Primary Indication Approval Milestones Sample Clauses

Primary Indication Approval Milestones. TGTX shall pay the milestone payments set forth below (which, when paid, shall be considered fully earned and non-refundable) for each Product and for each New Product following approval for commercialisation for one of the Primary Indications and achievement of the events set forth in the table below (each, a “Primary Indication Milestone Payment”). The Primary Indication Milestone Payments shall be paid only once per Product and once per New Product for each of the events set forth in this Section 6.3.2(b), whether such milestone event is achieved by TGTX, its Affiliates, its Sublicensees (but only in the event that the sublicense is executed subsequent to the NDA filing), or any Third Party acting on behalf of TGTX, its Affiliates, or its Sublicensees. No payment shall be due for any milestone event which is not achieved * Confidential material redacted and filed separately with the Commission.
Sample 1Sample 2
AutoNDA by SimpleDocs
Primary Indication Approval Milestones. TGTX shall pay the milestone payments set forth below (which, when paid, shall be considered fully earned and non-refundable) for each Product and for each New Product following approval for commercialisation for one of the Primary Indications and achievement of the events set forth in the table below (each, a “Primary Indication Milestone Payment”). The Primary Indication Milestone Payments shall be paid only once per Product and once per New Product for each of the events set forth in this Section 6.3.2(b), whether such milestone event is achieved by TGTX, its Affiliates, its Sublicensees (but only in the event that the sublicense is executed subsequent to the NDA filing), or any Third Party acting on behalf of TGTX, its Affiliates, or its Sublicensees. No payment shall be due for any milestone event which is not achieved * Confidential material redacted and filed separately with the Commission. Milestone(s) Milestone For Each Product approved for Primary Indication Approval $ * on US Launch $ * $ * on EMA Launch $ * $ * on Japan Launch $ * $ * on each of China, Russia, Brazil Launch $ * Approval Subtotal $ * If the milestone events in this Section 6.3.2(b) are achieved for a Product or a New Product following approval for a Primary Indication, TGTX shall be required to pay the corresponding approval milestone payments under this Section 6.3.2(b) for such Product or New Product notwithstanding that an approval milestone was already paid under Section 6.3.2(c) for a Secondary Indication.
Sample 1

Related to Primary Indication Approval Milestones

  • 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).

  • Regulatory Milestones Celgene shall make the following approval 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 Regulatory Milestone Events set forth below with respect to the first Co-Co Product that achieves such event. For clarity, each milestone set forth below shall be due and payable one time only (regardless of the number of Co-Co Products to achieve any such Regulatory Milestone Event). CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED. Regulatory Milestone Event (For the first Co-Co Product that achieves such event) Milestone Payments (in $ millions) [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] For each of Paragraphs (1) - (3) of this Exhibit C-2, the Parties understand and agree that in no event will more than one (1) milestone payment be paid with respect to any specific event triggering a payment under this Jounce Lead Co-Co Agreement.

  • Development and Regulatory Milestones With respect to each of the following milestones, Ikaria shall pay BioLineRx the corresponding payment set forth below within [**] days after the achievement by Ikaria, its Affiliates or Licensees of such milestone: MILESTONE PAYMENT

  • 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.

  • Sales Milestones Subject to the terms and conditions set forth in the Agreement, in the event that the Annual Net Sales made by or on behalf of a Selling Entity for all Licensed Products in a given calendar year first exceeds a threshold set forth in the table immediately below, Pyxis shall pay to LCB the following one-time, non-refundable, non-creditable milestone payments. Annual Net Sales Milestone Threshold Payment (US Dollars) [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] In the event that in a given calendar year more than one (1) Annual Net Sales milestone threshold is achieved, Pyxis shall pay to LCB each separate Annual Net Sales milestone payment with respect to each Annual Net Sales milestone threshold that is achieved in such calendar year. Pyxis shall notify LCB in writing upon the first achievement, in respect of a Licensed Product, by or on behalf of Pyxis or its Affiliate or Sublicensee, of each of the Milestones set forth in Section 5.2 (Development Milestones), Section 5.3 (Regulatory Milestones) and Section 5.4 (Sales Milestones) no later than [***] of Pyxis’s knowledge of achievement thereof, and in any event, each of the Milestones set forth in Section 5.4 (Sales Milestones) no later than [***] after the end of the applicable calendar year in which such Milestone is achieved. No later than [***] of receipt of an appropriate invoice from LCB, Pyxis shall pay the applicable payment due upon achievement of the corresponding Milestone Event. Each Milestone Event shall be deemed to be achieved once for all Licensed Products and shall be payable only once.

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

  • 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 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 Milestone Payments For each Licensed Product, Licensee shall pay Arvinas the following one-time milestone event payments when the aggregate Net Sales of such Licensed Product in one or more particular country(ies) for a given calendar year (“Annual Net Sales”), where such Licensed Product is a Valid Claim Licensed Product at the time of sale in each of such country(ies), first achieves the corresponding threshold as set forth in this Section 6.3.2 below, subject to the terms of this Section 6.3 and the payment provisions in Article 7 below: Commercial Milestone Event Milestone Event Payment (US$)

  • 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.

Time is Money Join Law Insider Premium to draft better contracts faster.