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 $[ * ] $[ * ]
Sample 1Sample 2See All (4)
AutoNDA by SimpleDocs
Milestone Event Milestone Payments. (1) 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. [**]
Sample 1Sample 2
Milestone Event Milestone Payments. (2) 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). [**]
Sample 1Sample 2
Milestone Event Milestone Payments. 1. [***] [***]
Sample 1Sample 2
Milestone Event Milestone Payments. 1. [***] [***] 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.
Sample 1Sample 2
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
Milestone Event Milestone Payments. (4) 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
AutoNDA by SimpleDocs
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 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

Related to Milestone Event Milestone Payments

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

  • Development Milestone Payments In partial consideration for the rights and licenses granted to Coya hereunder, within ten days after the first achievement of each milestone event in a given Indication set forth in this Section 5.2 (Development Milestone Payments) with respect to a Product (each, a “Development Milestone Event”) by or on behalf of Coya or any of its Affiliates or Sublicensees, Coya shall provide ARScience Bio written notice to ARScience Bio identifying the Development Milestone Event achieved. Upon receipt of any such notice of first achievement of a Development Milestone Event by Coya or its Affiliates or Sublicensees, ARScience Bio will promptly invoice Coya for the applicable Development Milestone Event and Coya will make a milestone payment to ARScience Bio in the amount set forth in this Section 5.2 (Development Milestone Payments) corresponding to such Development Milestone Event (each, a “Development Milestone Payment”) within 45 days of receipt of such invoice. On an Indication-by-Indication basis, each Development Milestone Payment shall be payable only upon the first achievement of the corresponding Development Milestone Event by a Product, in any given Indication for which the Development Milestone Events have not been previously achieved (each such Indication, a “New Indication”). No amounts shall be due for subsequent or repeated achievements of such Development Milestone Event with respect to the same or different Mono Product or Combination Product, as applicable, in such Indication. Accordingly and for clarity, the Development Milestone Payment shall be paid only once, when first achieved by Coya, an Affiliate or a Sublicensee, but no payment shall be due if the same milestone is subsequently achieved by one of Coya, an Affiliate or a Sublicensee. For clarity, the amounts owed in Column (a) below shall be due for the first Combination Product to achieve the Development Milestone Events in a New Indication and the amounts owned in Column (c) below shall be due for the first Mono Product to achieve the Development Milestone Events in a New Indication. Any Combination Product or Mono Product to achieve the Development Milestone Events in a New Indication after the first achievement of the Development Milestone Events as described in the foregoing sentence will cause the amounts in Column (b) with respect to a Combination Product and Column (d) with respect to a Mono Product to be due and payable by Coya upon each such occurrence. If the first Product to achieve a Development Milestone Event in any Indication is a Combination Product, the amounts in Column (a) below shall be due and payable by Coya. If the next Product to achieve a Development Milestone Event in a New Indication is a Mono Product, the amounts in Column (c) below would be due and payable by Coya; provided, that if such next Product to achieve a Development Milestone Event in a New Indication is a Combination Product, the amounts in Column (b) would be due and payable by Coya. By way of example, if a Combination Product achieves IND Acceptance in ALS, and is the first Product to achieve a Development Milestone Event under this Agreement, [***] will be due and payable by Coya. If subsequently a Mono Product achieves IND Acceptance in ALS, no Development Milestone Payments will be due and payable by Coya under this Agreement. However, if subsequently any Combination Product achieves IND Acceptance in Alzheimer’s disease, [***] would be due and payable by Coya.

  • Commercial Milestone Payments For each Licensed Product, Licensee shall pay Arvinas the following one-time milestone event payments when the aggregate Net Sales of such Licensed Product in one or more particular country(ies) for a given calendar year (“Annual Net Sales”), where such Licensed Product is a Valid Claim Licensed Product at the time of sale in each of such country(ies), first achieves the corresponding threshold as set forth in this Section 6.3.2 below, subject to the terms of this Section 6.3 and the payment provisions in Article 7 below: Commercial Milestone Event Milestone Event Payment (US$)

  • 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 Within thirty (30) days following the first Patent Issuance, Eton shall give written notice to Imprimis and shall pay to Imprimis a non-refundable and noncreditable payment of fifty thousand dollars ($50,000).

  • Sales Milestone Payments As further consideration for Daiichi Sankyo’s grant of the rights and licenses to Rain hereunder, Rain will pay to Daiichi Sankyo the following payments upon the first achievement of the following levels of aggregate annual Net Sales of all Products by Rain, its Affiliates, and its Sublicensees. If two or more sales milestone events are achieved in the same [***], then Rain shall pay to Daiichi Sankyo all of the applicable milestone payments achieved in such [***]. Rain shall deliver written notice to Daiichi Sankyo within [***] after the end of the [***] in which a sales milestone threshold described in this Section 5.3 is achieved for the first time. Aggregate annual Net Sales of all Products shall be calculated based on Net Sales for each Calendar Year. After receipt of such notice from Rain, Daiichi Sankyo shall issue Rain an invoice for the amount corresponding to the applicable sales milestones event. Rain shall pay Daiichi Sankyo within [***] after receipt of an invoice therefor from Daiichi Sankyo. Milestone Event Payment Amount Aggregate Annual Net Sales of all Products combined in the Territory in a Calendar Year equals or exceeds [***] [*** ] Aggregate Annual Net Sales of all Products combined in the Territory in a Calendar Year equals or exceeds [***] [*** ] [***] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED. EXECUTION VERSION Aggregate Annual Net Sales of all Products combined in the Territory in a Calendar Year equals or exceeds [***] [*** ] Aggregate Annual Net Sales of all Products combined in the Territory in a Calendar Year equals or exceeds [***] [*** ]

  • 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 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 Subject to the terms and conditions set forth in the Agreement, in the event that the Annual Net Sales made by or on behalf of a Selling Entity for all Licensed Products in a given calendar year first exceeds a threshold set forth in the table immediately below, Pyxis shall pay to LCB the following one-time, non-refundable, non-creditable milestone payments. Annual Net Sales Milestone Threshold Payment (US Dollars) [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] In the event that in a given calendar year more than one (1) Annual Net Sales milestone threshold is achieved, Pyxis shall pay to LCB each separate Annual Net Sales milestone payment with respect to each Annual Net Sales milestone threshold that is achieved in such calendar year. Pyxis shall notify LCB in writing upon the first achievement, in respect of a Licensed Product, by or on behalf of Pyxis or its Affiliate or Sublicensee, of each of the Milestones set forth in Section 5.2 (Development Milestones), Section 5.3 (Regulatory Milestones) and Section 5.4 (Sales Milestones) no later than [***] of Pyxis’s knowledge of achievement thereof, and in any event, each of the Milestones set forth in Section 5.4 (Sales Milestones) no later than [***] after the end of the applicable calendar year in which such Milestone is achieved. No later than [***] of receipt of an appropriate invoice from LCB, Pyxis shall pay the applicable payment due upon achievement of the corresponding Milestone Event. Each Milestone Event shall be deemed to be achieved once for all Licensed Products and shall be payable only once.

Draft better contracts in just 5 minutes Get the weekly Law Insider newsletter packed with expert videos, webinars, ebooks, and more!