Common use of Allocation of Development Activities Clause in Contracts

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 ▇▇▇▇▇▇▇ in accordance with Section 4.2.2(c), and subject to Section 4.2.2(b): (i) ▇▇▇▇▇▇▇ shall conduct all Clinical Studies of the Initial Product under the GDP [***]. (b) With respect to any Clinical Study conducted by ▇▇▇▇▇▇▇ 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 ▇▇▇▇▇▇▇ 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 ▇▇▇▇▇▇▇’▇ 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 ▇▇▇▇▇▇▇ Territory shall be allocated to ▇▇▇▇▇▇▇ (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 ▇▇▇▇▇▇▇ Territory shall be allocated to ▇▇▇▇▇▇▇ and (iv) the JDC shall determine how to allocate the annual budget for Medical Affairs Studies (i.e., the portion of such budget that will be allocated to providing funding or clinical supplies of Product for IIS or Cooperative Group Studies and the portion of such budget that will be allocated to conduct of Post-Approval Commercialization Studies by or on behalf of the Parties, and the portion of such budget that shall be allocated to each territory based on where data generation would be best accomplished) and shall oversee the conduct of such IIS or Cooperative Group Study that the JDC determines to support.