Class Generic Claims; Investigator’s Brochure. To the extent Novartis intends to make any claims in a Product label or regulatory filing that are class generic to Oligonucleotides, Akcea’s or its Affiliate’s generation 2.0 or 2.5 chemistry platform(s), Conjugate Technology, or any other Akcea technology included in a Product, Novartis will provide such claims and regulatory filings to Akcea in advance and will [***] any proposals and comments made by Akcea (or its Affiliates). Novartis will provide Akcea updated versions of the investigator’s brochure when Development of the Products results in any substantive change to the safety or risk to the Products. To the extent Akcea or Affiliates or licensors of Akcea intends to make any claims in a label or regulatory filing that (i) is reasonably likely to [***], and (ii) are [***], or any other [***], Akcea will provide such claims and regulatory filings to Novartis in advance and will consider in good faith any proposals and comments made by Novartis (or its Affiliates).
Appears in 5 contracts
Samples: Collaboration and Option Agreement, Strategic Collaboration, Option and License Agreement (Ionis Pharmaceuticals Inc), Strategic Collaboration, Option and License Agreement (Akcea Therapeutics, Inc.)