Common use of Regulatory Milestone Payments Clause in Contracts

Regulatory Milestone Payments. (a) Norgine shall pay to AMAG the one-time milestone payments listed below for the first achievement of the corresponding milestone event (each such event, a ACTIVE/105730326.3 “Regulatory Milestone Event” and each such payment, a “Regulatory Milestone Payment”), which in each case shall be non-refundable and non-creditable. Grant of conditional Regulatory Approval of the Product by the EMA pursuant to Commission Regulation (EC) No 507/2006 [***] Grant of 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 indication that includes [***], provided that this Regulatory Milestone Payment shall be payable only to the extent AMAG is required to pay the corresponding milestone payment under the [***]. [***] (b) Each of the Regulatory Milestone Payments described above shall be payable only once, regardless of the number of times the associated Regulatory Milestone 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 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 such credit. (c) Norgine shall provide written notification to AMAG of the achievement of each of the Regulatory Milestone Events described above within [***] after each such achievement. AMAG shall deliver to Norgine a written invoice for the Regulatory Milestone Payment promptly after receipt of such written notification from Norgine. All Regulatory Milestone Payments shall be due and payable within [***] after receipt of such invoice from AMAG.

Regulatory Milestone Payments. (a) Norgine Pfizer shall pay to AMAG OPKO the one-time milestone payments listed amounts set forth below for within *** days following the first achievement occurrence of the corresponding milestone each event described below (each such event, a ACTIVE/105730326.3 “Regulatory Milestone EventMilestone” and each such payment, a “Regulatory Milestone Payment”), which in each case amounts shall be non-refundable and non-creditablecreditable against any other payments due under this Agreement. Grant First achievement of conditional Regulatory Approval of the Product by the EMA pursuant to Commission Regulation (EC) No 507/2006 [***] Grant * of Regulatory Approval of the a Licensed Product by the EMA [for an Approved Indication in ***] Achievement of pricing and reimbursement approval for the Product in three (3) of the Major European Countries of at least [* ***] per vial [* First achievement of ***] Achievement * of pricing and reimbursement approval in all of the Major European Countries a Licensed Product for an indication that includes [Approved Indication in *** *], provided that this ** First achievement of *** of a Licensed Product for an Approved Indication *** *** 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 *** *** First achievement of *** of a Licensed Product for an Approved Indication in *** *** For the avoidance of doubt: (a) each Regulatory Milestone Payment shall be payable only to once upon first achievement of the extent AMAG is required to pay applicable Regulatory Milestone and only on the first occurrence of the corresponding milestone payment under the [***]. [***] (b) Each of the Regulatory Milestone Payments described above shall be payable only onceMilestone, regardless of the number of times the associated Licensed Products achieving such Regulatory Milestone; (b) a Regulatory Milestone Events are achieved. If satisfied by a sublicensee or Affiliate of OPKO shall be deemed to have been achieved by OPKO for the EMA grants Regulatory Approval purposes of this Section 5.2; and (c) to the Product without first granting conditional Regulatory Approval pursuant to Commission Regulation (EC) No 507/2006, then Norgine will pay the sum of [extent any ***] upon , which trigger a Regulatory Approval of the Product by the EMA. If the [***] is paid by Norgine and AMAG subsequently is entitled to any credit under the [***] with respect to the [***]Milestone, AMAG shall promptly pay to Norgine the amount of such credit. (c) Norgine shall provide written notification to AMAG of the achievement of each of the Regulatory Milestone Events described above within [***] after each such achievement. AMAG shall deliver to Norgine a written invoice for the Regulatory Milestone Payment promptly after receipt of such written notification from Norgine. All Regulatory Milestone Payments shall be due payable in respect of each such *** as provided above. In addition, and payable within [for greater clarity, milestones shall not be paid on ***] after receipt of such invoice from AMAG.

Regulatory Milestone Payments. (a) Norgine Pfizer shall pay to AMAG OPKO the one-time milestone payments listed amounts set forth below for within *** days following the first achievement occurrence of the corresponding milestone each event described below (each such event, a ACTIVE/105730326.3 “Regulatory Milestone EventMilestone” and each such payment, a “Regulatory Milestone Payment”), which in each case amounts shall be non-refundable and non-creditablecreditable against any other payments due under this Agreement. Grant First achievement of conditional Regulatory Approval *** of the a Licensed Product by the EMA 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 Commission Regulation a request for confidential treatment. An unredacted version of this exhibit has been filed separately with the Commission. For the avoidance of doubt: (ECa) No 507/2006 [***] Grant of 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 indication that includes [***], provided that this each Regulatory Milestone Payment shall be payable only to once upon first achievement of the extent AMAG is required to pay applicable Regulatory Milestone and only on the first occurrence of the corresponding milestone payment under the [***]. [***] (b) Each of the Regulatory Milestone Payments described above shall be payable only onceMilestone, regardless of the number of times the associated Licensed Products achieving such Regulatory Milestone; (b) a Regulatory Milestone Events are achieved. If satisfied by a sublicensee or Affiliate of OPKO shall be deemed to have been achieved by OPKO for the EMA grants Regulatory Approval purposes of this Section 5.2; and (c) to the Product without first granting conditional Regulatory Approval pursuant to Commission Regulation (EC) No 507/2006, then Norgine will pay the sum of [extent any ***] upon , which trigger a Regulatory Approval Milestone, *** shall be payable in respect of the Product by the EMAeach such *** as provided above. If the [In addition, and for greater clarity, milestones shall not be paid on ***] 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 such credit. (c) Norgine shall provide written notification to AMAG of the achievement of each of the Regulatory Milestone Events described above within [***] after each such achievement. AMAG shall deliver to Norgine a written invoice for the Regulatory Milestone Payment promptly after receipt of such written notification from Norgine. All Regulatory Milestone Payments shall be due and payable within [***] after receipt of such invoice from AMAG.

Regulatory Milestone Payments. (a) Norgine As additional consideration of the rights granted by VistaGen to EverInsight hereunder, within [*****] calendar days after the first achievement of the regulatory milestone events below (“Regulatory Milestone Events”) by or on behalf of EverInsight or any of its Affiliates or Sublicensees, EverInsight or its Affiliate or Sublicensee shall pay notify VistaGen of the achievement of such Regulatory Milestone Event. The Regulatory Milestone Event triggers the corresponding milestone payment due to AMAG VistaGen (“Milestone Payment”) and VistaGen shall invoice EverInsight for the oneapplicable non-time milestone payments listed below for refundable, non-creditable Milestone Payment corresponding to the Regulatory Milestone Event as shown below, and EverInsight shall remit payment within [*****] Business Days of the receipt of such invoice, as described in Section 8.6 (Currency; Exchange Rate; Payments). For clarity, each Regulatory Milestone Payment set forth above shall be due and payable only once upon the first achievement of the corresponding milestone event (each such event, a ACTIVE/105730326.3 “Regulatory Milestone Event” and each , regardless of how many times such payment, a “Regulatory Milestone Payment”), which Event is achieved in each case shall be non-refundable and non-creditablethe Territory. Grant of conditional ● Regulatory Approval of the Milestone Event for Licensed Product by the EMA pursuant to Commission Regulation Regulatory Milestone Payment (ECin U.S. Dollars): (1) No 507/2006 [***] Grant of Regulatory Approval of the Product by the EMA **]. (2) [***] Achievement of pricing and reimbursement approval for the Product in three (3) of the Major European Countries of at least **]. CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***] per vial [***] Achievement of pricing and reimbursement approval in all of the Major European Countries for an indication that includes [***], provided that this Regulatory Milestone Payment shall be payable only to the extent AMAG is required to pay the corresponding milestone payment under the [***]HAS BEEN OMITTED BECAUSE VISTAGEN THERAPEUTICS, INC. [***] HAS DETERMINED THE INFORMATION (bI) Each of the Regulatory Milestone Payments described above shall be payable only onceIS NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO VISTAGEN THERAPEUTICS, regardless of the number of times the associated Regulatory Milestone Events are achievedINC. 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 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 such creditIF PUBLICLY DISCLOSED. (c) Norgine shall provide written notification to AMAG of the achievement of each of the Regulatory Milestone Events described above within [***] after each such achievement. AMAG shall deliver to Norgine a written invoice for the Regulatory Milestone Payment promptly after receipt of such written notification from Norgine. All Regulatory Milestone Payments shall be due and payable within [***] after receipt of such invoice from AMAG.