After First Year Post-Launch Sample Clauses

After First Year Post-Launch. Not later than at Launch, the JJMC will seek separate API supply, fill/finish supply and, if applicable, Packaging and Release bids for a three (3) year period that will commence as of the beginning of the thirteenth (13th) month post-Launch (and as of each three year anniversary date thereafter of such 13th month during the term of this Agreement). Such bids will be sought on a timetable that takes into account the reasonable amount of time that will be needed (A) for the SCJ to provide a written request for, review of, and determination and approval of the winning bid, as well as taking into account the reasonable amount of time a winning bidder may require to plan for and supply the Collaboration’s API and/or fill/finish requirements (with the Parties to use reasonable efforts to enable the SCJ final decision to be made not later than the seventeenth (17th) month prior to the beginning of a new three-year cycle) and (B) for the negotiation and entry into an agreement approved by the SCJ (with the Parties to use reasonable efforts to finalize and execute within three months after the SCJ determination of the winning bidder and its bid). In making its determination for a given three-year period, the SCJ shall consider any recommendations of the JJMC, shall consider which bidding entity has the most competitive cost (taking into consideration the amount of any Third Party Payments that would need to be made with respect to such Party’s or Third Party’s bid and the Parties’ relative burdens thereof) for such three year period for the specific API formulation selected by the JJMC and approved by the SCJ, shall consider the reliability and accuracy of the forecasted, estimated Fully-Burdened Manufacturing Costs for the relevant three-year period provided by a bidder, and Confidential Treatment has been requested by ImClone Systems Incorporated for portions of this document. shall consider any other customary manufacturer selection criteria (e.g., quality control, risk factors, reliability, capacity, and timeliness of supply). The SCJ shall determine (or advise the JJMC as to or delegate to the JJMC the determination of) the process to be used for soliciting bids; provided, that the bids for a round of bidding for a given component or service of Final Product shall not be opened and reviewed by any other Party or its Affiliates that is bidding on the API supply or fill/finish, as applicable, until the bid deadline has passed for such round. Each bidding Party ...
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Related to After First Year Post-Launch

  • Adjustment of Minimum Quarterly Distribution and Target Distribution Levels (a) The Minimum Quarterly Distribution, First Target Distribution, Second Target Distribution, Third Target Distribution, Common Unit Arrearages and Cumulative Common Unit Arrearages shall be proportionately adjusted in the event of any distribution, combination or subdivision (whether effected by a distribution payable in Units or otherwise) of Units or other Partnership Securities in accordance with Section 5.10. In the event of a distribution of Available Cash that is deemed to be from Capital Surplus, the then applicable Minimum Quarterly Distribution, First Target Distribution, Second Target Distribution and Third Target Distribution, shall be adjusted proportionately downward to equal the product obtained by multiplying the otherwise applicable Minimum Quarterly Distribution, First Target Distribution, Second Target Distribution and Third Target Distribution, as the case may be, by a fraction of which the numerator is the Unrecovered Capital of the Common Units immediately after giving effect to such distribution and of which the denominator is the Unrecovered Capital of the Common Units immediately prior to giving effect to such distribution. (b) The Minimum Quarterly Distribution, First Target Distribution, Second Target Distribution and Third Target Distribution, shall also be subject to adjustment pursuant to Section 6.9.

  • Multi-year Planning Targets Schedule A may reflect an allocation for the first Funding Year of this Agreement as well as planning targets for up to two additional years, consistent with the term of this Agreement. In such an event, the HSP acknowledges that if it is provided with planning targets, these targets: a. are targets only, b. are provided solely for the purposes of planning, c. are subject to confirmation, and d. may be changed at the discretion of the Funder in consultation with the HSP. The HSP will proactively manage the risks associated with multi-year planning and the potential changes to the planning targets; and the Funder agrees that it will communicate any changes to the planning targets as soon as reasonably possible.

  • Sales Milestone Payments Artiva shall make the following one-time, non-refundable and non-creditable sales milestone payments to GCLC when the aggregate annual Net Sales of Products in the Territory first reach the thresholds specified below. Artiva shall notify GCLC promptly of the achievement of each such sales threshold. Each sales milestone payment shall be made by Artiva within [***] days after the end of the calendar quarter in which such sales threshold is achieved. To the extent more than one sales threshold is reached in any given calendar year, then the applicable milestone payment for each such achievement shall be due and owing with respect to such calendar year. For clarification, the total milestone payments payable hereunder if all milestone events are achieved is [***].

  • Transitional Period At the end of the transitional period as defined in Article 10(2) of the Directive, the contracting parties shall cease to apply the withholding/retention tax and revenue sharing provided for in this Agreement and shall apply in respect of the other contracting party the automatic exchange of information provisions in the same manner as is provided for in Chapter II of the Directive. If during the transitional period either of the contracting parties elects to apply the automatic exchange of information provisions in the same manner as is provided for in Chapter II of the Directive it shall no longer apply the withholding/retention tax and the revenue sharing provided for in Article 9 of this Agreement.

  • Development Milestone Payments (i) In addition to the Closing Date Merger Consideration (less the Remaining Option Consideration and Rights Proceeds Amount, if any) and any Net TNF Sales Payments (as defined below), upon the attainment of the development ** Portions of the Exhibit have been omitted and have been filed separately pursuant to an application for confidential treatment filed with the Securities and Exchange Commission pursuant to Rule 24b-2 under the Securities Exchange Act of 1934, as amended. milestones set forth below (each, a “Development Milestone”), Parent shall, or shall cause the Surviving Corporation to, [**] after the occurrence of each Development Milestone, deliver to the Paying Agent (for further payment to the holders of Stock Certificates and Stock Agreements outstanding immediately prior to the Effective Time), via wire transfer of immediately available funds, the respective amounts set forth below minus, in each case, the applicable Contingent Consideration Distribution Fee associated therewith and any amount designated by the Stockholders’ Representatives to be placed in the Administrative Expense Account (each, a “Development Milestone Payment” and collectively, the “Development Milestone Payments”): (A) Upon FDA approval of Reslizumab for the treatment of eosinophilic esophagitis, a cash payment of [**]; (B) Upon marketing authorization of Reslizumab for the treatment of eosinophilic esophagitis being granted by the European Commission in accordance with Regulation (EC) No. 726/2004, a cash payment of [**]; (C) If Res 5-0010 Asthma Study Completion has not occurred on or prior to the Closing Date, then upon the occurrence of the Res 5-0010 Asthma Study Completion, a cash payment of $50,000,000 (fifty million dollars) (the “Res 5-0010 Asthma Payment”); (D) Upon FDA approval of Reslizumab for any asthma indication, a cash payment of [**]; (E) Upon marketing authorization of Reslizumab for the treatment of any asthma indication being granted by the European Commission in accordance with Regulation (EC) No. 726/2004, a cash payment of [**]; and (F) Upon FDA approval of an Oral Anti-TNF Product, a cash payment of [**].

  • Multi-Year Planning The CAPS will be in a form acceptable to the LHIN and may be required to incorporate (1) prudent multi-year financial forecasts; (2) plans for the achievement of performance targets; and (3) realistic risk management strategies. It will be aligned with the LHIN’s then current Integrated Health Service Plan and will reflect local LHIN priorities and initiatives. If the LHIN has provided multi-year planning targets for the HSP, the CAPS will reflect the planning targets.

  • Planning Period All observations must be conducted openly and with full knowledge of the employee.

  • Sales Milestones (a) As to each Therapeutic Product, SANOFI-AVENTIS shall pay MERRIMACK up to a total of Sixty Million Dollars (US$60,000,000) upon the first achievement of the following Net Sales milestones, on a Therapeutic Product-by-Therapeutic Product basis: (i) Total Worldwide Net Sales for such Therapeutic Product exceed $[**] in any four (4) consecutive calendar quarters $ [**] (ii) Total Worldwide Net Sales for such Therapeutic Product exceed $[**] in any four (4) consecutive calendar quarters $ [**] (iii) Total Worldwide Net Sales for Therapeutic Product exceed $[**] in any four (4) consecutive calendar quarters $ [**] (b) Each milestone payment set forth in Section 8.4(a) shall be payable by SANOFI-AVENTIS upon the achievement of the related milestone event by SANOFI-AVENTIS and its Affiliates or sublicensees, and SANOFI-AVENTIS shall provide notice to MERRIMACK promptly upon achievement of such milestone event. SANOFI-AVENTIS shall pay MERRIMACK each such milestone payment within [**] days of such achievement of the related milestone event. (c) For purposes of clarity, more than one of the Net Sales milestones set forth above may be earned in the same four (4) consecutive calendar quarter period with respect to a Therapeutic Product. For example, if total worldwide Net Sales with respect to a given Therapeutic Product have not achieved any of the lower sales milestone thresholds set forth in clause (i) or (ii) of Section 8.3(a) above in any previous four (4) consecutive calendar quarter period, but total worldwide Net Sales with respect to such Therapeutic Product exceed $[**] in a subsequent four (4) consecutive calendar quarter period, then all three milestone payments, totaling $60 Million, payable upon achievement of the sales milestone thresholds set forth in clause (i), (ii) and (iii) of Section 8.3(a) above shall become payable to MERRIMACK hereunder.

  • Contract Year A twelve (12) month period during the term of the Agreement commencing on the Effective Date and each anniversary thereof.

  • 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.

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