LCM Indication definition
Examples of LCM Indication in a sentence
Prior to the initiation of any Global Study for any Viela LCM Indication in connection with the Mono Product, Viela will notify Hansoh of such proposed Global Study.
Viela shall consider Hansoh’s request in good faith; provided that for clarity, Viela shall have the sole discretion to decide whether to include any region in the Territory in any Global Study for the Licensed Product for any Viela LCM Indication.
Any non-compete obligations of Hansoh with respect to any pharmaceutical products for any Viela LCM indication will be discussed by both Parties in good faith once a Hansoh Opt-In occurs for the Licensed Product for such Viela LCM Indication.
Subject to the terms and conditions in this ARTICLE 3, Viela has the sole right and discretion to Develop and obtain Regulatory Approval for the Mono Product for any Viela LCM Indication outside and in the Territory.
At Hansoh’s option, Hansoh will use Commercially Reasonable Efforts to [***], and any other indication that is not a Viela LCM Indication to be proposed by Hansoh and approved by Viela during the Term to replace one or more of the foregoing, which approval shall not be unreasonably withheld (each of such selected indications, a “Hansoh Selected Indication”).
Within [***] ([***]) [***] of such notice, Hansoh may request that Viela include any region in the Territory in any Global Study for the Licensed Product for any Viela LCM Indication.
During the Royalty Term, neither Party nor any of its Affiliates or Sublicensees, will, directly or indirectly, or in collaboration with any Third Party, Commercialize in the Territory any [***], other than the Products, for the treatment or prevention of (a) NMOSD, (b) any LCM Indication being Developed or Commercialized in the Territory pursuant to this Agreement, or (c) and LCM Indication rejected by MTPC pursuant to Section 4.1.6 (“Competitive Product”).
Upon or prior to the expiration of such review period, MTPC will notify Viela in writing of its decision to accept or reject such proposed LCM Indication.
If MTPC rejects a proposed LCM Indication, (a) MTPC will provide in its written notice the reasoning in support of its conclusion, unless MTPC is legally prohibited from doing so, and (b) the Parties will discuss in good faith a plan to make such LCM Indication available to patients in the Territory.
The Development Plan will include, among other things, for the NMOSD indication and for each LCM Indication, critical activities to be undertaken, timelines, and allocations of responsibilities between the Parties for the various activities to be undertaken under the Development Plan.