Targeted Indication definition
Examples of Targeted Indication in a sentence
At the next JSC meeting (including any ad hoc JSC meeting) following AN2’s receipt of such notice, the JSC shall discuss such proposed specific Pre-PoC Development Activities in the Brii Bio Targeted Indication in the Licensed Territory, and determine whether such Pre-PoC Development Activities will create an Adverse Risk.
At least annually, during the Term, a Global Development Plan for each Collaboration Compound and Licensed Product and Targeted Indication shall be prepared or updated by the JDC and submitted to the JSC for approval at least * (*) days before the meeting of the JSC at which it will be considered.
At the next JSC meeting (including any ad hoc JSC meeting) following AN2’s receipt of such notice, the JSC shall discuss such proposed specific Pre-PoC Development Activities in the Brii Bio Targeted Indication, and determine whether AN2 has the resources to perform any such Pre-PoC Development Activities (in light of AN2’s Development activities for Licensed Products in the ▇▇▇ ▇▇▇▇▇▇▇▇▇).
For purposes of clarity, the use of the term Targeted Indication, if it is a Cancer Indication, in Section 4.2.1(a) above shall refer to a particular tumor type and not to changes in, or expansion of, the regulatory label applicable to a given tumor type.
If Brii Bio receives a Market Entry Award during the Term for the Licensed Product in the Brii Bio Targeted Indication in the Territory, then Brii Bio shall notify AN2 in writing, and the proceeds of such Market Entry Award will be allocated to each Party as follows, [***], and Brii Bio will pay AN2’s share of such proceeds from such Market Entry Award within [***] of Brii Bio’s receipt of such Market Entry Award.
Brii Bio shall provide to AN2, upon AN2’s request, and no more than once each Calendar Quarter, at Brii Bio’s cost, copies of any materials prepared by or on behalf of Brii Bio that are necessary or reasonably useful in connection with AN2’s Commercialization of Licensed Products in the AN2 Targeted Indication in the ▇▇▇ ▇▇▇▇▇▇▇▇▇ (including relevant training materials, global brand and global market research, in each case, with respect to Licensed Products).
A clinical development plan for the Development of the Collaboration Compound for each Targeted Indication has been agreed upon in writing by the Parties.
At least annually, during the Term, a Global Development Plan for each Collaboration Compound and Licensed Product and Targeted Indication shall be prepared or updated by DS for discussion by the JEC, and DS shall provide reasonable opportunity, but in no event less than * (*) days prior to the presentation of such Global Development Plan to the JEC, for ARQULE to provide comment on such Global Development Plan, which DS shall reasonably consider.
If Commercialization Regulatory Approval is obtained in the Target Indication that is not in a “niche” Targeted Indication that will materially increase the sale of the Licensed Product, as determined by the JSC as a Joint Decision, then all milestones based on Clinical Trials and Commercialization Regulatory Approval of the Targeted Indication will be due upon receipt of Commercialization Regulatory Approval (unless the relevant number of milestones have been fully paid for other Targeted Indications).