Role of the Neurology JDCs Sample Clauses

Role of the Neurology JDCs. Without limiting any of the foregoing, subject to Section 1.14.7, each Neurology JDC will perform the following functions, some or all of which may be addressed directly at any given Neurology JDC meeting: (a) review each Development Candidate Data Package and determine whether to designate the proposed lead Development Candidate or any of the Related Program Compounds as Development Candidates for such Collaboration Program, as described in Sections 1.8.3(a) and 1.8.3(d); (b) establish a Toxicology Strategy for each potential Development Candidate and approve the study design for each IND-Enabling Toxicology Study, as described in Sections 1.8.3(c) and 1.8.4(a); (c) determine whether Ionis is the more appropriate Party to conduct certain IND-Enabling Toxicology Studies, as described in Section 1.8.4(a); (d) update the “Approved CRO” list set forth on Schedule 1.8.4(a), as described in Section 1.8.4(a); (e) determine whether (and for how long) to extend or toll the [***]-day period during which each Party must Initiate the first IND-Enabling Toxicology Study for the applicable Development Candidate, as described in Sections 1.8.4(b) and 1.8.4(c); (f) determine the Party responsible for the CMC responsibilities for Development Candidate API batch to be used for IND-Enabling Toxicology Studies, as described in Section 1.8.6(a); (g) review and discuss the Program Determination provided by Biogen for each Collaboration Program, as described in Sections 6.5.2 and 6.5.3; (h) review the Draft Reports for all IND-Enabling Toxicology Studies, as described in Section 3.1.1; (i) determine whether Ionis is the more appropriate Party to conduct certain Clinical Studies or other activities under the Integrated Product Plan for a Collaboration Program, as well as the terms, budget and frequency of payments to be made to Ionis in connection with such activities, as described in Section 5.2.2; (j) approve cost estimates for activities to be conducted by Ionis pursuant to Section 1.8.4(d), Section 1.8.6, and Section 5.2.2; (k) review proposed collaborations with academic and non-profit institutions and discuss the [***] recommendations of the [***] with respect thereto, as described in Section 1.8.7; (l) review the overall progress of the Development activities and Clinical Studies under the applicable Integrated Product Plan and Clinical Studies with respect to a particular Development Candidate through [***]; (m) establish teams and committees to oversee and manage activi...

Role of the Neurology JDCs. Without limiting any of the foregoing, subject to Section 1.18.4, each Neurology JDC will perform the following functions, some or all of which may be addressed directly at any given Neurology JDC meeting: (i) establish the Initial Development Plan for each Development Candidate and update such plan as needed as provided in Section 1.10.2(d);

Role of the Neurology JDCs. Without limiting any of the foregoing, subject to Section 1.17.4, each Neurology JDC will perform the following functions, some or all of which may be addressed directly at any given Neurology JDC meeting: (i) establish the Initial Development Plan for each Development Candidate and update such plan as needed as provided in Section 1.10.2(d); (ii) recommend the Cost Estimates to the CSC for approval under Section 1.10.2(e); (iii) establish a high-level preclinical toxicology strategy for each Collaboration Program under Section 1.10.2(c); (iv) establishing teams and committees to oversee and manage activities under each Collaboration Program after Development Candidate designation as it deems necessary; and (v) such other review and advisory responsibilities as may be assigned to the Neurology JDC by the CSC pursuant to this Agreement.

Role of the Neurology JDCs. Without limiting any of the foregoing, subject to Section 1.18.4, each Neurology JDC will perform the following functions, some or all of which may be addressed directly at any given Neurology JDC meeting: (i) establish the Initial Development Plan for each Development Candidate and update such plan as needed as provided in Section 1.10.2(d); (ii) agree on Cost Estimates and the [***] milestone payments under Section 1.10.2(e); (iii) approve Biogen-Approved Costs pursuant to Section 1.14.1; (iv) if the milestone payment agreed upon in writing by the Parties pursuant to Section 1.10.2(e) with respect to a [***] exceeds $[***], establishing whether and how such payment shall be apportioned into smaller milestone payments as described in Section 1.10.2(e); (v) if any Biogen-Approved Costs that result from [***] exceed $[***], establishing whether and how such payments shall be apportioned into smaller milestone payments as described in Section 1.14.1(a); (vi) establish a high-level preclinical toxicology strategy for each Collaboration Program under Section 1.10.2(c); (vii) establishing teams and committees to oversee and manage activities under each Collaboration Program after Development Candidate designation as it deems necessary; and (viii) such other review and advisory responsibilities as may be assigned to the Neurology JDC by the CSC pursuant to this Agreement.