Ionis’ Internal Antisense Safety Database Sample Clauses

Ionis’ Internal Antisense Safety Database. (a) Ionis Pharmaceuticals maintains an internal database that includes information regarding the tolerability of its drug compounds, individually and as a class, including information discovered during pre-clinical and clinical development (the “Ionis Internal ASO Safety Database”). In an effort to maximize understanding of the safety profile and pharmacokinetics of Ionis’ and Akcea’s compounds, PTC will cooperate in connection with populating the Ionis Internal ASO Safety Database. To the extent collected by PTC and in the form in which PTC uses/stores such information for its own purposes, PTC will provide Akcea with information concerning toxicology, pharmacokinetics, safety pharmacology study(ies), serious adverse events and other safety information related to each Product as soon as practicable following the date such information is available to PTC (but not later than [**] after PTC’s receipt of such information). In connection with any reported serious adverse event, PTC will provide Akcea all serious adverse event reports, including initial, interim, follow-up, amended, and final reports. In addition, with respect to a Product, PTC will provide Akcea with copies of Annual safety updates filed with each IND and the safety sections of any final Clinical Study reports within [**] following the date such information is filed or is available to PTC, as applicable. Furthermore, PTC will promptly provide Akcea with any supporting data and answer any follow-up questions reasonably requested by Akcea. All such information disclosed by PTC to Akcea will be PTC Confidential Information; provided, however, that such PTC Confidential Information may be disclosed (i) by Akcea to Ionis to satisfy Akcea’s obligations to Ionis under the Ionis Pharmaceuticals/Akcea License Agreements, (ii) by Akcea and/or Ionis to Ionis’ other partners if such information is regarding class generic properties of oligonucleotides, or (ii) to any Third Party, in each case, so long as Akcea or Ionis does not disclose the identity of a Product or PTC. PTC will deliver all such information to Akcea for the Ionis Internal ASO Safety Database to Akcea Therapeutics, Inc., 00 Xxxxxx Xxxxx Xxxx, Xxxxxx, Xxxxxxxxxxxxx 00000, Attention: Chief Medical Officer (or to such other address/contact designated in writing by Akcea). PTC will also cause its Affiliates and Sublicensees to comply with this Section 3.9.3(a).