Joint Development Committee Clause Examples
The Joint Development Committee clause establishes a formal group composed of representatives from the parties involved in a joint development project. This committee is typically responsible for overseeing the progress of the project, making key decisions, resolving disputes, and coordinating activities between the parties. For example, the committee may set project milestones, approve budgets, or address technical challenges as they arise. Its core practical function is to provide a structured mechanism for collaborative decision-making and governance, ensuring that both parties have input and oversight throughout the development process.
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Joint Development Committee. Within [****] ([****]) days after the Effective Date, the Parties shall establish a joint development committee (the “Joint Development Committee” or the “JDC”), composed of [****] ([****]) representatives of each Party (or such other equal number of representatives from each Party as the Parties may agree in writing from time-to-time), to coordinate the Development of the Compound and Licensed Products and Commercialization Licensed Products in the Licensed Field in the Territory. Each JDC representative shall have appropriate knowledge and expertise and sufficient seniority within the applicable Party to make decisions arising within the scope of the JDC’s responsibilities. The JDC shall:
(a) serve as a forum for discussing and supervising Development of the Compound and Licensed Products in the Licensed Field in the Territory, including by (i) providing Sinovant with a forum to disclose to Angion Sinovant’s, or its Affiliates’ or Sublicensees’ activities with respect to achieving Regulatory Approvals of Licensed Products in the Territory; material clinical study results; and the Marketing Authorization Applications that Sinovant or any of its Affiliates reasonably expect to make, seek or attempt to obtain in the Territory; (ii) reviewing the Development Plan, including approving amendments and updates to the Development Plan, and (iii) coordinating the conduct of the Development activities;
(b) serve as a forum for discussing and supervising the Commercialization of Licensed Products in the Licensed Field in the Territory, including by (i) providing Sinovant with a forum to disclose to Angion Sinovant’s, or its Affiliates’ or Sublicensees’ Commercialization activities with respect to Licensed Products in the Territory; (ii) reviewing the Commercialization strategy for the Territory; (iii) reviewing the Commercialization Plan, including approving amendments and updates to the Commercialization Plan, and (iv) coordinating the conduct of the Commercialization activities;
(c) discuss intellectual property-related matters affecting, and affected by, the foregoing and other activities under this Agreement;
(d) coordinate the Parties’ activities under this Agreement; and
(e) perform such other functions as are set forth herein or as the Parties may mutually agree in writing, except where in conflict with any provision of this Agreement unless such provision is first amended in accordance herewith in order to avoid such conflict (including pursuant to such writ...
Joint Development Committee. (a) The Parties shall establish a Joint Development Committee (the “Joint Development Committee” or “JDC”), comprised of [**] representatives of Ikaria and [**] representatives of BioLineRx, to oversee the Development of Products. Each Party shall make its initial designation of its representatives not later than [**] days after the Effective Date. Each Party may change any one or more of its representatives to the Joint Development Committee at any time upon notice to the other Party.
(b) The JDC shall meet at least [**] during the Development Term or more or less frequently as the JDC may agree. The JDC may meet in person or by means of a telephone or video conference call. One meeting of the JDC per year shall be held in person at Ikaria’s headquarters in Clinton, NJ and one meeting of the JDC per year shall be held in person at BioLineRx’s headquarters in Israel, provided, that the Parties’ representatives may participate in person, via telephone, or video conference in their discretion. Each Party shall use reasonable efforts to cause its representatives to attend the meetings of the JDC. If a representative of a Party is unable to attend a meeting, such Party may designate an alternate to attend such meeting in place of the absent representative. Each Party shall bear its own costs with respect to its participation on the JDC. Prior to every meeting of the JDC, Ikaria will provide to the JDC detailed reports describing Ikaria’s current clinical and development activities and plans.
(c) The JDC shall be the vehicle by which BioLineRx may offer insight and guidance to Ikaria with respect to (i) establishing the Development Plan setting forth the Development Program’s objectives and the activities to be conducted, (ii) reviewing and updating the Development Plan from time to time, (iii) monitoring the progress and results of the Development Program, (iv) determining future Development Program activities, including Development activities relating to Manufacturing, to be conducted during the Development Term, and (v) establishing success criteria for the clinical trials (other than those for which success criteria are set forth in this Agreement), and determining whether the results of such clinical trials have achieved the applicable success criteria.
(d) The JDC shall only act unanimously, with each Party given one (1) vote regardless of the number of representatives. If, however, the JDC is unable to reach agreement with respect to any matter within [*...
Joint Development Committee. Promptly after the Effective Date, the Parties shall form a Joint Development Committee (the “JDC”).
Joint Development Committee. Promptly after the Effective Date, the JSC shall establish a joint development committee (“JDC”). The JDC shall have primary responsibility for the matters set forth in Section 3.1.2(a) - 3.1.2(f) and 3.1.2(h) - 3.1.2(j), together with such other matters as are delegated to the JDC by the JSC.
Joint Development Committee. The Parties will form a joint development committee (the “JDC”) to serve as a forum for information exchange and discussion with respect to development and regulatory activities relating to Compounds and Products in the Field in the Territory.
Joint Development Committee. Within [***] after the Effective Date, the Parties shall establish a joint development committee (the “Joint Development Committee” or the “JDC”), composed of one (1) representative of each Party, to guide the collaboration of the Parties under this Agreement and to oversee the exchange of information between the Parties with respect to the Development of Proprietary Drugs and Licensed Products until the end of the first Phase 3 Clinical Trial for any Licensed Product. Each JDC representative shall have appropriate knowledge and expertise and sufficient seniority within the applicable Party to make decisions arising within the scope of the JDC’s responsibilities. The JDC shall in particular:
(a) provide a forum for the discussion of the Development of Proprietary Drugs and Licensed Products until the end of the first Phase 3 Clinical Trial for any Licensed Product;
(b) oversee the transfer of Licensed Know-How and materials to Roivant under Section 2.4 (Initial Transfer of Know-How and Materials); and
(c) provide a forum for Roivant to keep TheraVida reasonably informed regarding the Development of Licensed Products including the status of any Regulatory Filings, Regulatory approvals, or clinical trials. The JDC shall have only such powers as are expressly assigned to it in this Agreement, and such powers shall be subject to the terms and conditions of this Agreement. For clarity, the JDC shall primarily be advisory and provide a forum for information exchange, with Roivant having ultimate decision making authority to the extent any decisions must be made by the JDC; provided, however, that neither the JDC, nor Roivant in the exercise of its ultimate decision making authority, shall have any right, power or authority: (i) to determine any issue in a manner that would conflict with the express terms and conditions of this Agreement; or (ii) to modify or amend the terms and conditions of this Agreement. Upon the first approval by the FDA of an NDA for any Licensed Product or the first approval by the EMA of an MAA for any Licensed Product (whichever occurs first), the JDC will cease to exist and the Parties will no longer have any obligations with respect to the JDC.
Joint Development Committee. The Parties will establish a single Joint Development Committee (the “JDC”) to oversee and coordinate the activities under all Research Programs in accordance with the remainder of this Article 3. The JDC shall be comprised of two (2) employees from Spyre or Aeglea and two (2) employees from Paragon, with each Party designating one (1) such employee as its JDC co-chairperson. Subject to the foregoing, each Party shall appoint its respective Representatives to the JDC from time to time, and may change its Representatives, in its sole discretion, effective upon notice to the other Parties designating such change. Representatives from each Party shall have appropriate technical credentials, experience and knowledge pertaining to and ongoing familiarity with the activities to be performed under the Research Programs.
Joint Development Committee. Within ninety (90) days from the Effective Date, the Parties shall establish a joint development committee (the “Joint Development Committee”) to coordinate and oversee the development of the Licensed Product in the Territory.
Joint Development Committee. (a) Each Member shall appoint four (4) members of a joint development oversight and management committee (the “Joint Development Committee” or “JDC”). Gilead Sub shall appoint one (1) of the members designated by Gilead Sub, to serve as chairperson of the JDC through the first anniversary of the Effective Date. Thereafter a member designated by BMS Sub and then a member designated by Gilead Sub shall serve alternately as chairperson, on a rotating annual basis from each anniversary of the Effective Date. The initial JDC members and the chairperson are identified in Annex A hereto. [ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
(b) Subject to the oversight of the JEC, the JDC shall have the following powers and duties: to (x) review and propose to the JEC for its approval each annual update of the Development Plan and Development Budget and (y) review and approve each interim update of the Development Plan and Development Budget, in each case proposed pursuant to Section 3.7; to oversee and coordinate the Parties’ activities under the Development Plan; to oversee and manage matters relating to clinical supply of the Combination Product, including, without limitation, Manufacturing requirements, inventory projections and inventory control; with the Alliance Managers, (x) to assist in coordinating scientific interactions between the Parties during the course of implementing the Development Plan and (y) to facilitate the exchange among the Parties of data, information, materials and results relating to clinical manufacturing, clinical trials, and communications and filings with Regulatory Authorities for the Combination Product (in each case solely to the extent that such data, information and materials are required to be exchanged among the Parties, or with respect to which one Member Party has the right to gain access from the other Member Party or the JV, pursuant to this Agreement or the Operating Agreement); to oversee regulatory matters for the JV, including, without limitation, approving all Combination Product Regulatory Documentation to the extent required pursuant to Section 3.4, overseeing Gilead’s activities as the JV’s liaison with Regulatory Authorities in the Territory, and overseeing the activities conducted pursuant to the SDEA and other pharmacovi...
Joint Development Committee. Within thirty (30) days of the Effective Date of this Agreement, GenuPro and Licensee shall assemble a JDC. Initially, the JDC will be composed of at least two, but no more than four, representatives each from GenuPro or its Affiliates and Licensee. The initial members of the JDC will be those representatives the names of whom will be provided to the other Party within ten days after the Effective Date. Each Party will promptly notify the other Party in writing of any change in its appointed representatives. The chairperson of the JDC will be one of Licensee’s representatives.