Joint Development Work Sample Clauses

Joint Development Work. Certain activities related to the Project and its Development Work have been and will be undertaken on a joint basis for the benefit of the Project and other CapX Projects ("Joint Development Work"). Joint Development Work activities include technical standards, certificate of need processes, the drafting and negotiation of CapX Project template agreements (including but not limited to this Agreement and the Project Agreements) to be undertaken by counsel appointed by the Management Committee in consultation with the Participants and their respective counsel, and general CapX Project planning, coordination and execution activities.

Joint Development Work. One or more of the Participants are participants in the CapX 2020 Initiative.

Joint Development Work. Each Party shall have the right to use and reference, without additional consideration, any and all Data generated by or on behalf of the other Party (including by any licensee of Rigel and any Sublicensee of Kissei) under the Joint Development Work, for obtaining and maintaining Regulatory Approval for the Products and otherwise Commercializing the Products in the referencing Party’s territory in accordance with the terms of this Agreement, subject to Section 2.10 and Section 5.1(b).

Joint Development Work. The costs of Joint Development Work shall be shared by the Parties as set forth in Section ‎8.2(a), with Rigel being solely responsible for all Development Costs (including Allowable Increases) arising from Joint Development Work conducted in or for the Rigel Territory and Kissei being solely responsible for all Development Costs (including Allowable Increases) arising from Joint Development Work conducted in or for the Kissei Territory. “Allowable Increases” means increased Development Costs resulting from (i) changes in study design after the Effective Date that are approved by the JSC [*], (ii) changes in regulatory requirements arising after the Effective Date ([*]), and (iii) [*].

Joint Development Work. The Development Plan shall also set forth the timeline and details of all Development activities to be conducted jointly by the Parties. The costs of Development work conducted jointly by the Parties shall be allocated between the Parties as set forth in Section 8.2, with Salubris being solely responsible for all Development Costs arising from joint Development work conducted in the Field in the Territory, and Viracta being solely responsible for all Development Costs arising from joint Development work conducted outside the Territory; provided, however, that if Salubris instructs Viracta to conduct any Development activities outside the Territory to support an application for or maintenance of Regulatory Approval of the Product in the Field in the Territory, Salubris shall be responsible for all Development Costs arising from such Development work conducted outside the Territory to the extent such work outside the Territory would not have been undertaken by Viracta but for the request of Salubris.

Joint Development Work. The Development Plan shall set forth the timeline and details ([*]) of all preclinical and clinical Development activities to be conducted jointly by the Parties as necessary to generate Data sufficient to meet the common requirements of the FDA, the PMDA, and other Regulatory Authorities agreed upon in writing by the Parties for MAA Approval of the Compound and Products for Indications agreed upon in writing by the Parties (“Joint Development Work”). Notwithstanding Section ‎4.2(b), the Parties shall discuss, through the JSC, potentially conducting Phase 3 Clinical Trials for IgAN so as to meet the common requirements of the FDA and PMDA and, if the JSC agrees to a protocol and study plan for such a Phase 3 Clinical Trial that meets the foregoing requirements, such Phase 3 Clinical Trial shall be deemed Joint Development Work. For clarity, if the [*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.