Reporting Adverse Events. If the development or commercialization or a given Product mandates the mutual reporting of Adverse Events, then the Parties will establish procedures for tracking and informing each other concerning such Adverse Events as required by Applicable Law, and shall maintain such databases and execute such agreements as needed for this purpose.
Reporting Adverse Events. Promptly following the Effective Date but not later than 60 days thereafter, Braeburn and Camurus shall develop and agree upon safety data exchange procedures governing the coordination of collection, investigation, reporting, and exchange of information concerning adverse events (as defined in the then current edition of International Conference on Harmonization guidelines for good clinical practice, or ICH Guidelines, and any other relevant regulations or regulatory guidelines or any other safety problem of any significance, hereafter “Adverse Events”), product quality and product complaints involving Adverse Events, sufficient to permit each Party, its Affiliates, Sublicensees or licensees to comply with its legal obligations, including to the extent applicable, those obligations contained in ICH Guidelines. The safety data exchange procedures shall be promptly updated if required by changes in legal requirements or by agreement between the Parties. In any event, each Party shall inform the other Party of any Adverse Event of which it becomes aware in a timely manner commensurate with the seriousness of the Adverse Event. Braeburn or its Sublicensees shall be responsible for reporting all Adverse Events to the appropriate regulatory authorities in the countries in the Licensed Territory and Camurus or its licensees shall be responsible for reporting all Adverse Events to the appropriate regulatory authorities in the countries in the Camurus Territory. Each Party shall ensure that its Affiliates, Sublicensees and licensees, as applicable, comply with such reporting obligations. Each Party shall designate a safety liaison to be responsible for communicating with the other Party regarding the reporting of Adverse Events. CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
Reporting Adverse Events. Rhythm shall be responsible for reporting all adverse events (as defined in the then current edition of ICH Guidelines and any other relevant regulations or regulatory guidelines or any other safety problem of any significance, hereafter “Adverse Events”) relating to the Product to the appropriate regulatory authorities in the countries in the Territory in accordance with the appropriate laws and regulations of the relevant countries and authorities. Rhythm shall ensure that its Affiliates and Sublicensees comply with all such reporting obligations. In the event that Rhythm knows or acquires knowledge that any Adverse Event relating to the Product is attributable to the FC Technology and is not attributable to the Drug, then Rhythm shall provide prompt written notice of such Adverse Event to Camurus. In addition, at each meeting of the JDC, a representative of Rhythm shall present to the JDC, and the JDC shall review, all Adverse Event relating to the Product that have occurred since the last meeting of the JDC
Reporting Adverse Events. Ascletis shall maintain, at its own cost, a common safety database for both clinical and post-marketing Adverse Events for the Products in the Territory in the Field, which database shall be managed by Ascletis and Ascletis shall ensure that 3-V, its Affiliates and any 3-V Collaborator is able to access the Safety Data from such database in order to comply with Applicable Law and obligations by Regulatory Authorities in their respective territories. 3-V shall maintain, at its own cost, a global safety database for both clinical and post-marketing Adverse Events for the Products, which database shall be managed by 3-V and 3-V shall ensure that Ascletis, its Affiliates and Sublicensees are able to access the Safety Data from such database in order to comply with Applicable Law and obligations by Regulatory Authorities in their respective territories. Ascletis will be responsible for reporting all Adverse Events to the appropriate Regulatory Authorities in the Territory, including the NMPA, in accordance with Applicable Law. In addition, Axxxxxxx shall report all Adverse Events to 3-V in a timely manner in order for 3-V to comply with its reporting obligations to Regulatory Authorities outside the Territory (including FDA). 3-V shall report all Adverse Events to Ascletis in a timely manner in order for Ascletis to comply with reporting obligations in the Territory. 3-V will be responsible for reporting all Adverse Events to the appropriate Regulatory Authorities outside the Territory in accordance with Applicable Law. 3-V shall provide Ascletis through the JSC with the name of a contact at each 3-V Collaborator’s pharmacovigilance department so that Ascletis may coordinate with such 3-V Collaborator regarding the allocation of responsibilities and determination of any procedures between them with respect to the collecting, sharing and reporting to applicable Regulatory Authorities regarding Adverse Events and other safety information, including providing Ascletis with access to Safety Data in accordance with Section 2.7(c).
Reporting Adverse Events. The Parties will cooperate with regard to the reporting and handling of safety information involving the Licensed Products in the Territory, in each case, in accordance with the applicable regulatory Laws and regulations on pharmacovigilance and clinical safety. As soon as practicable after the Effective Date (but in no event longer than [**] after the Effective Date), the Parties will negotiate in good faith and execute an agreed pharmacovigilance agreement specifying the procedures and timeframes for complying with applicable Law pertaining to safety reporting for each Licensed Product and their related activities (a “Pharmacovigilance Agreement”), which Pharmacovigilance Agreement will be overseen by the JDC. The Pharmacovigilance Agreement will set forth each Party’s responsibilities and obligations pertaining to safety collection, assessment and reporting of the Licensed Products based on relevant guidelines and applicable Law. The allocation of responsibilities between the Parties will be governed by the Pharmacovigilance Agreement. The Party that [**] with respect to a Licensed Product will own the global safety database for such Licensed Product.
Reporting Adverse Events. Not later than [***] ([***]) days prior to the IND filing for the first Product, Ra Pharma and Camurus shall develop and agree upon safety data exchange procedures governing the coordination of collection, investigation, reporting, and exchange of information concerning adverse events (as defined in the then current edition of ICH Guidelines and any other relevant regulations or regulatory guidelines or any other safety problem of any significance, hereafter “Adverse Events”), product quality and product complaints involving Adverse Events, sufficient to permit each Party, its Affiliates, Sublicensees or licensees to comply with its legal obligations, including to the extent applicable, those obligations contained in ICH Guidelines. The safety data exchange procedures shall be promptly updated if required by changes in legal requirements or by agreement between the Parties. In any event, each Party shall inform the other Party of any Adverse Event of which it becomes aware in a timely manner commensurate with the seriousness of the Adverse Event, provided that Ra Pharma shall only be required to inform Camurus of Adverse Events that Ra Pharma, in its sole reasonable discretion, determines may relate to the FC Technology. Ra Pharma shall be responsible for reporting all Adverse Events relating to the Product to the appropriate regulatory authorities in the countries in the Territory in accordance with the appropriate laws and regulations of the relevant countries and authorities. Ra Pharma shall ensure that its Affiliates and Sublicensees comply with all such reporting obligations. Each Party shall designate a safety liaison to be responsible for communicating with the other Party regarding the reporting of Adverse Events.
Reporting Adverse Events. “THE INSTITUTE” and “THE INVESTIGATOR” must report events that, according to the Official Mexican Regulation NOM-220-SSA1-2016, Installation and operation of pharmacovigilance, Guidelines of the “International Conference on Harmonisation (ICH)” and Good Clinical Practice, as well as “THE PROTOCOL”, are considered as serious or non-serious adverse events, from baseline and during the execution of the RESEARCH PROJECT or Protocol, without authorization to such effect being required by “THE SPONSOR”. These adverse events shall be reported within no more than (24) twenty-four hours after “THE INVESTIGATOR” and/or “THE INSTITUTE” have become aware of the event. “THE INSTITUTE” shall make all reasonable efforts possible to provide medical care to “THE PARTICIPATING PERSONS” who require in the event of adverse events related to the Study, which must be available at any time it is required. “THE INSTITUTE” has the facilities for hospitalization of “THE PARTICIPATING PERSONS” if this is required. The expenses arising from the medical care that “THE INSTITUTE” provides to “THE PARTICIPATING PERSONS” will be covered by “THE SPONSOR”, who must cover them under Level 7 of the Catalog of Recovery Quotas governing “THE INSTITUTE”, regardless of whether they have Medical Insurance, in light that care is being provided directly by “THE INSTITUTE”, in the event that they suffer an injury caused by the drugs that have been administered in accordance with “THE PROTOCOL”. In the event of any other cause, fortuitous event or force majeure, medical care cannot be provided by “THE INSTITUTE”, “THE SPONSOR” undertakes to insure it to the research subjects with adverse effects related to the drug so that the medical institution of “THE SPONSOR’s” choice provides such care, on the understanding that the expenses generated as a result will be covered by “THE SPONSOR”, but only for “THE PARTICIPATING PERSONS” injuries as specified in this Clause. TWENTY-SIX.
Reporting Adverse Events. If the Reseller is contacted by an end-user/consumer reporting an adverse reaction to an AdvoCare Product or receive a complaint, the Reseller should contact AdvoCare Customer Service without delay at 800.542.4800.
Reporting Adverse Events. I' Customer becomes aware of reports of Advcrs: Events that occur while patients are taking thť Product, Customer will notify BioMarin PharrrEacovigilance within one (1) business day by email at xxxxxxxxxx@xxxx.xxx and/or by facsimile to +1 (000) 000-0000. In additicn, Customer shall indefinitely maintain a recotd of all reports of Adverse Events the Customer has become aware of. Súch rccord shall include 1he dáte the Adverse Event was reported to Compaiy. Úpon expiration or termination of this Agreenent all records will be provided to Company.
Reporting Adverse Events. Serious adverse events must be reported to the Sponsor within 24 hours of the investigator becoming aware of the event along with an assessment of causality. If at the time the investigator submits an initial SAE report and the SAE has not been resolved, the investigator must provide a follow-up report as soon as the event resolves (or upon receipt of significant information if the event is still ongoing). Additional follow-up information, if required or available, should reported to the Sponsor within one business Day of receipt. This should be completed on a follow-up SAE form and placed with the original SAE information and kept with the appropriate section of the CRF and/or study file. All SAEs must be followed until resolution/stabilization or until a time that is mutually agreed upon between the Medical Monitor and the Investigator. Xxxxxx (or representative) is responsible for notifying the relevant regulatory authorities of certain events. It is the Investigator’s responsibility to notify the IRB or IEC of all SAEs that occur at his or her site. Investigators will also be notified of all unexpected, serious, drug-related events that occur during the clinical trial. Each site is responsible for notifying its IRB or IEC of these additional SAEs. AUC0-inf and Cmax. These ratios will be expressed as a percentage relative to the F2/F3 presumed XXXX placebo control group. Ninety percent (90%) confidence intervals (CIs) for the ratios will be derived by exponentiation of the CIs obtained for the difference between F2/F3 presumed XXXX groups LSM resulting from the analyses on the ln-transformed AUC0-inf and Cmax. The CIs will be expressed as a percentage relative to the F2/F3 presumed XXXX placebo control group.
