Event Reports definition

Event Reports means the reports described in this paragraph.

Examples of Event Reports in a sentence

  • Connetics shall be solely responsible for submitting Adverse Event Reports to the FDA, except to the extent (if at all) that MGI may be required by law to make such reports itself.

  • The Trustee shall so deliver the foregoing information and reports and shall file such Summary Reports and Annual Compliance Reports annually on Form 10-K and shall file such Special Event Reports on Form 8-K promptly upon the occurrence of the applicable event, in each case unless the Trust Fund is no longer filing Exchange Act Reports.

  • The contractor will provide all associated continued maintenance and support services as part of the Detailed Noise Event Reports Service to JWA.

  • The Parties shall each identify a person to coordinate the exchange of Adverse Event Reports (“Report Coordinators”) so as to enable timely reporting of such Adverse Event Reports to appropriate governmental and regulatory authorities consistent with all laws, rules and regulations.

  • The Parties shall each identify a person to coordinate the exchange of Adverse Event Reports so as to enable timely reporting of such Adverse Event Reports to appropriate Governmental Authorities consistent with all Applicable Laws.

  • The contractor will provide the Detailed Noise Event Reports Service.

  • Following Regulatory Approval for each Licensed Product in the United States (and Canada if applicable), Fujisawa shall provide DTI with copies of those Periodic Adverse Event Reports submitted by Fujisawa to the FDA or other applicable regulatory authority in Canada which relate to each Licensed Product.

  • Preventative Maintenance and Event Reports Services will be carried out within the Standard Hours.

  • Nevertheless, the Product Committee will review and discuss the Product's clinical and regulatory development including, but not limited to, the design and implementation of clinical trials, budgets, the content and status of regulatory filings and approvals, and Adverse Event Reports.

  • The Parties acknowledge and agree that such procedures, as well as the Parties’ exchange of Adverse Event Reports in general, must not be in contravention with the [****] Agreements relating to safety issues involving the [****] that is a Collaboration Product, or a Royalty Product.