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 [***].
(b) With respect to any Clinical Study conducted by Xxxxxxx under the GDP, Legend shall have a right to [***] such Clinical Study as follows: (i) during the [***] of such Clinical Study[***] and (ii) for [***] of such Clinical Study [***]. Such individuals shall have appropriate clinical development qualifications [***], and such individuals’ activities shall be [***]. [***]. The JDC will have authority over performance issues of such Legend [***]. Notwithstanding the foregoing (or clauses (c), (d) or (e) below) the Parties will [***] participating in Clinical Studies of the Product being conducted by [***] decisions with respect to the conduct of such Clinical Studies (to the extent [***] with respect to such Clinical Studies as specified in this Agreement)].
(c) If Xxxxxxx agrees, Legend may conduct Clinical Studies for the Initial Product [***].
(d) For any other Clinical Studies of the Products [***].
(e) In allocating responsibilities between the Parties, the JDC shall take into consideration each Party’s expertise, capabilities, staffing and available resources to take on such activities as well as the Parties’ intention to provide Legend a reasonable opportunity to build and expand its expertise, capabilities, staffing and available resources in connection with performing Development activities allocated to it.
(f) Notwithstanding the foregoing, (i) responsibility for conducting all regulatory activities in Greater China shall be allocated to Legend (subject to Xxxxxxx’x rights under Section 4.6.4) and Legend shall be the primary point of contact for interfacing with all Governmental Authorities in Greater China in accordance with Section 4.6, (ii) responsibility for conducting all regulatory activities in the U.S. and Xxxxxxx Territory shall be allocated to Xxxxxxx (subject to Legend’s rights under Section 4.6.4), (iii) responsibility for conducting all Early Access Programs for the Products in the U.S. and the Xxxxxxx Territory shall be allocated to Xxxxxxx and (iv) the JDC shall determine how to allocate the annual budget for Medical Affairs Studi...
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 [***].
(b) The GDP for each Licensed Product shall allocate responsibility between the Parties for the conduct of Clinical Studies and the various other Development activities addressed in such GDP. Unless otherwise approved by the DWG or set forth in the applicable GDP, with respect to Development of Licensed Product in the Field, (i) Arcellx shall be responsible for the Development of the Existing Product in the U.S. for the iMMagine-1 Program until [***] and other activities allocated to Arcellx under the Core Development Plan and Kite shall be responsible for Development of the Existing Product in the U.S. (other than for the iMMagine-1 Program until [***] or other activities allocated to Arcellx under the Core Development Plan), provided further that Arcellx and Kite shall both be responsible for CMC Development of the Existing Product prior to Manufacturing Transfer of the Existing Product to Kite, and Kite shall be responsible for CMC Development of the Existing Product following such Manufacturing Transfer, (ii) Kite shall be responsible for Development of the Existing Product in the ExUS Territory and Development of the NextGen Products and Non-Auto Products in the Territory, (iii) [***] except that [***], (iv) the [***], (v) each Party may [***], (vi) both Parties must agree to [***], (vii) both Parties will have [***], and (viii) both Parties will receive [***], in each case (iv)-(viii), for [***], subject to the mutual agreement of the Parties, and notwithstanding [***], provided that [***].
(c) Neither Party nor its Affiliates shall conduct [***], except as expressly set forth in the GDP for such Licensed Product. Any such [***] shall be subject to the governance and oversight as set forth in ARTICLE II and this ARTICLE IV.
Allocation of Development Activities. The JDC shall allocate responsibility between the Parties for the conduct of Clinical Trials and the various other Development activities included in the GDP, and shall set forth such allocation in the GDP. In allocating responsibilities between the Parties, the JDC shall take into consideration each Party’s expertise, capabilities, staffing and available resources to conduct such activities.
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.
(A) Clinical Studies for [*]. As further described in the GDP for [*]:
(a) Genmab shall maintain sponsorship for, and conduct: [*];
(b) Genmab shall maintain sponsorship for, and conduct, [*];
(c) Licensee shall maintain sponsorship for, and conduct, [*]; and
(d) Licensee and Genmab shall assume responsibility for the execution and delivery of all other [*] that are not described in subclause (A) above with the mutual understanding that [*] shall be responsible for most of such other [*], provided that [*] will be entitled to conduct at least [*]
(B) Clinical Studies for other Licensed Products. Each Party’s respective responsibilities for executing and delivering all other Clinical Studies for the Licensed Products shall be set forth in the GDPs, which GDPs shall provide that:
(a) Genmab shall have the right to assume responsibility and maintain sponsorship for, and conduct [*]; [*] = Certain information contained in this document, marked by brackets, has been omitted because it is both not material and is the type of information that we treat as private or confidential.
(b) Licensee shall have the right to assume responsibility and maintain sponsorship for, and conduct [*]; and
(c) If more than [*] under the applicable GDP, then [*] shall have the right to assume responsibility and maintain sponsorship for, and conduct, [*].
Allocation of Development Activities. (a) Subject to Section 4.1.6, the GDP shall allocate responsibility between the Parties for the conduct of Clinical Studies and the various other Development activities addressed in the GDP.
(b) The Party that has responsibility for conducting the Clinical Study shall have the responsibility for the packaging of clinical drug supplies, unless otherwise agreed by the Parties.
(c) Neither Party nor its Affiliates shall conduct any Clinical Study or other Development of any Licensed Compound or Product in the Field, except as expressly permitted in this ARTICLE 4.
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. *** 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.
