SAEs Sample Clauses

SAEs. All events meeting the definition of an SAE (Section 10.2) require expedited reporting.
AutoNDA by SimpleDocs
SAEs. PPD will handle expected or unexpected SAEs in accordance with mutually agreed project-specific protocols. PPD will send to CLIENT a [***] summary report of all SAEs no later than the [***] following receipt. For reportable events, PPD will send a draft MedWatch report to CLIENT for review and comment within [***] of the initial notification. CLIENT will be responsible for submitting this report to the agency within defined regulatory time frames. Follow-up will be done in accordance with mutually negotiated project-specific protocols. PPD will provide SAE narratives in agreed upon format, if so requested by CLIENT. Completed case files and source documents will be retained for a period of time determined by mutual agreement and in accordance with applicable laws and regulations, and cases will have been entered into the specified validated safety database.

Related to SAEs

  • Adverse Events Subsequent to the date hereof, there shall not have occurred any of the following: (i) a suspension or material limitation in trading in securities generally on the New York Stock Exchange, the NASDAQ National Market or the NASDAQ Global Market, (ii) a general moratorium on commercial banking activities in the People’s Republic of China or New York, (iii) the outbreak or escalation of hostilities involving the United States or the People’s Republic of China or the declaration by the United States or the People’s Republic of China of a national emergency or war if the effect of any such event specified in this clause (iii) in your reasonable judgment makes it impracticable or inadvisable to proceed with the public offering or the delivery of the Shares on the terms and in the manner contemplated in the Prospectus, or (iv) such a material adverse change in general economic, political, financial or international conditions affecting financial markets in the United States or the People’s Republic of China having a material adverse impact on trading prices of securities in general, as, in your reasonable judgment, makes it impracticable or inadvisable to proceed with the public offering of the Shares or the delivery of the Shares on the terms and in the manner contemplated in the Prospectus.

  • Job Evaluation The work of the provincial job evaluation steering committee (the JE Committee) will continue during the term of this Framework Agreement. The objectives of the JE Committee are as follows: • Review the results of the phase one and phase two pilots and outcomes of the committee work. Address any anomalies identified with the JE tool, process, or benchmarks. • Rate the provincial benchmarks and create a job hierarchy for the provincial benchmarks. • Gather data from all school districts and match existing job descriptions to the provincial benchmarks. • Identify the job hierarchy for local job descriptions for all school districts. • Compare the local job hierarchy to the benchmark-matched hierarchy. • Develop a methodology to convert points to pay bands - The confirmed method must be supported by current compensation best practices. • Identify training requirements to support implementation of the JE plan and develop training resources as required. Once the objectives outlined above are completed, the JE Committee will mutually determine whether a local, regional or provincial approach to the steps outlined above is appropriate. It is recognized that the work of the committee is technical, complicated, lengthy and onerous. To accomplish the objectives, the parties agree that existing JE funds can be accessed by the JE committee to engage consultant(s) to complete this work. It is further recognized that this process does not impact the established management right of employers to determine local job requirements and job descriptions nor does this process alter any existing collective agreement rights or established practices. When the JE plan is ready to be implemented, and if an amendment to an existing collective agreement is required, the JE Committee will work with the local School District and Local Union to make recommendations for implementation. Any recommendations will also be provided to the Provincial Labour Management Committee (PLMC). As mutually agreed by the provincial parties and the JE Committee, the disbursement of available JE funds shall be retroactive to January 2, 2020. The committee will utilize available funds to provide 50% of the wage differential for the position falling the furthest below the wage rate established by the provincial JE process and will continue this process until all JE fund monies at the time have been disbursed. The committee will follow compensation best practices to avoid problems such as inversion. The committee will report out to the provincial parties regularly during the term of the Framework Agreement. Should any concerns arise during the work of the committee they will be referred to the PLMC. Create a maintenance program to support ongoing implementation of the JE plan at a local, regional or provincial level. The maintenance program will include a process for addressing the wage rates of incumbents in positions which are impacted by implementation of the JE plan. The provincial parties confirm that $4,419,859 of ongoing annual funds will be used to implement the Job Evaluation Plan. Effective July 1, 2022, there will be a one-time pause of the annual $4,419,859 JE funding. This amount has been allocated to the local table bargaining money. The annual funding will recommence July 1, 2023.

  • Protocols Each party hereby agrees that the inclusion of additional protocols may be required to make this Agreement specific. All such protocols shall be negotiated, determined and agreed upon by both parties hereto.

  • CHILD ABUSE REPORTING CONTRACTOR hereby agrees to annually train all staff members, including volunteers, so that they are familiar with and agree to adhere to its own child and dependent adult abuse reporting obligations and procedures as specified in California Penal Code section 11164 et seq. and Education Code 44691. To protect the privacy rights of all parties involved (i.e., reporter, child and alleged abuser), reports will remain confidential as required by law and professional ethical mandates. A written statement acknowledging the legal requirements of such reporting and verification of staff adherence to such reporting shall be submitted to the LEA.

  • Random Drug Testing All employees covered by this Agreement shall be subject to random drug testing in accordance with Appendix D.

  • Feedback You have no obligation to provide us with ideas, suggestions, or proposals (“Feedback”). However, if you submit Feedback to us, then you grant us a non-exclusive, worldwide, royalty-free license that is sub-licensable and trans- ferable, to make, use, sell, have made, offer to sell, import, reproduce, publicly display, distribute, modify, or publicly perform the Feedback in any manner without any obligation, royalty, or restriction based on intellectual property rights or otherwise.

  • Research Use Reporting To assure adherence to NIH GDS Policy, the PI agrees to provide annual Progress Updates as part of the annual Project Renewal or Project Close-out processes, prior to the expiration of the one (1) year data access period. The PI who is seeking Renewal or Close-out of a project agree to complete the appropriate online forms and provide specific information such as how the data have been used, including publications or presentations that resulted from the use of the requested dataset(s), a summary of any plans for future research use (if the PI is seeking renewal), any violations of the terms of access described within this Agreement and the implemented remediation, and information on any downstream intellectual property generated from the data. The PI also may include general comments regarding suggestions for improving the data access process in general. Information provided in the progress updates helps NIH evaluate program activities and may be considered by the NIH GDS governance committees as part of NIH’s effort to provide ongoing stewardship of data sharing activities subject to the NIH GDS Policy.

  • Root Cause Analysis Upon Vendor's failure to provide the Services in accordance with the applicable Service Levels (for any reason other than a Force Majeure Event) Vendor will promptly (a) perform a root-cause analysis to identify the cause of such failure, (b) provide Prudential with a report detailing the cause of, and procedure for correcting, such failure, (c) obtain Prudential's written approval of the proposed procedure for correcting such failure, (d) correct such failure in accordance with the approved procedure, (e) provide weekly (or more frequent, if appropriate) reports on the status of the correction efforts, and (f) provide Prudential with assurances satisfactory to Prudential that such failure has been corrected and will not recur.

  • Adverse Event Reporting Both Parties acknowledge the obligation to comply with the Protocol and / or applicable regulations governing the collection and reporting of adverse events of which they may become aware during the course of the Clinical Trial. Both Parties agree to fulfil and ensure that their Agents fulfil regulatory requirements with respect to the reporting of adverse events.

  • SERVICE MONITORING, ANALYSES AND ORACLE SOFTWARE 11.1 We continuously monitor the Services to facilitate Oracle’s operation of the Services; to help resolve Your service requests; to detect and address threats to the functionality, security, integrity, and availability of the Services as well as any content, data, or applications in the Services; and to detect and address illegal acts or violations of the Acceptable Use Policy. Oracle monitoring tools do not collect or store any of Your Content residing in the Services, except as needed for such purposes. Oracle does not monitor, and does not address issues with, non-Oracle software provided by You or any of Your Users that is stored in, or run on or through, the Services. Information collected by Oracle monitoring tools (excluding Your Content) may also be used to assist in managing Oracle’s product and service portfolio, to help Oracle address deficiencies in its product and service offerings, and for license management purposes. 11.2 We may (i) compile statistical and other information related to the performance, operation and use of the Services, and (ii) use data from the Services in aggregated form for security and operations management, to create statistical analyses, and for research and development purposes (clauses i and ii are collectively referred to as “Service Analyses”). We may make Service Analyses publicly available; however, Service Analyses will not incorporate Your Content, Personal Data or Confidential Information in a form that could serve to identify You or any individual. We retain all intellectual property rights in Service Analyses. 11.3 We may provide You with the ability to obtain certain Oracle Software (as defined below) for use with the Services. If we provide Oracle Software to You and do not specify separate terms for such software, then such Oracle Software is provided as part of the Services and You have the non-exclusive, worldwide, limited right to use such Oracle Software, subject to the terms of this Agreement and Your order (except for separately licensed elements of the Oracle Software, which separately licensed elements are governed by the applicable separate terms), solely to facilitate Your use of the Services. You may allow Your Users to use the Oracle Software for this purpose, and You are responsible for their compliance with the license terms. Your right to use any Oracle Software will terminate upon the earlier of our notice (by web posting or otherwise) or the end of the Services associated with the Oracle Software. Notwithstanding the foregoing, if Oracle Software is licensed to You under separate terms, then Your use of such software is governed by the separate terms. Your right to use any part of the Oracle Software that is licensed under the separate terms is not restricted in any way by this Agreement.

Draft better contracts in just 5 minutes Get the weekly Law Insider newsletter packed with expert videos, webinars, ebooks, and more!