Adverse Drug Experiences. Novartis has informed Reliant of all relevant adverse drug experiences related to the Product of which it has knowledge.
Adverse Drug Experiences. For the reporting of adverse drug experiences, the responsibilities of the Parties are as follows:
Adverse Drug Experiences. (a) Alliance agrees to provide to Schering for initial and/or periodic submission to government agencies significant information on the Product from preclinical laboratory, animal toxicology and pharmacology studies, as well as adverse drug experience reports from clinical trials and commercial experiences with the Product;
Adverse Drug Experiences. ETHYPHARM has informed RELIANT of all relevant adverse drug experiences related to the Product of which it has knowledge.
Adverse Drug Experiences. In order to guarantee that all applicable regulatory requirements as well as the Parties’ interests regarding pharmacovigilance of the Licensed Product can be met, the parties shall exchange appropriate information. The parties shall make sufficient efforts to promptly establish and adopt sufficient procedures concerning this exchange. Therefore the Parties shall negotiate a separate agreement on pharmacovigilance.
Adverse Drug Experiences. Unless otherwise set forth on Schedule B, attached hereto, and made a part hereof, Mylan shall have responsibility for all pharmacovigilance activities associated with the marketing and sale of the Product in the Territory. Insys will submit to Mylan any and all reports of Adverse Drug Experiences that Insys or its third party manufacturer receives, together with all relevant information possessed by either within three (3) business days of receipt. Insys shall also promptly submit to Mylan any product complaints for investigation within three (3) business days of receipt. Mylan shall acknowledge receipt of Insys-submitted Adverse Drug Experiences and product complaints within one (1) business day of receipt. Each Party shall cooperate with the other and provide information in its possession to the extent necessary for the other Party to comply with all legal requirements relating to the manufacture or marketing of the Product in the Territory.
Adverse Drug Experiences. During the relevant Reporting Period (as defined below), each Party shall promptly inform the other Party of any information it obtains or develops regarding the safety of the Product anywhere in the world and shall promptly report to the other Party any information regarding serious adverse reactions or side effects related to the use of the Product. To allow the Parties to comply with the adverse drug experience reporting requirements for the Product to the U.S. FDA and its counterpart regulatory agencies around the world, each Party shall notify the other Party in writing of any "adverse drug experience" that is considered "serious" as defined in U.S. FDA regulations (21 CFR 314.80) or the comparable regulations of other regulatory agencies, regardless of source, so that the other Party will receive such notice within three (3) business days of a Party's first having "obtained or otherwise received" such "adverse drug experience" from "any source", as those terms are defined in U.S. FDA regulations (21 CFR 314.80). Such information shall be communicated by the Parties to each other at the following addresses: To Abboxx: Abboxx Xxxoratories Hospital Products Division Attn: Vice President, Medical and Regulatory Affairs Dept. 970, Bldg. AP30 200 Xxxxxx Xxxx Xxxx Abboxx Xxxk, Illinois, U.S.A. 60064-3500 Telephone: (847) 000-0000 Facsimile: (847) 000-0000 To API: API Pharmaceuticals, Inc. Attn: Senior Vice President, Medical and Regulatory Affairs 8707 Xxxxxxxxxx Xxxxxx Xxxxx Xxx Xxxxxxxxx, Xxxxx 00000-0000 Phone: (281) 000-0000 Facsimile: (281) 000-0000
Adverse Drug Experiences. 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 Collaboration Products under clinical investigation, Collaboration Products proposed for marketing, or marketed Collaboration Products. 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 Collaboration Product. In addition, supplemental information must be provided on Collaboration Products at periodic intervals and adverse drug experiences must be reported at more frequent intervals depending on the severity of the experience and whether or not the event is unexpected. Consequently, each Party agrees to:
Adverse Drug Experiences. During the Term, to the extent Elan has or receives any information regarding any adverse drug experience which may be related to the use of Licensed Products, Elan shall promptly provide Biogen Idec with all such information.
Adverse Drug Experiences. CUMBERLAND shall provide reasonable cooperation and assistance to INALCO in the investigation of complaints and adverse events with respect to the Product (see Exhibit E). Each party will bear its own expenses associated with its duties set forth in Exhibit E.
