Responsibilities of JDC. The JDC shall have the following responsibilities and authority:
(a) to provide a means of communication between the Parties regarding the Joint Development Program;
(b) subject to and within the parameters of the Development Plan, to monitor and oversee the implementation of the Development Plan;
(c) to review and approve any amendments or modifications to the Development Plan; and
(d) such other responsibilities as expressly assigned to the JDC under this JDA or by written agreement of the Parties.
Responsibilities of JDC. 20 SECTION 4.03. Lead Development Party..................................... 21 SECTION 4.04.
Responsibilities of JDC. (a) The JDC shall oversee the Development of (i) Collaboration Products for Development Indications, and (ii) to the extent ORTHO exercises its option(s) under Section 5.04 to expand the Field to include Additional Indications, Collaboration Products for such Additional Indications, in order to obtain Regulatory Approvals in the Co-Promotion Territory as set forth in this Article IV. The JDC will also oversee the preparation of Development Plans and Development Budgets and submit them to the Steering Committee for review and as required, approval and will facilitate the flow of Information with respect to Development being conducted for each Collaboration Product for each Development Indication and Additional Indication, if any. In addition, as part of an approved Commercialization Budget and/or an approved Launch Budget, the JDC will provide such support with respect to Phase IIIB Clinical Trials and Phase IV Clinical Trials as may be reasonably requested by the JCC.
(b) Decisions shall be made by the JDC by consensus after an open discussion of the matters as to which decisions are being made. If the JDC fails to reach consensus as to any matter involving Development, excepting (i) increasing a Development Budget, other than pursuant to Section 4.05 (ii) altering a Development Plan in any material respect, including changing the indications for which a Collaboration Product is being developed, or (iii) terminating a Phase III Clinical Trial prior to completion in accordance with its protocol ("Excepted Development Matters"), the decision of CTI will be final and determinative with respect to all Development Indications and matters related thereto and so long as such decision does not contradict or modify the terms of this Agreement. If the JDC fails to reach consensus as to any matter involving Additional Indications, the decision of ORTHO will be final and determinative so long as such decision does not contradict or modify the terms of this Agreement. Excepted Development Matters shall be referred to the Steering Committee for resolution pursuant to Section 2.04.
(c) The JDC will have the power to form subcommittees with appropriate representation from CTI and ORTHO, including the R&D Subcommittee pursuant to Section 5.01 in the event that ORTHO exercises its option to commence the Sponsored Research Program as provided therein.
Responsibilities of JDC. Subject to Section 2.2.4, the Joint Development Committee shall perform the following functions:
(i) review and amend the Development Plan, as needed;
(ii) review and approve the allocation of resources and efforts for the Development Program;
(iii) evaluate the progress of the Development Program;
(iv) establish and oversee a process by which each Party keeps the other Party informed of design or manufacturing changes, feedback from lead users (if any), or events which may affect work being performed under the Development Plan or GenMark’s development of Licensed Products;
(v) coordinate, and be the primary conduit for, the transfer of Technical Information and Materials between the Parties during the Development Term; and
(vi) perform such other functions referred to in the Development Plan, and as appropriate to further the purposes of the Development Program, or as otherwise specified in this Agreement or agreed to by the Parties.
Responsibilities of JDC. (a) The JDC shall, unless otherwise agreed to by the Parties:
(i) assume responsibility for the Development Plans as established in Section 2.03;
(ii) establish, update yearly and seek approval from the Steering Committee for the Development Plans so long as appropriate which plans will specify a reasonable level of detail by which Alliance and Schering will conduct R&D Work, Preclinical Work, Clinical Work, Production Work and Regulatory Work;
(iii) meet and review progress of R&D Work, Preclinical Work, Clinical Work, Production Work and Regulatory Work at least quarterly unless Alliance and Schering otherwise agree, and direct changes or modifications to the Development Plans;
(iv) decide on a publication strategy as set forth in Section 10.05; and
(v) present a report with a reasonable level of detail at least every three (3) months to the Steering Committee on all activities of the JDC, including progress by the Parties under the current Development Plans and progress by the JDC on developing Development Plans for the next year.
(b) Actions taken by the JDC pursuant to this Agreement shall be taken only following unanimous agreement of the Parties or at the direction of the Steering Committee.
(c) The JDC will have the power to form subcommittees with appropriate representation from Alliance and Schering.
(d) Notwithstanding any other provision of this Agreement, the JDC shall not have power over any Development of the Product as such Development relates to Commercialization of the Product outside the United States and Europe.
Responsibilities of JDC. Subject to the limitations set forth in Section 3.6, the JDC shall perform the following functions:
Responsibilities of JDC. Subject to Section 3.07, the JDC shall perform the following functions:
(a) review and approve the Development and Commercialization strategy for the Product in the Territory, including the Development Plan and Commercialization Plan (defined below);
(b) ensure harmonization of the Product Development and regulatory strategy in the Territory with Revance’s global development and commercialization strategy;
(c) approve all pre-clinical and/or clinical Development activities proposed to be conducted by or on behalf of Fosun with respect to the Product;
(d) review and approve the protocols for each clinical trial of Product proposed to be conducted by or on behalf of Fosun in the Territory;
(e) facilitate and approve the exchange of Product-related Data and information between the Parties as necessary;
(f) ensure that Fosun’s Development and Commercialization activities are in compliance with the Development Plan, Pharmacoviligance Agreement, Commercialization Plan, and other relevant obligations under this Agreement, including but not limited to, obligations to keep Revance reasonably informed and updated regarding (i) the status of such Development and Commercialization activities, (ii) results from any clinical trials, (iii) any adverse events, and (iv) material correspondence with a Regulatory Authority; and
(g) perform such other functions as are specifically designated for the JDC in this Agreement.
Responsibilities of JDC. The JDC shall be responsible for:
3.1.5.1 Developing and proposing to the JSC the strategy and plans for the Development of the Licensed Products, including regulatory strategies in the Territory;
3.1.5.2 assessing the medical and scientific viability of any proposals made by the Parties for Development of a New Indication for the Licensed Products in accordance with Section 2.5 hereof;
3.1.5.3 reviewing and approving the BioCryst Trials Plan and the Mundipharma Trials Plan on a regular basis (not less frequently than every *** (***) months), and presenting from time to time to the JSC for review and approval of substantive amendments to the Mundipharma Trials Plan and the BioCryst Trials Plan;
3.1.5.4 reviewing and approving clinical study endpoints, clinical methodology and monitoring requirements for the clinical studies;
3.1.5.5 undertaking and/or approving such other matters as are specifically provided for the JDC under this Agreement; and
3.1.5.6 facilitating and approving the reconciliation and reimbursement of Out of Pocket Development Costs in accordance with Section 4.6.2, below.
Responsibilities of JDC. 9 SECTION 2.03. DEVELOPMENT. . . . . . . . . . . . . . . . . . . . . . . . . . 10 SECTION 2.04. ** . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11 SECTION 2.05. DRUG APPROVAL APPLICATIONS . . . . . . . . . . . . . . . . . . 12 SECTION 2.06. COSTS OF DEVELOPMENT . . . . . . . . . . . . . . . . . . . . . 13 SECTION 2.07.
Responsibilities of JDC. The JDC shall perform the following functions:
4.2.1. establish the Candidate Criteria with respect to each Collaboration Program, and review and update such Candidate Criteria as necessary from time to time;
4.2.2. periodically review each Development Plan, and discuss and approve any amendments to such Development Plan (including any such amendment proposed by either Party under Section 2.1.3 to the IND-Enabling Activities set forth in such Development Plan based on the results of the Initial Development Activities, including identification of the Compound(s) with respect to which such IND-Enabling Activities would be performed if Allergan makes an Extension Exercise);
4.2.3. determine the information, data and results required to be included in the Initial Development Report and the IND-Enabling Data Package, respectively, for each Collaboration Program;
4.2.4. facilitate the exchange of information regarding activities conducted under the Development Plans and the results of such activities, including reviewing and discussing reports provided by Exicure under Section 2.6, and providing guidance with respect to such activities;
4.2.5. determine whether any Compound for which Exicure has conducted Initial Development Activities satisfies the Candidate Criteria for the applicable Collaboration Program;
4.2.6. determine, by reference to the applicable requirements determined by the JDC pursuant to Section 4.2.3, whether each Initial Development Report or IND-Enabling Activities Data Package is complete;
4.2.7. consult regarding the possible substitution of a Substitute Target for a Program Target upon Allergan’s request pursuant to Section 2.2;
4.2.8. facilitate the exchange of information and Materials for purposes of the conduct of any Allergan-Conducted Activities pursuant to Section 2.3;
4.2.9. review, discuss and attempt to resolve any technical or scientific issues arising in the conduct of the activities under the Development Plans;
4.2.10. in the case of an Extension Exercise with respect to a Collaboration Program, review, comment on and approve the initial IND for a Compound under such Collaboration Program for submission by Allergan if Allergan exercises the Option; and THE COMPANY HAS REQUESTED AN ORDER FROM THE SECURITIES AND EXCHANGE COMMISSION (THE “COMMISSION”) PURSUANT TO RULE 406 UNDER THE SECURITIES ACT OF 1933, AS AMENDED, GRANTING CONFIDENTIAL TREATMENT TO SELECTED PORTIONS. ACCORDINGLY, THE CONFIDENTIAL PORTIONS HAVE BEEN OMITTED FROM...
