REGULATORY ADMINISTRATION SERVICES BNY Mellon shall provide the following regulatory administration services for each Fund and Series: Assist the Fund in responding to SEC examination requests by providing requested documents in the possession of BNY Mellon that are on the SEC examination request list and by making employees responsible for providing services available to regulatory authorities having jurisdiction over the performance of such services as may be required or reasonably requested by such regulatory authorities; Assist with and/or coordinate such other filings, notices and regulatory matters and other due diligence requests or requests for proposal on such terms and conditions as BNY Mellon and the applicable Fund on behalf of itself and its Series may mutually agree upon in writing from time to time; and
Consultative Mechanism The parties agree that a precondition for the effective operation of the Agreement is the establishment of consultative mechanisms with the Company. To this end, a Consultative Committee, comprising of Company appointed representatives and employee elected representatives should be established and maintained. Officers of the Union shall have a standing invitation to attend any such meeting. The purpose of the Consultative Committee shall be to consult, develop, recommend and assist to implement strategies and measures designed to achieve the objectives outlined under Clause 4 of this Agreement.
Joint Commercialization Committee As of the Effective Date, the Parties have established a joint commercialization committee (the “Joint Commercialization Committee” or the “JCC”), composed of up to [ * ] representatives of each Party, to monitor and discuss the Commercialization of Products at the operational level. Each JCC representative shall have knowledge and expertise in the commercialization of products similar to Products. The JCC shall in particular:
(a) review and recommend the Commercialization Plans and related activities with respect to the Commercialization of Products in the Collaborator Territory, and report to the JEC on all significant Commercialization activities in the Collaborator Territory;
(b) provide a forum for and facilitate communications and coordination between the Parties with respect to the Commercialization of Products in the Collaborator Territory and the Exelixis Territory;
(c) on an annual basis, discuss and establish Collaborator’s Minimum Commercial Performance thresholds pursuant to Section 6.3(b) and propose recommendation to JEC; [ * ] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
(d) review the status of material Product manufacturing and supply activities and strategies associated with Commercialization;
(e) review and discuss the major findings of Collaborator’s market research with respect to any Product in the Collaborator Territory, if any;
(f) review and oversee the branding and product positioning strategy for Products in the Collaborator Territory and evaluate Collaborator’s brand strategy for the Product in the Collaborator Territory for consistency with the then-current global brand strategy for the Product;
(g) discuss Product list price and status of reimbursement in the Collaborator Territory; and
(h) perform such other functions as may be appropriate to further the purposes of this Agreement with respect to the Commercialization of Products, including endeavoring to resolve any disputes between the Parties arising from the deliberations of the JCC, or as otherwise directed by the JEC.
Commercialization Plan (a) Not later than three [***] after submission of Regulatory Filings for each Product in each country of the Territory, Licensee will provide to the JCC for review its initial Commercialization Plan for each Product for each country in the Territory. Such initial Commercialization Plan will describe Licensee’s plans for activities to be conducted for such Product for such country. Each Commercialization Plan shall include the details of obligations to be performed by Licensee to achieve the specific activities that are applicable to the stage of [***] 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. Commercialization (e.g., pre-launch, launch planning, launch, or post-launch) of the applicable Product during the time period covered by such Commercialization Plan and subsequent time periods.
(b) Prior to the First Commercial Sale for such Product in such country, Licensee will provide to the JCC for review an updated Commercialization Plan for such Product for such country. Such updated Commercialization Plan will include, but not be limited to, Licensee’s updated plans for activities to be conducted for such Product for such country prior to launch as well as activities to be conducted in connection with such launch.
(c) Promptly after each anniversary of the First Commercial Sale of such Product during the Term, Licensee will provide to the JCC for review updated Commercialization Plans for such Product for such country. Such further updated Commercialization Plan will include, but not be limited to, Licensee’s plans for Commercialization activities for such Product and such country for the twelve (12) month period following the date of delivery of such Commercialization Plan. No Commercialization Plan may be implemented by Licensee if [***]. Each Commercialization Plan shall be consistent with and shall not contradict the terms of this Agreement [***], and in the event of any inconsistency between the Commercialization Plan and this Agreement, the terms of this Agreement shall prevail. Notwithstanding the foregoing, if a [***], Licensee shall [***] and shall promptly [***].
CONSULTATIVE MECHANISMS 11.1 Effective consultation is essential for continuous workplace reform and such consultation can take place at any time during the life of a project. Consultative Committees may be set up on larger projects for this purpose. The Consultative Committee will operate for the purpose of continually assessing the efficiency of working arrangements, monitoring the outcomes of this Agreement, coordinating training activities and sharing pertinent information.
Commercialization Intrexon shall have the right to develop and Commercialize the Reverted Products itself or with one or more Third Parties, and shall have the right, without obligation to Fibrocell, to take any such actions in connection with such activities as Intrexon (or its designee), at its discretion, deems appropriate.
Technical Committee 1. The Technical Committee shall comprise:
(a) nine experts representing different regions of the Agreement Area, in accordance with a balanced geographical distribution;
(b) one representative from the International Union for Conservation of Nature and Natural Resources (IUCN), one from the International Waterfowl and Wetlands Research Bureau (IWRB) and one from the International Council for Game and Wildlife Conservation (CIC); and
(c) one expert from each of the following fields: rural economics, game management, and environmental law. The procedure for the appointment of the experts, the term of their appointment and the procedure for designation of the Chairman of the Technical Committee shall be determined by the Meeting of the Parties. The Chairman may admit a maximum of four observers from specialized international inter- governmental and non-governmental organizations.
2. Unless the Meeting of the Parties decides otherwise, meetings of the Technical Committee shall be convened by the Agreement secretariat in conjunction with each ordinary session of the Meeting of the Parties and at least once between ordinary sessions of the Meeting of the Parties.
3. The Technical Committee shall:
(a) provide scientific and technical advice and information to the Meeting of the Parties and, through the Agreement secretariat, to Parties;
(b) make recommendations to the Meeting of the Parties concerning the Action Plan, implementation of the Agreement and further research to be carried out;
(c) prepare for each ordinary session of the Meeting of the Parties a report on its activities, which shall be submitted to the Agreement secretariat not less than one hundred and twenty days before the session of the Meeting of the Parties, and copies shall be circulated forthwith by the Agreement secretariat to the Parties; and
(d) carry out any other tasks referred to it by the Meeting of the Parties.
4. Where in the opinion of the Technical Committee there has arisen an emergency which requires the adoption of immediate measures to avoid deterioration of the conservation status of one or more migratory waterbird species, the Technical Committee may request the Agreement secretariat to convene urgently a meeting of the Parties concerned. These Parties shall meet as soon as possible thereafter to establish rapidly a mechanism to give protection to the species identified as being subject to particularly adverse threat. Where a recommendation has been adopted at such a meeting, the Parties concerned shall inform each other and the Agreement secretariat of measures they have taken to implement it, or of the reasons why the recommendation could not be implemented.
5. The Technical Committee may establish such working groups as may be necessary to deal with specific tasks.
Statewide HUB Program Statewide Procurement Division Note: In order for State agencies and institutions of higher education (universities) to be credited for utilizing this business as a HUB, they must award payment under the Certificate/VID Number identified above. Agencies, universities and prime contractors are encouraged to verify the company’s HUB certification prior to issuing a notice of award by accessing the Internet (xxxxx://xxxxx.xxx.xxxxx.xx.xx/tpasscmblsearch/index.jsp) or by contacting
CENTRAL LABOUR RELATIONS COMMITTEE C4.1 OPSBA, the Crown and OSSTF agree to establish a joint Central Labour Relations Committee to promote and facilitate communication between rounds of bargaining on issues of joint interest.
Development Plan document specifying the work program, schedule, and relevant investments required for the Development and the Production of a Discovery or set of Discoveries of Oil and Gas in the Concession Area, including its abandonment.
