Adverse Experiences. The reporting of Adverse Experiences shall be governed by Article 10.
Adverse Experiences. (a) The Parties shall use their established operating procedures to report Adverse Experiences to the FDA in accordance with applicable laws. Such operating procedures shall include any measures necessary for each Party to fully comply with such laws as apply to such Party. In any event, each Party shall notify the other Party within [*] of any Serious Adverse Experience (as set forth in 21 CFR 314.80). The agreed procedures will be reviewed jointly on a regular basis or when there is a change in regulations governing Adverse Experience reporting. Valera shall be responsible for the timely filing with the FDA of all Adverse Experience reports, provided, that nothing herein shall be construed as restricting Indevus’ ability to take action that it deems, based upon the advice of counsel, to be required by applicable law. Valera shall promptly provide to Indevus copies of all such reports, analyses, summaries and all submissions to the FDA or other governmental agency.
(b) Valera’s central safety department will use its existing toll-free phone number for patients, physicians and others to report Adverse Experiences. The costs of such reporting and of all services provided in connection with Adverse Experiences hereunder shall be borne by Valera. Valera will timely collect information about the Adverse Experiences, initiate and conduct reasonably required investigations, determine if physical or other testing of Product appears to be reasonably required, determine the nature of the Adverse Experience based on data and reports it has obtained, and issue any reports, analyses, or summaries of its activities as may be required by applicable laws, including, without limitation, preparing and filing with the FDA on a timely basis such reports as are necessary and appropriate. Copies of all such reports, including reports filed by Valera with the FDA, will be promptly provided to Indevus.
Adverse Experiences. Each Party shall promptly in accordance with applicable country specific safety regulations/GCP guidelines advise the other Party of any reportable adverse reactions or side effects occurring during the conduct of the Study of which it becomes aware. In the event that any reportable adverse reactions associated with the Study Product indicate the possibility of health hazards, Institution shall notify Sponsor and CRO within twenty-four (24) hours of making the discovery. Institution shall further ensure that Investigator complies with the aforementioned obligations.
Adverse Experiences. Prior to AbbVie proceeding with the In-Licensing, Ablynx shall have responsibility (either itself or with the support of Third Party subcontractors) for communications with all Regulatory Authorities regarding the safety of the Lead Compound, including submitting or causing to be submitted to all Regulatory Authorities reports of adverse experiences and other required safety information and reports in accordance with all requirements of Applicable Laws. Ablynx shall provide a copy of any and all such reports and other required safety information to AbbVie within […***…] after regulatory submission.
Adverse Experiences. 7.1 During the term of this Agreement, Neurocrine shall keep, and shall cause its sublicensees to keep DOV promptly and fully informed of all pharmaceutical, toxicological, clinical, and all other findings, including clinical use, studies, investigations, tests and prescription, relating to any adverse experiences with the Marketed Product.
7.2 Neurocrine undertakes to notify DOV, as soon as possible, of any serious adverse event as such event is defined by the responsible regulatory agency in the United States, Japan, or within the EU, thought to be associated with clinical- studies of, or the use or application of, the Marketed Product. Such notification shall be made promptly but in no event later than five (5) working days after Neurocrine first learns of, or is advised of, any adverse event described above.
7.3 Neurocrine shall inform DOV without delay, of any governmental action, correspondence or reports to or from governmental authorities which may affect the continued distribution and sale of the Marketed Product and furnish DOV with copies of any relevant documents relating thereto.
Adverse Experiences. The investigator agrees to notify POI and/or YM within a maximum of 24 hours (whenever possible immediately by telephone or fax) of any serious (fatal, life threatening, requiring or prolonging hospitalisation, resulting in persistent or significant disability, representing a significant hazard, a congenital anomaly, or other medically important condition) and/or unexpected adverse events. An SAE form with all available information should be submitted within 24 hours to YM and POI. Details should be also noted on the appropriate form in the CRF, followed up and investigated further when necessary. All events should be followed-up until resolution and any new information should be promptly submitted to YM and POI on a follow-up SAE form. The investigator should also notify the local Ethics Committee, within the time frame specified by the Ethics Committee.
Adverse Experiences. With respect to adverse drug experiences, as defined by 21 C.F.R. Section 314.80, and IND safety reports, as referenced in 21 C.F.R. Section 312.32, relating to PRODUCT, the Development Team shall establish operating procedures to report to the appropriate REGULATORY AUTHORITIES in the countries in which PRODUCT is being developed or commercialized, in accordance with the appropriate laws and regulations of the relevant countries and authorities. Such operating procedures shall include any measures necessary for each Party to fully comply with such laws and regulations as apply to such Party. The Parties will collaborate to agree to and implement, within ninety (90) days following the Effective Date, a separate agreement concerning Pharmacovigilance responsibilities and case exchange.
Adverse Experiences. Xxxxxx has provided Targacept with all information concerning side effects, injury, toxicity or sensitivity reaction, or unexpected incidents, whether or not serious or unexpected, relating to the Product (“Adverse Experiences”), which Xxxxxx or Merck & Co., Inc. reported or are to be reported to the FDA. Any additional information regarding Adverse Experiences received by Xxxxxx before the Closing Date but not yet reported to the FDA will be provided to Targacept on or before the Closing Date. For purposes of this Section 4.7, “serious” and “unexpected” have the meanings set forth in Section 6.6.
Adverse Experiences. CMT shall promptly notify Investigator of any findings of new and unexpected serious adverse events rising from CMT’s monitoring of the Study that could affect the safety of subjects, and trends or patterns of non-serious or expected adverse events that occur at a specificity or severity that is inconsistent with prior observations all in accordance with the obligations set forth in 21 C.F.R. 312.32(c), 21 C.F.R. 312.55 (b), 21 C.F.R. 56.108 (b) and FDA’s Guidance on Adverse Event Reporting to Institutional Review Boards in Clinical Trials (January 2009). In the event that any adverse reactions associated with the Study Drug indicate the possibility of significant health hazards, Institution and Investigator shall notify Sponsor within twenty-four (24) hours of making such discovery. Institution and Investigator shall at all times have the right to provide information regarding such adverse events to Study subjects if it is determined that such adverse events may have an effect on the Study subject’s health.
Adverse Experiences. 28 <PAGE> (a)
