Adverse Reaction Reports Sample Clauses

Adverse Reaction Reports. (a) SELLER shall refer all adverse reaction reports and shall notify SB of the name and address of each person giving such a report to SB. It is the responsibility of SB to address any adverse reaction reports. SELLER shall exercise all reasonable efforts to provide SB any pertinent information regarding any claims against the manufacture of PRODUCTS as defined in this Agreement. (b) Should adverse reaction reports be sent to SELLER directly as the manufacturer, SELLER will promptly notify SB by telephone or Fax and forward the original to SB for response within 2 working days.
Sample 1
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Adverse Reaction Reports. In the case where a Party learns of any Adverse Reaction Report or of any other information pertaining to potential safety concerns of a Product, such Party shall notify the other Parties of such Adverse Reaction Report or information as promptly as is practicable (but in no event more than five (5) Business Days after receiving such report or information) by telephone or telefax and shall provide the notified Parties with relevant supporting documentation pertaining to the potential safety concerns of a Product. The Parties will meet promptly thereafter to determine the most appropriate way to handle any such Adverse Reaction Report or information. If reporting information relating to any Adverse Action Report or potential safety concerns related to a Product to any authority or administrative agency is necessary, LifeNet will be responsible for such reporting.
Sample 1
Adverse Reaction Reports. Sagent shall report to Anesiva all information necessary to permit Anesiva to make timely reports as required by any governmental regulatory agency in the Territory regarding Product and shall report at least quarterly concerning any findings associated with the use of Product that may suggest significant hazards, contraindications, side effects or precautions pertinent to the safety of Product (“Adverse Reaction Reports”). Anesiva shall promptly, and in all cases within [*] of confirmation of such Adverse Reaction Report, notify Sagent of any Adverse Reaction Report requiring the alteration of the manner in which Sagent performs the Services, which communication shall be held in confidence by Sagent pursuant and subject to the terms of Article 11. Should either Party learn of any hazard that is severe, serious or unexpected, concerning the Product, such hazard data shall be communicated to the other Party immediately in writing or confirmed in writing if such immediate communication is non-written. Anesiva shall be responsible for complying with all applicable laws regarding the reporting of such hazards to governmental authorities. The aforementioned information shall be addressed as follows: in the case of Sagent to: Sagent Pharmaceuticals, Inc. 0000 Xxxxx Xxxxxxx Xxxx Xxxxxxxxxx, Xxxxxxxx 00000 Attention: [*] Phone: [*]
Sample 1
Adverse Reaction Reports. During the Term of this Agreement, each party shall promptly notify the other party of all information required to be reported to the FDA coming into its possession concerning side effects, injury, toxicity or sensitivity reaction including unexpected increased incidence and severity thereof associated with commercial or clinical uses, studies, investigations or tests with the Product (animal or human), throughout the world, whether or not determined to be attributable to the Product (“Adverse Reaction Reports”). In the case of Adverse Reaction Reports within the scope of 21 CFR 314.80(c)(iii), Depomed shall transmit such adverse reaction reports so that they are received by Esprit within three (3) business days after receipt by Depomed, or such earlier reporting period as may be required by law. Esprit shall transmit adverse reaction reports to Depomed on a periodic basis, but no less often than once every six (6) months; provided, however, that Esprit shall promptly notify Depomed of any Adverse Reaction Report requiring the cessation or substantial alteration of detailing activities by the Depomed Sales Force. All such communications shall be held in the strictest confidence by Depomed and shall be subject to the terms of Article 11 hereof.
Sample 1

Related to Adverse Reaction Reports

  • 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.

  • Adverse Report The Employer shall notify an employee in writing of any expression of dissatisfaction concerning his work within ten (10) working days of the event of the complaint, with a copy to the Union. This notice shall include particulars of the work performance which led to such dissatisfaction. If this procedure is not followed, such expression of dissatisfaction shall not become a part of his work record for use against him at any time. This Article shall be applicable to any complaint or accusation which may be detrimental to an employee's advancement or standing with the Employer, whether or not it relates to his work. The employee's reply to such complaint, accusation or expression of dissatisfaction shall become part of his record. The record of an employee shall not be used against him at any time after twelve (12) months following the serving of a suspension or disciplinary action, including letters of reprimand or any adverse reports.

  • 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.

  • Evaluation Reports Where a formal evaluation of an employee's performance is carried out, the employee shall be provided with a copy to read and review. Provision shall be made on the evaluation form for an employee to sign it. The form shall provide for the employee's signature in two (2) places, one indicating that the employee has read and accepts the evaluation, and the other indicating that the employee disagrees with the evaluation. The employee shall sign in one of the places provided within seven (7) calendar days. No employee may initiate a grievance regarding the contents of an evaluation report unless the signature indicates disagreement with the evaluation. The employee shall receive a copy of the evaluation report at the time of signing. An evaluation report shall not be changed after an employee has signed it, without the knowledge of the employee, and any such changes shall be subject to the grievance procedure.

  • Inspection Reports A "full inspection report" comprises a Site Master File (compiled by the manufacturer or by the inspectorate) and a narrative report by the inspectorate. A "detailed report" responds to specific queries about a firm by the other Party.

  • Accident Reports If any of the Equipment is damaged, lost stolen, or destroyed, or if any person is injured or dies, or if any property is damaged as a result of its use, maintenance, or possession, You will promptly notify Us of the occurrence, and will file all necessary accident reports, including those required by law and those required applicable insurers. You, Your employees, and agents will cooperate fully with Us and all insurers providing insurance under this Agreement in the investigation and defense of any claims. You will promptly deliver to Us any documents served or delivered to You, Your employees, or Your agents in connection with any claim or proceeding at law or in equity begun or threatened against You, Us, or both You and Us.

  • Transaction Reports Subadviser shall provide Investment Manager a daily trade file with information relating to all transactions concerning the allocated portion of the Fund’s assets for which Subadviser is responsible and shall provide Investment Manager with such other information regarding the Fund upon Investment Manager’s reasonable request. Subadviser shall affirm or send a trade file of these transactions as instruction to the custodian of the Fund.

  • Project Reports The Recipient shall monitor and evaluate the progress of the Project and prepare Project Reports in accordance with the provisions of Section 4.08 of the General Conditions and on the basis of the indicators agreed with the Association. Each Project Report shall cover the period of one calendar semester, and shall be furnished to the Association not later than one month after the end of the period covered by such report.

  • Evaluation Report The state must provide a narrative summary of the evaluation design, status (including evaluation activities and findings to date), and plans for evaluation activities during the extension period. The narrative is to include, but not be limited to, describing the hypotheses being tested and any results available.

  • Servicer Compliance Statement On or before March 1 of each calendar year, commencing in 2007, the Servicer shall deliver to the Owner and any Depositor a statement of compliance addressed to the Owner and such Depositor and signed by an authorized officer of the Servicer, to the effect that (i) a review of the Servicer’s activities during the immediately preceding calendar year (or applicable portion thereof) and of its performance under this Agreement and any applicable Reconstitution Agreement during such period has been made under such officer’s supervision, and (ii) to the best of such officers’ knowledge, based on such review, the Servicer has fulfilled all of its obligations under this Agreement and any applicable Reconstitution Agreement in all material respects throughout such calendar year (or applicable portion thereof) or, if there has been a failure to fulfill any such obligation in any material respect, specifically identifying each such failure known to such officer and the nature and the status thereof.

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