Ongoing Exchange of Safety Data Sample Clauses

Ongoing Exchange of Safety Data. To the extent that the Parties are obliged, under U.S federal regulations codified in 21CFR312.32 and 21CFR312.33 to report certain clinical data for safety purposes, Insmed and Napo each agree that, in addition to making any requisite filing(s), it shall notify directly the other party and provide the other party with all such clinical data regarding adverse events involving Masoprocal, with respect to the Endocrine IND and any future Masoprocal INDs sponsored by Insmed or Napo. Such notification shall occur within the same timeframe and using the format and content as described in 21CFR312.32. Such notification(s) shall be by facsimile, and/or overnight courier at such number(s) and/or addresses designated by each party. Napo and Insmed shall also have an ongoing obligation to summarize for the other party all other adverse drug experiences not described above on an annual basis using the format as described in 21CFR312.33 Annual Reports.
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Related to Ongoing Exchange of Safety Data

  • Material Safety Data Sheet Seller shall provide to Buyer with each delivery any Material Safety Data Sheet applicable to the work in conformance with and containing such information as required by the Occupational Safety and Health Act of 1970 and regulations promulgated thereunder or its State approved counterpart.

  • Certification Regarding Prohibition of Boycotting Israel (Tex Gov. Code 2271)

  • Information for Regulatory Compliance Each of the Company and the Depositary shall provide to the other, as promptly as practicable, information from its records or otherwise available to it that is reasonably requested by the other to permit the other to comply with applicable law or requirements of governmental or regulatory authorities.

  • MATERIAL SAFETY DATA SHEETS As applicable, Contractor shall provide Purchaser with all appropriate Material Safety Data Sheets (“MSDS”) at the time of delivery of each shipment of Goods which requires such compliance and/or and for materials used by Contractor while performing Services and any updates of the same.

  • Disturbance Analysis Data Exchange The Parties will cooperate with one another and the NYISO in the analysis of disturbances to either the Large Generating Facility or the New York State Transmission System by gathering and providing access to any information relating to any disturbance, including information from disturbance recording equipment, protective relay targets, breaker operations and sequence of events records, and any disturbance information required by Good Utility Practice.

  • Implementation of Corrective Action Plan After the Corrective Action Plan is finalized, the Purchasers shall use reasonable best efforts to implement the finalized Corrective Action Plan on the timeline set forth therein and provide periodic reports (as provided for therein) to the Sellers on the status of their implementation of the Corrective Action Plan.

  • Musculoskeletal Injury Prevention and Control The hospital in consultation with the Joint Health and Safety Committee (JHSC) shall develop, establish and put into effect, musculoskeletal prevention and control measures, procedures, practices and training for the health and safety of employees.

  • Notification of Breach / Compliance Reports The Adviser shall notify the Trust immediately upon detection of (i) any material failure to manage any Fund in accordance with its investment objectives and policies or any applicable law; or (ii) any material breach of any of the Funds’ or the Adviser’s policies, guidelines or procedures. In addition, the Adviser shall provide a quarterly report regarding each Fund’s compliance with its investment objectives and policies, applicable law, including, but not limited to the 1940 Act and Subchapter M of the Code, as applicable, and the Fund’s policies, guidelines or procedures as applicable to the Adviser’s obligations under this Agreement. The Adviser agrees to correct any such failure promptly and to take any action that the Board may reasonably request in connection with any such breach. Upon request, the Adviser shall also provide the officers of the Trust with supporting certifications in connection with such certifications of Fund financial statements and disclosure controls pursuant to the Xxxxxxxx-Xxxxx Act. The Adviser will promptly notify the Trust in the event (i) the Adviser is served or otherwise receives notice of any action, suit, proceeding, inquiry or investigation, at law or in equity, before or by any court, public board, or body, involving the affairs of the Trust (excluding class action suits in which a Fund is a member of the plaintiff class by reason of the Fund’s ownership of shares in the defendant) or the compliance by the Adviser with the federal or state securities laws or (ii) an actual change in control of the Adviser resulting in an “assignment” (as defined in the 0000 Xxx) has occurred or is otherwise proposed to occur.

  • PREVENTION OF BRIBERY 26.1 The Supplier represents and warrants that neither it, nor to the best of its knowledge any Supplier's Personnel, have at any time prior to the Commencement Date: (a) committed a Prohibited Act or been formally notified that it is subject to an investigation or prosecution which relates to an alleged Prohibited Act; and/or (b) been listed by any government department or agency as being debarred, suspended, proposed for suspension or debarment, or otherwise ineligible for participation in government procurement programmes or contracts on the grounds of a Prohibited Act. 26.2 The Supplier shall not during the term of this agreement: (a) commit a Prohibited Act; and/or (b) do or suffer anything to be done which would cause the Authority or any of the Authority's employees, consultants, contractors, sub-contractors or agents to contravene any of the Bribery Act or otherwise incur any liability in relation to the Bribery Act. 26.3 The Supplier shall during the term of this agreement: (a) establish, maintain and enforce, and require that its Sub- contractors establish, maintain and enforce, policies and procedures which are adequate to ensure compliance with the Bribery Act and prevent the occurrence of a Prohibited Act; and (b) keep appropriate records of its compliance with its obligations under clause 26.3(a) and make such records available to the Authority on request. 26.4 The Supplier shall immediately notify the Authority in writing if it becomes aware of any breach of clause 26.1 and/or clause 26.2, or has reason to believe that it has or any of the Supplier's Personnel have: (a) been subject to an investigation or prosecution which relates to an alleged Prohibited Act; (b) been listed by any government department or agency as being debarred, suspended, proposed for suspension or debarment, or otherwise ineligible for participation in government procurement programmes or contracts on the grounds of a Prohibited Act; and/or (c) received a request or demand for any undue financial or other advantage of any kind in connection with the performance of this agreement or otherwise suspects that any person or Party directly or indirectly connected with this agreement has committed or attempted to commit a Prohibited Act. 26.5 If the Supplier makes a notification to the Authority pursuant to clause 26.4, the Supplier shall respond promptly to the Authority's enquiries, co-operate with any investigation, and allow the Authority to audit any books, records and/or any other relevant documentation in accordance with clause 22. 26.6 If the Supplier is in Default under clause 26.1 and/or clause 26.2, the Authority may by notice: (a) require the Supplier to remove from performance of this agreement any Supplier's Personnel whose acts or omissions have caused the Default; or (b) immediately terminate this agreement. 26.7 Any notice served by the Authority under clause 26.6 shall specify the nature of the Prohibited Act, the identity of the Party who the Authority believes has committed the Prohibited Act and the action that the Authority has elected to take (including, where relevant, the date on which this agreement shall terminate).

  • 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.

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