Adjustments Due to Technical Changes or Regulatory Authority Requirements Sample Clauses

Adjustments Due to Technical Changes or Regulatory Authority Requirements. Amendments to the Specifications or the Quality Agreement requested by Client will only be implemented following a technical and cost review that Patheon will perform at Client’s cost and are subject to Client and Patheon reaching agreement on Price changes required because of the amendment. Amendments to the Specifications, the Quality Agreement, or the Manufacturing Site requested by Patheon will only be implemented following the written approval of Client, the approval not to be unreasonably withheld. If Client accepts a proposed Price change, the proposed change in the Specifications and the associated scope of work will be implemented at Client’s cost, and the Price change will become effective, only for those orders of Products that are manufactured under the revised Specifications. In addition, Client agrees to purchase, at [***] all Inventory used under the “old” Specifications and purchased or maintained by Patheon in order to fill Firm Orders or under Section 5.2, if the Inventory can no longer be used under the revised Specifications. Open purchase orders for Components no longer required under any revised Specifications that were placed by Patheon with suppliers in order to fill Firm Orders or under Section 5.2 will be cancelled where possible, and if the orders may not be cancelled without penalty, will be assigned to and satisfied by Client. Additional payments or price increases may also be required to compensate Patheon for fees and other expenses incurred by Patheon to comply with Regulatory Authority requirements which apply to the Manufacturing Services.
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Adjustments Due to Technical Changes or Regulatory Authority Requirements. (a) Amendments requested by Patheon. Any amendments to the Manufacturing Services, including but not limited to the Specifications, the Quality Agreement, the Components or the Manufacturing Site requested by Patheon, for reasons other than those provided under Section 4.4(c) below, will only be implemented following the written approval of Client, such approval not to be unreasonably withheld or delayed and shall be implemented at Patheon’s sole cost and expense, unless otherwise agreed by the parties in writing.
Sample 1

Related to Adjustments Due to Technical Changes or Regulatory Authority Requirements

  • New Hampshire Specific Data Security Requirements The Provider agrees to the following privacy and security standards from “the Minimum Standards for Privacy and Security of Student and Employee Data” from the New Hampshire Department of Education. Specifically, the Provider agrees to: (1) Limit system access to the types of transactions and functions that authorized users, such as students, parents, and LEA are permitted to execute; (2) Limit unsuccessful logon attempts; (3) Employ cryptographic mechanisms to protect the confidentiality of remote access sessions; (4) Authorize wireless access prior to allowing such connections; (5) Create and retain system audit logs and records to the extent needed to enable the monitoring, analysis, investigation, and reporting of unlawful or unauthorized system activity; (6) Ensure that the actions of individual system users can be uniquely traced to those users so they can be held accountable for their actions; (7) Establish and maintain baseline configurations and inventories of organizational systems (including hardware, software, firmware, and documentation) throughout the respective system development life cycles; (8) Restrict, disable, or prevent the use of nonessential programs, functions, ports, protocols, and services; (9) Enforce a minimum password complexity and change of characters when new passwords are created; (10) Perform maintenance on organizational systems; (11) Provide controls on the tools, techniques, mechanisms, and personnel used to conduct system maintenance; (12) Ensure equipment removed for off-site maintenance is sanitized of any Student Data in accordance with NIST SP 800-88 Revision 1; (13) Protect (i.e., physically control and securely store) system media containing Student Data, both paper and digital; (14) Sanitize or destroy system media containing Student Data in accordance with NIST SP 800-88 Revision 1 before disposal or release for reuse; (15) Control access to media containing Student Data and maintain accountability for media during transport outside of controlled areas; (16) Periodically assess the security controls in organizational systems to determine if the controls are effective in their application and develop and implement plans of action designed to correct deficiencies and reduce or eliminate vulnerabilities in organizational systems; (17) Monitor, control, and protect communications (i.e., information transmitted or received by organizational systems) at the external boundaries and key internal boundaries of organizational systems; (18) Deny network communications traffic by default and allow network communications traffic by exception (i.e., deny all, permit by exception); (19) Protect the confidentiality of Student Data at rest; (20) Identify, report, and correct system flaws in a timely manner; (21) Provide protection from malicious code (i.e. Antivirus and Antimalware) at designated locations within organizational systems; (22) Monitor system security alerts and advisories and take action in response; and (23) Update malicious code protection mechanisms when new releases are available.

  • System Upgrade Facilities and System Deliverability Upgrades Connecting Transmission Owner shall design, procure, construct, install, and own the System Upgrade Facilities and System Deliverability Upgrades described in Appendix A hereto. The responsibility of the Developer for costs related to System Upgrade Facilities and System Deliverability Upgrades shall be determined in accordance with the provisions of Attachment S to the NYISO OATT.

  • CERTIFICATION OF NO ASBESTOS CONTAINING MATERIALS OR WORK 8.1 The Contractor shall be responsible for ensuring that no asbestos containing materials or work is included within the scope of the Work. The Contractor shall take whatever measures it deems necessary to insure that all employees, suppliers, fabricators, material men, subcontractors, or their assigns, comply with this requirement. 8.2 The Contractor shall ensure that Texas Department of Health licensed individuals, consultants or companies are used for any required asbestos work including asbestos inspection, asbestos abatement plans/specifications, asbestos abatement, asbestos project management and third-party asbestos monitoring.

  • Duration of processing and erasure or return of data Processing by the data importer shall only take place for the duration specified in Annex I.

  • Benchmarks for Measuring Accessibility For the purposes of this Agreement, the accessibility of online content and functionality will be measured according to the W3C’s Web Content Accessibility Guidelines (WCAG) 2.0 Level AA and the Web Accessibility Initiative Accessible Rich Internet Applications Suite (WAI-ARIA) 1.0 for web content, which are incorporated by reference.

  • Selection of Subcontractors, Procurement of Materials and Leasing of Equipment The contractor shall not discriminate on the grounds of race, color, religion, sex, national origin, age or disability in the selection and retention of subcontractors, including procurement of materials and leases of equipment. The contractor shall take all necessary and reasonable steps to ensure nondiscrimination in the administration of this contract. a. The contractor shall notify all potential subcontractors and suppliers and lessors of their EEO obligations under this contract. b. The contractor will use good faith efforts to ensure subcontractor compliance with their EEO obligations.

  • Loop Testing/Trouble Reporting 2.1.6.1 Telepak Networks will be responsible for testing and isolating troubles on the Loops. Telepak Networks must test and isolate trouble to the BellSouth portion of a designed/non-designed unbundled Loop (e.g., UVL-SL2, UCL-D, UVL-SL1, UCL-ND, etc.) before reporting repair to the UNE Customer Wholesale Interconnection Network Services (CWINS) Center. Upon request from BellSouth at the time of the trouble report, Telepak Networks will be required to provide the results of the Telepak Networks test which indicate a problem on the BellSouth provided Loop. 2.1.6.2 Once Telepak Networks has isolated a trouble to the BellSouth provided Loop, and had issued a trouble report to BellSouth on the Loop, BellSouth will take the actions necessary to repair the Loop if a trouble actually exists. BellSouth will repair these Loops in the same time frames that BellSouth repairs similarly situated Loops to its End Users. 2.1.6.3 If Telepak Networks reports a trouble on a non-designed or designed Loop and no trouble actually exists, BellSouth will charge Telepak Networks for any dispatching and testing (both inside and outside the CO) required by BellSouth in order to confirm the Loop’s working status. 2.1.6.4 In the event BellSouth must dispatch to the end-user’s location more than once due to incorrect or incomplete information provided by Telepak Networks (e.g., incomplete address, incorrect contact name/number, etc.), BellSouth will xxxx Xxxxxxx Networks for each additional dispatch required to repair the circuit due to the incorrect/incomplete information provided. BellSouth will assess the applicable Trouble Determination rates from BellSouth’s FCC or state tariffs.

  • Disclosure to FERC or its Staff Notwithstanding anything in this Section 17 to the contrary, and pursuant to 18 C.F.R. § 1b.20, if FERC or its staff, during the course of an investigation or otherwise, requests information from one of the Interconnection Parties that is otherwise required to be maintained in confidence pursuant to this Interconnection Service Agreement, the Interconnection Party, shall provide the requested information to FERC or its staff, within the time provided for in the request for information. In providing the information to FERC or its staff, the Interconnection Party must, consistent with 18 C.F.R. § 388.122, request that the information be treated as confidential and non-public by FERC and its staff and that the information be withheld from public disclosure. Interconnection Parties are prohibited from notifying the other Interconnection Parties prior to the release of the Confidential Information to the Commission or its staff. An Interconnection Party shall notify the other Interconnection Parties to the Interconnection Service Agreement when it is notified by FERC or its staff that a request to release Confidential Information has been received by FERC, at which time any of the Interconnection Parties may respond before such information would be made public, pursuant to 18 C.F.R. § 388.112.

  • Proposed Policies and Procedures Regarding New Online Content and Functionality By October 31, 2017, the School will submit to OCR for its review and approval proposed policies and procedures (“the Plan for New Content”) to ensure that all new, newly-added, or modified online content and functionality will be accessible to people with disabilities as measured by conformance to the Benchmarks for Measuring Accessibility set forth above, except where doing so would impose a fundamental alteration or undue burden. a) When fundamental alteration or undue burden defenses apply, the Plan for New Content will require the School to provide equally effective alternative access. The Plan for New Content will require the School, in providing equally effective alternate access, to take any actions that do not result in a fundamental alteration or undue financial and administrative burdens, but nevertheless ensure that, to the maximum extent possible, individuals with disabilities receive the same benefits or services as their nondisabled peers. To provide equally effective alternate access, alternates are not required to produce the identical result or level of achievement for persons with and without disabilities, but must afford persons with disabilities equal opportunity to obtain the same result, to gain the same benefit, or to reach the same level of achievement, in the most integrated setting appropriate to the person’s needs. b) The Plan for New Content must include sufficient quality assurance procedures, backed by adequate personnel and financial resources, for full implementation. This provision also applies to the School’s online content and functionality developed by, maintained by, or offered through a third-party vendor or by using open sources. c) Within thirty (30) days of receiving OCR’s approval of the Plan for New Content, the School will officially adopt, and fully implement the amended policies and procedures.

  • Human and Financial Resources to Implement Safeguards Requirements The Borrower shall make available necessary budgetary and human resources to fully implement the EMP and the RP.

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