Operational Provisions. 1. Transmission of inspection reports Upon reasoned request, the relevant inspection services shall forward a copy of the last inspection report of the manufacturing site or control site, in the case where analytical operations are contracted out. The request may concern a ‘full inspection report’ or a ‘detailed report’ (see item 2 below). Each Party shall deal with these inspection reports with the degree of confidentiality requested by the Party of origin. If the manufacturing operations of the medicinal product in question have not been inspected recently, i.e. when the last inspection dates back to more than two years or a particular need to inspect has been identified, a specific and detailed inspection may be requested. Parties shall ensure that inspection reports are forwarded in no more than 30 calendar days, this period being extended to 60 days should a new inspection be carried out.
Operational Provisions. Contractor shall develop and maintain administrative and management staff and systems necessary and appropriate for Insert Type of Agreement Contract. Such systems include, without limitation, accounting controls, personnel standards, evaluation procedures, staff training and development as well as other policies that are necessary to operate the program including those specified in the SDWP Operations Manual as may be modified and amended from time to time. These administrative and management systems, policies and/or controls must, in SDWP’s sole discretion, meet SDWP standards. Contractor shall immediately advise SDWP of any changes to the administrative and management systems, policies and/or controls as referenced in Attachment D- Contractor’s Original Proposal or that may affect the program services, operation and/or performance of the program. Contractor shall maintain or exceed all products and services currently provided through this Insert Type of Agreement Contract and at all times shall emphasize coordination and cooperation with SDWP.
Operational Provisions. The Borrowing Base shall be administered by the Lender as follows:
Operational Provisions. Special provisions for identifying Products being purchased by EMC are set forth in the attached Exhibit D.
Operational Provisions. 9.1.1. PG&E will form a Diversion and Curtailment Working Group to explore alternatives and/or clarifications to PG&E’s current rules relating to a system supply diversion or to a local transmission curtailment. These events are driven by supply shortages and/or by very cold weather, usually over several days. Although these events are infrequent, some Parties are concerned that the current rules and mechanisms for managing such crisis events may not properly reflect current policies, especially those related to the operation of gas-fired electric generation. The Working Group will explore this and other related diversion and curtailment issues raised by participants in the Working Group.
Operational Provisions. While this Agreement is in effect, the following actions may be taken with respect to the Company only with the consent of each Shareholder:
Operational Provisions. The Tenant’s use and operation of the Improvements and the Premises shall also be subject to the District’s laws and regulations governing the use and operation of District property. Certain operational provisions for Tenant are set forth in Exhibit F. The operational provisions constitute obligations of Tenant additional to all other obligations set forth in this Lease. If a conflict arises in connection with any operational guideline and any obligation set forth in this Lease, Tenant shall inform District and District shall determine, at its sole discretion, which obligations Tenant must fulfill. Exhibit F may be amended at any time by the mutual agreement of the parties hereto, which agreement shall be evidenced by the signature of an authorized representative of each party on a revised version of Exhibit F. Any such amendment shall be effective as of the date thereof and shall replace the then current version of Exhibit F, but shall have no other effect on the content and validity of this Lease.
Operational Provisions. Field Based Roles
Operational Provisions. The agreement foresees in Section III exchange of documents and information and joint activities. For this a number of documents have been drafted and agreed. Joint Sectoral Group Establishment of a Joint Sectoral Group is recommended with the proposed Terms of Reference detailed in Attachment 1. Information Exchange A maintenance programme has been developed. The programme will cover both human and veterinary medicinal products and includes provision for information exchange, inspectors’ training and joint inspections. Alert System – The EC uses the EC procedure ENTR/6266/00 for notifying Rapid Alerts and Recalls arising from Quality Defects. – Australian authorities are using the same classification and criteria of the EC’s procedure in their own recall procedures. Batch and GMP Compliance Certificates Standard formats for Certificate of GMP Compliance of Manufacturer and Batch Certificate have been developed to facilitate operation of the Agreement. The Certificate of GMP Compliance of Manufacturer is a proposed revision of the ‘Certificate of Pharmaceutical Manufacturer’ included in Appendix 2 of the Agreement. The Certificate of GMP Compliance of Manufacturer is submitted as Attachment 2 for consideration and endorsement by the Joint Committee. Guide to the Medicinal Annex of the EC-Australia MRA A guide to the Medicinal Product Annex of the Agreement is being prepared to facilitate its understanding by industry and regulators. Official Batch Release The parties have not been able to reach an understanding on whether the official batch release provisions of Section III, paragraph 8 of the Annex apply to both human and veterinary immunological medicinal products (vaccines) and blood derivatives. The Joint Committee is requested to clarify whether these provisions apply to veterinary immunological medicinal products.
Operational Provisions. Contractor shall develop and maintain administrative and management staff and systems necessary and appropriate Out-of School Youth WIOA Youth Program for Youth Services Contract. Such systems include, without limitation, accounting controls, personnel standards, evaluation procedures, staff training and development as well as other policies that are necessary to operate the program including those specified in the SDWP Operations Manual as may be modified and amended from time to time. These administrative and management systems, policies and/or controls must, in SDWP’s sole discretion, meet SDWP standards. Contractor shall immediately advise SDWP of any changes to the administrative and management systems, policies and/or controls as referenced in Attachment F- Contractor’s Original Proposal or that may affect the program services, operation and/or performance of the program. Contractor shall maintain or exceed all products and services currently provided through this Out-of-School WIOA Youth Program for Youth Services Contract in San Diego County and at all times shall emphasize coordination and cooperation with SDWP.
