Approval Milestones. Event Achieved by Licensed Product(s) 1st Major Indication (regardless of Profile) 1st Minor Indication (regardless of Profile) 2nd Major Indication (regardless of Profile) First to occur of 2nd Minor Indication or 3rd Major Indication (regardless of Profile) NDA filing with the FDA $[**] $[**] $[**] $[**] Regulatory Approval by the FDA $[**] $[**] $[**] $[**] for 2nd Minor Indication or $[**] for 3rd Major Indication NDA filing with the EMEA or an EU Major Market Country $[**] $[**] $[**] $[**] First Commercial Sale and/or receipt of Regulatory Approval in any three (3) EU Major Market Country(ies) $[**] $[**] $[**] $[**] for 2nd Minor Indication or $[**] for 3rd Major Indication Regulatory Approval by the MHLW in Japan $[**] $[**] $[**] $[**] for 2nd Minor Indication or $[**] for 3rd Major Indication The NDA filing milestones set forth in this Section 7.4.3 shall be payable only once for a Major Indication for each Regulatory Authority (i.e., either the FDA or the EMEA/EU Major Market Country) and only once for a Minor Indication for each Regulatory Authority regardless of the Profile. For the avoidance of doubt: in the event that an NDA is filed with the FDA in [**] in a Profile and a second NDA is filed with the FDA in [**] in another Profile, only one (1) FDA filing milestone shall be due. The Regulatory Approval milestones set forth in this Section 7.4.3 shall be payable only once for an Oncology Indication relating to [**] for each Regulatory Authority (i.e., either the FDA or the EMEA/EU Major Market Country or the MHLW in Japan) regardless of the Profile. For the avoidance of doubt:
(a) in the event that a Regulatory Approval by the FDA is achieved in [**] in a Profile and a second Regulatory Approval by the FDA is achieved in [**] in another Profile, only one (1) FDA Regulatory Approval milestone shall be due;
(b) in the event that a Regulatory Approval by the FDA is achieved in an indication relating to [**] in a Profile [**] then no further FDA Regulatory Approval milestone shall be due in any Profile for any indication relating to [**], whether relating to (i) [**], (ii) [**], or (iii) [**];
(c) in the event that Regulatory Approvals by the FDA are achieved in [**] (a Minor Indication) in a Profile and in [**], and [**] (3 Major Indications) in any Profile, no further FDA Regulatory Approval milestones shall thereafter be due; and
(d) in the event that Regulatory Approvals by the FDA are achieved in [**] and [**] (2 Minor Indications) in a Pro...
Approval Milestones. UPI shall make a nonrefundable milestone payment of ¥200,000,000 to NPC within [***] Business Days of [***].
Approval Milestones. (a) Novartis shall make the non-refundable, non-creditable payments ("Approval Milestone Payments") to Idenix set forth below not later than thirty (30) days after the date on which it receives written notice from Idenix that the corresponding milestone event set forth below has been achieved for a Product for the primary indication and patient population for which such Product is intended:
Approval Milestones. Milestone Event Milestone Payment
Approval Milestones. (a) For each Selected Gene Target, the milestone payments under Column 1 of Table 2 below will be payable by OMI to Isis for the first achievement of the specified milestone events by OMI, its Licensees or their Affiliates for the first Research Compound or Research Product that target such Selected Gene Target to reach the specified milestone event.
(b) The milestone payments under Column 2 of Table 2 below will be payable as set forth below after the first achievement of the specified milestone events by OMI, its Licensees or their Affiliates for the first GCGR Compounds or GCGR Products to reach the specified milestone event.
(c) The milestone payments under Column 3 of Table 2 below will be payable as set forth below after the first achievement of the specified milestone events by OMI, its Licensees or their Affiliates for the first GCCR Compounds or GCCR Products to reach the specified milestone event. [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] In the event that an original Compound or Product for a Collaboration Gene Target fails in development and is replaced by OMI with a back-up Compound or Product targeting the same Collaboration Gene Target, any milestone payments previously paid with respect to such original Compound or Product shall be fully creditable toward the same milestone due with respect to the back-up Compound or Product, and OMI shall notify Isis in writing of the selection of the back-up Compound or Product. The Parties acknowledge that, after the approval milestone payments for a Second Indication are paid to Isis, OMI shall not be obligated to make any additional approval milestone payments with respect to a Product comprising the same Compound or Product or its back-up Compound or Product, regardless of the number of additional indications for which such Compound or Product is developed. The Parties also acknowledge that different formulations (e.g., dosage strength, delivery forms) of a Compound or Product (back-up Compound or Product) or bioequivalents therefore (i.e., salts, esters, polymorphs) shall be deemed the same Compound or Product, and all milestones due shall be payable one time only per Compound or Product.
Approval Milestones. Whether such event is achieved by TGTX, its Affiliates, its Sublicensees or any Third Party acting on behalf of TGTX, its Affiliates or its Sublicensees, TGTX shall pay Novimmune a fully earned, non-refundable, one-time, milestone payment in each of the territories listed below upon the approval of the first BLA in each such territory: Approval Milestone: $* $* $* Any milestone payments owed under Sections 4.3.1 and 4.3.2 may be paid on cash and/or TGTX Shares, or a combination of both, at the discretion of TGTX. TGTX shall provide Novimmune with written notice within 17 ( * ) working days of the occurrence of any of the foregoing milestone events and the relevant milestone payment is payable by TGTX to Novimmune within * ( * ) days of receipt of a corresponding invoice issued by Novimmune. If TGTX determines that there is a reasonable likelihood of a particular milestone event being achieved on or about a particular date, TGTX shall use reasonable efforts to provide advance notice thereof to Novimmune, which notice shall be provided solely for Novimmune’ planning purposes and shall not be construed as a representation, warranty or covenant by TGTX that such milestone event will occur when anticipated or at all.
Approval Milestones. As partial consideration for the grant to Biodel of the rights under Section 3.1, within [**] days following the achievement of each of the following milestones, Biodel shall give written notice to Aegis thereof and shall pay to Aegis the corresponding nonrefundable one time only milestone payments described below. Milestone Event Total Payment (U.S. $) [**] $[**] [**] $[**] [**] [**] [**] [**] [**] [**] [**] [**]
Approval Milestones. Xxxxxxxxx shall immediately notify AEZS in writing upon the achievement of the corresponding milestone event (each an "Approval Milestone") and AEZS shall issue to Xxxxxxxxx a signed pro-forma invoice for the applicable Milestone Payment. Sinopharm shall pay AEZS the applicable non-refundable Milestone Payment within [*] [Exclusion of confidential information related to milestone payments] after its receipt of the applicable pro-forma invoice signed by AEZS.
Approval Milestones. GSK shall make the non-refundable, non-creditable payments to Alector set forth below in accordance with Section 7.2.4 upon the occurrence of the corresponding milestone event set forth below (each, an “Approval Milestone”): *** Certain information has been excluded from this agreement because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed. [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] Each Approval Milestone shall be payable one time only, even if such Approval Milestone occurs for a given Indication with respect to more than one Licensed Product (including Combination Products).
Approval Milestones. On a Licensed Product-by-Licensed Product basis, Ultragenyx will pay to Solid the milestone payments set forth in this Section 9.2.2 (each an “Approval Milestone Payment”) upon the achievement of the relevant milestone event (each an “Approval Milestone Event”) with respect to a Licensed Product that is not an Option Product, subject to the limitations set forth in this Section 9.2.2:
