Change Control Operating Procedure Sample Clauses

Change Control Operating Procedure. The procedure to be followed if either GSK Canada or Corixa desires to change any aspect of the Product, including without limitation, any change in validation requirements, or the Specifications, shall be set forth in the Quality Policy Manual (such procedure is hereinafter referred to as the "Change Control Operating Procedure"). The Parties agree to comply with the terms of the Quality Policy Manual including, without limitation, the Change Control Operating Procedure.
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Change Control Operating Procedure. The procedure to be followed if either Corixa or Nordion desires to change any aspect of the manufacturing procedure for Labeled Drug, including without limitation, any change in Validation requirements, the Specifications as described in Section 4.4(a) above, the B1 Antibody specifications or the CD-20 Antigen Cell specifications is set forth in ---------------------------------- * Confidential treatment requested. the Quality Policy Manual (such procedure is hereinafter referred to as the "Change Control Operating Procedure"). Until such time as the Change Control Operating Procedure is agreed to by the Parties, they shall continue to follow the existing change control procedures. In addition, Nordion undertakes not to implement any change to the Isotope Specifications or modification to the Isotope process that could impact the quality or safety of the Isotope or the Labeled Drug or impact the BLA without the prior written consent of Corixa, not to be unreasonably withheld. The Parties agree to comply with the terms of the Quality Policy Manual, including, without limitation, such Change Control Operating Procedure.
Change Control Operating Procedure 

Related to Change Control Operating Procedure

  • Change Control Procedures (a) No changes or additions may be made to any Work Order without the written agreement of LAUSD as evidenced by a duly executed Change Order.

  • Change Control All systems processing and/or storing PHI COUNTY discloses to 14 CONTRACTOR or CONTRACTOR creates, receives, maintains, or transmits on behalf of COUNTY 15 must have a documented change control procedure that ensures separation of duties and protects the 16 confidentiality, integrity and availability of data.

  • Reporting Procedures Enter in the XXX Entity Management area the information that XXX requires about each proceeding described in paragraph 2 of this award term and condition. You do not need to submit the information a second time under assistance awards that you received if you already provided the information through XXX because you were required to do so under Federal procurement contracts that you were awarded.

  • Operational Control Directing the operation of the Transmission Facilities Under ISO Operational Control to maintain these facilities in a reliable state, as defined by the Reliability Rules. The ISO shall approve operational decisions concerning these facilities, made by each Transmission Owner before the Transmission Owner implements those decisions. In accordance with ISO Procedures, the ISO shall direct each Transmission Owner to take certain actions to restore the system to the Normal State. Operational Control includes security monitoring, adjustment of generation and transmission resources, coordination and approval of changes in transmission status for maintenance, determination of changes in transmission status for reliability, coordination with other Control Areas, voltage reductions and Load Shedding, except that each Transmission Owner continues to physically operate and maintain its facilities.

  • Accounting Procedures 7.3.1. Principal and Interest Computation.......................... 7.3.2.

  • Exchange Control Notification Exchange control reporting is required for cash transactions exceeding A$10,000 and international fund transfers. If there is an Australian bank assisting with the transaction, the Australian bank will file the report for the Participant. If there is no Australian bank involved in the transaction, the Participant must file the report.

  • Change Management BellSouth provides a collaborative process for change management of the electronic interfaces through the Change Control Process (CCP). Guidelines for this process are set forth in the CCP document as amended from time to time during this Agreement. The CCP document may be accessed via the Internet at xxxx://xxx.xxxxxxxxxxxxxxx.xxxxxxxxx.xxx.

  • Accounting Policies and Procedures Permit any change in the accounting policies and procedures of the Company or any Guarantor, including a change in fiscal year, provided, however, that any policy or procedure required to be changed by the Financial Accounting Standards Board (or other board or committee thereof) in order to comply with Generally Accepted Accounting Principles may be so changed.

  • Internal Control Over Financial Reporting The Company and each of its Subsidiaries maintain a system of internal control over financial reporting (as such term is defined in Rule 13a-15(f) of the Exchange Act Regulations) that complies with the requirements of the Exchange Act and the Exchange Act Regulations and has been designed by the Company’s principal executive officer and principal financial officer and is sufficient to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with GAAP, including that (A) transactions are executed in accordance with management’s general or specific authorizations; (B) transactions are recorded as necessary to permit preparation of financial statements in conformity with GAAP and to maintain asset accountability; (C) access to assets is permitted only in accordance with management’s general or specific authorization; (D) the recorded accountability for assets is compared with the existing assets at reasonable intervals and appropriate action is taken with respect to any differences; and (E) the interactive data in eXtensible Business Reporting Language included or incorporated by reference in the Registration Statement is accurate and fairly presents the information called for in all material respects and has been prepared in accordance with the Commission’s rules and guidelines applicable thereto. The systems of internal control over financial reporting of the Company and its Subsidiaries are overseen by the Audit Committee of the Board of Directors of the Company in accordance with Nasdaq rules and regulations. Except as described in the Registration Statement, the Pricing Disclosure Package and the Prospectus, since the end of the Company’s most recent audited fiscal year, (i) there has been no material weakness in the Company’s internal control over financial reporting (whether or not remediated), (ii) there has been no change in the Company’s internal control over financial reporting that has materially affected, or is reasonably likely to materially affect, the Company’s internal control over financial reporting and (iii) the Company has not been advised of (a) any significant deficiencies in the design or operation of internal controls that could adversely affect the ability of the Company or any Subsidiary to record, process, summarize and report financial data, or any material weakness in internal controls, or (b) any fraud, whether or not material, that involves management or other employees who have a significant role in the internal controls of the Company and each of the Subsidiaries.

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