Formation and Purpose. Promptly following the Effective Date, the Parties shall confer and then create the JSC and the IPC, and, optionally, create one or more of the other Committees listed in the chart below. Each Committee shall have the purpose indicated in the chart. To the extent that after conferring both Parties agree to not create a Committee (other than the JSC and the IPC), the creation of such Committee shall be deferred until one Party informs the other Party of its then desire to create the so-deferred Committee, at which point the Parties will thereafter promptly create the so-deferred Committee. Joint Steering Committee (“JSC”) Establish projects for the Bacteriophage Program and establish the priorities, as well as approve budgets for such projects. Approve all subcommittee projects and plans (except for decisions of the IPC). The JSC shall establish budgets not less than on a quarterly basis. Chemistry, Manufacturing and Controls Committee (“CMCC”) Establish project plans and review and approve activities and budgets for chemistry, manufacturing, and controls under the Bacteriophage Program. Regulatory Committee (“RC”) Review and approve all research and development plans and projects, including clinical projects, associated with any necessary regulatory approvals, all associated publications, and all regulatory filings and correspondence relating to gaining regulatory approval for new Ampliphi Products under the Bacteriophage Program; and review and approve itemized budgets with respect to the foregoing. Commercialization Committee (“CC”) Establish project plans and review and approve activities and budgets for Commercialization activities under the Bacteriophage Program. Portions herein identified by [*****] have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. A complete copy of this document has been filed separately with the Securities and Exchange Commission. Intellectual Property Committee (“IPC”) Evaluate all intellectual property issues in connection with the Bacteriophage Program; review and approve itemized budgets with respect to the foregoing.
Formation and Purpose. A. Authority State and the Contractor enter into this Exhibit A, Attachment I, by authority of Chapter 3 of Part 1, Division 10.5 of the Health and Safety Code (HSC) and with approval of Contractor’s County Board of Supervisors (or designee) for the purpose of providing alcohol and drug services, which shall be reimbursed pursuant to Exhibit A, Attachment
I. State and the Contractor identified in the Standard Agreement are the only parties to this Intergovernmental Agreement. This Intergovernmental Agreement is not intended, nor shall it be construed, to confer rights on any third party.
B. Control Requirements
1) Performance under the terms of this Exhibit A, Attachment I, is subject to all applicable federal and state laws, regulations, and standards. In accepting DHCS drug and alcohol combined program allocation pursuant to HSC Sections 11814(a) and (b), Contractor shall: (i) establish, and shall require its subcontractors to establish, written policies and procedures consistent with the following requirements; (ii) monitor for compliance with the written procedures; and (iii) be held accountable for audit exceptions taken by DHCS against the Contractor and its subcontractors for any failure to comply with these requirements:
a) HSC, Division 10.5, commencing with Section 11760; b) Title 9, California Code of Regulations (CCR) (herein referred to as Title 9), Division 4, commencing with Section 9000;
Formation and Purpose. The Parties agree to establish and convene a joint steering committee (the “JSC”) within [**] after the Effective Date. The JSC shall consist of representatives from each Party as further described in Section 2.1(d) and operate in accordance with this Section 2.1. The purpose of the JSC shall be to provide a forum for the overall coordination, communication and oversight of the Parties’ activities under this Agreement, including the resolution of disputes properly referred to the JSC under this Agreement. The JSC shall be dissolved upon the expiration of the Research Term, unless otherwise agreed in writing by the Parties.
Formation and Purpose. Within thirty (30) days after the Effective Date, the Parties shall promptly establish and convene a Joint Steering Committee (the “Joint Steering Committee” or “JSC”) in accordance with Section 2.3(c)(i) that will direct and oversee activities relating to the Licensed Products under this Agreement. The JSC shall consist of representatives and operate by the procedures in accordance with Section 2.3. Except as otherwise provided herein, the role of the Joint Steering Committee shall be:
Formation and Purpose. 2.1 Formation.......................................................13 2.2 Name............................................................13 2.3 Principal and Registered Office.................................14 2.4 Term............................................................14 2.5
Formation and Purpose. Within [***] ([***]) days after the Effective Date, the Parties shall establish a joint development committee (the “JDC”), which shall perform the primary function of designing, implementing, monitoring, reviewing and discussing the Development Plan and Development budget for the Product, including progress and performance thereunder, and for proposing updates or amendments to the Development Plan and Development budget for approval by the JSC.
Formation and Purpose. Within [***] ([***]) days after the Effective Date, the Parties shall establish a joint commercialization committee (the “JCC”), which shall perform the primary functions of:
(a) facilitating cooperation and coordination between the Parties regarding Commercialization matters;
(b) designing, implementing, monitoring, reviewing and discussing the Commercialization Plan and Commercialization budget for the Product, including progress and performance thereunder, and for proposing updates or amendments to the Commercialization Plan and Commercialization budget for approval by the JSC;
(c) monitoring, reviewing, coordinating, and discussing the overall progress of Commercialization under this Agreement; and
(d) providing regular updates, and making recommendations (as appropriate), to the JSC regarding the foregoing matters.
Formation and Purpose. Within [***] ([***]) days after the Effective Date, the Parties shall establish a joint manufacturing committee (the “JMC”) which will have strategic oversight of the manufacture and distribution of the Products including receiving updates from Orexigen regarding the Third Party Manufacturers, and monitoring the production capabilities of the Third Party Manufacturers in order that Takeda may forecast when Takeda demand for the Products in a given [***] exceed (or are likely to exceed) the maximum production capability of the Third Party Manufacturers in such [***] and overseeing the arrangements for the distribution of Products which are to be delivered as specified on the relevant binding order.
Formation and Purpose. Promptly after the Effective Date, the Parties shall create a joint supply committee (the “JSC”) to facilitate the management and implementation of the Parties’ activities with regard to the Manufacture and supply of Collaboration Products worldwide. The JSC shall have the membership and shall operate by the procedures set forth in Section 2.6.
Formation and Purpose. Promptly after the Effective Date, the Parties shall create a joint intellectual property committee (the “JIPC”) to facilitate the exchange of information between the Parties to the extent required by this Agreement regarding the prosecution, maintenance and enforcement of the Licensed Patents, Licensed Know-How, Shire Collaboration Patents, Shire Collaboration Know-How, and Joint Inventions. The JIPC shall have the membership and shall operate by the procedures set forth in Section 2.6.
