Regulatory Approval Milestone Payments Clause Samples
The Regulatory Approval Milestone Payments clause establishes that certain payments are triggered upon the achievement of specified regulatory approvals for a product or service. Typically, this clause outlines which regulatory milestones—such as FDA approval or CE marking—will result in payment, the amount due at each milestone, and the process for confirming that the milestone has been met. Its core function is to incentivize progress toward regulatory clearance and to allocate financial rewards based on the successful attainment of key development stages, thereby aligning the interests of the parties and managing risk associated with regulatory uncertainty.
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 [***].
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;
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 [***] days 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 [***]. [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***]
Regulatory Approval Milestone Payments. Licensee shall pay to Licensor the one-time, non-refundable and non-creditable milestone payment of USD five (5) million within thirty (30) days after the earlier of (i) the approval of the Marketing Authorization Application of the Product by NMPA and (ii) fifth (5th) anniversary of the Effective Date. Licensee will promptly notify Licensor of the approval of the Marketing Authorization Application of the Product by NMPA.
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.
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.
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.
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.