Event Reporting. Upon the completion of the Event and at the request of the Commission, User will provide to the Commission, for reporting purposes the following information; the number of teams that participated in the Event, the number of participants per team, the age of each participant, the gender of each participant, the zip code of each participant and the number of games played by each team.
Event Reporting. The ACA must receive reports on all insured PAC activities in order to provide insurance coverage to all participants, and to keep insurance costs to minimum. Therefore, the PAC and its activity leaders agree to submit reports for their insured activities to the ACA, in accordance with the requirements listed below.
Event Reporting a. The Contractor must ensure the Aircraft are equipped with event reporting equipment to meet the engine and flight event reporting requirements of the NAFC Standard OPS- 014 Aircraft Tracking, Event Reporting and Messaging.
Event Reporting. CKD shall be responsible for reporting all Events (as defined below) associated with the development or Commercialization of a Licensed Product in the Territory to the appropriate Regulatory Authorities in the Territory, in accordance with all CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS EXHIBIT. THE COPY FILED HEREWITH OMITS THE INFORMATION SUBJECT TO A CONFIDENTIALITY REQUEST. OMISSIONS ARE DESIGNATED [*]. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
Event Reporting a) Flight Crew Members shall notify the Flight Operations Department of a Safety Event within 48 hours of first becoming aware of the event taking place. Notification may be by phone, e-mail or fax. In addition, each Flight Crew Member shall submit a written report, in a form agreed to by the parties, at the earliest opportunity, but no later than seven days after first reporting the Safety Event.
Event Reporting. Each Party shall be responsible for reporting all Events (as defined below) associated with the development or Commercialization of a Licensed Product in its respective territory (as to Maruishi, the Territory) to the appropriate Regulatory Authorities in its respective territory, in accordance with all Applicable Laws, and shall provide the other Party copies of all such reports promptly after filing with the Regulatory Authorities. Additionally, in the event either Party receives information regarding Events related to the use of a Licensed Product, such Party shall promptly provide the other Party with such information in accordance with the separate Safety Agreement to be entered into by the Parties promptly. For purposes of this Section 3.7, “Event” shall mean any adverse event, adverse drug reaction or medical device report, including, without limitation, malfunctions, product failure, improper or inadequate design, manufacturer labeling or user error reported during the use of the Licensed Product by or on behalf of Maruishi, its Affiliates, and customers (including, without limitation, end users purchasing any Licensed Product or using any Licensed Product purchased from any of the foregoing). Each Party shall notify the other Party immediately of any Information received regarding any threatened or pending action by any public authority that may affect or related to the safety, efficacy, or other labeling claims of any CR-845 product.
Event Reporting. Both the USU IRB and <<insert name of external institution>> agree to promptly inform to the reciprocal institution of reports of serious or continuing noncompliance in the conduct of the study and unanticipated problems involving risks to participants or others, encountered in research as specified in this agreement. Notices and Primary Contacts Any notices to the undersigned institutional officials or correspondence regarding IRB review and oversight must be addressed as follows: If to USU IRB: Xxxxxxx X. Xxxxx, Ph.D. Interim Vice President for Research Utah State University 0000 Xxx Xxxx Xxxx, Xxxxx 000 Xxxxx, XX 00000 Phone: 000.000.0000 Email: xxxxx.xxxxx@xxx.xxx Xxxxxx Xxxxxxxx IRB Director Utah State University 0000 Xxx Xxxx Xxxx, Xxxxx 000 Xxxxx, XX 00000 Phone: 000.000.0000 Email: xxxxxx.xxxxxxxx@xxx.xxx If to <<insert name of applicable external institutional official(s)>>: <<Insert name(s), title(s), address(es), phone number(s), and email address(es)>> Signature of External Institution’s Signatory Official: ________________________________________ Signature _____________________________________________ Date ________________________________________ Print Full Name _____________________________________________ Institutional Title Address: Phone: Signature of Signatory Official (Utah State University): ________________________________________ Signature _________________________________________ Date ________________________________________ Print Full Name _________________________________________ Institutional Title Address: Phone:
Event Reporting. 7.2 RELATIONSHIP TO THE INVESTIGATIONAL DEVICE The investigator should assess the relationship of the adverse event to the investigational device. The relationship should be assessed using the categories presented in Table 7.2-1. TABLE 7.2-1. RELATIONSHIP BETWEEN ADVERSE EVENTS AND INVESTIGATIONAL DEVICE Definite Definite relationship exists between the device/procedure and an adverse event Probably Related A reasonable causal relationship between the device/procedure and an adverse event is more likely than not. Possibly Related A reasonable relationship exists between the device/procedure and an adverse event, but the causal relationship is unclear or lacking. Not Likely Related A temporal relationship exists between the device/procedure and an adverse event, but there is no reasonable causal relationship. For example the adverse event occurs in a time frame, which makes a causal relationship to device treatment improbable. Unrelated No relationship between treatment with the device/procedure and the adverse event exists.
Event Reporting. SYNOVICS shall be responsible for reporting all Events (as defined below) associated with the Product to the appropriate Regulatory 8 * Portions of this exhibit have been omitted and filed separately pursuant to an application for confidential treatment filed with the Securities and Exchange Commission pursuant to Rule 24b-2 under the Securities Exchange Act of 1934, as amended.
Event Reporting. If SELLER receives a complaint from any Third Party, or if SELLER’s quality assurance group, infant formula business unit managers, or senior management otherwise become aware of a complaint or issue, about Martek Product involving safety concerns, SELLER shall promptly notify PURCHASER in writing. In addition, during the Term of this Agreement, PURCHASER shall promptly notify SELLER of any report of an adverse event once it has determined that it is potentially associated with the use of Martek Products in any Wyeth Product or Growing Up Milk Product, and SELLER shall notify PURCHASER of any report of an adverse event received by SELLER regarding a Wyeth Product or Growing Up Milk Product irrespective of whether the adverse event is potentially associated with the use of a Martek Product. All adverse event notifications as stated above shall occur within five (5) calendar days of receipt of a report of such adverse event. PURCHASER shall have sole discretion in determining what action, if any, is to be taken by PURCHASER in connection with any such adverse event relating to a Wyeth Product or Growing Up Milk Product. The Parties shall be notified as follows (or in such other manner as provided by notice pursuant to Section 11.4): For SELLER: Fax number: (000) 000-0000 Mr. Xxxxx Xxxxxx Regulatory Manager Martek Biosciences Corporation 0000 Xxxxxx Xxxx Columbia, MD 21045 (tel) 000-000-0000 For PURCHASER: Fax number: (000) 000-0000 Overnight Courier (only): Global Safety Surveillance Epidemiology & Labeling Wyeth Research GSSEL Triage Unit Dock E 000 Xxxxxx Xxxx Xxxxxxxxxxxx, XX 00000 * The asterisk denotes that confidential portions of this exhibit have been omitted in reliance on Rule 24b-2 of the Securities Exchange Act of 1934. The confidential portions have been submitted separately to the Securities and Exchange Commission.
