Approval Milestone Payment definition

Approval Milestone Payment means three dollars and fifty cents ($3.50) per CVR.
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Approval Milestone Payment means one dollar ($1.00) per CVR.
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Approval Milestone Payment has the meaning set forth in Section 9.2.2.
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Examples of Approval Milestone Payment in a sentence

  • Notwithstanding the foregoing, in no event shall the Company be required to pay the Approval Milestone Payment more than once.

  • In addition, following the Closing Date, this Agreement may be terminated by the Seller if the FDA Approval Milestone for the Bile Acid Indications is not paid by Buyer in full on or prior to the FDA Approval Milestone Payment Date (after expiration of the 7 day cure period).

  • The Company may assign this CVR Agreement without the prior written consent of the other Parties to this CVR Agreement to one or more of its direct or indirect Subsidiaries, provided, however, that in the event of any such assignment the Company shall remain subject to its obligations and covenants hereunder, including, but not limited to, its obligation to make any Product Sales Milestone Payments, the Approval Milestone Payment and the Production Milestone Payment.

  • If Buyer fails to deliver to Seller the full FDA Approval Milestone for the Bile Acid Indication on or before the FDA Approval Milestone Payment Date, Buyer shall have an additional seven (7) days in which cure such payment, during which time the late charges contemplated by Section 3.6(g) shall accrue and become payable to Seller.

  • The Sellers acknowledge and agree that any shares of Purchaser common stock received by the Sellers as the Contingent Equity Payment or FDA Approval Milestone Payment shall be subject to a lockup period through the second anniversary of the Closing Date, which shall be set forth in the subscription agreements for such shares to be entered into by the Sellers at the time of any such issuance.

  • On a date no later than thirty (30) days following the date on which the Company or another Company Entity or any Affiliate thereof receives FDA Approval for New Ulesfia, Purchaser shall pay the FDA Approval Milestone Payment, allocated between the Sellers in proportion to their Percentage Interests, with any cash portion of such payment paid by wire transfer of immediately available funds to the account(s) designated in writing by the Sellers.

  • The payment pertaining to each Development and Regulatory Milestone, other than the BLA Approval Milestone Payment which shall be governed in accordance with Section 3.2(a), shall be made by Buyer to Seller within ninety (90) days after the achievement of the corresponding Development and Regulatory Milestone.

  • On a Kite Target-by-Kite Target basis, until the Marketing Approval Milestone Payment set forth in Section 8.1.4 (Milestone Payments) has been made with respect to the first Kite Product directed against such Kite Target, on […***…], Kite shall submit to Amgen a report providing a status of Kite’s and its Affiliates’ and Sublicensees’ activities related to the Exploitation of Kite Products directed against such Kite Target during the preceding […***…].

  • Notwithstanding the foregoing, in no event shall the Company be required to pay the Approval Milestone Payment more than once, and the Company shall not be required to pay the Approval Milestone Payment if: (i) the FDA issue an order under 21 CFR 814.45 denying FDA Approval of Augment; or (ii) the Approval Milestone occurs after the Termination Date.

  • Soils on all the properties are not considered prime farmland and are covered by existing development or have been otherwise disturbed by excavation or filling in the past.


More Definitions of Approval Milestone Payment

Approval Milestone Payment means is defined in Section 6.2.
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Related to Approval Milestone Payment

  • Development Milestone Payment shall have the meaning set forth in Section 9.2(a).

  • Milestone Payment has the meaning set forth in Section 4.2.

  • Sales Milestone Payment shall have the meaning set forth in Section 8.4.

  • Milestone means an event or task described in the Implementation Plan which must be completed by the corresponding date set out in such plan;

  • Milestone 1 means achievement of annual Net Sales of at least $20,000,000 during the Calendar Year ending on December 31, 2021.

  • Milestone Event has the meaning set forth in Section 8.2.1.

  • Milestone 2 means achievement of annual Net Sales of at least $35,000,000 during any Calendar Year ending on or before December 31, 2024.

  • Development Milestone Event has the meaning set forth in Section 7.2.1.

  • Milestone Date means the date set against the relevant Milestone in the Implementation Plan;

  • Development Milestone is defined in Section 5.3.

  • Milestone Payments means payments made in connection with any Permitted Acquisition or other acquisition (including any license or the acquisition of any license) of any rights in respect of any drug or other pharmaceutical product (and any related property or assets) to sellers (or licensors) of the assets or Equity Interests acquired (or licensed) therein based on the achievement of specified revenue, profit or other performance targets (financial or otherwise).

  • Milestone Payment Date has the meaning set forth in Section 2.4(a).

  • Milestone Events has the meaning set forth in Section 7.2.

  • Milestones means control points in the project that help to chart progress. Milestones may correspond to the completion of a key deliverable, allowing the next phase of the work to begin. They may also be needed at intermediary points so that, if problems have arisen, corrective measures can be taken. A milestone may be a critical decision point in the project where, for example, the consortium must decide which of several technologies to adopt for further development.

  • Project Milestone means the project milestone set forth in Schedule-J;

  • Milestone Dates means the dates for completion of specified Project activities as contained in the Project Schedule.

  • Project Milestones means the project milestones set forth in Schedule-G;

  • Milestone Notice has the meaning set forth in Section 2.4(a).

  • Performance Milestone means an act or event specified in section 5.1 and described in section 9 of the EPLA.

  • Milestone Schedule means Seller’s milestone schedule, the form of which is attached to this Agreement as Exhibit Q.

  • Milestone Failure means a failure by the Grant Recipient fully to achieve any Milestone by the relevant Milestone Date;

  • MAA Approval means approval of an MAA by the applicable Regulatory Authority for marketing and sale of a Product in the Collaborator Territory, but excluding any Pricing and Reimbursement Approval.

  • FDA Approval means the approval, license, clearance or authorization of the FDA necessary for the marketing and sale of a product for human use in the United States.

  • NDA Approval means the Approval of an NDA by the FDA for a Product in the U.S.

  • Phase I Clinical Study means a human clinical study of a product, the principal purpose of which is a preliminary determination of safety in healthy individuals or patients, as described in 21 C.F.R. 312.21(a).

  • Phase III Clinical Study means a trial involving administration of a Compound to sufficient numbers of human patients with the goal of establishing that the Compound is safe and efficacious for its intended use, to define warnings, precautions and adverse reactions that are associated with the drug or label expansion of such Compound, and to be considered as a pivotal study for submission of an NDA.