FIELD ALERT REPORTING Sample Clauses

FIELD ALERT REPORTING. If PowderJect receives information concerning any bacteriological contamination, or any significant chemical, physical, or other change or deterioration in a Gas Cylinder supplied to AlgoRx, or any failure of one or more batches of Gas Cylinders supplied to AlgoRx to meet the Gas Cylinder Specification (a "FIELD ALERT"), PowderJect shall notify AlgoRx immediately by telephone (to be confirmed in writing within twenty-four (24) hours). AlgoRx shall be responsible for receiving, investigating, and documenting all such information relating to such Field Alerts. AlgoRx will be solely responsible for filing all post-marketing Field Alert reports required by Regulatory Authorities, or as required by applicable laws or regulations. PowderJect will cooperate as reasonably required by AlgoRx with the investigation of such incidents. If the Field Alert arises out of PowderJect's failure to supply Gas Cylinders that were Manufactured in compliance with GMP or that conform to the Gas Cylinder Specification, PowderJect shall bear the cost and expense of investigating and responding to such Field Alert, and shall use diligent efforts to replace the affected Gas Cylinders with replacement Gas Cylinders Manufactured in compliance with GMP that conform to the Gas Cylinder Specification as soon as reasonably practicable. In the event
Sample 1Sample 2
AutoNDA by SimpleDocs
FIELD ALERT REPORTING. If either party receives information concerning any viral, bacterial, or similar contamination, or any significant chemical, physical, or other change or deterioration in a distributed Conor Device incorporating Product, or any failure of any distributed Conor Device incorporating Product to meet the Product Specifications or other CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED. relevant specifications (a “Field Alert”), such party shall notify the other party immediately by telephone (to be confirmed in writing within [*]). Conor shall be responsible for investigating and documenting all such information relating to Field Alerts. Conor will be solely responsible for filing all post-marketing Field Alert reports required by Regulatory Authorities, or as required by applicable laws or regulations. Phytogen will cooperate as reasonably required by Conor with the investigation of such incidents. Subject to a full investigation by the Regulatory Committee, to the extent it is determined that the Field Alert arises out of Phytogen’s failure to manufacture the Product in compliance with GMP or other applicable laws or regulations or in conformance with the Product Specifications and Conor did not handle the Product in any manner which altered or caused to be defective the Product or otherwise caused such failure, Phytogen shall bear the cost and expense of investigating and responding to such Field Alert, and shall provide an amount of Product that has been manufactured the affected Product compliance with GMP and other applicable laws and regulations and that conform to the Product Specifications necessary to produce the number of Conor Devices equal to the quantity of Conor Devices incorporating Product that are the subject of the Field Alert within [*] days from the date that Phytogen becomes aware of such Field Alert.
Sample 1
FIELD ALERT REPORTING. If either Party receives any information with respect to Licensed Products (a) concerning any incident that causes the Licensed Product or its labeling to be mistaken for, or applied to another article, or (b) concerning any bacteriological contamination, or any significant chemical, physical, or other change or deterioration in a distributed Licensed Product, or any failure of one or more distributed Batches to meet the Specifications (a "FIELD ALERT"), such Party shall notify the other Party immediately in person or by telephone, facsimile, or email (to be confirmed in writing within the reasonable period to be agreed in the Quality Memorandum). Peninsula shall be responsible for receiving, investigating, and documenting all such information relating to such Field Alerts. Peninsula will be solely responsible for filing all post-marketing Field Alert reports required by Regulatory Authorities, or as required by applicable laws or regulations in the Territory. Shionogi will cooperate as reasonably required by Peninsula with the investigation of such incidents in the Territory. If the Field Alert arises out of Shionogi's failure to manufacture the Licensed Products in compliance with GMP or other applicable laws or regulations or in conformance with the Specifications,
Sample 1

Related to FIELD ALERT REPORTING

  • Progress Reporting 5. The IP will submit to UNICEF narrative progress reports against the planned activities contained in the Programme Document, using the PDPR. Unless otherwise agreed between the Parties in writing, these reports will be submitted at the end of every Quarter. The final report will be submitted no later than thirty (30) calendar days after the end the Programme and will be provided together with the FACE form.

  • 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.

  • Fault Reporting 5.1 We are responsible for correcting faults in supplying the Voice Services. You must provide all necessary assistance to enable us to locate and repair any fault which is our responsibility. 5.2 We are not responsible for any fault which is on your side of the network termination point, except in relation to Purchase Equipment, or Other Equipment that we are maintaining. 5.3 We are not responsible for any fault which is within the network of a Supplier. However, we will notify that Supplier of the fault and request that the fault be corrected promptly.

  • Diversity Reporting Upon request, the Contractor will report to the Department its spend with business enterprises certified by the OSD. These reports must include the time period covered, the name and Federal Employer Identification Number of each business enterprise utilized during the period, commodities and contractual services provided by the business enterprise, and the amount paid to the business enterprise on behalf of each agency purchasing under the Contract.

  • 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.

  • Contract Reporting The Contractor shall report information on orders received from Customers associated with this Contract. No price adjustments will be considered for any Contractor who has outstanding reports, or any other documentation required under this Contract. The Contractor shall submit reports in accordance with the following schedule: MFMP Transaction Fee Report Calendar month 15 calendar days after the end of each month Quarterly Sales Report State’s Fiscal Quarter 30 calendar days after close of the period Diversity Report(submitted to the Customer) State Fiscal Year 30 Business Days after close of the period Preferred Pricing Affidavit (in accordance with the Special Contract Conditions) Annual Contract Anniversary Date

  • Sales Reporting Requirements This is a requirement of the TIPS Contract and is non-negotiable. By submitting this proposal, Vendor certifies that Vendor will properly report all TIPS sales. With the exception of TIPS Automated Vendors, who have signed an exclusive agreement with TIPS regarding reporting, all TIPS Sales must be reported to TIPS by either: (1) Emailing the purchase order or similar purchase document (with Vendor’s Name, as known to TIPS, and the TIPS Contract Name and Number included) to TIPS at xxxxxx@xxxx-xxx.xxx with “Confirmation Only” in the subject line of the email within three business days of Vendor’s acceptance of the order, or; (2) Within 3 business days of the order being accepted by Vendor, Vendor must login to the TIPS Vendor Portal and successfully self-report all necessary sale information within the Vendor Portal and confirm that it shows up accurately on your current Vendor Portal statement. No other method of reporting is acceptable unless agreed to by the Parties in writing. Failure to report all sales pursuant to this provision may result in immediate cancellation of Vendor’s TIPS Contract(s) for cause at TIPS’ sole discretion.

  • Regulatory Reporting Ultimus agrees to provide reports to the federal and applicable state authorities, including the SEC, and to the Funds’ Auditors. Applicable state authorities are those governmental agencies located in states in which the Fund is registered to sell shares.

  • 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.

  • Management Reporting (a) Provide periodic reports, in accordance with agreed upon frequency and content parameters, to the Funds. As reasonably requested by the Funds, the Transfer Agent shall furnish ad hoc reports to the Funds.

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