Adverse Reaction Reports definition

Adverse Reaction Reports means an adverse event or adverse drug reaction as defined (i) in the ICH E2A document, (ii) in any clinical safety reports, as referenced in 21 C.F.R. 312.32 (as may be amended from time to time), or (iii) any international equivalent definitions used by Regulatory Authorities in the Territory. The definition will be considered updated as these documents are officially amended by the ICH and applicable Regulatory Authorities to ensure compliance with regulatory reporting requirements.
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Adverse Reaction Reports shall have the meaning assigned to such term in Section 6.2.2 hereof.
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Adverse Reaction Reports. Adverse Reaction Reports shall have the meaning assigned to it in Section 4.7(i)(ii).
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Examples of Adverse Reaction Reports in a sentence

  • ROCHE shall transmit Adverse Reaction Reports to GILEAD on a periodic basis, but no less often than once every three (3) months; provided, however, that ROCHE shall promptly notify GILEAD of any Adverse Reaction Report requiring the alteration of detailing activities by the GILEAD sales force.

  • In the case of Adverse Reaction Reports within the scope of 21 CFR 314.80(c)(iii), GILEAD shall transmit such Adverse Reaction Reports so that they are received by ROCHE within three (3) business days after receipt by GILEAD, or such other reporting period as may be required by law.

  • ALLERGAN shall be solely responsible for all activities in connection with the Regulatory Approvals for Elestat in the Territory, including without limitation communicating and preparing and filing all reports (including, without limitation, Adverse Reaction Reports) with the FDA.

  • During the Term of the Agreement, each party shall notify the other of all information coming into its possession concerning side effects, injury, toxicity, pregnancy or sensitivity reaction associated with commercial or clinical uses, studies, investigations or tests with Product, throughout the world, whether or not determined to be attributable to Product ("Adverse Reaction Reports").

  • In the case of Adverse Reaction reports within the scope of 21 CFR 314.80(c)(iii), PRAECIS shall transmit such Adverse Reaction Reports relating to Product to ROCHE and ▇▇▇▇▇-▇▇▇▇▇▇ so that they are received by both ROCHE and ▇▇▇▇▇-▇▇▇▇▇▇ within two (2) calendar days after receipt by PRAECIS, or such other reporting period as may be required by law, and ROCHE shall notify PRAECIS of any Adverse Reaction Report relating to Product within two (2) calendar days after receipt thereof by ROCHE.

  • If KPI receives any Adverse Reaction Reports relating to the Product, KPI shall notify CIBA thereof within twenty-four (24) hours via telephone and shall follow-up with a written notification within forty-eight (48) hours after receiving such report.

  • 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.

  • Sagent shall notify Anesiva of any complaints and/or Adverse Reaction Reports it receives within [*] as required per 21 CFR 314.80(c)(iii).

  • Anesiva shall notify Sagent within [*] of confirmation of such Adverse Reaction Reports requiring the alteration of the manner in which Sagent performs its services.


More Definitions of Adverse Reaction Reports

Adverse Reaction Reports shall have the meaning provided in Section 6.1 hereof.
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Related to Adverse Reaction Reports

  • Adverse Event means any untoward medical occurrence in a human clinical trial subject or in a patient who is administered a Licensed Product, whether or not having a causal relationship with such Licensed Product, including, without limitation, any unfavorable and unintended sign (including, without limitation, abnormal laboratory findings of clinical concern), symptom or disease temporally associated with the use of such Licensed Product.

  • Exception Report The report of the Trustee referred to in Section 2.02.

  • SOS Reports means the official reports from the Secretaries of State of each Collateral State, Chief Executive Office State and the Borrower State and other applicable federal, state or local government offices identifying all current security interests filed in the Collateral and Liens of record as of the date of such report.

  • Inspection Report means the report delivered by the Master Servicer or the Special Servicer, as the case may be, substantially in the form of Exhibit L hereto.

  • Evaluation Report means that document which becomes a part of the employee’s personnel file.