Common use of Approval Milestones Clause in Contracts

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 Profile and in [**] and [**] (2 Major Indications) in any Profile, no further FDA Regulatory Approval milestones shall thereafter be due.

Approval Milestones. Event Achieved KemPharm shall promptly notify Company upon the receipt of (a) written confirmation from the FDA of acceptance of the NDA submitted by Licensed Product(sKemPharm for any Initial Product (as contemplated by the applicable PDP) 1st Major Indication and (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 Profileb) NDA filing 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: 1) FDA acceptance of NDA submission for KP415 [**] $***] 2) Regulatory Approval of KP415 in the U.S. [*****] $[**] ***] 3) Regulatory Approval of a KP415 in the U.S., with a label approved by the FDA $that includes 30-minute onset and 13-hour duration (the “30/13 Label”): a. If Regulatory Approval with the 30/13 Label is received [**] $***]; or [**] $***] b. If Regulatory Approval with the 30/13 Label is not achieved [**] $[**] 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) but the 30/13 Label is included in a subsequent Regulatory Approval for KP415 received by [**], (ii) ***] [*****], or (iii 4) Regulatory Approval for KP484 by the FDA [**]; (c) in the event that Regulatory Approvals by the FDA are achieved in [***] (a Minor Indication) With respect to each approval milestone event in a Profile numbers 1 through 4 above, the milestone payments to be made under this Agreement shall be due and in [**]payable only once upon the first achievement of the applicable milestone, regardless of the number of Products Developed or Commercialized, and [**] (3 Major Indications) in any Profileregardless of the number of indications pursued or approved, 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 or whether a Profile and in [**] and [**] (2 Major Indications) in any Profile, no further FDA Regulatory Approval milestones shall thereafter be dueProduct is discontinued after a milestone payment has been made.