Milestone Event Milestone Payments Sample Clauses

Milestone Event Milestone Payments. For RCC (2nd line) For HCC (2nd line) Tier 1 Additional Indication Tier 2 Additional Indication Milestone #1: Initiation of first Phase 3 Clinical Trial n.a. n.a. $[ * ] $[ * ] Milestone #2: First MAA filing with the EMA n.a $10 million $[ * ] $[ * ] Milestone #3: First MAA Approval by EMA $60 million $40 million $[ * ] $[ * ] TOTAL $60 million $50 million $[ * ] $[ * ]
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Milestone Event Milestone Payments. The earlier to occur of (a) Initiation by or on behalf of EPIZYME, its Affiliates or Sublicensees of a first Phase 3 Clinical Trial of any Licensed Product for any Indication and in any specific patient population, and (b) the first submission by or on behalf of EPIZYME, its Affiliates or Sublicensees in the United States or a Major EU Country (or to the EMA through the centralized approval procedure) of an NDA for any Licensed Product for any Indication and in any specific patient population. [**]
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Milestone Event Milestone Payments. 1. [***] [***] 2. [***] [***] For clarity, Milestone Event No. 2 set forth in Table 7.2 shall only be reduced in the event that one of the first two (2) Phase 3 Clinical Studies is not Successful, and Journey reasonably believes that Regulatory Approval for a rosacea Indication is unlikely without conducting a third (3rd) Phase 3 Clinical Study.
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Milestone Event Milestone Payments. [***] [***] For the avoidance of doubt, Journey will have no obligation to obtain Regulatory Approval for any non-rosacea Indication that is not consistent with its application of Commercially Reasonable Efforts.
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Milestone Event Milestone Payments. The earlier to occur of (a) Initiation by or on behalf of EPIZYME, its Affiliates or Sublicensees of a first Phase 3 Clinical Trial for any Licensed Product either (i) for an Indication different from the Indication for which a previous Phase 3 Clinical Trial for any Licensed Product has been Initiated or an NDA for any Licensed Product previously has been submitted in the United States or a Major EU Country (or to the EMA through the centralized approval procedure), or (ii) for the same the Indication for which a previous Phase 3 Clinical Trial for any Licensed Product has been Initiated or for which an NDA for any Licensed Product previously has been submitted in the United States or a Major EU Country (or to the EMA through the centralized approval procedure), but in a different specific patient population from the specific patient population for which a previous Phase 3 Clinical Trial for any Licensed Product for such Indication has been Initiated or for which an NDA for any Licensed Product previously has been submitted in the United States or a Major EU Country (or to the EMA through the centralized approval procedure), and (b) the first submission by or on behalf of EPIZYME, its Affiliates or Sublicensees in the United States or a Major EU Country (or to the EMA through the centralized approval procedure) of an NDA for any Licensed Product either (i) for an Indication different from the Indication for which a previous Phase 3 Clinical Trial for any Licensed Product has been Initiated or for which an NDA for any Licensed Product previously has been submitted in the United States or a Major EU Country (or to the EMA through the centralized approval procedure), or (ii) for the same the Indication for which a previous Phase 3 Clinical Trial for any Licensed Product has been Initiated or for which an NDA for any Licensed Product previously has been submitted in the United States or a Major EU Country (or to the EMA through the centralized approval procedure), but in a different specific patient population from the specific patient population for which a previous Phase 3 Clinical Trial for any Licensed Product for such Indication has been Initiated or for which an NDA for any Licensed Product previously has been submitted in the United States or a Major EU Country (or to the EMA through the centralized approval procedure). [**]
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Milestone Event Milestone Payments. Initiation of the first Phase I Trial [***] Initiation of the first Phase III Trial [***] Obtaining the first Regulatory Approval from FDA or comparable regulatory authority in any jurisdiction outside the U.S. [***] Upon First Commercial Sale in the US [***] Upon First Commercial Sale in a EMEA country: [***] The above Milestone Payments shall be non-refundable and non-creditable against royalty payments hereunder, whether such Milestone Payments are reached by Licensee and/or its Affiliates. Each Milestone Payment is payable only once for the first such Product to achieve the applicable Milestone Event, regardless of the number of Products which achieve such Milestone Event. The Milestone Payments payable to Inserm Transfert, if all the Milestone Events are achieved by Licensee and/or its Affiliates or by a subcontractor on behalf of Licensee and/or its Affiliates, shall not exceed [***].
Sample 1
Milestone Event Milestone Payments. For HCC (2nd line) For RCC (2nd line) For RCC (1st line) as a combination therapy (including, for clarity, the Takeda 0XX Xxxxx Xxx-Xx) For RCC (1st line) as a single agent Tier 1 Indications Tier 2 Indications Tier 3 Indications: Clinical Trial sponsored by Collaborator or its Affiliate Tier 3 Indications: Investigator-Initiated Clinical Trial Milestone #1: Upon [*] the first Phase 3 Clinical Trial for the Product in Collaborator Territory [*] [*] $[*] [*] $[*] $[*] $[*] [*] Milestone #2: Upon [*] the first MAA for the Product in Collaborator Territory $[*] $[*] $[*] [*] $[*] $[*] [*] $[*] Milestone #3: Upon First Commercial Sale for the Product in the relevant indication in Collaborator Territory $[*] $[*] $[*] $[*] $[*] $[*] [*] [*]
Sample 1
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Milestone Event Milestone Payments. For RCC (2nd line) For RCC (1st line) For HCC (2nd line) Tier 1 Indications Tier 2 Indications Milestone #1: Upon [ * ] the first Phase 3 Clinical Trial for the Product in the Collaborator Territory [ * ] $[ * ] [ * ] $[ * ] $[ * ] Milestone #2: Upon [ * ] the first MAA for the Product in the Collaborator Territory $[ * ] $[ * ] $[ * ] $[ * ] $[ * ] Milestone #3: Upon First Commercial Sales for the Product in the relevant indication in the Collaborator Territory $[ * ] $[ * ] $[ * ] $[ * ] $[ * ]
Sample 1
Milestone Event Milestone Payments. First Regulatory Approval of any Licensed Product in the United States or a Major EU Country (or by EMA through the centralized approval procedure) (a) for an Indication different from the Indication for which a previous Regulatory Approval for any Licensed Product has been obtained or (b) for the same the Indication for which a previous Regulatory Approval for any Licensed Product has been obtained, but in a different specific patient population from the specific patient population for which a previous Regulatory Approval for any Licensed Product has been obtained. [**] No milestone payment in this Section 6.3.1 will be made more than once irrespective of the number of Licensed Products that have achieved the milestone events set forth in this Section 6.3.1. The maximum aggregate amount payable by EPIZYME pursuant to this Section 6.3.1 is $70,000,000.
Sample 1

Related to Milestone Event Milestone Payments

  • Milestone Event Milestone Payment [***] [***]

  • Development Milestone Payments (i) In addition to the Closing Date Merger Consideration (less the Remaining Option Consideration and Rights Proceeds Amount, if any) and any Net TNF Sales Payments (as defined below), upon the attainment of the development ** Portions of the Exhibit have been omitted and have been filed separately pursuant to an application for confidential treatment filed with the Securities and Exchange Commission pursuant to Rule 24b-2 under the Securities Exchange Act of 1934, as amended. milestones set forth below (each, a “Development Milestone”), Parent shall, or shall cause the Surviving Corporation to, [**] after the occurrence of each Development Milestone, deliver to the Paying Agent (for further payment to the holders of Stock Certificates and Stock Agreements outstanding immediately prior to the Effective Time), via wire transfer of immediately available funds, the respective amounts set forth below minus, in each case, the applicable Contingent Consideration Distribution Fee associated therewith and any amount designated by the Stockholders’ Representatives to be placed in the Administrative Expense Account (each, a “Development Milestone Payment” and collectively, the “Development Milestone Payments”): (A) Upon FDA approval of Reslizumab for the treatment of eosinophilic esophagitis, a cash payment of [**]; (B) Upon marketing authorization of Reslizumab for the treatment of eosinophilic esophagitis being granted by the European Commission in accordance with Regulation (EC) No. 726/2004, a cash payment of [**]; (C) If Res 5-0010 Asthma Study Completion has not occurred on or prior to the Closing Date, then upon the occurrence of the Res 5-0010 Asthma Study Completion, a cash payment of $50,000,000 (fifty million dollars) (the “Res 5-0010 Asthma Payment”); (D) Upon FDA approval of Reslizumab for any asthma indication, a cash payment of [**]; (E) Upon marketing authorization of Reslizumab for the treatment of any asthma indication being granted by the European Commission in accordance with Regulation (EC) No. 726/2004, a cash payment of [**]; and (F) Upon FDA approval of an Oral Anti-TNF Product, a cash payment of [**].

  • Milestone A principal event specified in the Contract Documents including the Material Completion and Occupancy Date and other events relating to an intermediate completion date or time.

  • Milestone Payment The first time Net Sales in the Territory in a Royalty Period exceed US$[***] ([***] dollars) US$[***] ([***] dollars)

  • Sales Milestone Payments Artiva shall make the following one-time, non-refundable and non-creditable sales milestone payments to GCLC when the aggregate annual Net Sales of Products in the Territory first reach the thresholds specified below. Artiva shall notify GCLC promptly of the achievement of each such sales threshold. Each sales milestone payment shall be made by Artiva within [***] days after the end of the calendar quarter in which such sales threshold is achieved. To the extent more than one sales threshold is reached in any given calendar year, then the applicable milestone payment for each such achievement shall be due and owing with respect to such calendar year. For clarification, the total milestone payments payable hereunder if all milestone events are achieved is [***].

  • Milestone Payments In the event that any Sellers believe that any Additional Milestone has been achieved during the Post-Closing Milestone Period, the Sellers’ Representative shall provide notice of such achievement to Purchaser. If Purchaser determines in its sole and reasonable discretion that such Additional Milestone has been achieved during the Post-Closing Milestone Period, then within thirty (30) days of such notice from Sellers’ Representative or, if earlier, within thirty (30) days of Purchaser’s determination that such Additional Milestone has been achieved, Purchaser shall notify Sellers’ Representative of its determination and pay to Sellers the Additional Milestone Payment payable in respect of such Additional Milestone. If Sellers’ Representative delivers such a notice and Purchaser determines, in its sole and reasonable discretion, that the applicable Additional Milestone has not been achieved, then, within thirty (30) days of Sellers’ Representative’s notice Purchaser shall notify Sellers’ Representative of such determination. If Sellers’ Representative believes that Sellers are entitled to payment of all or any portion of an Additional Milestone Payment hereunder which they have not received within thirty (30) days following the achievement of the Additional Milestone for which payment is due, Sellers’ Representative may, not later than twelve (12) months following the achievement of such Additional Milestone, deliver to Purchaser a notice setting forth Sellers’ Representative’s determination that all or a portion of such Additional Milestone Payment is due under this Agreement (the “Post-Closing Assessment Notice”). If Sellers’ Representative does not deliver to Purchaser a Post-Closing Assessment *** Portions of this page have been omitted pursuant to a request for Confidential Treatment filed separately with the Commission. Notice within such twelve (12) month period, then Sellers shall have been deemed to agree that the Additional Milestone has not been met and no payment with respect to such Additional Milestone is due to Sellers hereunder and Sellers shall have no further rights to such Milestone Payment or any portion thereof. Such Post-Closing Assessment Notice may be delivered before or after the expiration of the Post-Closing Milestone Period without affecting Sellers’ rights to the applicable Milestone Payment, provided that that applicable Additional Milestone was actually achieved prior to the expiration of such Post-Closing Milestone Period. If Purchaser shall object to Sellers’ determination that a Additional Milestone has been achieved as set forth in the Post-Closing Assessment Notice, then Purchaser shall deliver a dispute notice (a “Post-Closing Milestone Dispute Notice”) to Sellers’ Representative within fifteen (15) days following Sellers’ Representative’s delivery of the Post-Closing Assessment Notice. A representative of Purchaser, on the one hand, and the Sellers’ Representative, on the other, shall attempt in good faith to resolve any such objections within fifteen (15) days of the receipt by Sellers of the Post-Closing Milestone Dispute Notice. If no Post-Closing Milestone Dispute Notice is delivered within the fifteen (15) day time period, then Sellers’ determination that the Additional Milestone has been achieved, and that the amount of the Milestone Payment specified in the Post-Closing Milestone Dispute Notice is due hereunder, shall be deemed to be accepted and Purchaser shall pay to Sellers those amounts set forth in the Post-Closing Assessment Notice no later than five (5) days after the expiration of such fifteen (15) day time period.

  • Development Milestones In addition to its obligations under Paragraph 7.1, LICENSEE specifically commits to achieving (either itself or through the acts of a SUBLICENSEE) the following development milestones in its diligence activities under this AGREEMENT: (a) (b).

  • Milestone Fees Licensee will pay Milestone Fees indicated in Section 3.1(b) of the Patent & Technology License Agreement by the Quarterly Payment Deadline for the Contract Quarter in which the milestone events set forth in Section 3.1(b) of the Patent & Technology License Agreement are achieved.

  • Sales Milestones (a) As to each Therapeutic Product, SANOFI-AVENTIS shall pay MERRIMACK up to a total of Sixty Million Dollars (US$60,000,000) upon the first achievement of the following Net Sales milestones, on a Therapeutic Product-by-Therapeutic Product basis: (i) Total Worldwide Net Sales for such Therapeutic Product exceed $[**] in any four (4) consecutive calendar quarters $ [**] (ii) Total Worldwide Net Sales for such Therapeutic Product exceed $[**] in any four (4) consecutive calendar quarters $ [**] (iii) Total Worldwide Net Sales for Therapeutic Product exceed $[**] in any four (4) consecutive calendar quarters $ [**] (b) Each milestone payment set forth in Section 8.4(a) shall be payable by SANOFI-AVENTIS upon the achievement of the related milestone event by SANOFI-AVENTIS and its Affiliates or sublicensees, and SANOFI-AVENTIS shall provide notice to MERRIMACK promptly upon achievement of such milestone event. SANOFI-AVENTIS shall pay MERRIMACK each such milestone payment within [**] days of such achievement of the related milestone event. (c) For purposes of clarity, more than one of the Net Sales milestones set forth above may be earned in the same four (4) consecutive calendar quarter period with respect to a Therapeutic Product. For example, if total worldwide Net Sales with respect to a given Therapeutic Product have not achieved any of the lower sales milestone thresholds set forth in clause (i) or (ii) of Section 8.3(a) above in any previous four (4) consecutive calendar quarter period, but total worldwide Net Sales with respect to such Therapeutic Product exceed $[**] in a subsequent four (4) consecutive calendar quarter period, then all three milestone payments, totaling $60 Million, payable upon achievement of the sales milestone thresholds set forth in clause (i), (ii) and (iii) of Section 8.3(a) above shall become payable to MERRIMACK hereunder.

  • Commercial Milestones (a) Within [*****] calendar days after the end of the first Calendar Year in which aggregate annual Net Sales for that Calendar Year for the Licensed Product in the Territory reach any threshold indicated in the Commercial Milestone Events listed below, EverInsight shall notify VistaGen of the achievement of such Commercial Milestone Event and VistaGen shall invoice EverInsight for the corresponding non-refundable, non-creditable Milestone Payment set forth below and EverInsight shall remit payment to VistaGen within [*****] Business Days after the receipt of the invoice, as described in Section 8.6 (Currency; Exchange Rate; Payments). Annual Net Sales Milestones for Licensed Product Milestone Payments (in Dollars) (each a “Commercial Milestone Event”): (1). [*****] (2). [*****] (3). [*****] (4). [*****] (5). [*****] (b) For the purposes of determining whether a Net Sales Milestone Event has been achieved, Net Sales of Licensed Product(s) in the Territory shall be aggregated. For clarity, the annual Net Sales Milestone Payments set forth in this Section 8.3 (Commercial Milestones) shall be payable only once, upon the first achievement of the applicable Commercial Milestone Event, regardless of how many times such Commercial Milestone Event is achieved. (c) If a Commercial Milestone Event in Section 8.3 (Commercial Milestones) is achieved and payment with respect to any previous Commercial Milestone Event in Section 8.3 has not been made, then such previous Commercial Milestone Event shall be deemed achieved and EverInsight shall notify VistaGen within fifteen (15) calendar days of such achievement. VistaGen shall then invoice EverInsight for such unpaid previous Commercial Milestone Event(s) and EverInsight shall pay VistaGen such unpaid previous milestone payment(s) within thirty (30) Business Days of receipt of such invoice. (d) In the event that, VistaGen believes any Commercial Milestone Event under Section 8.3(a) has occurred but EverInsight has not given VistaGen the notice of the achievement of such Commercial Milestone Event, it shall so notify EverInsight in writing and shall provide to EverInsight data, documentation or other information that supports its belief. Any dispute under this Section 8.3(d) (Commercial Milestones - subsection (d)) that relates to whether or not a Commercial Milestone Event has occurred shall be referred to the JSC to be resolved in accordance with ARTICLE 3 (Governance) and shall be subject to resolution in accordance with Section 14.10 (Dispute Resolution). The Milestone Payments made for each Commercial Milestone Event shall be non-creditable and non-refundable.

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