definiens: as such term is defined in 21 CFR § 312.32 and 21 CFR § 314.80, relating to the SELECTED CONFIDENTIAL Page 52 of 107 [ ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED . REAGENT or the SELECTED PRODUCT, to the extent that such adverse dn.1 g 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 COI\JFIDENTIAL 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, I\JEKTAR AL shall promptly notify COMPANY ; I\JEKTAR 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