Joint Development Committee Clause Samples

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. Within [**] following the Effective Date, the Parties shall establish the JDC. The JDC shall: (a) discuss and approve any Additional Indication or Combination Therapy to be Developed in the Territory, or any clinical trial to be performed in whole or in part in the Territory, in each case, that is not set forth in the then-current Clinical Development Plan and is proposed by a Party in accordance with Section 4.3. If Hutchmed proposes a Local Trial to be added to the Clinical Development Plan, the JDC may approve converting such Local Trial into a Joint Global Trial; (b) discuss the current Clinical Development Plan and approve any updates or amendments to the Clinical Development Plan, including the addition of any Additional Indication, Combination Therapy or Local Trial or Joint Global Trial not set forth in the then-current Clinical Development Plan, and discuss the use of any relevant diagnostic in the Territory; (c) monitor and discuss the alignment of Hutchmed Entities’ Development of Licensed Products in the Territory with Epizyme’s Development of the Licensed Products outside of the Territory, and discuss and provide strategic guidance on the Development of the Licensed Products in the Field in the Territory; (d) discuss whether Hutchmed shall participate in a global trial for the Licensed Product presented by Epizyme, which would include clinical sites both in the Territory and outside the Territory; (e) discuss the clinical sites in the Territory to be included in each Local Trial and each Joint Global Trial; (f) discuss the protocols for each Local Trial and Joint Global Trial and discuss the status and progress thereof; (g) coordinate the operations of the Hutchmed Entities and Epizyme Entities with respect to Joint Global Trials; (h) discuss the budget for the Joint Global Trials (and approve the budget for costs under Section 9.3(c)(iii)) to be conducted under this Agreement; provided that each Party shall solely determine the budget for its activities in its respective territory; ​ (i) discuss and approve the Permitted Subcontractors defined in Section 1.145(a), if any, that may be used for Joint Global Trials by Hutchmed in the Territory; (j) discuss Pre-Clinical Research activities with respect to the Licensed Products that any Hutchmed Entity wishes to conduct in the Territory, and discuss the status and progress of such activities; (k) provide a forum for the Parties to share information with respect to the Development of the Licensed P...

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. Promptly after the Effective Date, the Parties shall form a Joint Development Committee (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 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. (a) Within ten (10) days after the Effective Date, a Joint Development Committee (“JDC”) shall be established with the responsibilities and authority set forth in this Section 3.4. The JDC shall consist of six (6) members, three (3) members to be appointed by each of Premas and Licensee. Each Party may, with notice to the other, substitute any of its members serving on the JDC and may invite ad hoc non-voting members as desired. The Parties may also, by mutual agreement, increase or decrease the number of members serving on the JDC; provided that the number of members representing each Party remains equal. Licensee will have the right to appoint one of its members to be the chairperson of the JDC. The JDC will be in place until the earlier of (i) expiration and/or termination of the Development Period or (ii) there is a written agreement between the Parties to disband the JDC. (b) The JDC shall have the responsibility and authority to: (i) provide a forum for exchange of information related to the development of Products in the Field in the Territory; (ii) review and discuss any proposed material amendments or updates to the Development Plan; (iii) oversee the implementation of the Development Plan; (iv) monitor the progress of the Development Plan against the metrics agreed to by the Parties (such as timeline and costs); and (iv) perform any other functions as the Parties may agree in writing. (c) The JDC shall hold meetings as mutually agreed by the Parties, but in no event less than quarterly unless Licensee and Premas mutually agree in writing (which may include email), no later than thirty (30) days in advance of any meeting following the initial meeting of the JDC, that no new business has transpired that would require a meeting of the JDC. Meetings may be held by telephone or video conference as agreed by the Parties. (d) The quorum for JDC meetings shall be four (4) members, provided there are at least two (2) members from each of Licensee and Premas present. The JDC will render decisions by unanimous vote. The members of the JDC shall act in good faith to cooperate with one another and to reach agreement with respect to issues to be decided by the JDC. (e) Disagreements among the JDC will be resolved via good-faith discussions; provided, that in the event of a disagreement that cannot be resolved within thirty (30) days after the date on which the disagreement arose, the matter shall be resolved as requested by Licensee. (f) At each JDC meeting, P...

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. 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.