Drug Safety. (a) ADVERSE EVENT REPORTING; SAFETY DATABASE. Roche shall report, at its expense, to appropriate authorities, in accordance with local requirements, all adverse events related to use of the Product in the Field in the Territory. Adverse [ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
Drug Safety. Institution shall EMD Serono R&D immediately (and if required by law, will also inform any regulatory authority) of any safety concerns identified while conducting the Research Study. Institution agrees that EMD Serono R&D may take action regarding such safety concerns, including informing regulatory authorities or healthcare providers, or otherwise making the safety concern public, even in advance of publication of the Research Study by Institution.
Drug Safety. Sponsor will provide Institution with a Protocol and supporting information necessary for Institution to conduct the Study. The Protocol will be considered effective following its approval by Sponsor, IRB, Investigator, and, if applicable, the FDA or other applicable regulatory authority. Institution will conduct the Study in accordance with the Protocol. However, Institution may deviate from the Protocol to protect Subject safety and welfare. Any such deviation will not constitute a failure to comply with the Protocol. Only the Sponsor may modify the Protocol or add an addendum to the Study. Any modification or addendum to the Protocol must be approved by the IRB to become effective. If the IRB does not approve a modification within 20 days, Sponsor may terminate this Agreement. If, in Institution’s judgment, any modifications or addendums, collectively from the beginning of the Study at Institution, increase Institution’s costs, Sponsor will increase the Budget accordingly or Institution may terminate this Agreement. Sponsor will provide Institution with a comprehensive and accurate Protocol and Investigator’s Brochure, especially with respect to information pertaining to the safety of the Study Drug. Sponsor will advise Institution of all information for inclusion in the informed consent form that is material to Study Subjects’ decision to participate or to continue to participate in the Study. It will inform Institution in a timely manner of new information pertaining to the safety of the Study Drug. It will inform Institution in advance of any requirements beyond GCP. It will respond to Institution and/or Principal Investigator questions and issues in a prompt and timely manner. Sponsor warrants that: It has obtained all necessary governmental and regulatory approvals to conduct the Study and provide the Study Drug including without limitation, all applicable FDA approvals; and that all approvals will be in full force and effect during the Study. Study Drug has been manufactured and passed quality control tests in accordance with applicable regulations. It has disclosed to Institution and applicable government authorities all relevant, material information concerning the safety, use, efficacy and Study Drug experience. Use of the Study Drug for Study purposes will not infringe the rights, patent or otherwise, of any third-party. Any hazardous material packaging provided by Sponsor meets regulatory requirements for Institution’s use according to the Pr...
Drug Safety. Strakan shall maintain its Drug Safety Team in the same manner as before the Signature Date, including:
Drug Safety. As soon as practicable after the Date of this Agreement, the Parties will enter into a separate drug safety agreement (“Drug Safety Agreement”) which will address, among other things, the reporting, investigation and handling of adverse events, product complaints and product recalls. The Parties agree that Chiron shall prepare the first draft of such agreement to initiate the negotiation process. In the event of a conflict specific to an issue of drug safety between the provisions of the Drug Safety Agreement and any provisions of this Agreement, the provisions of the Drug Safety Agreement shall govern; otherwise, the provisions of this Agreement shall govern. The Drug Safety Agreement may be amended from time to time by written mutual consent of the Parties in the light of changing regulatory requirements or other circumstances.
Drug Safety. 3.8.1 Prior to enrollment of the first patient in the Trial, the Parties shall agree upon and implement a procedure for the mutual exchange of safety information associated with their respective portion of the Combination. The details of the operating procedures relating to the exchange shall be the subject of a mutually-agreed upon written safety data exchange agreement (the “Safety Data Exchange Agreement”). Such Safety Data Exchange Agreement shall govern the exchange of safety data related to each portion of the Combination between the Parties in connection with this Agreement and contain reasonable and customary terms sufficient to enable each to comply with its respective obligations under applicable laws, regulations and guidelines with regard to adverse event data collection, analysis and reporting. The Parties will negotiate and enter into the Safety Data Exchange Agreement prior to dosing of the first patient in the Trial.
Drug Safety. 3.7.1 Within a reasonable amount of time, not to exceed six (6) months from the Effective Date, the Parties shall agree upon and implement a procedure for the mutual exchange of safety information associated with the Product. The details of the operating procedures relating to the exchange shall be the subject of a mutually-agreed upon written safety data exchange agreement (the “Safety Data Exchange Agreement”). Such Safety Data Exchange Agreement shall govern the exchange of safety data related to the Product between the Parties in connection with this Agreement and contain reasonable and customary terms sufficient to enable each to comply with its respective obligations under applicable laws, regulations and guidelines with regard to adverse event data collection, analysis and reporting. The Parties will endeavor to negotiate and enter into the Safety Data Exchange Agreement prior to dosing of the first patient in connection with POC Activities.
Drug Safety. 6. The Borrower shall maintain in existence and operation the service agreement entered into between the DCL and MOH for the purpose of ensuring proper coordination between the regulatory functions under MOH and the DCL function in the area of drug safety regulation.
Drug Safety. The Parties shall separately execute a pharmacovigilance agreement (“Pharmacovigilance Agreement”) for exchanging Adverse Event and other safety information relating to ThermoDox Products prior to Yakult’s initiation of any clinical activity for the ThermoDox Product in the Territory. Such Pharmacovigilance Agreement shall ensure that Adverse Event and other safety information is exchanged according to a schedule that will permit each Party to comply with local regulatory requirements and all Laws.
Drug Safety. The Parties shall meet and agree upon a written plan for exchanging adverse event and other safety information relating to Licensed Products prior to Pfizer’s initiation of any clinical activity for the Licensed Product in the Territory. Such written plan shall ensure that adverse event and other safety information is exchanged according to a schedule that will permit each Party to comply with local regulatory requirements and all Laws.
