Joint Development Committee Clause Samples
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. 8.2.1 The Parties hereby establish a joint development committee (“JDC”) with the responsibility to oversee, review and coordinate the Development of the Licensed Antibodies and Licensed Products in the Field in the Territory. Subject to the oversight of the JSC, the JDC shall perform the following functions, subject to the final decision-making authority of the respective Parties as set forth in Section 8.7.4:
(a) in consultation with the JMC (with respect to supply of Licensed Antibodies and Licensed Products), discussing, preparing and submitting to the JSC for approval material amendments to the Joint Development Plan (including the budget therein), on at least an annual basis, and reviewing, discussing and approving all other amendments to the Joint Development Plan (including the budget therein); provided that if either Party’s representative(s) on the JDC believes that an amendment is material, then such amendment shall be submitted to the JSC for approval;
(b) overseeing and monitoring all Development activities for the Territory, including the implementation of the Joint Development Plan and the costs incurred;
(c) creating, implementing and reviewing the overall strategy for Development of the Licensed Antibodies and Licensed Products (including the Global Regulatory Strategy) and the design and objectives of all Clinical Trials and non-clinical studies conducted under the Joint Development Plan;
(d) preparing the Global Regulatory Strategy for inclusion within the Joint Development Plan;
(e) facilitating the exchange of all regulatory information and data between the Parties and ensuring all regulatory reviews by and between the Parties are conducted in parallel (not sequentially) and on a timely basis;
(f) reviewing and approving all Regulatory Documentation for the Licensed Antibody or any Licensed Products in the Territory (other than (i) Pricing and Reimbursement Approvals and (ii) with respect to Clinical Trials under the Independent Development Plan), including for consistency with the Global Regulatory Strategy; (g) reviewing the regulatory documentation on Schedule 4.2.5 with respect to activities under the Independent Development Plan;
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. The Parties will establish a joint development committee (“JDC” or “Joint Development Committee”) within 30 days after the Effective Date to oversee, coordinate, and discuss development of the Instrument and Cartridges as set forth in the applicable SOWs attached to this Agreement, and the Parties’ corresponding activities under this Agreement.
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. 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. As soon as practicable but no later than [***] after the Effective Date, the Parties shall establish a joint development committee (the “Joint Development Committee”) to monitor and facilitate the Development of Licensed Products in the Field in the Territory and the ROW 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. 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.
Joint Development Committee i. As soon as practicable following the Commencement Date, the Parties shall establish a joint development committee (“JDC”) to oversee the regulatory and development efforts regarding the [**] Development and any Joint New Development. The JDC shall be comprised of an equal number of representatives of USWM and BPL (who need to be employees of such Party), not to exceed three from each Party, and shall include at least one person who has a technical role and one who has a commercial role within that Party’s organisation. At least [**] days prior to the [**] and thereafter in each case of a change of the representative each Party shall give written notice with full details about the name, employer and professional background of each representatives. In case a Party has any serious objections against a representative for a Joint Development Committee named by the other Party, said Party shall make such objections known to the other Party. The other Party shall thereupon in good faith consider said objections and upon such consideration may, at its sole discretion, name another representative. If a Party wishes to appoint a representative who is not an employee of such Party, the other Party may no later than [**] Business Days following notice of such proposed appointment veto the appointment of such consultant, but such veto shall not be unreasonably exercised. The appointing Party shall ensure that such consultant is bound by agreements (in particular confidentiality and assignment of Intellectual Property Rights obligations) containing provisions which are consistent with the terms and conditions of this Agreement. The Party appointing such consultant shall be liable for any breach of this Clause 6.5.1.
ii. The JDC shall agree on the regulatory and development efforts regarding the [**] Development and any Joint New Development, as well as any Peripherals to be marketed with other Products, which shall include: 37155043.2 [**] = CERTAIN CONFIDENTIAL INFORMATION OMITTED
a. the receipt of regular reports from each Party’s Project Leader on, and monitor, the conduct, nature, progress and results of the [**] Development or Joint New Development (recognising that the day-to-day monitoring of data and results from the same shall be the responsibility of such Project Leader);
b. defining the milestones and objectives of the [**] Development or the Joint New Development and determine if each milestone or objective in respect thereof has been met;
c. supervising ...