Adverse Drug Events. The Parties recognize that the holder of a Drug Approval Application may be required to submit information and file reports to various governmental agencies on compounds under clinical investigation, compounds proposed for marketing, or marketed drugs. Information must be submitted at the time of initial filing for investigational use in humans and at the time of a request for market approval of a new drug. In addition, supplemental information must be provided on compounds at periodic intervals and adverse drug experiences must be reported at more frequent intervals depending on the severity of the experience. Consequently, each Party agrees to:
Adverse Drug Events. During the Term, Alzheon shall be responsible for all matters relating to the reporting of adverse events concerning the Licensed Products in the Territory, including the creation and maintenance of global safety database(s) for adverse drug events, and shall do so in conformity with all applicable Laws.
Adverse Drug Events. HPPI must advise Mayne Pharma as soon as reasonably practicable after becoming aware of any Adverse Drug Event.
Adverse Drug Events. The Parties recognize that as the holder of a Drug Approval Application, ALTUS will be required to submit information and file reports to various governmental agencies on compounds under clinical investigation, compounds proposed for marketing, or marketed drugs. Information must be submitted at the time of initial filing for investigational use in humans and at the time of a request for market approval of a new drug. In addition, supplemental information must be provided on compounds at periodic intervals and adverse drug experiences must be reported at more frequent intervals depending on the severity of the experience. The specific obligations of each Party with respect to adverse drug experiences will be governed by the safety and adverse event reporting agreement(s) described in Section 13.1 above.
Adverse Drug Events. Each Party shall promptly report to the other Party any adverse event observed during any use of a Product. Prior to the first commercial sale of a Product in the Territory, the Parties shall in good faith enter into a data safety exchange agreement consistent with applicable law and regulatory requirements and practices in the United States and European Union.
Adverse Drug Events. Any adverse drug event or reaction complaint reports or any other reports or information received by POZEN indicating that any POZEN Product has any toxicity, sensitivity reaction, or is otherwise alleged to cause illness or injury of any kind or is adulterated or misbranded, which toxicity, sensitivity reaction, illness or injury is caused or alleged to be caused by the LX Bulk Drug Substance contained therein, will be reported promptly by POZEN to Nycomed, or as otherwise may be required under any applicable laws, rules or regulations, with copies of any such written reports, and Nycomed will thereafter expeditiously investigate the information contained in such reports and communicate such results promptly to POZEN upon conclusion of such investigation. POZEN will copy Nycomed on all correspondence with regulatory authorities relating to adverse drug events in relation to the LX Bulk Drug Substance supplied by Nycomed or any POZEN Products or Nycomed Products.
Adverse Drug Events. The parties recognize that P&U, as the holder of the NDA, may be required to submit information and file reports to various governmental agencies on compounds under clinical investigation, compounds proposed for marketing, or marketed drugs. Information must be submitted at the time of initial filing for investigation use in humans and at the time of a request for market approval of a new drug. In addition, supplemental information must be provided on compounds at periodic intervals and adverse drug experiences must be reported at more frequent intervals depending on the severity of the experience. Consequently, each party agrees to follow P&U's standard operating procedures ("SOPs") for the reporting of adverse events in effect from to time to time and, to the extent not inconsistent with the SOPs, the following:
Adverse Drug Events. As required under applicable regulatory requirements, each Party shall submit any necessary adverse event information and file reports to various governmental agencies on compounds under clinical investigation, compounds proposed for marketing, or marketed drugs in accordance with applicable regulatory requirements. Each Party shall promptly provide the other Party a copy of any such adverse drug experience reports and, in the case of serious adverse events, notice thereof shall be provided to the other Party within twenty-four (24) hours of receiving notification of the event.
Adverse Drug Events. The parties recognize that the holder of a drug approval application may be required to submit information and file reports to various governmental agencies on compounds under clinical investigation, compounds proposed for marketing, or marketed drugs, including adverse event reports. The Project Team shall develop and the parties shall adhere to appropriate procedures to insure compliance with all such applicable regulatory requirements.
Adverse Drug Events. Each Party will be responsible for the safety surveillance and pharmacovigilance regulatory obligations with respect to the Covered Product in those territories where it is the sponsor of non-clinical or clinical development, including but not limited to animal toxicology or pharmacology studies. Company shall be responsible for establishing and maintaining a global safety database of adverse events for the Covered Products, which shall be used for regulatory reporting and responses to safety queries from Regulatory Authorities by both Parties. NovaMedica shall, and shall cause its Affiliates to, transfer all adverse events information in its or their possession or control to the global safety database within a mutually agreed period of time that provides Company with sufficient time to enter all of the data and to obtain validation of the database, and Company shall use Commercially Reasonable Efforts to enter data from all adverse events information in its possession or control into the global safety database. Within sixty (60) days after the submission of the Initial Development Plan, the Parties’ respective regulatory affairs or other applicable departments, including the members of the JDC with regulatory and drug safety expertise, shall meet and agree upon processes and procedures to recommend to the JDC for monitoring of clinical experiences with respect to Covered Products and sharing information relating to such clinical experiences as needed to support each Party’s respective regulatory responsibilities with respect to safety reporting requirements in its respective territory, including without limitation, development of appropriate safety databases relating to Covered Products. All reports, updates, Adverse Events, product complaint and other information provided by one Party to the other Party under this Agreement (including under this Section 7.2), shall be considered Confidential Information of the disclosing Party, subject to the terms of Section 8 hereof it being understood that the FDA or other applicable Regulatory Authority may publish information relating to Adverse Events on its website.
