Secondary Indication definition

Secondary Indication means a use of a Licensed Product for an indication that is not the first indication for which such Licensed Product is seeking or has received Regulatory Approval, but is another indication intended to be the subject of an application submitted to a Regulatory Authority that includes clinical trial data from a Clinical Study seeking Regulatory Approval to market the Licensed Product for such use.

Secondary Indication means [ * ].

Secondary Indication means [**], as more particularly defined in the Development Plan.

Examples of Secondary Indication in a sentence

• The Secondary Indication Milestone Payments shall be paid only once per Product and once per New Product for each of the events set forth in this Section 6.3.2(c), whether such milestone event is achieved by TGTX, its Affiliates, its Sublicensees (but only in the event that the sublicense is executed subsequent to the NDA filing), or any Third Party acting on behalf of TGTX, its Affiliates, its Sublicensees.

• TGTX shall pay the milestone payments set forth below (which, when paid, shall be considered fully earned and non-refundable) for each Product and for each New Product following approval for commercialisation for any Secondary Indication and achievement of the events outlined in the table below (the “Secondary Indication Milestone Payments”).

• If the PSC fails to approve for inclusion in the Split Territory Global Development Plan an Additional Development Proposal proposed by a Party for a Secondary Indication Study(ies) for a Split Territory Licensed Product, such Proposing Party may, upon notice to the other Party (the “ Non-Proposing Party”), conduct the proposed Secondary Indication Study(ies) at its own expense; provided, however, that if the Proposing Party receives written notice from the Non-Proposing Party [***].

• Each Genzyme Territory Development Plan shall subsequently be updated by Genzyme from time-to-time at least once each Calendar Year not later than September 1 until such time as no further Development or Secondary Indication Studies are occurring or expected to occur with respect to the applicable Split Territory Licensed Product.

• If a Party desires to conduct a Secondary Indication Study of a Split Territory Licensed Product for the purpose of seeking Regulatory Approval to market such Split Territory Licensed Product for a Secondary Indication, such Party (the “Proposing Party”) shall submit to the PSC responsible for such Split Territory Licensed Product a proposal to add such Secondary Indication Study to the applicable Split Territory Global Development Plan (an “Additional Development Proposal”).

More Definitions of Secondary Indication

Secondary Indication means any oncology indication other than a Primary Indication.

Secondary Indication. : means any oncology indication other than a Primary Indication.

Secondary Indication means any use of the Compounds or Products in the Field for viral treatments in humans other than the first Indication.

Secondary Indication means the treatment, prevention or diagnosis of any indication that is not a Primary Indication.

Secondary Indication means, with respect to a Licensed Product and a regulatory jurisdiction, any Indication that (a) is not the first Indication for which such Licensed Product has received Marketing Approval (and, if applicable, Price Approval) in such regulatory jurisdiction and (b) is not an Ultra-Rare Indication in such jurisdiction.

Secondary Indication has the meaning set out in Section 6.4.1.

Secondary Indication means an indication for the Product for treatment of acute myocardial infarctions as defined in an approved Research & Development Plan.