Change Control Requirements Sample Clauses

Change Control Requirements. First Data shall comply with the following change control requirements: (i) Prior to using any new software or new equipment to provide the Services, First Data shall have verified that the item has been properly installed, tested, is operating in accordance with its Specifications, continues to meet RCSI’s functional requirements (as made known to First Data) at least as well as the prior software or equipment, and is performing its intended functions in a reliable manner. (ii) Subject to Section 15.3 of Schedule A which governs changes in the First Data System, First Data shall not take an action or make a decision which adversely affects the function or performance of, or may decrease the resource efficiency of, the Services, or RCSI’s costs or efficiency in conducting its business, including implementing changes in technology or equipment and software configuration, without first ***. First Data may make temporary changes required by an emergency if it has been unable to contact an appropriate RCSI manager to obtain such approval after making reasonable efforts. First Data shall document and promptly report such emergency changes to RCSI. First Data shall, as requested by RCSI, provide support for changes to the RCSI systems and procedures, if any, necessitated by changes in the First Data Software or First Data System. (iii) First Data shall move programs from development and test environments to production environments in a controlled and documented manner, so that no changes are introduced into the programs during such activity. Table of Contents (iv) First Data shall, as requested by RCSI, support RCSI’s testing of changes to the First Data System.
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Change Control Requirements. First Data shall comply with the following change control requirements: (i) Prior to using any new software or new equipment to provide the Services, First Data shall have verified that the item has been properly installed, tested, is operating in accordance with its specifications, interfaces with RFS properly, continues to meet RFS’ functional requirements (as made known to First Data) at least as well as the prior Software or Equipment, and is performing its intended functions in a reliable manner. (ii) First Data shall not take an action or make a decision which (A) has a material adverse effect on RFS or an RFS Affiliate; (B) adversely affects the function or performance of, or may decrease the resource efficiency of, the Services; (C) adversely affects RFS’ costs or efficiency in conducting its business; or (D) adversely affects First Data’s capability or commitment to provide disaster recovery or business continuity services for the Services, including implementing changes in technology or Equipment and Software configuration that has such effect, without first ***; provided changes in the production cycle for the Production Services shall be governed by Section 12.5(a)(v) below. First Data may make temporary changes required by an emergency if it has been unable to contact an appropriate RFS manager to *** after making reasonable efforts. First Data shall document and promptly report such emergency changes to RFS. First Data shall, as requested by RFS, provide support for changes to the RFS systems and procedures, if any, necessitated by changes in the First Data Software or First Data System. (iii) First Data shall move programs from development and test environments to production environments in a controlled and documented manner, so that no changes are introduced into the programs during such activity. (iv) First Data shall, as requested by RFS, support RFS’ testing of changes to the First Data System and RFS’ testing of its information and processing systems and those of the RFS Affiliates in connection with changes which may affect such systems. (v) With respect to the addition of material new RFS volumes within the Production Services Tower requested by RFS for (A) existing RFS customers resulting from the acquisition of material new business volumes from third parties by such customers (rather than volume growth related to their existing business operations) or (B) persons who become RFS customers after the Effective Date into then-existing ...
Change Control Requirements. 7.1 RPS shall notify CTI of all major changes to the process, equipment, facilities, analytical methods, specifications or materials that affect Zileuton API. These changes will then be approved by CTI prior to implementation by RPS. For the purposes of this document, a major change is defined as any change that has a substantial potential to have an adverse effect on the identity, strength, quality, purity or potency of the product or which necessitates revalidation work or which affects any regulatory submissions in such a way as to require prior notification to the regulatory body (e.g. requires a minimum of a CBE in the US). The following categories of change require prior notification to and authorisation by CTI: - Any change to the basic synthetic route (e.g. use of different reagents) - Any change to a critical process parameter outside the previously accepted critical range - Any change from one facility to another (even if on the same site) - Major equipment changes affecting the API process from the final solution onwards - Major equipment changes affecting registration prior to the final API solution - Use of recycled solvents - Changes to the specifications of the API - Changes to the specifications associated with critical in-process tests or critical raw materials - Changes to API analytical methods that require some revalidation or requalification of the method and/or which affect either registrations or SP analytical methodology - Changes to in-process and critical raw material analytical methods that require some revalidation or requalification of the method and which affect registrations - Proposed use of out-of-specification raw materials. - Changes to suppliers of critical raw materials - Change of packaging or labelling - Intent to outsource a GMP activity related to manufacture of Zileuton API that was previously performed in-house (or vice versa) - Change of company name - Change in the use of the Zileuton API facilities to include hazardous or sensitising materials (see Section 3.6) - Reprocessing or reworking of a batch of Zileuton API (see Section 8.2) - Change to the retest date of the API (see Section 10.1) - Change of contractors for following tests : Surface Area - Particle Size Distribution -Microbio 7.2 RPS shall provide CTI at the time of implementation with a copy of any minor changes that impact on the regulatory submission(s). RPS shall also provide CTI with a summary of all changes affecting the Zileuton regulatory docu...

Related to Change Control Requirements

  • Exchange Control Requirements You understand and agree that, pursuant to local exchange control requirements, you will be required to repatriate the cash proceeds from the sale of the Shares issued to you upon settlement of the Units and from the receipt of any dividends or Dividend Equivalents to China. You further understand that, under applicable laws, such repatriation of your cash proceeds will need to be effectuated through a special exchange control account established by the Company or any Affiliate, including the Employer, and you hereby consent and agree that any proceeds may be transferred to such special account prior to being delivered to you. You also understand that the Company will deliver the proceeds to you as soon as possible, but that there may be delays in distributing the funds to you due to exchange control requirements in China. Proceeds may be paid to you in U.S. dollars or local currency at the Company's discretion. If the proceeds are paid to you in U.S. dollars, you will be required to set up a U.S. dollar bank account in China so that the proceeds may be deposited into this account. If the proceeds are paid to you in local currency, the Company is under no obligation to secure any particular currency conversion rate and the Company may face delays in converting the proceeds to local currency due to exchange control restrictions. You further agree to comply with any other requirements that may be imposed by the Company in the future in order to facilitate compliance with exchange control requirements in China.

  • Exchange Control Restrictions The Optionee understands and agrees that, due to exchange control laws in China, he or she will be required to immediately repatriate to China any cash proceeds from dividends and/or the cashless exercise of the Option. The Optionee further understands that, under local law, such repatriation of the cash proceeds will be effected through a special exchange control account established by a member of the Mondelēz Group and the Optionee hereby consents and agrees that any cash proceeds received in connection with the Plan will be transferred to such special account prior to being delivered to him or her. The proceeds may be paid in U.S. dollars or local currency at the Company’s discretion. If the proceeds are paid in U.S. dollars, the Optionee acknowledges that he or she will be required to set up a U.S. dollar bank account in China so that the proceeds may be delivered to this account. If the proceeds are converted to local currency, the Optionee acknowledges that the Mondelēz Group is under no obligation to secure any currency conversion rate and may face delays in converting the proceeds to local currency due to exchange control restrictions in China. The Optionee agrees to bear any currency fluctuation risk between the date the Option is exercised or dividends are paid and the time that (i) the Tax-Related Items are converted to local currency and remitted to the tax authorities and (ii) net proceeds are converted to local currency and distributed to the Optionee. The Optionee acknowledges that the Mondelēz Group will not be held liable for any delay in delivering the proceeds to the Optionee. The Optionee agrees to sign any agreements, forms and/or consents that may be requested by the Company or the Company’s designated broker to effectuate any of the remittances, transfers, conversions or other processes affecting the proceeds. The Optionee further agrees to comply with any other requirements that may be imposed by the Company in the future in order to facilitate compliance with exchange control requirements in China.

  • Foreign Asset/Account Reporting; Exchange Controls Participant’s country may have certain foreign asset and/or account reporting requirements and/or exchange controls which may affect Participant’s ability to acquire or hold shares of Stock under the Plan or cash received from participating in the Plan (including from any dividends received or sale proceeds arising from the sale of shares of Stock) in a brokerage or bank account outside Participant’s country. Participant may be required to report such accounts, assets or transactions to the tax or other authorities in his or her country. Participant also may be required to repatriate sale proceeds or other funds received as a result of Participant’s participation in the Plan to his or her country through a designated bank or broker and/or within a certain time after receipt. Participant acknowledges that it is his or her responsibility to be compliant with such regulations, and Participant should consult his or her personal legal advisor for any details.

  • Foreign Assets Control Regulations Neither the borrowing by the Borrower hereunder nor its use of the proceeds thereof will violate the Foreign Assets Control Regulations, the Cuban Assets Control Regulations or the Iranian Assets Control Regulations of the United States Treasury Department (31 CFR Subtitle B, Chapter V) or any similar law or regulation.

  • Foreign Assets Control Regulations, Etc (a) Neither the Company nor any Controlled Entity (i) is a Blocked Person, (ii) has been notified that its name appears or may in the future appear on a State Sanctions List or (iii) is a target of sanctions that have been imposed by the United Nations or the European Union. (b) Neither the Company nor any Controlled Entity (i) has violated, been found in violation of, or been charged or convicted under, any applicable U.S. Economic Sanctions Laws, Anti-Money Laundering Laws or Anti-Corruption Laws or (ii) to the Company’s knowledge, is under investigation by any Governmental Authority for possible violation of any U.S. Economic Sanctions Laws, Anti-Money Laundering Laws or Anti-Corruption Laws. (c) No part of the proceeds from the sale of the Notes hereunder: (i) constitutes or will constitute funds obtained on behalf of any Blocked Person or will otherwise be used by the Company or any Controlled Entity, directly or indirectly, (A) in connection with any investment in, or any transactions or dealings with, any Blocked Person, (B) for any purpose that would cause any Purchaser to be in violation of any U.S. Economic Sanctions Laws or (C) otherwise in violation of any U.S. Economic Sanctions Laws; (ii) will be used, directly or indirectly, in violation of, or cause any Purchaser to be in violation of, any applicable Anti-Money Laundering Laws; or (iii) will be used, directly or indirectly, for the purpose of making any improper payments, including bribes, to any Governmental Official or commercial counterparty in order to obtain, retain or direct business or obtain any improper advantage, in each case which would be in violation of, or cause any Purchaser to be in violation of, any applicable Anti-Corruption Laws. (d) The Company has established procedures and controls which it reasonably believes are adequate (and otherwise comply with applicable law) to ensure that the Company and each Controlled Entity is and will continue to be in compliance with all applicable U.S. Economic Sanctions Laws, Anti-Money Laundering Laws and Anti-Corruption Laws.

  • Export Control Regulations Buyer understands that Seller and the Goods are subject to the United States Export Administration Act, the Trading with the Enemy Act, the International Traffic in Arms Regulations (in the case of Goods that are considered defense articles), and other laws and regulations of the United States of America (collectively, the “Regulations”), which Regulations are enforced, inter alia, by the United States Departments of Commerce, State and Treasury. The Regulations, in part, prohibit export or diversion of the Goods to certain countries. Xxxxx agrees to abide by all Regulations, including those concerning the resale and disposition of the Goods. Buyer warrants that it will not sell, transfer or support, directly or indirectly, or assist in any sale or transfer of any products or product technology in countries or to users concerning which such sale, transfer or support is not permitted under applicable Regulations. Buyer shall defend, hold harmless and indemnify Seller for any damages resulting to Seller from a breach of this paragraph by Xxxxx.

  • Financial Requirements A report of monthly and cumulative financial requirements; and

  • 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.

  • Foreign Asset Control Regulations Neither of the advance of the Loans nor the use of the proceeds of any thereof will violate the Trading With the Enemy Act (50 U.S.C. § 1 et seq., as amended) (the “Trading With the Enemy Act”) or any of the foreign assets control regulations of the United States Treasury Department (31 CFR, Subtitle B, Chapter V, as amended) (the “Foreign Assets Control Regulations”) or any enabling legislation or executive order relating thereto (which for the avoidance of doubt shall include, but shall not be limited to (a) Executive Order 13224 of September 21, 2001 Blocking Property and Prohibiting Transactions With Persons Who Commit, Threaten to Commit, or Support Terrorism (66 Fed. Reg. 49079 (2001)) (the “Executive Order”) and (b) the Uniting and Strengthening America by Providing Appropriate Tools Required to Intercept and Obstruct Terrorism Act of 2001 (Public Law 107-56)). Furthermore, none of the Borrowers or their Affiliates (a) is or will become a “blocked person” as described in the Executive Order, the Trading With the Enemy Act or the Foreign Assets Control Regulations or (b) engages or will engage in any dealings or transactions, or be otherwise associated, with any such “blocked person” or in any manner violative of any such order.

  • Foreign Asset/Account, Exchange Control and Tax Reporting The Participant may be subject to foreign asset/account, exchange control and/or tax reporting requirements as a result of the acquisition, holding and/or transfer of shares of Common Stock or cash (including dividends and the proceeds arising from the sale of shares of Common Stock) derived from his or her participation in the Plan, to and/or from a brokerage/bank account or legal entity located outside the Participant’s country. The applicable laws of the Participant’s country may require that he or she report such accounts, assets, the balances therein, the value thereof and/or the transactions related thereto to the applicable authorities in such country. The Participant acknowledges that he or she is responsible for ensuring compliance with any applicable foreign asset/account, exchange control and tax reporting requirements and should consult his or her personal legal advisor on this matter.

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