ADVERSE EVENT REPORTING PROCEDURES Sample Clauses

ADVERSE EVENT REPORTING PROCEDURES. The Parties hereby agree that the following terms will govern disclosures of each Party to the other with respect to adverse event reporting relating to the Product as clinically tested or marketed by or on behalf of either Party.
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ADVERSE EVENT REPORTING PROCEDURES. The terms adverse event or experience (AE) and adverse drug reaction (ADR), used in this Exhibit 4.4 shall have the meanings set forth in worldwide reporting regulations. The Parties agree to comply with any and all governmental laws, regulations and orders that are applicable now and in the future in connection with product safety collection and reporting. The Parties agree to meet after the Effective Date to establish a detailed Safety Agreement outlining the pharmacovigilance responsibilities of each Party including but not limited to: AE or ADR reporting including literature review and associated reporting; AE or ADR follow-up reporting; preparation and submission of all safety reports to the Regulatory Authorities as required by local laws and/or regulations in the Territory; maintaining the global safety database; all interactions with health authorities regarding safety; periodic submissions; labeling modifications; safety monitoring and detection; and safety measures (e.g., Dear Doctor Letter, restriction on distribution). Wyeth shall maintain the global safety database for the Licensed Products. Notwithstanding the foregoing and until such time as the Safety Agreement is executed, to the extent Trubion has or receives any information regarding any AE/ADR which may be related to the use of any Licensed Product or to Licensed Product Development, Trubion shall promptly forward such information as follows: - Fatal or life-threatening serious AE(s)/ADR(s) judged by either the investigator and/or sponsor to be reasonably related to the Licensed Product(s) Development/protocol shall be transmitted to Wyeth within three (3) calendar days from the date received by Trubion. - All other serious AE(s)/ADR(s) not fatal or life-threatening but judged by either the investigator and/or sponsor to be reasonably related to the Licensed Product(s) Development/protocol shall be transmitted to Wyeth within five (5) calendar days from the date received by Trubion. AE/ADR information may be transmitted to Wyeth by:
ADVERSE EVENT REPORTING PROCEDURES. Discovery shall be responsible for required reporting of adverse events and drug safety issues related to the use of the Product. Discovery shall advise Quintiles of its standard procedures for the reporting of adverse events, and the Quintiles Sales Force shall comply with such procedures. The Discovery procedures for the reporting of adverse events shall be included in the training program for the Quintiles Sales Force. Quintiles shall report to Discovery within twenty-four (24) hours any adverse events of which Quintiles becomes aware reported to it.
ADVERSE EVENT REPORTING PROCEDURES. CVT shall be responsible for the reporting of adverse events and drug safety issues related to the use of the Product. CVT shall advise Innovex of its standard procedures for the reporting of adverse events, and the Innovex Sales Force shall comply with such procedures. The CVT procedures for the reporting of adverse events shall be included in the training program for the Innovex Sales Force. Innovex shall report to CVT within twenty-four (24) hours any adverse events reported to it.
ADVERSE EVENT REPORTING PROCEDURES. The Parties hereby agree that the following terms will govern disclosures of each Party to the other with respect to adverse event reporting relating to any R&D Candidate or Product as clinically tested or marketed by or on behalf of either Party.
ADVERSE EVENT REPORTING PROCEDURES. Each Party will (a) provide the other Party with safety data from clinical studies in its control and post-marketing reports necessary or desirable for the other Party to comply with all applicable laws and regulations with respect to Product and (b) report and provide such information to the other Party in such a manner and time so as to enable the other Party to comply with all applicable laws and regulations. Nycomed shall maintain a global safety database for Product and shall generate adverse event reports for NPS’ use in North America. NPS shall have access to all data in the global safety database. Nycomed shall be responsible for submitting such adverse events reports to the applicable Regulatory Authorities in the Territory. Details on procedures and responsibilities shall be negotiated by the pharmacovigilance personnel of the Parties and set forth in a Pharmacovigilance Agreement to be entered into by the Parties within ninety (90) days after the Effective Date.
ADVERSE EVENT REPORTING PROCEDURES. Pilot shall be responsible for reporting to any governmental agency of adverse events and drug safety issues related to the use of the Product of which Pilot becomes aware, to the extent required by law or regulation. Pilot shall advise Innovex of its standard procedures for the reporting of adverse events, and the Innovex Sales Force shall comply with such procedures. The Pilot procedures for the reporting of adverse events shall be included in the training program for the Innovex Sales Force. Innovex shall report to Pilot within twenty-four (24) hours any adverse events of which Innovex becomes aware.
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Related to ADVERSE EVENT REPORTING PROCEDURES

  • 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.

  • Reporting Procedures Enter in the XXX Entity Management area the information that XXX requires about each proceeding described in paragraph 2 of this award term and condition. You do not need to submit the information a second time under assistance awards that you received if you already provided the information through XXX because you were required to do so under Federal procurement contracts that you were awarded.

  • 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.

  • Safety Procedures The Contractor shall: (a) comply with all applicable safety regulations according to Attachment H; (b) take care for the safety of all persons entitled to be on the Site; (c) use reasonable efforts to keep the Site and Works clear of unnecessary obstruction so as to avoid danger to these persons; (d) provide fencing, lighting, guarding and watching of the Works until completion and taking over under clause 10 [Employer's Taking Over]; and (e) provide any Temporary Works (including roadways, footways, guards and fences) which may be necessary, because of the execution of the Works, for the use and protection of the public and of owners and occupiers of adjacent land.

  • Evaluation Procedures The following procedures for employee evaluation shall be utilized for the term of this Agreement: 1. Orientation materials related to evaluation procedures will be provided to all employees by the 10th school day. 2. Employees shall submit to their evaluator a complete listing of proposed objectives, and measurement activities related thereto, to be considered in the annual evaluation by the 25th school day. 3. The evaluator shall have completed by 30th school day annual objective setting conference with employee. 4. The evaluator shall by the 40th school day determine and shall provide the employee with a complete listing of actual objectives from those proposed by the evaluator and employee, and measurement activities from those proposed by the evaluator and employee, and measurement activities related thereto, that will be incorporated in the annual evaluation that the evaluator will prepare for the employee. The objectives and related measurement activities referred to herein shall be in accordance with the employee job description prescribed by the District. The District will make every attempt to have the number of objectives required to be uniform from site to site. 5. Within a reasonable time after the request, the evaluator shall be provided with a written progress report from the employee containing the latter's perception of the progress being made toward the achievement of the objectives prescribed in Item 3, above. During the course of the evaluation period, circumstances may change which may result in the modification of the original standards and objectives. These changes may be initiated by the supervisor or the employee. Agreement of both parties is required. 6. The evaluator, by the 145th school day, shall have conducted classroom observations in order to gather data on employee performance as the evaluator believes to be related to: A. The actual objectives and measurement activities described in Item 3, above; B. Other criteria for employee evaluation and appraisal that are established by the District Xxxxx Act Guidelines. At the discretion of the evaluator, tenured teachers may receive only one (1) formal instructional observation per year. Probationary teachers will receive two (2) formal instructional observations per year. Prior to conducting formal instructional observations regarding the teacher's duties related to the instructional objectives herein described, the teacher shall be notified of the observation prior to the beginning of the teacher's actual instructional day. Upon the request of the evaluatee or when, in the evaluator's judgment, additional instructional classroom observations are necessary, such observations may be conducted. Within a reasonable time, an employee shall be provided with a written statement regarding instructional observations that have been conducted. Such written statements shall contain a summary of the instructional activities observed, and any suggestions being made by the observer for possible improvement by the employee to include, but not be limited to, the following: 1) Specific directives for improvement 2) Assistance to implement such directives as (a) Provisions of additional resources; (b) Mandatory training programs designed to improve performance to be paid by the District. A final and written report of the achievement of objectives, and measurement information related thereto shall be submitted by the employee to the evaluator by the 140th school day. 7. The evaluator shall prepare a written District evaluation form of employee performance and transmit the evaluation to the employee. The employee may submit a written reaction or response to the evaluation and such response shall be attached to the evaluation and placed in the employee's permanent personnel file which shall be maintained in the District Office. Permanent employees shall be evaluated at least once every other year, and in no event later than 30 days before the last school day scheduled on the school calendar of the current school year. Probationary employees shall be evaluated at least once each year and in no event later than the 150th school day. 8. Employees who meet each of the following conditions shall be evaluated up to every five

  • Testing Procedures Testing will be conducted by an outside certified Agency in such a way to ensure maximum accuracy and reliability by using the techniques, chain of custody procedures, equipment and laboratory facilities which have been approved by the U.S. Department of Health and Human Services. All employees notified of a positive controlled substance or alcohol test result may request an independent test of their split sample at the employee’s expense. If the test result is negative the Employer will reimburse the employee for the cost of the split sample test.

  • Billing Procedures The Supporting Party will xxxx the Protecting Party for actual costs incurred for Assistance by Hire. Reimbursements will be limited to the provisions of the Agreement and the applicable OP, regardless of whether or not it is authorized on the Resource Order or other documentation produced by the incident. Reimbursable costs may include transportation, salary, overtime, per diem and other approved expenses of Supporting agency personnel. Rates and conditions of use for the equipment and personnel are documented in the OP. Parties shall submit a xxxx within 90 days of the incident. Parties must use their own invoice form for billing under this Agreement to avoid any confusion with other services that may have been ordered under other agreements. Invoices must identify Supporting Party’s name, address, and Taxpayer Identification Number (Department only), fire name, order and request number, and xxxx number and amount. Invoice supporting documentation must include description of services performed, period of services performed, and any applicable cost share agreements. Supporting documentation will itemize details of billing, listing personnel, equipment, travel and per diem, aircraft, supplies and purchases as approved in the attached AOP. It will also include itemized deductions for maintenance and repair of equipment. Department invoices will include “Record of Activities” (FSLA-5) and U.S. Forest Service invoices will include transaction register. Invoices for services under this agreement must be sent to: Name: Xxxx Xxxxxx-Xxxxx, ECC Manager Address: 0000 Xxxxxxxxx Xxxxx Xxxx, Xxxxx, Xxx: Xxxxxxxxxx, XX 00000 Telephone: (000) 000-0000 FAX: (000) 000-0000 Email: xxxxxxxxxxxx@xx.xxx.xx Name: Spalding Community Service District Address: 000-000 Xxxxxxxx Xxx Xxxx, Xxxxx, Xxx: Xxxxxxxxxx, XX 00000 Telephone: (000) 000-0000 FAX: (000) 000-0000 Email: xxxxxxxxxxxxx@xxxxxxx.xxx All bills will have a payment due date 30 days upon receipt. Contested Xxxxxxxx: Written notice that a xxxx is contested will be mailed to the Party within 30 days of receipt of the invoice and will fully explain the contested items. Contested items should be resolved no later than 60 days following receipt of the written notice. Parties are responsible for facilitating resolution of contested xxxxxxxx. Billing requirements and rates are documented in the attached OP.

  • RECOVERY PROCEDURES The nature and severity of any disaster will influence the recovery procedures. One crucial factor in determining how BellSouth will proceed with restoration is whether or not BellSouth's equipment is incapacitated. Regardless of who's equipment is out of service, BellSouth will move as quickly as possible to aid with service recovery; however, the approach that will be taken may differ depending upon the location of the problem.

  • Compliance Policies and Procedures To assist the Fund in complying with Rule 38a-1 of the 1940 Act, BBH&Co. represents that it has adopted written policies and procedures reasonably designed to prevent violation of the federal securities laws in fulfilling its obligations under the Agreement and that it has in place a compliance program to monitor its compliance with those policies and procedures. BBH&Co will upon request provide the Fund with information about our compliance program as mutually agreed.

  • Notification Procedures To address non-compliance, the receiving Competent Authority would notify the providing Competent Authority pursuant to Article 5 of the IGA. The notification procedures would differ depending upon whether the receiving Competent Authority seeks to address administrative or other minor errors or significant non-compliance.

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