Example ContractsClausesJoint Manufacturing Committee
Joint Manufacturing Committee
Joint Manufacturing Committee contract clause examples

Joint Manufacturing Committee. The JMC will act as an information-sharing forum with respect to the Manufacture of clinical and commercial supplies of ACTR T-cells and SGI Antibodies for a Reversion Product. The Continuing Party will provide such information and data regarding the Manufacture of the Reversion Product as the JMC would customarily receive regarding a Product to the extent that it specifically relates to, if Unum is the Opt-Out Party, ACTR T-cells or the ​ INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED

Joint Manufacturing Plan. All Manufacturing of ACTR T-cells and SGI Antibodies in the Territory will be conducted pursuant to a joint manufacturing plan to be prepared as follows: # SGI will be responsible for preparing the portions of the joint manufacturing plan relating to SGI Antibodies, and # Unum will be responsible for preparing the portions of the joint manufacturing plan relating to ACTR T-cells.

Specific Responsibilities of the Joint Manufacturing Committee. Subject to [Section 4.5(d)], the JMC will be responsible for coordinating and overseeing the Manufacturing activities under this Agreement with respect to Research Candidates, Development Candidates and Products in the Territory in accordance with the Supply Agreements, in particular the JMC will provide a venue for the discussions contemplated by Section 9.6 and Section 9.7. In additions, # topics to be discussed will include intellectual property protection and freedom-to-operate concerns for Manufacturing activities and # the JMC may provide Manufacturing updates to the JSC.

Joint Development Committee. In accordance with Section 6.6(c), the JDC will act as an information-sharing forum with respect to the Research and Development of each Reversion Product. The Continuing Party will provide such information and data regarding the Development of the Reversion Product as the JDC would customarily receive regarding a Product to the extent that it specifically relates to, if Unum is the Opt-Out Party, ACTR T-cells or the ACTR platform technology and, if SGI is the Opt-Out Party, the applicable SGI Antibody. In addition, the Continuing Party will provide summaries of all other material information and data regarding the Development of such Reversion Product. The Parties acknowledge and agree that the Joint Development Committee will have no decision-making authority or approval rights with respect to a Reversion Product.

Joint Steering Committee. Promptly following the Effective Date, the Parties shall establish a joint steering committee (the “JSC”) to provide for the exchange of information and ideas regarding the continued research and development of the Licensed Compounds, to plan and monitor the conduct of such research and activities during the Term and to provide and receive updates regarding the invention or development of any Improvements. The JSC shall not have any decision-making authority and is not authorized to ​ or to ​. Each of the Parties shall designate in writing ​ representatives to the JSC. Each Party shall have the right at any time to substitute individuals, on a permanent or temporary basis, for any of its previously designated representatives to the JSC by giving written notice to the other Party. The JSC shall establish a schedule of times for regular meetings to be conducted by teleconference or in person as it shall determine. The Parties shall each bear all expenses of their respective JSC representatives related to their participation on the JSC and attendance at JSC meetings; provided that if Spero reimburses any of its, or its Affiliates, officers, directors or employees for such participation it shall so notify Northern and it shall reimburse Northern for the participation of any of its, or its Affiliates, officers, directors or employees for such participation on the same terms.

“Committee” means the Joint Steering Committee, Joint Development Committee, Joint Commercialization Committee or Joint Manufacturing Committee, or any other subcommittee established under Article 4, as applicable.

“Joint Manufacturing Committee” or “JMC” means the committee formed by the Parties as described in [Section 4.5(a)].

Joint Committee Dispute Resolution. If the JDC or JCC cannot, or does not, reach consensus on an issue within the scope of its authority as defined in this Agreement at a meeting or within a period of […​…] thereafter or such other period as the Parties may agree, then the dispute shall be referred to the JSC for resolution and a special meeting of the JSC may be called for such purpose. If the JSC cannot, or does not, reach consensus on an issue within […​…] of said issue being referred to the JSC for resolution, including any dispute arising in the JDC or JCC, then the dispute shall first be referred to the Senior Officers of the Parties, who shall confer in good faith on the resolution of the issue. Any final decision mutually agreed to by the Senior Officers shall be conclusive and binding on the Parties. If the Senior Officers are not able to agree on the resolution of any such issue within […​…] after such issue was first referred to them, then, such dispute shall be finally and definitively resolved by […​…]. Notwithstanding the foregoing, disputes related to the […​…] Development Plan and RA Phase 3 Development Plan shall not be subject to the escalation procedures set forth in this Section 2.4.3. Disputes arising between the Parties in connection with or relating to this Agreement or any document or instrument delivered in connection herewith, and that are outside of the jurisdiction of the JSC, shall be resolved pursuant to Section 13.8.

Manufacturing. Notwithstanding that Axsome’s grant of the license to Licensee under Section 2.1 is not conditioned on Licensee electing to have Axsome manufacture Licensed Product for Licensee, Licensee shall have the option to have Axsome Manufacture or have Manufactured the Licensed Compound and any Licensed Products for use by Licensee. If Licensee makes such election it shall notify Axsome immediately after the Effective Date and thereafter the Parties, within thirty (30) days after the Effective Date, shall negotiate and enter into such supply agreement that contains the terms in the manufacturing term sheet attached hereto as [Schedule 3.6] the together with other material and non-material terms typically included in agreements of such type and scope (the “Supply Agreement”). In the event Licensee exercises such option and the Parties enter into the Supply Agreement, Licensee shall purchase from Axsome all requirements of any such Licensed Products at the price set forth therein.

The Transition Agreement will require the Opt-Out Party or its Affiliate to enter into a supply and quality agreement to supply or have supplied the applicable SGI Antibody or ACTR T-cells (as the case may be) in the Reversion Product to the Continuing Party until such time as the Continuing Party provides written notice to the Opt-Out Party of its decision, in its sole discretion, to cease permanently the Research, Development, and Commercialization of such Reversion Product. The cost to the Continuing Party for such supply will be the Manufacturing Costs plus a ​ markup for the applicable SGI Antibody or ACTR T-cells (as the case may be) in the Reversion Product.

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