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. 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 [***] ([***]) days following the Effective Date, the Parties shall establish the JDC. The JDC shall:
(a) discuss the Preclinical Development Plan and Clinical Development Plan and any proposed updates or amendments to the same (including the addition of indications), and propose revisions to such plans in accordance with Section 4.01 (Joint Development in the Field in the Territory);
(b) secure alignment of the Astellas Entities’ Development of Licensed Products in the Astellas Territory with Frequency’s Development of the Licensed Products in the Frequency Territory;
(c) discuss, with respect to each clinical study and on an indication-by-indication basis, whether to include clinical sites in both Parties’ respective portions of the Territory and whether such study shall be a Joint Study or a Regional Study; [***] Certain information in this document has been excluded pursuant to Regulation S-K, Item 601(b)(10). Such excluded information is not material and would likely cause competitive harm to the registrant if publicly disclosed.
(d) discuss the clinical sites in the Territory to be included in each Joint Study;
(e) for each Joint Study, coordinate the operations of the Frequency Entities and Astellas Entities with respect to such Joint Study;
(f) discuss the contract research organizations in the Territory to be used for each Joint Study;
(g) provide a forum for the Parties to share information with respect to the Development of the Licensed Products in the Field, including reasonably detailed updates on progress and status of Regional Studies and Joint Studies in the Territory and updates regarding interactions with Regulatory Authorities;
(h) discuss publications and publication plans as to the Development and Commercialization of Licensed Products in the Territory;
(i) discuss, coordinate and provide strategic guidance on the Development of the Licensed Products in the Field in the Territory;
(j) discuss the content of any IND or Drug Approval Application for any Licensed Product in the Territory;
(k) provide a forum for the Parties to share and discuss GCP quality information with respect to each Party’s Development activities;
(l) discuss and establish a GCP Quality Plan within [***] ([***]) days following the Effective Date;
(m) submit recommendations to the JSC regarding the matters set forth above; and
(n) perform such other duties as are specifically assigned to the JDC under this Agreement.
Joint Development Committee. The Parties hereby establish a joint development committee (the “JDC”), to coordinate and oversee the Development of the Product in the Norgine Territory before Regulatory Approval therein. The JDC shall consist of [***] representatives from each Party. The Parties shall ensure that each of their representatives on the JDC shall have knowledge and on-going familiarity with the Product, this Agreement and the activities hereunder, and shall be of suitable seniority and possess the authority to make decisions reserved to the JDC. AMAG shall designate [***] of its representatives as the initial chairperson of the JDC. The chairperson of the JDC shall alternate between the Parties on an annual basis. Each Party may replace its appointed JDC representatives at any time upon reasonable written notice to the other Party. The initial representatives and chair of the JDC shall be established within [***] after the Effective Date. The chair, in conjunction with the Alliance Managers, shall have the responsibility to call meetings, circulate meeting agendas at least [***] prior to each regular JDC meeting, draft minutes for each JDC meeting and circulate such minutes for both Parties’ written approval. The chair shall have no other authority or special voting power. The JDC may, in its discretion, form sub-teams or subcommittees to address any of the issues within its purview.
(a) Responsibilities of the JDC. The JDC shall have the following responsibilities: ACTIVE/105730326.3
(i) the general strategy and budget for the Development of the Product, including for seeking and obtaining Regulatory Approval of the Product in the Norgine Territory, pursuant to the global development plan for the Phase 3 Program attached hereto as Exhibit B, which shall be reviewed and updated [***] by the JDC (as amended from time to time, the “Development Plan”), and agreeing to the Phase 3 Budget;
(ii) alignment on protocol and strategy for the Pivotal Clinical Trial, and determining whether to suspend or terminate the Pivotal Clinical Trial if (A) a priori protocol defined stopping rules are met for safety or efficacy, (B) safety signals are observed by either Party that such Party believes present an unacceptable risk to patients participating in the Pivotal Clinical Trial or (C) if applicable, the data and safety monitoring board overseeing the Pivotal Clinical Trial determines the Product presents an unacceptable risk to patients participating in the Pivotal Clinical Trial; provided...
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. 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. 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 [***] 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.
