CONTROL DOCUMENTATION AND CHANGE CONTROL Sample Clauses

CONTROL DOCUMENTATION AND CHANGE CONTROL. 6.1 Millennium shall maintain a system of written quality procedures, manufacturing instructions and facilities details that accurately reflect the processing specifications. In cases where Millennium receives contract manufacturing or testing services from an Authorized Contractor, Millennium's access to such information is subject to the terms of the Third Party Agreements. In addition, subject to the terms of the relevant Third Party Agreements existing as of the Execution Date, a change management system that tracks and controls changes to such documents exists at each Third Party Manufacturer. Schering must receive advance notification of any change to these documents with a potential regulatory impact as part of change management. 6.2 Significant changes to the manufacturing or packaging process, raw materials, product specifications or quality control methods for the Product require the prior written agreement of Schering. Examples of condition where prior agreement of Schering is required include, but is not necessarily limited to, the following: i. Changes affecting the validated process, packaging or testing methodology ii. Changes to dedicated facilities, utilities or systems iii. Any change having an impact on the regulatory filing 6.3 Schering and Millennium recognize the importance of expeditious review and implementation of changes, particularly those affecting product quality or the ability to supply Product. Subject to the terms of the Supply Agreement and relevant Third Party Agreements a. Schering reserves the right upon written notice to Millennium to amend Product Specifications to comply with cGMPs, health registrations or incorporate improvements and b. Millennium will implement such changes to, minimally, ensure compliance with regulatory agency and cGMP requirements. Millennium will manage such changes with its Authorized Contractors as applicable. Changes will be reviewed by Schering and Millennium prior to implementation utilizing a change control procedure. Disputes of implementation feasibility, scope, or strategy will be addressed by the Joint Production Committee Processes as described in the Supply Agreement. Any cost impact will be governed by the relevant Supply Agreement. c. Changes, as described in Section 6.2, initiated by Millennium, Millennium's Authorized Contractor, or Schering, that do not require regulatory agency submission or are annual reportable, will be reviewed and dispositioned within 10 business days of re...
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Related to CONTROL DOCUMENTATION AND CHANGE CONTROL

  • 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.

  • Control Documents Except as disclosed in Section 4.13 of the Disclosure Schedule, each of the representations and warranties as follows is true and accurate with respect to Domestic Companies: (a) The Control Documents enable the Company to consolidate the Financial Statements with the Domestic Companies. Each party to the Control Documents has the legal right, power and authority (corporate and other) to enter into and perform its obligations under each Control Document to which it is a party and has taken all necessary corporate action to authorize the execution, delivery and performance of, and has authorized, executed and delivered, each Control Document to which it is a party. (b) Each executed Control Document constitutes a valid and legally binding obligation of the parties named therein enforceable in accordance with its terms, except (i) as limited by applicable bankruptcy, insolvency, reorganization, moratorium and other laws of general application affecting enforcement of creditors’ rights generally, and (ii) as limited by Laws relating to the availability of specific performance, injunctive relief or other remedies in the nature of equitable remedies. (c) Each Control Document is in proper legal form under applicable Law of the PRC for the enforcement thereof against each of the parties thereto in the PRC without further action by any of them except (i) as limited by applicable bankruptcy, insolvency, reorganization, moratorium, and other laws of general application affecting enforcement of creditors’ rights generally, and (ii) as limited by Laws relating to the availability of specific performance, injunctive relief, or other equitable remedies. (d) The execution and delivery by each party named in each Control Document, and the performance by such party of its obligations thereunder and the consummation by it of the transactions contemplated therein shall not (i) result in any violation of, be in conflict with, or constitute a default under, with or without the passage of time or the giving of notice, any provision of its corporate documents as in effect at the date hereof, any applicable Law, or any contract to which any Group Company is a party or by which any Group Company is bound, (ii) accelerate, or constitute an event entitling any Person to accelerate, the maturity of any indebtedness or other liability of any Group Company or to increase the rate of interest presently in effect with respect to any indebtedness of any Group Company, or (iii) result in the creation of any Lien upon any of the properties or assets of any Group Company. (e) All consents required in connection with the Control Documents have been made or unconditionally obtained in writing, and no such consent has been withdrawn or is subject to any condition precedent, which has not been fulfilled or performed. (f) Each Control Document is in full force and effect and no party to any Control Document is in breach or default in the performance or observance of any of the terms or provisions of such Control Document. None of the parties to any Control Document has sent or received any communication regarding termination of or intention not to renew any Control Document, and no such termination or non-renewal has been threatened by any of the parties thereto. (g) The share pledge agreements as part of the Control Documents of Domestic Companies have been duly registered with competent PRC Governmental Authority.

  • 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.

  • 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.

  • Implementation Plan The Authority shall cause to be prepared an Implementation Plan meeting the requirements of Public Utilities Code Section 366.2 and any applicable Public Utilities Commission regulations as soon after the Effective Date as reasonably practicable. The Implementation Plan shall not be filed with the Public Utilities Commission until it is approved by the Board in the manner provided by Section 4.9.

  • 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

  • Implementation and Review The Parties shall consult annually, or as otherwise agreed, to review the implementation of this Chapter and consider other matters of mutual interest affecting trade in services. (10) 10 Such consultations will be addressed under Article 170 (Free Trade Commission) of Chapter 14 (Administration of the Agreement).

  • Control Data <<customer_name>> will send one confirmation record per pack that is received from BellSouth. This confirmation record will indicate <<customer_name>> received the pack and the acceptance or rejection of the pack. Pack Status Code(s) will be populated using standard ATIS EMI error codes for packs that were rejected by <<customer_name>> for reasons stated in the above section.

  • Exchange Control Notice Exchange control reporting is required for cash transactions exceeding A$10,000 and international fund transfers of any amount. The Australian bank assisting with the transaction will file the report for the Participant. If there is no Australian bank involved in the transfer, the Participant will be responsible for filing the report.

  • Exchange Control Information Exchange control reporting is required for cash transactions exceeding AUD10,000 and for international fund transfers. The Australian bank assisting with the transaction will file the report for you. If there is no Australian bank involved in the transfer, you will have to file the report.

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