Allocation of Development Activities. If the JDC does not reach consensus on the determination of which Party will conduct an activity in the GDP in accordance with Section 4.2.2 and, after escalation to the JSC and Executive Officers, the Executive Officers do not reach consensus on such matter, [***].
Allocation of Development Activities. (a) The JDC shall allocate responsibility between the Parties for the conduct of Development activities included in the GDP in accordance with this Section 4.2.2, and shall set forth such allocation in the GDP. Unless otherwise agreed by Xxxxxxx in accordance with Section 4.2.2(c), and subject to Section 4.2.2(b): (i) Xxxxxxx shall conduct all Clinical Studies of the Initial Product under the GDP [***].
Allocation of Development Activities. The GDPs shall allocate responsibility between the Parties for the conduct of Clinical Studies and the various other Development activities addressed in the GDPs.
Allocation of Development Activities. (a) The Parties shall mutually agree upon a transfer plan for the transfer of the IND, and the corresponding clinical trial database, and the global safety database for the Existing Product to Kite, [***]. Kite shall conduct a [***]. Prior to the transfer of [***], upon Kite’s request and at its sole cost and expense, Arcellx will provide Kite [***].
Allocation of Development Activities. *** Certain information has been excluded from this agreement because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed.
Allocation of Development Activities. 17 4.4 Diligence for Licensed Products.................................................17 [*] = CERTAIN CONFIDENTIAL INFORMATION iv 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. PAGE (a) General...................................................................17 (b) Local/Regional ONYX-015...................................................17 (c) Other Licensed Products...................................................18
Allocation of Development Activities. The Development Team shall determine the allocation of responsibility for Development activities between Warner and Onyx personnel, PROVIDED, HOWEVER, that, as determined in good faith by the Development Team, Onyx clinical staff shall be permitted to assist in the management of the clinical trials of all Licensed Products in the Shared Territory. Onyx shall assist in the Development of Licensed Products in any manner reasonably requested by the Development Team. [ * ] = 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.
Allocation of Development Activities. Xxxxxxx shall be solely responsible for conducting all Clinical Trials and all other Development activities in the GDP for the Profit Share Product.
Allocation of Development Activities. (a) The GDP shall allocate responsibility between the Parties for the conduct of Clinical Studies and the various other Development activities addressed in the GDP. Unless otherwise approved by the JDC, Clinical Studies of the Products in the Field shall be assigned to the Parties on an Indication-by-Indication, rather than a region-by-region or country-by-country, basis with one Party having the responsibility for overseeing, conducting and managing all Clinical Studies related to the applicable Indication. At all times, unless otherwise agreed by Pharmacyclics, Pharmacyclics shall be designated as such lead Party with respect to at least two Indications under the GDP (or, if less, at least one-half of the Clinical Studies being performed under the GDP at any given time). If necessary in order for Pharmacyclics maintain the lead with respect to the required number of Indications, the JDC shall in good faith select, and the JSC approve, a replacement Indication for which Pharmacyclics shall be the lead Party if Development activities under the GDP are completed or discontinued with respect to one or more Indications for which Pharmacyclics is the lead Party.
Allocation of Development Activities. (a) As soon as practicable after the Effective Date, argenx shall transfer to Xxxxxxx, and Xxxxxxx shall assume, responsibility for the conduct of the Ongoing Phase 1/2 Clinical Study. At the same time, argenx shall transfer to Xxxxxxx the IND/CTA for the Ongoing Phase 1/2 Clinical Study in accordance with Section 5.1.2. argenx shall continue to conduct such Clinical Study until completion of such transfer. After such transfer, Xxxxxxx shall continue to conduct such Clinical Study until completion.
