregoing, [*].
Companion Diagnostic. The term “Companion Diagnostic” shall mean any product or service that:
Companion Diagnostic. Oncoheroes shall develop the Products together with the DRP® for Stenoparib as a companion diagnostic. For European Clinical Trials, Allarity shall support such clinical development by running the DRP® for Stenoparib on clinical biopsy materials provided by Oncoheroes to identify likely responder patients. Allarity shall provide such support at its own cost. For U.S. Clinical Trials, Allarity shall facilitate DRP® testing support at the expense of Oncoheroes.
Companion Diagnostic. The Parties will discuss the details of the development or licensing of a companion diagnostic in connection with the Compound (a “CDx”) in the JSC, with C4T retaining decision-making authority with respect to [*]. If either Party decides to develop a CDx that may be used in the Licensee Territory, the Parties shall review and discuss the development plan for such CDx in the JSC, with Licensee retaining ultimate decision-making authority with respect to [*]. If either Party becomes aware of any Third Party IP related to a CDx that may be [*] for the Development, Manufacture or Commercialization of the Compound ACTIVE/119414966.70 or Products in the Field, the Parties shall [*] obtain such Third Party IP License in accordance with Section 2.7. For clarity, Licensee shall be the holder of all Regulatory Approvals for the CDx in the Field in the Licensee Territory. Sections 4.1, 4.2 and 4.3 shall apply, mutatis mutandis, to the regulatory matters related to any CDx.
Companion Diagnostic. The Parties intend NantOmics to develop and commercialize a companion diagnostic test to determine responsiveness to any therapeutic product developed, to be developed, commercialized or to be commercialized under the Research Programs (each, a “Companion Diagnostic”). In furtherance of the foregoing, Benitec will grant to NantOmics and its affiliates (a) an exclusive, world-wide, fully paid up license, including sublicensing rights, under the Designated Patents (as defined below), to develop and commercialize Companion Diagnostics on a world-wide basis and (b) the right to use the Results for any purpose in connection with the foregoing (the “Companion Diagnostic License”). The Companion Diagnostic License will include provisions requiring NantOmics to (a) use commercially reasonable efforts to develop and commercialize the Companion Diagnostic on a world-wide basis and (b) meet reasonable development milestones. Unless otherwise agreed by Benitec, NantOmics will not make the Sample Results available to third parties. In the event NantOmics decides not to develop or commercialize a Companion Diagnostic or is not developing and commercializing a Companion Diagnostic contemporaneously with Benitec’s development and commercialization of the Results and achievement of the milestones specified in the Sublicense, then NantOmics will xxxxx Xxxxxxx a non-exclusive, world-wide, fully paid up license, including sublicensing rights, under the the relevant intellectual property and data to permit Benitec to develop and commercialize a Companion Diagnostic.
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Companion Diagnostic. If, at any time during the Term, Optherion and/or an Optherion Affiliate(s) and/or their respective sublicensee(s) desires to develop a Licensed Product that is a companion diagnostic for an Optherion Therapeutic Product, which companion diagnostic would either be marketed as a laboratory developed test under CLIA regulations or its successor regulations or foreign counterparts or be submitted for FDA approval or other regulatory approval (a “Companion Diagnostic”), Optherion shall provide written notice thereof to Sequenom (a “Companion Diagnostic Notice”), and following receipt by Sequenom thereof, Sequenom and Optherion shall negotiate in good faith regarding the terms pursuant to which Sequenom may undertake the development and registration of such Companion Diagnostic for Optherion and/or an Optherion Affiliate(s) and/or their respective sublicensee(s); provided, however, that neither party shall be obligated to proceed with such activities unless and until they enter into a separate written agreement with respect to such activities. If Sequenom comes to the conclusion that it is unable to develop and register such Companion Diagnostic or the parties are unable to agree upon commercially reasonable terms within […***…] of Sequenom’s receipt of a Companion Diagnostic Notice, then the following shall apply:
Companion Diagnostic. The Lead Party may include the development and use of a Companion Diagnostic as part of a Joint Development Plan (to be approved by the JDC followed by the JSC), in which case any costs associated with the development or procurement of such Companion Diagnostic borne by a Party in accordance with the Annual Development Budget shall be considered Joint Development Costs. The Lead Party will be solely responsible for selecting a Third Party partner for the development of such Companion Diagnostic.

Related to Companion Diagnostic

  • Diagnostic procedures to aid the Provider in determining required dental treatment.

  • 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.

  • 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.

  • 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).

  • 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.

  • Clinical 2.1 Provides comprehensive evidence based nursing care to patients including assessment, intervention and evaluation.

  • Research Use The Requester agrees that if access is approved, (1) the PI named in the DAR and (2) those named in the “Senior/Key Person Profile” section of the DAR, including the Information Technology Director and any trainee, employee, or contractor1 working on the proposed research project under the direct oversight of these individuals, shall become Approved Users of the requested dataset(s). Research use will occur solely in connection with the approved research project described in the DAR, which includes a 1-2 paragraph description of the proposed research (i.e., a Research Use Statement). Investigators interested in using Cloud Computing for data storage and analysis must request permission to use Cloud Computing in the DAR and identify the Cloud Service Provider (CSP) or providers and/or Private Cloud System (PCS) that they propose to use. They must also submit a Cloud Computing Use Statement as part of the DAR that describes the type of service and how it will be used to carry out the proposed research as described in the Research Use Statement. If the Approved Users plan to collaborate with investigators outside the Requester, the investigators at each external site must submit an independent DAR using the same project title and Research Use Statement, and if using the cloud, Cloud Computing Use Statement. New uses of these data outside those described in the DAR will require submission of a new DAR; modifications to the research project will require submission of an amendment to this application (e.g., adding or deleting Requester Collaborators from the Requester, adding datasets to an approved project). Access to the requested dataset(s) is granted for a period of one (1) year, with the option to renew access or close-out a project at the end of that year. Submitting Investigator(s), or their collaborators, who provided the data or samples used to generate controlled-access datasets subject to the NIH GDS Policy and who have Institutional Review Board (IRB) approval and who meet any other study specific terms of access, are exempt from the limitation on the scope of the research use as defined in the DAR.

  • Clinical Studies The animal and other preclinical studies and clinical trials conducted by the Company or on behalf of the Company were, and, if still pending are, to the Company’s knowledge, being conducted in all material respects in compliance with all Applicable Laws and in accordance with experimental protocols, procedures and controls generally used by qualified experts in the preclinical study and clinical trials of new drugs and biologics as applied to comparable products to those being developed by the Company; the descriptions of the results of such preclinical studies and clinical trials contained in the Registration Statement and the Prospectus are accurate and complete in all material respects, and, except as set forth in the Registration Statement and the Prospectus, the Company has no knowledge of any other clinical trials or preclinical studies, the results of which reasonably call into question the clinical trial or preclinical study results described or referred to in the Registration Statement and the Prospectus when viewed in the context in which such results are described; and the Company has not received any written notices or correspondence from the FDA, the EMA, or any other domestic or foreign governmental agency requiring the termination, suspension or modification of any preclinical studies or clinical trials conducted by or on behalf of the Company that are described in the Registration Statement and the Prospectus or the results of which are referred to in the Registration Statement and the Prospectus.

  • 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.

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