Role of the JSC. Without limiting any of the foregoing, the JSC will perform the following functions, some or all of which may be addressed directly at any given JSC meeting:
(a) review Akcea’s progress on performing the Commercialization and Akcea Non-Commercial Activities under the Strategic Plan;
(b) review each Party’s progress on performing the Development activities for IONIS-TTR-LRx assigned to it under the Strategic Plan;
(c) review and discuss the strategy for Manufacturing and supply of API and Drug Product sufficient to support Commercialization of each Product (and to perform any Akcea Non-Commercial Activities) and a sequence of activities and associated timelines for the orderly transition from Ionis to Akcea of CMC activities for each Product;
(d) review and provide advice on the execution of activities and strategies set forth under the Strategic Plan with respect to each Product;
(e) review, discuss, and determine whether to approve the initial Strategic Plan and all updates thereto that contain Material Changes, as described in Section 3.2.2;
(f) discuss key regulatory interactions and strategy for the Products;
(g) review, discuss, and determine whether to approve the Commercial Budget for each Product, including any updates thereto, as described in Section 3.2.2;
(h) review, discuss, and determine whether to approve the Development Budget, including any updates thereto, as described in Section 3.2.2;
(i) establish the Allowable Overage for each Calendar Year;
(j) review and provide advice on Clinical Trial designs for each Product;
(k) if referred by a Party following the JPC’s failure to reach consensus, determine the strategy with regard to the defense against actual or potential allegations of infringement of any Patent Controlled by a Third Party, including the institution of any inter partes review, opposition or other proceeding related to any such Patent;
(l) establish subcommittees as necessary to conduct the activities set forth in the Strategic Plan, including a Regulatory Sub-Committee, and, as may be determined necessary by the JSC, clinical development sub-committee, a manufacturing sub-committee, and a clinical operations sub-committee (with the expectation that such sub-committees will evolve as required by the status of Development or Commercialization of the Products); and
(m) such other review, approval, and advisory responsibilities as may be assigned to the JSC under this Agreement.
Role of the JSC. The JSC will be responsible for oversight of the Collaboration Research Projects, including, but not limited to, (a) approving Research Plans for all Collaboration Research Projects prior to their submission to Ambrx pursuant to Section 4.2, (b) approving day-to-day or tactical performance of the research activities that require changes and updates to Approved Research Plans, (c) monitoring, reviewing and recording the progress of the Collaboration Research Projects, and (d) setting, and monitoring the spending against, the budget for Research Project costs, as set forth in an Approved Research Plan.
Role of the JSC. Without limiting any of the foregoing, the JSC will perform the following functions, some or all of which may be addressed directly at any given JSC meeting:
(a) review Isis’ and Akcea’s progress on performing the development and commercialization activities under the Strategic Plan;
(b) review and provide advice on the Strategic Plan as it applies to each Product;
(c) amend the Strategic Plan, subject to Section 3.1.2;
(d) approve material increases to the scope of work assigned to Isis and the budget for such work to conduct Development and Commercialization activities under the Strategic Plan;
(e) review and provide advice on clinical trial designs for each Product;
(f) discuss progress under the Transition Plan, including Akcea’s capabilities and capacity to assume responsibility for conducting various tasks under the Strategic Plan;
(g) establish subcommittees as necessary to conduct the Strategic Plan and the Transition Plan, including, as determined necessary by the JSC, a Regulatory Sub-Committee, Clinical Development Sub-Committee, a Manufacturing Sub-Committee and Clinical Operations Sub-Committee, with the expectation that such Sub-Committees will evolve as required by the status of Development or Commercialization of the Products; and
(h) such other review and advisory responsibilities as may be assigned to the JSC pursuant to this Agreement.
Role of the JSC. Without limiting any of the foregoing, subject to Section 1.3.3, the JSC will perform the following functions, some or all of which may be addressed directly at any given meeting of the JSC:
(a) review progress on improvements to Antisense technology and advances in mechanistic understandings of Antisense technology;
(b) review and provide advice on the Collaboration Program Research Plan (defined below) for each Collaboration Program, and the Early Development Plan (defined below) for each Development Candidate;
(c) review the overall progress of Isis' efforts to discover, identify, optimize and otherwise Develop Compounds under each Collaboration Program;
(d) in each case subject to [***], review and provide advice on (i) the design and content of the Phase I Success Criteria and the Phase I Trial Design/Endpoints for each ID/Additional Program, including design of, and human patient allocation in, all Clinical Studies, (ii) the design and content of the PoC Success Criteria for each Collaboration Program, and (iii) the PoC Trial Design/Endpoints for each Collaboration Program;
(e) discuss and approve the design and expenditure for animal efficacy studies for the ID/Additional Programs;
(f) review and determine whether In Vivo Efficacy has been demonstrated under the ID/Additional Programs;
(g) coordinate and manage activities to develop the regulatory strategy and CMC strategy for the TTR Program through Option exercise to ensure a smooth transition of such activities; and
(h) such other review and advisory responsibilities as may be assigned to the JSC pursuant to this Agreement or as may be mutually agreed upon in writing by the Parties from time to time."
Role of the JSC. Without limiting any of the foregoing, subject to Section 3.7.3, the JSC will perform the following functions in accordance with this Agreement, some or all of which may be addressed directly at any given JSC meeting.
(a) Review, provide advice on, and approve the Research Plan;
(b) Review the overall progress of Ionis’ efforts to discover, identify, optimize and select the Development Candidate and any Back-Up Compound(s);
(c) In accordance with Section 3.4.1, review the Development Candidate Data Package and determine whether and which Development Candidate and Back-Up Compound(s) to designate;
(d) In accordance with Section 7.3, mutually agree on the Development Plan and any changes thereto;
(e) Review the overall progress and provide advice on IND-Enabling Studies, the Phase 1 Clinical Trial design, the first Phase 2 Clinical Trial design and any additional pharmacokinetic and toxicology studies required to support such trials; and
(f) Such other review and advisory responsibilities as may be assigned to the JSC pursuant to this Agreement. [***] Certain information in this document has been excluded pursuant to Regulation S-K, Item 601(b)(10). Such excluded information is not material and would likely cause competitive harm to the registrant if publicly disclosed.
Role of the JSC. Without limiting any of the foregoing, subject to Section 1.3.3, the JSC will perform the following functions, some or all of which may be addressed directly at any given meeting of the JSC:
(a) review progress on improvements to Antisense technology and advances in mechanistic understandings of Antisense technology;
(b) review and provide advice on the Collaboration Program Research Plan (defined below) for each Collaboration Program, and the Early Development Plan (defined below) for each Development Candidate;
(c) review the overall progress of Isis’ efforts to achieve Sanctioned Target status with respect to each Collaboration Program that has not achieved Sanctioned Target status;
(d) review the overall progress of Isis’ efforts to discover, identify, optimize and otherwise Develop Compounds under each Collaboration Program;
(e) review and approve new gene targets for substituting any Unvalidated Collaboration Program and determine whether the new Collaboration Targets are primarily associated with a Rare Disease in accordance with Section 1.5.2;
(f) review and provide advice on (i) design and content of the [***] for each Collaboration Program and (ii) the [***] for each Collaboration Program, with each of (i) and (ii) being subject to [***] as described in Section 1.3.3; and
(g) such other review and advisory responsibilities as may be assigned to the JSC pursuant to this Agreement or as may be mutually agreed upon in writing by the Parties from time to time.
Role of the JSC. Without limiting any of the foregoing, subject to Section 1.2.3, the JSC will perform the following functions, some or all of which may be addressed directly at any given JSC meeting:
(a) review the overall progress of Isis’ efforts to discover, identify, optimize and select the Development Candidate under the ISIS-DMPKRx R&D Plan;
(b) review and provide advice on the ISIS-DMPKRx R&D Plan, including whether and how to conduct any of the activities listed on SCHEDULE 1.2.2(b);
(c) amend the ISIS-DMPKRx R&D Plan upon unanimous written consent;
(d) review and provide advice on the Phase 1 Trial Design and the PoC Trial Design; and
(e) such other review and advisory responsibilities as may be assigned to the JSC pursuant to this Agreement.
Role of the JSC. Without limiting any of the foregoing, subject to Section 4.1.1(b), the JSC will perform the following functions, some or all of which may be addressed directly at any given JSC meeting: (i) Review and approve updates to the Development Plan with respect to the Proposed Phase 2 Trials as well as with respect to any Phase 2 Trial undertaken per Section 3.1.3 (including any material changes) as contemplated under Section 3.1;
Role of the JSC. Without limiting any of the foregoing, the JSC will perform the following functions, some or all of which may be addressed directly at any given JSC meeting:
(a) Maintain the list of Reserved Targets;
(b) Maintain the list of Oncology Targets that are the subject of the Oncology Collaboration Programs;
(c) Set the Target Sanction criteria for each Oncology Target;
(d) Consider whether and for how long a back up candidate for the [***] Lead Candidate or the Oncology Lead Candidate shall be considered in parallel with the [***] Lead Candidate or Oncology Lead Candidate (as applicable).
(e) Create each Oncology Research and Development Plan using the template attached hereto as APPENDIX 3 as a starting point;
(f) review the overall progress of the activities under the applicable Collaboration Plan, including forecasts of costs associated with supplies of API/finished Product;
(g) review and provide advice on the applicable Collaboration Plan;
(h) subject to Section 4.1.3(a), materially amend the applicable Collaboration Plan upon unanimous consent; and
(i) such other review and advisory responsibilities as may be assigned to the JSC pursuant to this Agreement.
Role of the JSC. Without limiting any of the foregoing, subject to Section 1.3.2, the JSC will perform the following functions, some or all of which may be addressed directly at any given JSC meeting:
(i) review and approve amendments to the ASO Development Candidate Identification Plan proposed by either Party in accordance with Section 1.4.1(d);
(ii) review the overall progress of Ionis’ efforts to discover, identify and optimize potential Development Candidates for each Collaboration Program;
(iii) establish teams and committees to oversee and manage activities under each Collaboration Program up to Development Candidate designation as it deems necessary;
(iv) review the Development Candidate Data Package for each Collaboration Program and, subject to Section 1.4.2(b), designate the Development Candidate for each Collaboration Program;
(v) establish a high-level preclinical toxicology strategy for each Development Candidate under Section 1.5;
(vi) review and discuss the initial development plan set forth in the Integrated Development Plan under Section 5.1.1 for each Development Candidate until Initiation of a Phase 3 Trial;
(vii) review the overall progress of Biogen’s efforts to Develop the Development Candidates for each Collaboration Program until Initiation of a Phase 3 Trial;
(viii) establish teams and committees to oversee and manage activities under the preclinical toxicology strategy for each Development Candidate as it deems necessary;
(ix) provide input to the JPC as appropriate;
(x) assist with and participate in the resolution of disputes as contemplated in Section 12.1; and
(xi) such other review and advisory responsibilities as may be assigned to the JSC by the Parties pursuant to this Agreement.
