CONTROL DOCUMENTS AND CHANGE CONTROL Sample Clauses

CONTROL DOCUMENTS AND CHANGE CONTROL. IMPLEMENTATION Any change(s) made to the Specifications, including but not limited to the manufacturing process and/or analytical methods which may affect the quality or performance of the Product, exceed validation parameters or commitments made in regulatory filings must be approved by Theravance QA., in writing, prior to implementation for routine production or Release of any lot made after the revision. Documents referenced in this Section must be amended as required by the Product Application or license or as required by applicable laws, rules, regulations or regulatory agencies. Copies of all revised documents applicable to Theravance products are to be provided to Theravance QA at time of issuance. Theravance QA will provide copies to the applicable markets.
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Related to CONTROL DOCUMENTS AND CHANGE CONTROL

  • Control Documents (a) Each of the parties to the Control Documents has the legal right, power and authority to enter into and perform its/his/her obligations under each Control Document to which it/he/she 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/he/she is a party; (b) each Control Document constitutes a legally binding obligation of the parties thereto, enforceable in accordance with its terms; and (c) each Control Document is in full force and effect.

  • Change Control (a) If either party wishes to propose any amendment or modification to, or variation of, the Services including the scope or details of the Services (a “Change”) then it shall notify the other party of that fact by sending a written request (a “Change Request”) to the party, specifying in as much detail as is reasonably practicable the nature of the Change. X.X. Xxxxxx shall maintain a log of all Change Requests.

  • 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.

  • No Changes in Internal Controls Since the date of the most recent evaluation of the disclosure controls and procedures described in Section 1(tt) hereof, there have been no significant changes in the Partnership’s internal controls that materially affected or are reasonably likely to materially affect the Partnership’s internal controls over financial reporting.

  • Exchange Control Obligations The Employee is solely responsible for complying with applicable exchange control regulations and rulings (the “Exchange Control Regulations”) in South Africa. As the Exchange Control Regulations change frequently and without notice, the Employee should consult the Employee’s legal advisor prior to the acquisition or sale of Shares under the Program to ensure compliance with current Exchange Control Regulations. Neither the Company nor any of its Subsidiaries shall be liable for any fines or penalties resulting from the Employee’s failure to comply with applicable laws, rules or regulations.

  • Exchange Control Notice Exchange control reporting is required for cash transactions exceeding AUD10,000 and for international fund transfers. The Australian bank assisting with the transaction may file the report on the Employee’s behalf. If there is no Australian bank involved in the transfer, the Employee is required to file the report. The Employee understands that the Employee should consult with her or her personal advisor to ensure compliance with the applicable reporting obligations.

  • Exchange Control If at any time legal restrictions prevent the prompt remittance of part or all royalties with respect to any country in the Territory where Licensed Product is sold, payment shall be made through such lawful means or method as the Parties reasonably shall determine.

  • Change Control Procedures Any proposed changes to the Services set forth in this Engagement Schedule must be made in accordance with the Change Control Procedures set forth in Attachment F.

  • 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.

  • Exchange Control Information Exchange control reporting is required for cash transactions exceeding AUD10,000 and for international fund transfers. If an Australian bank is assisting with the transaction, the bank will file the report on your behalf.

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