Regulatory Milestones. Celgene shall make the following approval milestone payments to Jounce that are set forth below upon the first achievement by or on behalf of Celgene, its Affiliates or Sublicensees of the Regulatory Milestone Events set forth below with respect to the first Co-Co Product that achieves such event. For clarity, each milestone set forth below shall be due and payable one time only (regardless of the number of Co-Co Products to achieve any such Regulatory Milestone Event). CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED. [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] For each of Paragraphs (1) - (3) of this Exhibit C-2, the Parties understand and agree that in no event will more than one (1) milestone payment be paid with respect to any specific event triggering a payment under this Jounce Lead Co-Co Agreement.
Regulatory Milestones. In partial consideration of the rights granted by Lightlake to Adapt hereunder and subject to the terms and conditions set forth in this Agreement, Adapt shall pay to Lightlake a milestone payment within thirty (30) days after the achievement of each of the following milestones:
5.2.1 Adapt’s first receipt of notice from the FDA that an NDA in respect of a Product has received approval, *** REDACTED ***Dollars;
5.2.2 First Commercial Sale of a Product in the United States, *** REDACTED ***Dollars;
Regulatory Milestones. [***] [***] [***]
Regulatory Milestones. In partial consideration of the rights granted by Galapagos to Xxxxxx hereunder for the Lead Indication and subject to the terms and conditions set forth in this Agreement, Xxxxxx shall pay to Galapagos a milestone payment within […***…] ([…***…]) days after the achievement of each of the following milestones, calculated as follows:
6.3.1 upon […***…], […***…] Dollars ($[…***…]);
6.3.2 upon […***…], […***…] Dollars ($[…***…]);
6.3.3 Upon […***…], […***…] Dollars ($[…***…]);
6.3.4 Upon […***…], […***…] Dollars ($[…***…]);
6.3.5 Upon […***…], […***…] Dollars ($[…***…]);
6.3.6 Upon […***…], […***…] Dollars ($[…***…]);
6.3.7 Upon […***…], […***…] Dollars ($[…***…]);
6.3.8 Upon […***…], […***…] Dollars ($[…***…]);
6.3.9 Upon […***…], […***…] Dollars ($[…***…]);
6.3.10 Upon […***…], […***…] Dollars ($[…***…]);
6.3.11 Upon […***…], […***…] Dollars ($[…***…]);
6.3.12 Upon […***…], […***…] Dollars ($[…***…]);
6.3.13 Upon […***…], […***…] Dollars ($[…***…]);
6.3.14 Upon […***…], […***…] Dollars ($[…***…]);
6.3.15 Each milestone payment in this Section 6.3 shall be non-refundable, non-creditable and payable only upon the first achievement of such milestone and no amounts shall be due for subsequent or repeated achievements of such milestone, whether for the same or a different Licensed Compound or Licensed Product.
Regulatory Milestones. (a) In partial consideration of the rights granted by AstraZeneca to Mereo hereunder, Mereo shall pay to AstraZeneca the following payments within [***] days after the achievement of each of the following milestone events with respect to the first Product to reach such milestone event only (unless otherwise provided below), which amounts shall be fully earned upon the achievement of the applicable milestone event: [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] TOTAL: [***] For the second (2nd) Indication for which a milestone is achieved for a Product, a milestone payment shall be due but shall be reduced to [***] of the milestone amounts set forth in the table above. For the third (3rd) Indication for which a milestone is achieved for a Product, a milestone payment shall be due but shall be reduced to [***] of the milestone amounts set forth in the table above. For clarity, for purposes of the payments due under this Section 8.4.1, the 9668 Product [***] shall be considered different Products. Each milestone in this Section 8.4.1 shall be payable on a Product-by-Product basis based on the first achievement of such milestone for the applicable Product (subject to the paragraph immediately following the table above).
Regulatory Milestones. Braeburn shall pay to Titan, by wire transfer of immediately available funds to an account designated by Titan, the applicable nonrefundable, non-creditable, one-time milestone payment after achievement of each milestone event as set forth below; provided, however, that the milestone payment referred to in this Section 6.1(b)(i) shall be subject to the provisions of Section 12.2(c)(ii) hereto. Titan shall notify Braeburn in writing within five (5) Business Days of achievement of the first milestone event listed in the table below and the corresponding milestone payment shall be due within ten (10) Business Days of receipt by Braeburn of such notice. Each other milestone payment listed in the table below shall be due within ten (10) Business Days after achievement of the corresponding milestone event.
(i) FDA Approval of Product NDA [***] Priority Review designation, US$50,000,000 (fifty million dollars)
(ii) Submission of NDA for Subsequent Indication of chronic pain [***]
(iii) FDA Approval of NDA for Subsequent Indication of chronic pain [***]
(iv) Submission of NDA for each additional Subsequent Indication (i.e., not for chronic pain) [***]
(v) FDA Approval of NDA for each additional Subsequent Indication (i.e., not for chronic pain) [***] CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
Regulatory Milestones. After the first achievement of each milestone event set forth in the table below for any Licensed Product (each, a “Regulatory Milestone Event”), Jazz shall make the corresponding milestone payment to Zymeworks (each, a “Regulatory Milestone Payment”) in accordance with Section 9.5(a). Each Regulatory Milestone Payment shall be fully-earned and payable once upon the first achievement of the corresponding Regulatory Milestone Event by or on behalf of Jazz, its Affiliates or sublicensees with respect to a Licensed Product in the Territory. The maximum aggregate amount payable pursuant to this Section 9.3 following achievement of all Regulatory Milestone Events is five hundred twenty-five million U.S. dollars (USD 525,000,000). [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***]
Regulatory Milestones. In consideration for the rights granted to Kyowa Kirin under this Agreement, Kyowa Kirin will make the following one-time, non-refundable, non-creditable payments to Reata within thirty (30) days after the first achievement by Kyowa Kirin or its Affiliate of each of the following milestone events for a Licensed Product (each a “Regulatory Milestone Payment”). If any given Regulatory Milestone Payment is due (except for any of the Regulatory Milestone Events for countries other than Japan, which shall not trigger any of the preceding milestones), and one or more preceding Regulatory Milestone Payments have not been paid for any reason, then payment of all preceding unpaid Regulatory Milestone Payments will be paid at such time as well. For the avoidance of doubt, each of the following milestones (and corresponding Regulatory Milestone Payment) shall be payable only once. [***] $ [***] [***] $ [***] [***] $ [***] [***] $ [***] [***] $ [***] [***] $ [***] [***] $ [***]
Regulatory Milestones. Aptose shall notify CG within thirty (30) days after the first achievement by Aptose or its Affiliates or Sublicensees of the following regulatory milestone events by each Product. Thereafter, CG shall invoice Aptose for the corresponding milestone payment, and Aptose shall pay each such invoice within forty-five (45) days after receipt thereof. Acceptance for filing by the FDA of the first NDA for a Product $7 million Acceptance for filing by the EMA of the first MAA for a Product $7 million Acceptance for filing by the MHLW of the first MAA for a Product $4 million First Regulatory Approval of a Product by the FDA $10 million Earlier of (a) first Regulatory Approval of a Product by the EMA by the centralized procedure (including Pricing Approvals reasonably acceptable to Aptose in at least three (3) Major European Countries) or (b) first Regulatory Approval of a Product in at least three (3) Major European Countries $10 million First Regulatory Approval of a Product by the MHLW $6 million Each of the above milestone payments is payable one time per Product, regardless of the number of times the corresponding event is achieved by such Product, except that each milestone payment for a Regulatory Approval event is payable up to five times as follows for each Product: at 100% of the amount set forth above for the first Indication, at 100% of the amount set forth above for up to two (2) additional non-oncology Indications and at 50% of the amount set forth above for up to two (2) additional oncology Indications. All formulations containing the same Licensed Compound will be considered the same Product for purposes of this Section 7.1(b). For example, if Aptose develops a tablet formulation comprising CG’806 and pays the applicable regulatory milestone payments for such tablet formulation as set forth above, and later develops an injectable formulation comprising CG’806, the achievement of the regulatory milestones by the injectable formulation will not trigger another payment of the applicable regulatory milestone payment. Under no circumstances shall Aptose be obligated to pay CG more than one hundred twenty-two million Dollars ($122,000,000) per Product pursuant to this Section 7.1(b).
Regulatory Milestones. Subject to Section 6.7 (Exceptions), Spark shall pay Selecta a milestone payment upon the first achievement by Spark, its Affiliate or a sublicensee of the applicable regulatory milestone event set forth in the table below with respect to a Licensed Product directed to each Target, on a Target-by-Target basis (each, a “Regulatory Milestone Payment”). Each Regulatory Milestone Payment shall be paid [***] that can become payable under this Section 6.5 is $[***] per Target.
(a) [***] [***]
(b) [***] [***]
(c) [***] [***] [***] 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
