Regulatory Approval Milestone Fee. On the terms set forth in Section 6.4.3 of the Agreement, [* * *].
Regulatory Approval Milestone Fee. (a) [* * *].
Regulatory Approval Milestone Fee Sample Clauses
Related to Regulatory Approval Milestone Fee
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.
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 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.
Required Regulatory Approvals Certain transactions required, permitted or otherwise contemplated by this Agreement may under certain circumstances require prior filings with and approvals, or non-disapprovals, from the Indiana Department of Insurance or the Indiana Insurance Commissioner. Such transactions include: (a) issuance or purchase of any additional capital stock of the Company or other securities convertible into or exchangeable or exercisable for capital stock of the Company pursuant to Sections 1.2 or 3.4; (b) transfer of Shares to a wholly owned subsidiary of a Shareholder, to another Shareholder or to a wholly owned subsidiary of another Shareholder pursuant to Sections 3.1(a) or 3.4; (c) exercise of preemptive rights by a Shareholder pursuant to Section 3.2; and (d) exercise of call rights by the Company or a Shareholder pursuant to Section 3.3 (including pursuant to the two provisos in Section 3.1(b)). Notwithstanding anything to the contrary contained in this Agreement, any such transactions requiring filings with and approvals, or non-disapprovals, from the Indiana Department of Insurance or the Indiana Insurance Commissioner shall not, to the extent within the control of a party hereto, be entered into or consummated unless and until the required filings have been made and the required approvals (or non-disapprovals) have been obtained, and to the extent not within the control of an applicable party hereto, such party shall use best efforts to cause such transactions not to be entered into or consummated unless and until the required filings have been made and the required approvals (or non-disapprovals) have been obtained.
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.
Commercial Milestones In partial consideration of the rights granted by AstraZeneca to Licensee hereunder, Licensee shall pay to AstraZeneca the following payments, which shall be non-refundable, non-creditable and fully earned upon the first achievement of the applicable milestone event:
Milestone Payment (i) The first time Net Sales in the Territory in a Royalty Period exceed [***] [***]
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 [***] [*** ]
Sales Milestones On a Co-Co Product-by-Co-Co Product basis, Celgene shall make the following sales milestone payments to Jounce that are set forth below upon the first achievement by or on behalf of Celgene, its Affiliates or Sublicensees of the sales milestone events (“Sales Milestone Events”) set forth below with respect to sales of such Co-Co Product in the ROW Territory. Sales Milestone Event (Per Co-Co Product, ROW (i.e., ex-U.S.)) Milestone Payments (in $ millions) [***] [***] [***] [***]
