JDC. The JDC shall no longer meet unless requested by MorphoSys and all obligations of MorphoSys relating to the JDC according to Article 2 shall not be applicable any longer.
JDC. For each Co-Funded Product, the Parties shall establish and maintain a JDC in accordance with Section 5.4 below, which shall be responsible for establishing the plan and budget for the development of each Development Candidate (each, a “Co-Development Plan and Budget”) and overseeing the implementation of such plan. Such Co-Development Plan and Budget shall be comprehensive and shall fully describe at least the proposed activities related to ongoing preclinical studies, formulation, process development, clinical studies and regulatory plans, and other activities and timelines directed to obtaining the initial and subsequent Regulatory Approvals in each applicable country. Unless otherwise specified in a Co-Development Plan and Budget amounts reflected for a full year shall be deemed budgeted in equal amounts for each calendar quarter of such year.
JDC. The term “
JDC. A Party may replace any designee to the JDC by written notice to the other Party. Such representatives will include individuals with expertise and responsibilities in the areas of pre-clinical development, clinical development or regulatory affairs. The JDC will be responsible for coordinating all aspects of the Development of each Product through the filing of an NDA or equivalent by unanimous decisions. "Development" shall mean the development of any Product occurring from and after the filing of an IND, through and including approval of an NDA and any other governmental approvals required for the commercialization of such Product in a country.
JDC. Decisions by the JDC shall be by consensus, provided that (i) any concerns of PIRS related to SGEN’s Development of a Potential CoDev Product shall be escalated to the JSC for final determination (i.e., no further escalation), and (ii) any disputes related to a CoDev Product shall be escalated to the JSC;
JDC. (a) From and after the Effective Date, the parties will continue to utilize a joint development committee (JDC):
(i) to make recommendations to HPPI on research, development and registration activities relating to the exploitation of the Product in the Field in the Territory, including medico regulatory strategy;
(ii) to review progress against the current Development Plan and Budget and recommend amendments to HPPI;
(iii) to review HPPI clinical trial protocols relating to the Product in the Field before they are finalised (which protocols HPPI must provide to the JDC);
(iv) to review the progress of any clinical trial relating to the Product; and
(v) to share and discuss clinical data and developments related to the Licensed IPR, including without limitation in furtherance of clause 3.6 and item 2 of Schedule 7, which JDC will continue until the Actual Launch Date. The parties acknowledge and agree that the JDC is solely advisory in nature, shall have no power or authority to legally bind HPPI or Mayne Pharma, and at all times shall remain subject to the authority of the board of directors of HPPI.
(b) Each of the parties will appoint two representatives to the JDC. In addition, from time to time the parties may, by agreement in writing, invite additional representatives from either party, or industry experts or consultants, to participate in certain meetings on specific issues as needed, at HPPI’s cost and expense. A representative of and designated by HPPI will be the chairperson of the JDC.
(c) Each of the parties may change its representatives at any time during the term of this Agreement by notice to the other party, except that Xxxxxxxx X. Xxxxx will be a representative of HPPI from the Start Date unless or until it is no longer possible for reasons outside HPPI’s reasonable control.
(d) Each member of the JDC (including the chairperson) shall be entitled to one (1) vote on all matters which must be presented under this Agreement (or which are otherwise presented) to the JDC for approval, with the chairperson to have a casting vote that resolves any deadlock. The JDC shall fully abide by such vote or action in the conduct of its affairs, subject always to clause 4.2(a) and the continuing authority of the board of directors of HPPI.
(e) The JDC may hold meetings in person, by teleconference or by video conference:
(i) on a regular basis until the Actual Launch Date, but not less than one per Quarter;
(ii) as otherwise reasonably requested by the par...
JDC. Responsibilities The responsibilities of the JDC shall also include, but shall not be limited to:
(a) preparing, or overseeing the preparation of, Co-Development Plans (and related Co-Development Budgets) for final approval by the JSC, and updating each such Plan not less frequently than once per Contract Year;
(b) monitoring compliance with the Co-Development Plans (including the Co-Development Budgets) and, in connection therewith, reviewing and approving any changes therein;
(c) approving protocols for Clinical Trials of VEGF Products in the Territory, and monitoring and making modifications to such Clinical Trials;
(d) reviewing and approving material regulatory correspondence, final study reports, filings and submissions to Regulatory Authorities with respect to VEGF Products, including BLAs;
(e) [*************************];
(f) facilitating an exchange between the Parties of data, information, material and results relating to the Development of VEGF Products in the Territory;
(g) formulating a life-cycle management strategy for VEGF Products and evaluating new opportunities for new formulations, delivery systems and improvements in concert with the JCC;
(h) preparing procedures for the timely exchange of Adverse Reaction Reports and other information necessary or useful for regulatory filings pursuant to the terms of this Agreement; and
(i) considering and acting upon such other matters as are specified in this Agreement or by the Joint Steering Committee.
JDC. For each Co-Funded Product, the Parties shall establish and maintain a JDC in accordance with Section 4.3 below, which shall be responsible for establishing [ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. the plan and budget for the development of each Co-Funded Product (each, a “Co-Development Plan and Budget”) and overseeing the implementation of such plan. Such Co-Development Plan and Budget shall be comprehensive (as of the time of preparation and delivery hereunder) and shall fully describe at least the proposed activities and data related to [ * ], and other activities and timelines directed to obtaining the initial and subsequent Regulatory Approvals in each applicable country. Unless otherwise specified in a Co-Development Plan and Budget amounts reflected for a full year shall be deemed budgeted in equal amounts for each calendar quarter of such year.
JDC. Each Party will discuss and attempt to resolve any potential or evolving disagreement related to the Development Plans through their respective [***] members before it is brought before [***]. Each Party’s designees on the JDC shall, collectively, have [***] (the “Party Vote”) on all matters brought before the JDC. The JDC shall operate as to matters within its responsibility by [***] Party Vote. If the JDC is unable, after good faith efforts and with involvement of the Alliance Managers, to achieve [***] Party Vote on any issue, such issue shall be referred to the Executives.
JDC. Such minutes shall provide a description, in reasonable detail, of the discussions at the meeting, a list of material actions and decisions made by the JDC, a list of action items made by the JDC and a list of material issues not resolved by the JDC. The JDC Co-Chair who drafts the minutes shall provide the other Co-Chair and each Party’s Alliance Managers with the initial draft meeting minutes, who shall return the draft with any proposed changes, and this process shall be repeated until a final version of the meeting minutes is agreed upon and signed (or acknowledged as final via email) by the two Co-Chairs. The Parties shall reasonably cooperate to complete and agree upon a final version of meeting minutes within [***] from the date of the relevant meeting. The final version of the meeting minutes shall be signed (or acknowledged as final via email) by the two Co-Chairs, and each Party shall be provided with a copy of the final meeting minutes for its safekeeping. A [***] of additional representatives of a Party may attend meetings of the JDC in advisory capacity with the prior written consent of the other Party; provided that any JDC meetings that includes representatives of either Party who are not JDC members may, at the request of any JDC member, include a closed session consisting of only JDC members and Alliance Managers. All representatives to the JDC or attending JDC meetings shall be subject to confidentiality and nonuse restrictions at least as restrictive as those set forth herein.
