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 Procedure 34.1 In the event that either Party desires any change the terms of this Agreement or any Contract which may materially impact on the timings, scope, Specification or Charges of the Goods or Services, or the scope of either parties’ obligations under this Agreement or the relevant Contract, or which the relevant Party otherwise reasonably determines warrants the use of this change control procedure, the following procedures will apply: (a) the Party requesting the change will deliver a “Change Request” (in the form (or substantially in the same form) contained in Schedule 5 to this Agreement) which describes: (i) the nature of the change; (ii) the reason for the change; (iii) the effect that the requested change will have on the scope or Specification for the Goods or Services; and (iv) any change to the Charges and the Term. (b) Upon receipt of a Change Request, the receiving Party’s authorised representative will contact his/ her counterpart within 5 working days to discuss and agree the Change Request. The parties will negotiate the proposed changes to the Agreement and/or affected Contract in good faith and agree a timeline in which to finalise the Change Notice. (c) Neither party is obliged to agree to a Change Request, but if the parties do agree to implement such a Change Request, the appropriate authorised representatives of both parties will sign the Change Request which will be effective from the date set out in the Change Request. (d) If there is any conflict between the terms and conditions set out in the Agreement or any Contract and the Change Request, then the terms and conditions set out in the most recent fully executed Change Request will apply. (e) The Supplier shall neither be relieved of its obligations to supply the Goods and/or Services in accordance with the terms and conditions of this Agreement or any Contract, nor be entitled to an increase in the Charges as the result of: (i) a General Change in Law; or (ii) a Specific Change in Law where the effect of that Specific Change in Law on the Goods and/or Services is reasonably foreseeable at the Commencement Date of this Agreement, or, where the Change Request relates to a Contract, the applicable Contract Commencement Date. 34.2 The Parties agree that any variations to the Agreement or any Contract to reflect non- material changes (including for example a change to the name/contact details of a Party’s representative) may be agreed in writing and shall not be required to be made in accordance with the procedure in this clause 34, provided always that UKRI shall, in their absolute discretion, decide whether a proposed change is non-material for these purposes.

  • 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. (b) Contractor will not take an action or make a decision which may have a material effect on LAUSD or which adversely affects the function or performance of, or decreases the resource efficiency of, the Services, including implementing changes in technology or equipment and software configuration, without first obtaining LAUSD’s written approval, which approval LAUSD may withhold in its sole discretion as respects any change which may have an adverse effect on LAUSD or the Services.

  • 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.

  • AMENDMENT AND CHANGE CONTROL Any amendment or change of any nature made to this Agreement and the Schedule of Requirements thereof shall only be valid if it is in writing, signed by both Parties and added to this Agreement as an addendum hereto. In this regard a Change Notice must first be defined and issued by the requesting Party. A Change Notice Response must then be issued by responding Party. A formal approval of the Change Request will then trigger the issue of the addendum to this Agreement.

  • Implementation Report Within 150 days after the Effective Date, Ensign Group shall submit a written report to OIG summarizing the status of its implementation of the requirements of this CIA (Implementation Report). The Implementation Report shall, at a minimum, include: 1. the name, address, phone number, and position description of the Compliance Officer required by Section III.A, and a summary of other noncompliance job responsibilities the Compliance Officer may have; 2. the names and positions of the members of the Compliance Committee required by Section III.A; 3. the names and positions of the members of the Board of Directors who are responsible for satisfying the Board of Directors compliance obligations described in Section III.A.3; 4. a copy of Ensign Group’s Code of Conduct required by Section III.B.1; 5. the number of individuals required to complete the Code of Conduct certification required by Section III.B.1, the percentage of individuals who have completed such certification, and an explanation of any exceptions (the documentation supporting this information shall be available to OIG upon request); 6. a summary of all Policies and Procedures required by Section III.B (copies of the Policies and Procedures shall be made available to OIG upon request); 7. the following information regarding each type of training required by Section III.C: a. a description of such training, including a summary of the topics covered, the length of sessions, and a schedule of training sessions; b. the number of individuals required to be trained, percentage of individuals actually trained, and an explanation of any exceptions. A copy of all training materials and the documentation supporting this information shall be made available to OIG upon request. 8. a description of the Disclosure Program required by Section III.E; 9. the following information regarding the IRO(s): (a) identity, address, and phone number; (b) a copy of the engagement letter; (c) information to demonstrate that the IRO has the qualifications outlined in Appendix A to this CIA; (d) a summary and description of any and all current and prior engagements and agreements between Ensign Group and the IRO; and (e) a certification from the IRO regarding its professional independence and objectivity with respect to Ensign Group; 10. a description of the process by which Ensign Group fulfills the requirements of Section III.F regarding Ineligible Persons; 11. a list of all of Ensign Group’s locations (including locations and mailing addresses); the corresponding name under which each location is doing business; the corresponding phone numbers and fax numbers; each location’s Medicare and state Medicaid program provider number and/or supplier number(s); and the name and address of each Medicare and state Medicaid program contractor to which Ensign Group currently submits claims; 12. a description of Ensign Group’s corporate structure, including identification of any parent and sister companies, subsidiaries, and their respective lines of business; and

  • 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.

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