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:
6.4.1 Wyeth shall be responsible for follow-up of all reports of adverse events or experiences (“AEs”) or Other Information Reportable to Wyeth (as hereinafter defined) and for the preparation and submission to the FDA of all safety reports required per US Code of Federal Regulations (CFR), title 21 § 314.80.
6.4.2 An AE is any untoward, undesired, or unplanned event in the form of signs, symptoms, disease, or laboratory or physiological observations occurring in a person administered any Detailed Product or in a clinical study. The event or experience does not need to be causally related to such Detailed Product or clinical study. An AE includes, but is not limited to:
(a) Any clinically significant worsening of a pre-existing condition;
(b) An AE occurring from Detailed Product overdose (i.e., a dose higher than that prescribed by a healthcare professional for clinical reasons, or a dose higher than that described on the Detailed Product label) whether accidental or intentional;
(c) An AE occurring from abuse (e.g., use for non-clinical reasons) of the Detailed Product;
(d) An AE occurring from discontinuation of the Detailed Product (Detailed Product withdrawal); and
(e) Any failure of expected pharmacological action.
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:
(a) Provide to the other for initial and/or periodic submission to government agencies significant information on the Collaboration Product from preclinical laboratory, animal toxicology and pharmacology studies, as well as adverse drug experience reports from clinical trials and commercial experiences with the Collaboration Product;
(b) In connection with investigational Collaboration Products, report to the other within three (3) days of the initial receipt of a report of any unexpected or serious experience with the drug, if required for either Party to comply with regulatory requirements; and
(c) In connection with marketed Collaboration Products, report to the other within five (5) business days of the initial receipt of a report of any adverse experience with the drug that is serious and unexpected or sooner if required for either Party to comply with regulatory requirements. Serious adverse experience means any experience that suggests a significant hazard, contraindication, side effect or precaution, or any experience that is fatal or life threatening, is permanently disabling, requires or prolongs inpatient hospitalization, or is a congenital anomaly, cancer, or overdose. An unexpected adverse experience is one not identified in nature, specificity, severity or frequency in the current investigator brochure or the U.S. labeling for the drug. Each Party also agrees that if it contracts with a Third Party for research to be performed by such Third Party on the drug, that Party agrees to require such Third Party to report to the contracting Party the information set forth in subparagraphs (a), (b), and (c) above. The Parties agree that at all times after the approval of...
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;
(b) Each Party agrees to, in connection with investigational Products and Potential New Indications, report to the other Party as soon as possible (and, in any event, within three (3) days) the receipt of a report of any unexpected or serious experience, if required for the other Party to comply with regulatory requirements;
(c) Each Party agrees to, in connection with marketed Products, report to the other Party within three (3) business days of the receipt of a report of any adverse experience that is serious and unexpected or sooner if required for the other Party to comply with regulatory requirements. Serious adverse experience means any experience that suggests a significant hazard, contraindication, side effect or precaution, or any experience that is fatal or life threatening, is permanently disabling, requires or prolongs inpatient hospitalization, or is a congenital anomaly, cancer, or overdose. An unexpected adverse experience is one not identified in nature, specificity, severity or frequency in the current investigator brochure or the U.S. labeling for the drug; and
(d) If requested by Schering, Alliance agrees to enter into a standard operating procedure by and between the Parties to govern the exchange of Information relating to adverse drug experiences and product quality.
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. 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. 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. 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.
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.
