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:
Approval Milestones. UPI shall make a nonrefundable milestone payment of ¥200,000,000 to NPC within [***] Business Days of [***]. [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.
Approval Milestones. (a) Novartis shall make the non-refundable, non-creditable payments ("
Approval Milestones. KemPharm shall promptly notify Company upon the receipt of (a) written confirmation from the FDA of acceptance of the NDA submitted by KemPharm for any Initial Product (as contemplated by the applicable PDP) and (b) NDA approval of such Initial Product by the FDA. Without limiting its obligations under Section 4.5, KemPharm shall promptly provide Company with a copy of any NDA submitted to the FDA for approval, along with written evidence of the FDA’s acceptance thereof, and a copy of the associated NDA approval. As further partial consideration for KemPharm’s grant of the rights and licenses to Company hereunder, Company shall pay to KemPharm the corresponding one-time, non-refundable and non-creditable milestone payments set forth below within [*****] days after the receipt of the copy of such NDA acceptance notice or NDA approval, as applicable, from KemPharm: Approval Milestone Event Milestone Payment
Approval Milestones. Milestone Event Milestone Payment Regulatory Approval for a Contingent Payment Product is granted by the FDA [***] Regulatory Approval for a Contingent Payment Product is granted by the EMA (or by the applicable Governmental Authority in a country within the European Union) and the approval from the applicable Governmental Authority establishing price and/or reimbursement is granted for such Contingent Payment Product in at least one of the following countries: U.K., Spain, France, Germany and Italy (provided, that if a Buyer Related Party commercially launches the Contingent Payment Product in such country prior to receipt of such approval establishing price and/or reimbursement, other than named patient sales, then the Milestone Event shall be deemed achieved) [***]
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:
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. 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. (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.
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”): 80 *** Certain information has been excluded from this agreement because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed. Milestone Event Payment Minor Indication Major Indication [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] 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).
