Core Development Activities Clause Samples
Core Development Activities. 4.3.1 Subject to the terms of this Agreement and the requirements of Applicable Laws, and except as otherwise mutually agreed upon in writing by the Parties, the Parties Development responsibilities shall be allocated as follows:
(a) UGNX shall be the lead Party for the Development of Licensed Products in the Field in the Profit Share Territory and the European Territory (“Lead Development Party”) for the following activities beginning on the Effective Date (collectively, “UGNX Core Development Activities”): (i) [***] conducted in the Profit Share Territory [***]; and (ii) [***] conducted in the European Territory [***]; provided, however, that UGNX shall in each case under (i) and (ii) continue to be the Lead Development Party for any Phase 4 Clinical Trials and/or Clinical Trials for additional indications in the Field (but excluding for clarity Phase 5 Clinical Trials), if any, commenced (Initiation) by [***] in the [***] or the [***] prior to the [***] or the applicable [***], as applicable, until completion of such respective Clinical Trial (“On-Going Clinical Trials”).
(b) [***] shall be the Lead Development Party for the following activities (collectively, “[***] Core Development Activities”): (i) [***]; (ii) [***]; and (iii) [***], all of the Core Development Activities conducted in the [***], until completion of such studies, excluding, for clarity, in the case of (ii) and (iii), any On-Going Clinical Trials.
4.3.2 The Lead Development Party shall use Commercially Reasonable Efforts to conduct (or have conducted) the Core Development Activities allocated to it under this Section 4.3 (i.e., the UGNX Core Development Activities in the case of UGNX and the KHK Core Development Activities in the case of KHK) in accordance with the Core Development Plan and Applicable Laws. The non-Lead Development Party shall provide the Lead Development Party such timely assistance as reasonably requested by the Lead Development Party to enable such Party to perform its obligations and accomplish the activities allocated to such Party under the Core Development Plan. Subject to the terms of this Agreement and the requirements of Applicable Laws, the Lead Development Party shall make all decisions relating to the Day-to-Day Core Development Activities allocated to it under this Section 4.3, including all decisions related to the matters set forth on Schedule 4.3.2, provided such decisions are consistent with the then-current Core Development Plan. In addition, UGNX wi...
Core Development Activities. The conduct of all GLP toxicology studies or other IND enabling studies, and Clinical Studies in support of the Core Dossier, of Cost Profit Sharing Products shall be governed by the GDP, and the Parties agree to conduct all such activities in accordance with the GDP. The Initial GDP is attached hereto as Exhibit 1.58 (which also includes overall total budget figures for the initial Development Budget as described in Section 4.2.3, and budget forecasts for subsequent periods as described in Section 4.2.5(b)). The GDP shall allocate responsibility for each Development activity set forth in the GDP to a Party. The GDP shall include general study design parameters, specific staffing requirements and the funding budget for each stage of clinical development for each Indication in the GDP, and shall be consistent with the terms of this Agreement. Guidelines for additional data and/or criteria, if any, to be generated for assessment prior to commencement of any specific Clinical Study shall be included in the GDP. The terms of and activities set forth in the GDP shall at all times be designed to be in compliance with all applicable Laws and Good Clinical Practice and to be conducted in accordance with professional and ethical standards customary in the pharmaceutical industry, taking into account, in accordance with Section 4.3.7, the Relevant Internal Policies.
Core Development Activities. The conduct of all GLP toxicology studies or other IND enabling studies, and Clinical Studies for any Co-Promote Products in the U.S. or in support of U.S. Regulatory Approval as part of a global Clinical Study shall be governed by the applicable Core Development Plan, and the Parties agree to conduct all such activities in accordance with such Core Development Plan. The Initial Core Development Plan is attached hereto as Exhibit 1.38 (which also includes budget figures for the initial Core Development Budget as described in Section 4.2.3, and budget forecasts for subsequent periods as described in Section 4.2.5). The Core Development Plan shall allocate responsibility for each Development activity set forth in the Core Development Plan to a Party. The Core Development Plan shall include [***], and shall be consistent with the terms of this Agreement. [***] shall be included in the Core Development Plan. The terms of and activities set forth in the Core Development Plan shall at all times be designed to be in compliance with all applicable Laws and to be conducted in accordance with professional and ethical standards customary in the biopharmaceutical and/or cell therapy industry.
Core Development Activities. Vertex and/or its licensees, if any, will be undertaking development activities, including preclinical and clinical studies and process development, which Vertex deems necessary or appropriate in order to obtain Regulatory Approval for the sale of Drug Products outside the Territory from the U.S. FDA and the EMEA of the European Union (the "Core Development Activities"). Vertex expects the Core Development Activities will be undertaken applying standards which will allow the results of those activities to be used by Taisho in its regulatory filings in the Territory. If drug development standards and practices in the Territory are substantially at variance with usual and customary practices in the United States or the European Union in connection with Core Development Activities proposed to be conducted by Vertex, Taisho shall so inform Vertex on a timely basis. Vertex shall create a development plan for Core Development Activities with respect to Licensed Compounds (the "Core Development Plan"), which shall be provided to the JDC and Taisho in advance for its review and comment. ** [************************************************************ ************************************************************* ************************************************************* ************************************************************* ************************************************************* ************************************************************* ************************************************************* ************************************************************* ************************************************************* ************************************************************* ************************************************************* ************************************************************* ************************************************************* ************************************************************* **********************************]