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. 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. 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. Zogenix shall be responsible for collection, investigation, reporting of information concerning adverse events with respect to the Product (as defined in the then current edition of ICH Guidelines and any other relevant regulations or regulatory guidelines) or any other safety problem of significance (each such adverse event or problem, an “Adverse Event”) to the appropriate Regulatory Authorities in the Territory in accordance with Applicable Laws. Each Party shall notify the other of all Adverse Events which qualify as a “serious adverse drug experience” as defined or contemplated by 21 C.F.R. 312.32 or 314.80, as may be amended from time to time, associated with use of the Product (“Serious Adverse Drug Experience”) within [* * *] of the time such Adverse Event becomes known to such Party (including its employees). In addition, the Parties shall enter into a supplemental safety agreement prior to First Commercial Sale setting forth additional reporting obligations with respect to the Product. Confidential treatment has been sought for portions of this Agreement. The copy filed herewith omits the information subject to the confidential treatment request. Omissions are designated as * * *. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission.
Reporting Adverse Events. In accordance with the Global Safety Agreement between the Parties, Strakan shall continue to own the global safety database for the Product. Orexo shall keep Strakan informed of any information of which it becomes aware concerning adverse events (as defined in the applicable FDA regulations, 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 relating to the Product. The Parties will negotiate in good faith any necessary amendments to the Global Safety Agreement within sixty (60) days of the Signature Date. Each of the Parties hereto shall disclose to the other Party all safety reports and other information (collectively “Safety Data”) which they may from time to time receive or obtain (whether from sources within or without the Orexo Territory) with respect to any adverse drug experiences with respect to the Product, in accordance with a reporting protocol to be mutually agreed by the Parties as promptly as possible following the Signature Date. Orexo shall be responsible for the reporting of Safety Data to FDA as of the Transition Date, Strakan shall be responsible for such reporting before the Transition Date.
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. All serious adverse events (regardless of causality) will be recorded from the signing of the ICF until the Day 45 Follow-up visit. Any serious adverse events considered possibly or probably related to the investigational product and discovered by the Investigator at any time after the study should be reported. All serious adverse events must be reported to Sage or Xxxx’s designee immediately in writing within 24 hours of the first awareness of the event. The Investigator must complete, sign and date the serious adverse event form, verify the accuracy of the information recorded on the serious adverse event form with the corresponding source documents, and send a copy to Sage Therapeutics or designee. Additional follow-up information, if required or available, should be sent to Sage Therapeutics or designee within 24 hours of receipt; a follow-up serious adverse event form should be completed and placed with the original serious adverse event information and kept with the appropriate section of the eCRF and/or study file. Sage Therapeutics or designee is responsible for notifying the relevant regulatory authorities of certain events. It is the Principal Investigator’s responsibility to notify the IRB of all serious adverse events that occur at his or her site if applicable per the IRB’s requirements. Investigators will also be notified of all unexpected, serious, drug-related events (7-/15-Day Safety Reports) that occur during the clinical study. Each site is responsible for notifying its IRB of these additional serious adverse events.
Reporting Adverse Events. Zogenix shall be responsible for collection, investigation, reporting of information concerning adverse events with respect to the Product (as defined in the then current edition of ICH Guidelines and any other relevant regulations or regulatory guidelines) or any other safety problem of significance (each such adverse event or problem, an “Adverse Event”) to the appropriate Regulatory Authorities in the Territory in accordance with Applicable Laws. Each Party shall notify the other of all Adverse Events which qualify as a “serious adverse drug experience” as defined or contemplated by 21 C.F.R. 312.32 or 314.80, as may be amended from time to time, associated with use of the Product *** Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions. (“Serious Adverse Drug Experience”) within [***] of the time such Adverse Event becomes known to such Party (including its employees). In addition, the Parties shall enter into a supplemental safety agreement prior to First Commercial Sale setting forth additional reporting obligations with respect to the Product.
