Regulatory Approval Milestone Payments Sample Clauses

Regulatory Approval Milestone Payments. UHN shall be paid the following milestone payments in respect of each Licensed Product(s). Avro shall promptly provide Notice to UHN of the fulfillment of a milestone (whether such milestone is achieved by Avro or its Affiliate or Sublicensee). Each noted milestone payment is payable by Avro within [***] from the date that such milestone is met: 5.8.1 [***]; 5.8.2 [***]; and 5.8.3 [***].
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Regulatory Approval Milestone Payments. Licensor will promptly notify CMS Bridging of the achievement of the milestone events set forth below and CMS Bridging shall pay to Licensor or its nominated Affiliate the corresponding one-time and non-refundable and non-creditable milestone payment set forth below within thirty (30) days after the achievement of such milestone event. · [***] shall be paid upon the earliest of the grant of an applicable Marketing Authorization for each Product by one of the FDA, the EMA or any Regulatory Authority in the European Recognized Countries; · [***] shall be paid upon the grant of the Marketing Authorization for each Product by the Regulatory Authority in China;
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Regulatory Approval Milestone Payments. (a) If Pfizer Exercises the [***], Pfizer will make Regulatory Approval Milestone Payments to BIND, as set forth in the following table, upon the first achievement of each of the Regulatory Approval Milestones Events by the first [***] Covered Product to achieve such Event, whether such achievement is made by Pfizer, an Affiliate of Pfizer or a Sublicensee. (b) If Pfizer Exercises the [***], Pfizer will make Regulatory Approval Milestone Payments to BIND, as set forth in the following table, upon the first achievement of each of the Regulatory Approval Milestones Events by the first [***] Covered Product to achieve such Event, whether such achievement is made by Pfizer, an Affiliate of Pfizer or a Sublicensee. (c) Each Regulatory Approval Milestone Payment will be payable by Pfizer to BIND within [***] after becoming due hereunder and will be non-refundable and non-creditable (upon the request of Pfizer, BIND will issue an invoice for any Regulatory Approval Milestone Payment due hereunder). (d) Each Regulatory Approval Milestone Payment will be due and payable a maximum of [***]. [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***]
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Regulatory Approval Milestone Payments. Licensee shall pay to Licensor the one-time, non-refundable, and non-creditable regulatory milestone payment of USD five (5) million within fifteen (15) Business Days upon receiving the relevant invoice from Licensor after the Amendment Effective Date. Licensee will promptly notify Licensor of the approval of the Marketing Authorization Application of the Product by NMPA.
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Regulatory Approval Milestone Payments. Teva will promptly notify Licensee of the achievement of the milestone events set forth below, as the case may be, in the following exclusive events of (1), (2), and or (3) and Licensee shall settlepay to Teva the corresponding one-time, non-refundable and non-creditable milestone payment set forth below within thirty (30) days after the achievement of such milestone event. Licensee will promptly notify Teva of the achievement of the milestone event set forth below in (4) and Licensee shall pay to Teva the corresponding one-time, non-refundable and non-creditable milestone payment set forth below within thirty (30) days after the achievement of such milestone event. The date that Teva receives the Approval Opinions Notice Letter or other official approvals with equivalent effect, in whatsoever form or name, from CFDA to exempt BUDESONIDE from all and any further Development: [TBD] ($TBD) shall be paid to the bank account as designated by Teva; The date that Teva is exempt from Validation Clinical Trials but required to start the Biological Equivalence Trials for BUDESONIDE by CFDA in the Approval Opinions Notice Letter or other official approvals with equivalent effect, in whatsoever form or name: [TBD] ($TBD) shall be paid to the bank account as designated by Teva, while [TBD] ($TBD) shall, at the sole election of Teva, either (i) be immediately transmitted back to Licensee as a reimbursement for conducting such Biological Equivalence Trials within Five (5) Business Day upon Teva’s receipt of such amount from Licensee; or (ii) be deducted or exempt in whole from such milestone payment. The date that Teva is required to start the Validation Clinical Trials for BUDESONIDE in contrast to the RLD by CFDA in the Approval Opinions Notice Letter or other official approvals with equivalent effect, in whatsoever form or name: [TBD] ($TBD) shall, at the sole election of Teva, either (i) be immediately transmitted back to Licensee as a reimbursement for conducting such Validation Clinical Trials within Five (5) Business Day upon Teva’s receipt of such amount from Licensee; or (ii) be deducted or exempt in whole from such milestone payment.
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Regulatory Approval Milestone Payments. 5.3.1 As additional consideration of the licenses and rights granted to AXSOME hereunder, AXSOME shall pay to PFIZER the REGULATORY APPROVAL MILESTONE PAYMENTS after achievement of the corresponding REGULATORY APPROVAL MILESTONE set forth in Schedule 5.3 is achieved. 5.3.2 The REGULATORY APPROVAL MILESTONE PAYMENTS shall be paid as set forth in Section 6.2.
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Regulatory Approval Milestone Payments. AXSOME shall pay to PFIZER each REGULATORY APPROVAL MILESTONE PAYMENTS no later than [***] ([***]) [***] following the occurrence of the corresponding REGULATORY APPROVAL MILESTONE.
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Regulatory Approval Milestone Payments. In partial consideration of the Licensed Patents sublicensed to Pfizer hereunder, Pfizer shall pay to Medarex the following milestone payments as follows: (a) [***] within thirty (30) days after NDA (or BLA) approval of the first Pfizer Product which is approved for the first clinical indication; (b) [***] within thirty (30) days after NDA (or BLA) approval of (i) the first Pfizer Product which is approved for the second clinical indication or (ii) the second Pfizer Product; and (c) [***] within thirty (30) days after NDA (or BLA) approval of (i) the first Pfizer Product which is approved for the third clinical indication, (ii) the second Pfizer Product which is approved for the second clinical indication or (iii) the third Pfizer Product, provided that if NDA (or BLA) approval of any such Pfizer Product is not received within eighteen (18) months after the date of NDA (or BLA) approval of the first Pfizer Product for the second clinical indication or the second Pfizer Product, this [***] milestone shall be due eighteen (18) months after the date of NDA (or BLA) approval of the first Pfizer Product for the second clinical indication or the second Pfizer Product, whichever is earlier. Each milestone payment shall be non-refundable, non-creditable and non-cancelable. [***] REPRESENTS CONFIDENTIAL PORTION WHICH HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.
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Related to Regulatory Approval Milestone Payments

  • 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 [**].

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

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

  • Regulatory Approval 25.1 The Parties understand and agree that this Agreement and any amendment or modification hereto will be filed with the Commission for approval in accordance with Section 252 of the Act and may thereafter be filed with the FCC. The Parties believe in good faith and agree that the services to be provided under this Agreement are in the public interest. Each Party covenants and agrees to fully support approval of this Agreement by the Commission or the FCC under Section 252 of the Act without modification.

  • 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.

  • 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.

  • Required Regulatory Approvals (a) The obligations of each Party under this Agreement are expressly contingent upon (i) each Party receiving all licenses, permits, permissions, certificates, approvals, authorizations, consents, franchises and releases from any local, state, or federal regulatory agency or other governmental agency or authority (which may include, without limitation and as applicable, the NYISO and the PSC) or any other third party that may be required for such Party in connection with the performance of such Party’s obligations under or in connection with this Agreement (the “Required Approvals”), (ii) each Required Approval being granted without the imposition of any modification or condition of the terms of this Agreement or the subject transactions, unless such modification(s) or condition(s) are agreed to by both Parties in their respective sole discretion, and (iii) all applicable appeal periods with respect to the Required Approvals having expired without any appeal having been made or, if such an appeal has been made, a full, final and non-appealable determination having been made regarding same by a court or other administrative body of competent jurisdiction, which determination disposes of or otherwise resolves such appeal (or appeals) to the satisfaction of both Parties in their respective sole discretion. (b) If any application or request is made in connection with seeking any Required Approval and is denied, or is granted in a form, or subject to conditions, that either Party rejects, in its sole discretion, as unacceptable, this Agreement shall terminate as of the date that a Party notifies the other Party of such denial or rejection, in which event the obligations of the Parties under this Agreement shall cease as of such date and this Agreement shall terminate, subject to NYSEG’s obligation to pay National Grid in accordance with the terms of this Agreement (including, without limitation, Section 10.3 above) for all Reimbursable Costs. All of National Grid’s actual costs in connection with seeking Required Approvals shall be included within the meaning of the term Reimbursable Costs and shall be paid for by NYSEG.

  • Milestones Subject to the provisions of the SGIP, the Parties shall agree on milestones for which each Party is responsible and list them in Attachment 4 of this Agreement. A Party’s obligations under this provision may be extended by agreement. If a Party anticipates that it will be unable to meet a milestone for any reason other than a Force Majeure event, it shall immediately notify the other Parties of the reason(s) for not meeting the milestone and (1) propose the earliest reasonable alternate date by which it can attain this and future milestones, and (2) requesting appropriate amendments to Attachment 4. The Party affected by the failure to meet a milestone shall not unreasonably withhold agreement to such an amendment unless it will suffer significant uncompensated economic or operational harm from the delay, (1) attainment of the same milestone has previously been delayed, or (2) it has reason to believe that the delay in meeting the milestone is intentional or unwarranted notwithstanding the circumstances explained by the Party proposing the amendment.

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