Adverse Reaction Reporting. EAGLE shall be responsible for handling all adverse event reporting (including with regulatory authorities) relating to the PRODUCTS in the TERRITORY.
Adverse Reaction Reporting. (a) Each Party shall record, evaluate, summarize and review all adverse drug experiences associated with the Compound and the Product. In order that each Party may be fully informed of the adverse drug experiences associated therewith that are known to the other Party, each Party shall report:
Adverse Reaction Reporting. To the extent permitted by LAW, COMPANY shall keep NEKTAR AL informed of all "adverse drug experiences" as such term is defined in 21 CFR §312.32 and 21 CFR §314.80, relating to the SELECTED REAGENT or the SELECTED PRODUCT, to the extent that such adverse drug experiences are required to be reported to the FDA pursuant to 21 CFR §312.32(c) or 21 CFR §314.80. COMPANY also agrees to promptly provide to NEKTAR AL (i) a copy of all reports filed with the FDA under 21 CFR §312.32(c) and (d) and 21 CFR §314.80, (ii) notice of a decision by the COMPANY to withdraw the IND for the SELECTED PRODUCT or a decision by the FDA to CONFIDENTIAL [*] = 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. place a clinical hold on the SELECTED PRODUCT, and (iii) a copy of the annual report that COMPANY submits to the FDA under 21 CFR §312.33, excluding in each case CONFIDENTIAL INFORMATION that does not specifically relate to the safety of the SELECTED REAGENT. If it is not clear whether an adverse drug experience specifically relates to the SELECTED REAGENT, then COMPANY shall be obligated to notify NEKTAR AL hereunder if COMPANY suspects or has reason to suspect that such adverse drug experience relates to the SELECTED REAGENT. If NEKTAR AL is informed or becomes aware of any safety issues or concerns specifically relating to the safety of the SELECTED REAGENT, NEKTAR AL shall promptly notify COMPANY; NEKTAR AL shall also provide to COMPANY such other information specifically relating to safety of the SELECTED REAGENT as is reasonably necessary to comply with requirements of HAS of MAJOR MARKET COUNTRIES.
Adverse Reaction Reporting. Each Party shall keep the other Party informed of information in or coming into its possession or control concerning side effects, injury, toxicity or sensitivity reaction and incidents of severity thereof associated with commercial and clinical uses, studies, investigations or tests of each Product in the Territories, whether or not determined to be attributable to the Product. SuperGen shall be responsible for filing with the FDA, as required pursuant to 21 C.F.R. Sec. 314.80, any adverse reaction reports that it receives. Xxxxxx shall be responsible for filing with the appropriate regulatory authorities in the International Territory, as required, adverse reaction reports that it receives. Within four (4) months of the Effective Date, the respective pharmacovigilance groups of SuperGen and Xxxxxx shall enter into a separate agreement covering adverse event information exchange relating to the Product.
Adverse Reaction Reporting. (a) Alcon shall advise Pharmacyclics, by telephone or facsimile, within such time as is required by the FDA or foreign equivalent (with respect to the severity and/or increased frequency of such adverse reaction) after it becomes aware of any adverse reaction to the use of the Licensed Product developed, marketed or sold by Alcon. Alcon shall provide Pharmacyclics with a written report delivered by confirmed facsimile of any reported adverse reaction, stating
Adverse Reaction Reporting. Each of Dyax and Genzyme shall notify the other Parties of any adverse reaction information relating to any Collaboration Product within twenty-four (24) hours of the receipt of such information and as necessary for compliance with regulatory requirements. "Adverse reaction information" includes without limitation information relating to any experience that (a) suggests a significant hazard, contraindication, side effect or precaution, (b) is fatal or life threatening, (c) is permanently disabling, (d) requires or prolongs inpatient hospitalization, (e) involves a congenital anomaly, cancer or overdose or (f) is one not identified in nature, specificity, severity or frequency in the current investigator brochure or the United States labeling for the Collaboration Product.
Adverse Reaction Reporting. To the extent permitted by LAW, each PARTY shall notify the other in writing of all information that comes to its attention concerning serious adverse events relating to REAGENT or PRODUCT. Such reports shall be provided to the other PARTY within [**] business days after receipt of the information in the case of any experience coincident with the use of REAGENT or PRODUCT, whether or not considered related to the REAGENT or PRODUCT, that suggests a significant hazard, contraindication, side effect or precaution or results in death, a lifethreatening experience, inpatient hospitalization, prolongation of an existing hospitalization, a persistent or significant disability or incapacity, or a congenital anomaly or birth defect. Information concerning all other adverse events not covered by the preceding sentence (including those covered in summary reports that may be prepared annually by a PARTY covering product complaints and complaint handling) shall be provided on a semi-annual basis by each PARTY to the other.
Adverse Reaction Reporting. Each of Diacrin and Genzyme shall notify Diacrin/Genzyme LLC and the other Party of any adverse reaction information relating to any Collaboration Product within twenty-four (24) hours of the receipt of such information and as necessary for compliance with regulatory requirements. Adverse reaction information includes without limitation information relating to any experience that suggests a significant hazard, contraindication, side effect or precaution, any experience that is fatal or life threatening, is permanently disabling, requires or prolongs inpatient hospitalization, or is a congenital anomaly, cancer, or overdose or any experience that is one not identified in nature, specificity, severity or frequency in the current investigator brochure or the United States labeling for the Collaboration Product.
Adverse Reaction Reporting. (a) SkyePharma shall record, evaluate, summarize and review all adverse drug experiences associated with the Products, and report all such information to the FDA in accordance with its regulatory requirements as holder of the Product Registration. In addition, each Party shall:
Adverse Reaction Reporting. ORTHO shall retain exclusive authority and responsibility for the handling of any adverse drug experience (as defined in 21 CFR 314.80) reported to ORTHO involving the Product, including the filing with the FDA of any such reports that it receives directly from third parties or WFHC. ORTHO shall provide WFHC's Regulatory Department with copies of the periodic adverse drug experience reports, submitted to the FDA pursuant to 21 CFR 314.80(c)(2), at about the time of submission to the FDA. ORTHO shall promptly notify WFHC of any adverse drug experience report or series of adverse drug experiences that may affect the labeling of the Product or the use thereof in the Field.
