Common use of Regulatory Milestone Payments Clause in Contracts

Regulatory Milestone Payments. Pfizer shall pay to OPKO the amounts set forth below within *** days following the first occurrence of each event described below (each event, a “Regulatory Milestone” and each payment, a “Regulatory Milestone Payment”), which amounts shall be non-refundable and non-creditable against any other payments due under this Agreement. First achievement of *** of a Licensed Product for an Approved Indication in *** *** First achievement of *** of a Licensed Product for an Approved Indication in *** *** First achievement of *** of a Licensed Product for an Approved Indication in *** *** First achievement of *** of a Licensed Product for an Approved Indication in *** *** First achievement of *** of a Licensed Product for an Approved Indication in *** *** First achievement of *** of a Licensed Product for an Approved Indication in *** *** First achievement of *** of a Licensed Product for an Approved Indication in *** *** *** = Portions of this exhibit have been omitted pursuant to a request for confidential treatment. An unredacted version of this exhibit has been filed separately with the Commission. For the avoidance of doubt: (a) each Regulatory Milestone Payment shall be payable only once upon first achievement of the applicable Regulatory Milestone and only on the first occurrence of the corresponding Regulatory Milestone, regardless of the number of Licensed Products achieving such Regulatory Milestone; (b) a Regulatory Milestone satisfied by a sublicensee or Affiliate of OPKO shall be deemed to have been achieved by OPKO for the purposes of this Section 5.2; and (c) to the extent any ***, which trigger a Regulatory Milestone, *** shall be payable in respect of each such *** as provided above. In addition, and for greater clarity, milestones shall not be paid on ***.

Regulatory Milestone Payments. Pfizer (a) Norgine shall pay to OPKO AMAG the amounts set forth one-time milestone payments listed below within *** days following for the first occurrence achievement of each the corresponding milestone event described below (each such event, a ACTIVE/105730326.3 “Regulatory MilestoneMilestone Event” and each such payment, a “Regulatory Milestone Payment”), which amounts in each case shall be non-refundable and non-creditable against any other payments due under this Agreementcreditable. First achievement Grant of conditional Regulatory Approval of the Product by the EMA pursuant to Commission Regulation (EC) No 507/2006 [*** *] Grant of a Licensed 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 Approved Indication in indication that includes [*** *** First achievement of *** of a Licensed Product for an Approved Indication in *** *** First achievement of *** of a Licensed Product for an Approved Indication in *** *** First achievement of *** of a Licensed Product for an Approved Indication in *** *** First achievement of *** of a Licensed Product for an Approved Indication in *** *** First achievement of *** of a Licensed Product for an Approved Indication in *** *** First achievement of *** of a Licensed Product for an Approved Indication in *** *** *** = Portions of ], provided that this exhibit have been omitted pursuant to a request for confidential treatment. An unredacted version of this exhibit has been filed separately with the Commission. For the avoidance of doubt: (a) each Regulatory Milestone Payment shall be payable only once upon first achievement to the extent AMAG is required to pay the corresponding milestone payment under the [***]. [***] (b) Each of the applicable Regulatory Milestone and Payments described above shall be payable only on the first occurrence of the corresponding Regulatory Milestoneonce, regardless of the number of Licensed Products achieving such Regulatory Milestone; (b) a times the associated Regulatory Milestone satisfied 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 a sublicensee or Affiliate 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 OPKO shall be deemed to have been achieved by OPKO for the purposes of this Section 5.2; and such credit. (c) Norgine shall provide written notification to AMAG of the extent any achievement of each of the Regulatory Milestone Events described above within [***, which trigger ] after each such achievement. AMAG shall deliver to Norgine a written invoice for the Regulatory Milestone, *** Milestone Payment promptly after receipt of such written notification from Norgine. All Regulatory Milestone Payments shall be due and payable in respect of each such *** as provided above. In addition, and for greater clarity, milestones shall not be paid on within [***] after receipt of such invoice from AMAG.

Regulatory Milestone Payments. Pfizer shall pay to OPKO the amounts set forth below within *** days following the first occurrence of each event described below (each event, a “Regulatory Milestone” and each payment, a “Regulatory Milestone Payment”), which amounts shall be non-refundable and non-creditable against any other payments due under this Agreement. First achievement of *** of a Licensed Product for an Approved Indication in *** *** First achievement of *** of a Licensed Product for an Approved Indication in *** *** First achievement of *** of a Licensed Product for an Approved Indication in *** *** First achievement of *** of a Licensed Product for an Approved Indication in *** *** First achievement of *** of a Licensed Product for an Approved Indication in *** *** First achievement of *** of a Licensed Product for an Approved Indication in *** *** First achievement of *** of a Licensed Product for an Approved Indication in *** *** *** = Portions of this exhibit have been omitted pursuant to a request for confidential treatment. An unredacted version of this exhibit has been filed separately with the Commission. For the avoidance of doubt: (a) each Regulatory Milestone Payment shall be payable only once upon first achievement of the applicable Regulatory Milestone and only on the first occurrence of the corresponding Regulatory Milestone, regardless of the number of Licensed Products achieving such Regulatory Milestone; (b) a Regulatory Milestone satisfied by a sublicensee or Affiliate of OPKO shall be deemed to have been achieved by OPKO for the purposes of this Section 5.2; and (c) to the extent any ***, which trigger a Regulatory Milestone, *** Regulatory Milestone Payments shall be payable in respect of each such *** as provided above. In addition, and for greater clarity, milestones shall not be paid on ***.