Common use of Adverse Reaction Reporting Clause in Contracts

Adverse Reaction Reporting. Each party shall advise the other party, by telephone or facsimile, within such time as is required to comply with Applicable Laws after it becomes aware of any adverse reaction involving the Licensed Product. Such advising party shall provide the other party with a written report delivered by confirmed facsimile of any adverse reaction, stating the full facts known to it, including but not limited to customer name, address, telephone number, batch, lot and serial numbers, as required by Applicable Laws. To the extent permitted by Applicable Laws, E-Z-EM shall have full responsibility for monitoring such adverse reactions and making any reports to the Competent Authorities, with a complete copy provided to Pharmacyclics at the same time the report is made to the Competent Authorities. Within thirty (30) days before the First Commercial Sale or any test or trial conducted on GADOLITE(R) by E-Z-EM or its designee, the parties agree to agree upon and finalize the SOP, provided that such SOP shall be E-Z-EM's current SOP, modified only to the extent necessary to provide a mechanism for E-Z-EM to provide information to Pharmacyclics that is necessary under Applicable Laws for Pharmacyclics to provide to the FDA. The parties agree to follow the SOP. In the event responsibilities exist with respect to compliance with Applicable Laws pursuant to this section which cannot be delegated to E-Z-EM by * INDICATES THAT MATERIAL HAS BEEN OMITTED AND CONFIDENTIAL TREATMENT HAS BEEN REQUESTED THEREFOR. ALL SUCH OMITTED MATERIAL HAS BEEN FILED SEPARATELY WITH THE COMMISSION PURSUANT TO RULE 24b-2.

Adverse Reaction Reporting. Each party shall advise the other party, by telephone or facsimile, within such time as is required to comply with Applicable Laws after it becomes aware of any adverse reaction involving the Licensed Product. Such advising party shall provide the other party with a written report delivered by confirmed facsimile of any adverse reaction, stating the full facts known to it, including but not limited to customer name, address, telephone number, batch, lot and serial numbers, as required by Applicable Laws. To the extent permitted by Applicable LawsLAW, E-Z-EM COMPANY shall have full responsibility for monitoring keep NEKTAR AL informed of all "adverse drug experiences" as such adverse reactions term is defined in 21 CFR §312.32 and making any reports 21 CFR §314.80, relating to the Competent AuthoritiesSELECTED REAGENT or the SELECTED PRODUCT, with a complete copy provided to Pharmacyclics at the same time the report is made to the Competent Authorities. Within thirty (30) days before the First Commercial Sale or any test or trial conducted on GADOLITE(R) by E-Z-EM or its designee, the parties agree to agree upon and finalize the SOP, provided that such SOP shall be E-Z-EM's current SOP, modified only 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 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 provide a mechanism for E-Z-EM to provide information to Pharmacyclics that is necessary under Applicable Laws for Pharmacyclics to provide to the FDA. The parties agree to follow the SOP. In the event responsibilities exist comply with respect to compliance with Applicable Laws pursuant to this section which cannot be delegated to E-Z-EM by * INDICATES THAT MATERIAL requirements of HAS BEEN OMITTED AND CONFIDENTIAL TREATMENT HAS BEEN REQUESTED THEREFOR. ALL SUCH OMITTED MATERIAL HAS BEEN FILED SEPARATELY WITH THE COMMISSION PURSUANT TO RULE 24b-2of MAJOR MARKET COUNTRIES.