Regulatory Milestone Payments. For each Exclusive Target for which Genentech has exercised an Option pursuant to Section 3.2 above, Licensee shall pay Arvinas the following one-time milestone event payments for the first achievement of the corresponding milestone events for any Licensed Product that is a Valid Claim Licensed Product at the time of such achievement, with respect to such Exclusive Target, subject to the terms of this Section 6.3 and the payment provisions in Article 7 below: 1st Indication 2nd Indication [**] [**] [**] [**] [**] [**] [**] [**] [**]
Regulatory Milestone Payments. (a) Norgine shall pay to AMAG the one-time milestone payments listed below for the first achievement of the corresponding milestone event (each such event, a ACTIVE/105730326.3 “Regulatory Milestone Event” and each such payment, a “Regulatory Milestone Payment”), which in each case shall be non-refundable and non-creditable. Grant of conditional Regulatory Approval of the Product by the EMA pursuant to Commission Regulation (EC) No 507/2006 [***] Grant of Regulatory Approval of the Product by the EMA [***] Achievement of pricing and reimbursement approval for the Product in three (3) of the Major European Countries of at least [***] per vial [***] Achievement of pricing and reimbursement approval in all of the Major European Countries for an indication that includes [***], provided that this Regulatory Milestone Payment shall be payable only to the extent AMAG is required to pay the corresponding milestone payment under the [***]. [***]
(b) Each of the Regulatory Milestone Payments described above shall be payable only once, regardless of the number of times the associated Regulatory Milestone Events are achieved. If the EMA grants Regulatory Approval of the Product without first granting conditional Regulatory Approval pursuant to Commission Regulation (EC) No 507/2006, then Norgine will pay the sum of [***] upon Regulatory Approval of the Product by the EMA. If the [***] is paid by Norgine and AMAG subsequently is entitled to any credit under the [***] with respect to the [***], AMAG shall promptly pay to Norgine the amount of such credit.
(c) Norgine shall provide written notification to AMAG of the achievement of each of the Regulatory Milestone Events described above within [***] after each such achievement. AMAG shall deliver to Norgine a written invoice for the Regulatory Milestone Payment promptly after receipt of such written notification from Norgine. All Regulatory Milestone Payments shall be due and payable within [***] after receipt of such invoice from AMAG.
Regulatory Milestone Payments. Jazz shall provide Zymeworks with notice of the achievement of each Regulatory Milestone Event within [***] thereafter. Following receipt of each such notice, Zymeworks will issue to Jazz a written invoice for the applicable Regulatory Milestone Payment. Jazz will pay to Zymeworks the applicable Regulatory Milestone Payment within [***] after its receipt of such invoice.
Regulatory Milestone Payments. BMS shall pay to BN the following one-time non-refundable milestone payments set forth in Table 1 within [***] after the first achievement of the specified milestone event for the first indication by BMS, its Affiliates or its Sublicensees for the first Product to achieve such milestone event. In no event shall milestone payments to be made pursuant to this Section 8.3 exceed $110 million in the aggregate. For clarity, such milestone payments shall not be paid on any other Products that might achieve the same milestone event. BMS shall provide written notice to BN within [***] after the first achievement of the specified milestone event by BMS or its Affiliates and within [***] after the first achievement of the specified milestone event by its Sublicensees. [***] $ [***] [***] $ [***] [***] $ [***]
Regulatory Milestone Payments. From and after the Closing, following the first achievement of each regulatory milestone event set forth in the table below (each such event, a “Regulatory Milestone Event”), Buyer shall pay, or cause to be paid, to Seller a one-time, non-refundable and non-creditable corresponding milestone payment (each, a “Regulatory Milestone Payment”) within [***] Business Days after receipt of an invoice from Seller issued no earlier than the first achievement of such Regulatory Milestone Event. Buyer shall notify Seller as soon as reasonably practicable (but no more than [***] Business Days) after each Regulatory Milestone Event is first achieved. For the avoidance of doubt, each Regulatory Milestone Payment shall be payable one time only for each Ento Product, Lanra Product and Other Product upon the first achievement of the corresponding Regulatory Milestone Event for such Ento Product, Lanra Product and Other Product (as applicable), regardless of the number of times such Regulatory Milestone Event may be achieved. As used in the table below, “Indication” means an individual, separate and distinct disease or medical condition for which (a) [***] or (b) a [***]. For clarity, subpopulations of patients with a [***] or [***] shall be deemed to be separate “Indications”, including [***] by [***] or [***]. In addition, [***] with a Product [***]. Regulatory Milestone Event Ento Compound: 1st Indication Ento Compound: 2nd Indication Lanra Compound: 1st Indication Lanra Compound: 2nd Indication Other Compound: 1st Indication Other Compound: 2nd Indication [***] $[***] $[***] $[***] $[***] $[***] $[***] [***] $[***] $[***] $[***] $[***] $[***] $[***]
Regulatory Milestone Payments. In further consideration for the rights and licenses granted to PTC hereunder, on a Product-by-Product basis, PTC shall pay Akcea a non-refundable, non-creditable, irrevocable milestone payment of four million U.S. Dollars ($4,000,000) upon the first achievement for each such Product of receipt of Regulatory Approval from ANVISA (each, a “Milestone Payment”). PTC shall pay each Milestone Payment within thirty (30) days after receipt by PTC of formal written notice from ANVISA has granted Regulatory Approval for a Product for Brazil. For purposes of clarity, the maximum aggregate payments under this Section 9.2 shall be eight million U.S. dollars ($8,000,000).
Regulatory Milestone Payments. Emergent shall promptly inform Aridis of the achievement of each of the milestones set forth below by Emergent or any of its Affiliates or, if applicable, any Emergent sublicensee. In partial consideration of the licenses and other rights granted herein and subject to the terms and conditions set forth in this Agreement, Emergent shall make the following non-refundable milestone payments to Aridis within thirty (30) days of receipt by Emergent from Aridis of a written invoice therefor:
5.2.1 [***]at the first dosing of the first subject in the first Phase I Clinical Trial of a Licensed Product;
5.2.2 [***] at the first dosing of the first subject in the first Phase II Clinical Trial of a Licensed Product;
5.2.3 [***] upon the earlier of (i) the first dosing of the first subject in the first Phase III Clinical Trial of a Licensed Product and (ii) award of a contract executed by HHS, or any successor agency thereto, for the manufacture and delivery of a Licensed Product for placement in the Strategic National Stockpile;
5.2.4 [***] upon the first submission of a Marketing Authorization in the United States, Japan or any EU Member State with respect to a Licensed Product;
5.2.5 [***] upon the First Sale after receipt of the first Marketing Authorization for a Licensed Product; Emergent shall make the foregoing milestone payments to Aridis for the first Licensed Product per Biodefense Indication within the Field. These payments will be made only once per Licensed Product per Biodefense Indications within the Field.
Regulatory Milestone Payments. X4 shall pay Genzyme the following one-time, non-refundable, non-creditable milestone payments [***] after the first achievement of the corresponding Milestone Event by X4, its Sublicensees or their respective Affiliates: [***] [***] [***] [***] [***] [***] [***] [***]
Regulatory Milestone Payments. As additional consideration for the Transactions, upon the satisfaction of the criteria described in each subsection of this Section 2.4(a) (each, a “Regulatory Milestone”), Buyer shall, subject to the terms of this Section 2.4, pay or cause to be paid to Seller in cash the amount specified in such subsection (each such payment, a “Regulatory Milestone Payment”). Except as expressly specified below, each Regulatory Milestone Payment shall be payable only once [**]:
(i) [**];
(ii) [**];
(iii) [**];
(iv) [**];
(v) [**];
(vi) [**];
(vii) [**];
(viii) [**];
(ix) [**]; and
(x) [**].
Regulatory Milestone Payments. Following achievement of a milestone event set forth in this Section 4.3 by each distinct Xilio Licensed Product that would [**] (each, a “Milestone Event”), Xilio shall pay to AskGene the corresponding milestone payment set forth in the table below in this Section 4.3 (each, a “Milestone Payment”) in accordance with Section 4.6. Notwithstanding anything to the contrary, each Milestone Payment shall be payable only once for the achievement of the applicable Milestone Event for each distinct Xilio Licensed Product. For the avoidance of doubt, two Xilio Licensed Products shall only be distinct Xilio Licensed Products eligible for a subsequent Milestone Payment under this Section 4.3 if the Xilio Licensed Products each require a separate NDA/BLA Approval or MAA Approval, unless such separate NDA/BLA Approval or MAA Approval is (a) [**], or (b) [**]. [**] $ [**] [**] $ [**] [**] $ [**]
