Companion Diagnostics Sample Clauses
The Companion Diagnostics clause defines the terms and conditions under which diagnostic tests that are specifically designed to be used alongside a particular therapeutic product are addressed in an agreement. This clause typically outlines the responsibilities for development, regulatory approval, commercialization, and intellectual property rights related to such diagnostics, often specifying which party will lead these activities and how costs and data will be shared. Its core practical function is to ensure that both parties clearly understand their roles and obligations regarding companion diagnostics, thereby facilitating coordinated development and regulatory strategies while minimizing potential disputes.
Companion Diagnostics. (a) If either party (including, in the case of Arcus, an Arcus Partner) intends to, itself or with a Third Party, develop, supply or commercialize a Companion Diagnostic, such party shall promptly notify the other party and, upon the request of the other party, the parties (including the Arcus Partner as required by Arcus if applicable) shall discuss a mutual agreement and cooperate in good faith to make such Companion Diagnostic available on a global basis. Any such agreement would include provisions on how costs should be shared in connection with the development, supply and commercialization of a Companion Diagnostic (to be determined taking into account factors such as market share and benefit). In no event shall a party (or an Arcus Partner as required by Arcus) restrict by contract any such Third Party from developing, manufacturing, or commercializing such Companion Diagnostic for the other party (or an Arcus Partner) or for outside its respective territory, provided that the foregoing shall not limit either party’s rights to enforce the terms of its agreement with any such Third Party or terminate its agreement with any such Third Party. *** 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.
(b) The provisions of Sections 4.1, 4.4, 4.6, 4.10, 4.11, and 4.12 and Articles 7 - 9 and 11 hereof shall apply with respect to Companion Diagnostics, to the same extent as they apply to Licensed Products, mutatis mutandis.
Companion Diagnostics. If the JDC determines that it is necessary to Develop a companion diagnostic to support the Development and Commercialization of a Product in the Field, the Parties shall amend this Agreement to include the terms and conditions for the Exploitation of such companion diagnostic. [***]
Companion Diagnostics. BMS and its Affiliates may elect to Develop, either alone or in conjunction with any Third Party, one or more Companion Diagnostic. The Parties will discuss in good faith the role and responsibility that BN may have in connection with the Development of such Companion Diagnostics including whether BN will make available for BMS’s use in connection with same, subject to applicable privacy laws and the terms under which same were provided to BN, any patient samples and related clinical data and other materials possessed and Controlled by BN. BN agrees not to Develop or Commercialize any Companion Diagnostic unless the JC (or BMS, in the absence of the JC) has agreed for it to do so, including the basis, scientific rationale, and financial and other terms for BN’s Development and/or Commercialization of a Companion Diagnostic, in which case the decision of the JC shall govern BN’s Development and/or Commercialization of such Companion Diagnostic. BN shall retain operational control of any such Development and Commercialization authorized by the JC subject to the decisions of the JC. BMS and its Affiliates will not, directly or indirectly, Commercialize any Companion Diagnostic (but may Develop though Regulatory Approval a Companion Diagnostic on its own or in collaboration with, or via a sublicense to, a Third Party), unless and until agreed by the JC (with neither Party having the final say). [***]. If BMS enters into an agreement with a Third Party granting such Third Party the right to Commercialize a Companion Diagnostic that was Developed using samples or data provided by BN, then BMS will pay BN [***] percent ([***]%) of any amounts BMS or its Affiliates receives from such Third Party in connection with sales of such Companion Diagnostics, once BMS has recovered any out-of-pocket expenses incurred in the development of such Companion Diagnostic; provided that BMS shall provide BN with reasonable documentation of any such expenses following BN’s request.
Companion Diagnostics. Array shall use Diligent Efforts to make available in the Ono Territory any Companion Diagnostic developed by or on behalf of Array for use with one or more Products.
Companion Diagnostics. If during the Term, Pyxis elects to Develop a companion diagnostic for use in conjunction with the Licensed Products or to Develop Licensed Compound or Licensed Product for diagnostic use, it may do so under a separate license to Intellectual Property Rights Controlled by LCB. Such license to include reasonable additional consideration for LCB, which, when taken as a whole, is no greater than the consideration paid to LCB for the Licensed Product under the Agreement, and the Parties will enter (i) an amendment to the Agreement, or (ii) a separate agreement between Pyxis and LCB regarding such license for the companion diagnostics (in the case of each of (i) or (ii) for the purpose of licensing such Intellectual Property Rights to Pyxis).
Companion Diagnostics. With respect to the Third Party engaged by Zymeworks or its Affiliates as of the Execution Date to develop and commercialize a Companion Diagnostic, Zymeworks[***] shall use reasonable efforts to cause such Third Party [***]. In addition, upon ▇▇▇▇’s request, Zymeworks shall introduce Jazz to such Third Party [***].
Companion Diagnostics. Celgene may, in its sole discretion, Develop, Manufacture or Commercialize a Companion Diagnostic for use with the Licensed Products and may, in its sole discretion, use a Third Party Contractor to perform all Development, Manufacturing and Commercialization for the Companion Diagnostic, which activities may include continued Development of a Companion Diagnostic for which Development was commenced under the Master Agreement. In no event shall any payments be owed by Celgene to Vividion (including pursuant to Article IX) with respect to a Companion Diagnostic; provided, however, that [***] shall be solely responsible for all costs associated with the Development, Manufacture or Commercialization of any Companion Diagnostics and shall reimburse [***] for any such costs incurred by [***] within [***] days after receipt of any invoice therefor.
Companion Diagnostics. From time to time, as reasonably requested by Novartis, Legend shall [***].
Companion Diagnostics. For each Designated Target, as between the Parties, BMS shall have the sole right to Exploit Companion Diagnostics for Licensed Collaboration Compounds or Licensed Collaboration Products for such Designated Target in the Field in the Territory at its sole cost and expense (including having an Affiliate or Third Party Develop on its behalf). BMS shall not Develop any Licensed Collaboration Compounds or Licensed Collaboration Products as a stand-alone diagnostic product except as a Companion Diagnostic.
Companion Diagnostics. Celgene may, in its sole discretion, Develop, Manufacture or Commercialize a Companion Diagnostic for use with the Licensed Products and may, in its sole discretion, use a Third Party Contractor to perform all Development, Manufacturing and Commercialization for the Companion Diagnostic, which activities may include continued Development of a Companion Diagnostic for which Development was commenced under the Master Agreement. In such event, (i) the definition of “Licensed Product” shall include the Companion Diagnostic for purposes of defining Agios Patents, Celgene Patents, Celgene Collaboration Patents and Joint Patents, and each of the licenses granted to Celgene under Article VIII; provided, however, that in no event shall any payments be owed by Celgene to Agios (including pursuant to Article IX) with respect to a Companion Diagnostic.