Formation and Purpose Sample Clauses

Formation and Purpose. In order to oversee, review and coordinate the activities of the Parties under this Agreement, Pfenex and Hospira will form an executive steering committee promptly after the Signature Date (the “Executive Steering Committee”), whose initial members are listed in that certain memorandum exchanged between the Parties on the Signature Date and referencing this Agreement. The Executive Steering Committee shall, in accordance with the procedures set forth in Section 7.4, (a) review and comment on the development, manufacture and commercialization of Product, including the Development Plan, the Technical Transfer Plan, and any clinical protocols for the conduct of the Comparative Clinical Study, (b) consult with Hospira regarding Hospira’s plan for seeking Regulatory Approval, (c) review and approve any modifications or amendments to the Development Plan, (d) review and approve the clinical protocols for the conduct of the Comparative Clinical Study and any modifications or amendments thereto, (e) review and approve the Technical Transfer Plan and any modifications or amendments thereto, (f) review and comment on the IP Strategy and any modifications or amendments thereto, (g) serve as a forum for discussion for matters relating to the development, manufacture and commercialization of Product, (h) establish an estimated budget for Regulatory Approval Costs to be paid by Hospira for each calendar year by October 31st of the prior calendar year, (i) establish one or more working committees, which shall include a product development working committee, a manufacturing working committee and other working groups, committees and subcommittees as may be established by mutual consent of Pfenex and Hospira (each, a “Working Committee”), and (j) performing such other duties as are specifically assigned to the Executive Steering Committee in this Agreement. The Executive Steering Committee shall be the primary forum for Pfenex and Hospira to communicate with one another regarding the plans for, and progress of, the development and commercialization of Product as well as any associated problems. [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

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. 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. 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. A. This Exhibit A, Attachment I A1, Part V of the Contract is entered into by and between the State and the Contractor for the purpose of identifying and providing for covered DMC services for substance use disorder treatment in the Contractor’s service area pursuant to Sections 11848.5(a) and (b) of the Health and Safety Code (hereinafter referred to as HSC), Sections 14124.20, 14021.51 – 14021.53, and 14124.20 – 14124.25 of the W&I , and Title 22 of the California Code of Regulations (hereinafter referred to as Title 22), Sections 51341.1, 51490.1, and 51516.1. B. It is further agreed this Contract is controlled by applicable provisions of: (a) the W&I, Chapter 7, Sections 14000, et seq., in particular, but not limited to, Sections 14100.2, 14021, 14021.5, 14021.6, 14043, et seq., (b) Title 22, including but not limited to Sections 51490.1, 51341.1 and 51516.1; and (c) Division 4 of Title 9 of the California Code of Regulations (hereinafter referred to as Title 9).

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.

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.