Clinical Development Manufacturing Costs Sample Clauses

Clinical Development Manufacturing Costs. Xxxxxxx will be responsible for [***] of the documented Clinical Development Manufacturing Costs; provided, however, that in no event will any Clinical Development Manufacturing Costs for any Calendar Quarter exceed the applicable Clinical Development Manufacturing Budget for such Calendar Quarter, except as otherwise provided in Section 10.4(b). All Clinical Development Manufacturing Costs shall be reconciled and paid in accordance with the procedure described in Section 10.4. Notwithstanding anything herein to the contrary, [***].
Sample 1
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Clinical Development Manufacturing Costs. Within [***] after receipt of such invoice and report, Xxxxxxx will pay to MeiraGTx [***] the Clinical Development Manufacturing Costs set forth in each such invoice; provided, however, that if the total Clinical Development Manufacturing Costs for such Calendar Quarter exceeds the Clinical Development Manufacturing Budget for such Calendar Quarter, then MeiraGTx will provide written notice to Xxxxxxx as far in advance as reasonably possible of such cost overrun along with a reasonably detailed explanation of such cost overrun. Xxxxxxx shall pay for such excess only if: (i) the JSC approves of such excess; or (ii) such excess exceeds the Clinical Development Manufacturing Budget for such Calendar Quarter by [***] percent ([***]%) or less and is attributable to (A) a change in Applicable Law, (B) a variation in actual patient enrollment from projected patient enrollment or (C) a change to a clinical trial protocol required or requested by any Regulatory Authority; provided, however, that in no event will total Clinical Development Manufacturing Costs in any given Calendar Year exceed the Clinical Development Manufacturing Budget for such Calendar Year by more than [***] percent ([***]%), which excess may only be approved by the Parties in writing. Xxxxxxx Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for confidential treatment and have been filed separately with the Securities and Exchange Commission. Confidential Treatment Requested by MeiraGTx Holdings plc shall not be obligated to pay for any Clinical Development Manufacturing Costs in excess of the Clinical Development Manufacturing Budget except as otherwise set forth in this Section 10.4(b). All such payments of MeiraGTx’s Clinical Development Manufacturing Costs shall be non-creditable and non-refundable. In addition, subject to the terms and conditions herein, if any Clinical Development Manufacturing Activities will exceed the respective portion of the applicable Clinical Development Manufacturing Budget or extend beyond the applicable CMC Development Term, then (x) MeiraGTx shall provide written notice to Xxxxxxx, as far in advance as reasonably possible, that MeiraGTx intends to not perform such Clinical Development Manufacturing Activities (with reasonable detail regarding such Clinical Development Manufacturing Activities and Clinical Development Manufacturing Costs), (y) MeiraGTx shall afford the JSC or the Parties, as applicable, a reasonable op...
Sample 1

Related to Clinical Development Manufacturing Costs

  • Manufacturing Costs In the event of termination by Merck pursuant to Section 6.2, 6.3 or 6.6 above, Merck shall be entitled to [*****] (as defined herein) incurred by Merck for its Compound Delivered for the Study. [*****]

  • Clinical Development (a) Stellartech shall design, develop and construct a Clinical Unit for each of the Thermage Disposable Device and the Thermage Generator, and any required component or subassembly thereof and shall deliver such Clinical Units to Thermage in accordance with the Development Program; (b) Stellartech shall deliver to Thermage such other Deliverables as are contemplated by the Development Program in accordance with the Development Program; and (c) as requested by Thermage and automatically at the conclusion of the Development Program, Stellartech, so long as Thermage is not in breach of its material obligation hereunder, shall deliver in writing to Thermage any and all data and information held by or in the control of Stellartech which is necessary or useful to obtain regulatory approval of the Products in the United States or any foreign country.

  • Development Activities NovaDel shall not be required to commence any Development Activities until Licensee has paid at least twenty-five percent (25%) of the non-refundable License Fee described in Section 4.4.

  • Commercialization Activities Within North America, the Parties will use Commercially Reasonable Efforts to Commercialize Licensed Products in the Field. In addition, within North America and subject to Section 2.7.6, the Parties will use Commercially Reasonable Efforts to conduct the Commercialization activities assigned to them pursuant to the Commercialization Plan/Budget, including the performance of detailing in accordance therewith. In conducting the Commercialization activities, the Parties will comply with all Applicable Laws, applicable industry professional standards and compliance policies of Celgene which have been previously furnished to Acceleron, as the same may be updated from time to time and provided to Acceleron. Neither Party shall make any claims or statements with respect to the Licensed Products that are not strictly consistent with the product labeling and the sales and marketing materials approved for use pursuant to the Commercialization Plan/Budget.

  • Development Plan As defined in Section 3.2(a).

  • Joint Manufacturing Committee A joint manufacturing committee (the “Joint Manufacturing Committee” or “JMC”) will be established pursuant to the Supply Agreement. The roles and responsibilities of the JMC shall be as specified in the Supply Agreement.

  • Manufacturing Services Jabil will manufacture the Product in accordance with the Specifications and any applicable Build Schedules. Jabil will reply to each proposed Build Schedule that is submitted in accordance with the terms of this Agreement by notifying Company of its acceptance or rejection within three (3) business days of receipt of any proposed Build Schedule. In the event of Jabil’s rejection of a proposed Build Schedule, Jabil’s notice of rejection will specify the basis for such rejection. When requested by Company, and subject to appropriate fee and cost adjustments, Jabil will provide Additional Services for existing or future Product manufactured by Jabil. Company shall be solely responsible for the sufficiency and adequacy of the Specifications [***].

  • Commercialization Intrexon shall have the right to develop and Commercialize the Reverted Products itself or with one or more Third Parties, and shall have the right, without obligation to Fibrocell, to take any such actions in connection with such activities as Intrexon (or its designee), at its discretion, deems appropriate.

  • 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

  • Commercialization Plan On a Product by Product basis, not later than sixty (60) days after the filing of the first application for Regulatory Approval of a Product in the Copromotion Territory, the MSC shall prepare and approve a rolling multiyear (not less than three (3) years) plan for Commercializing such Product in the Copromotion Territory (the "Copromotion Territory Commercialization Plan"), which plan includes a comprehensive market development, marketing, sales, supply and distribution strategy for such Product in the Copromotion Territory. The Copromotion Territory Commercialization Plan shall be updated by the MSC at least once each calendar year such that it addresses no less than the three (3) upcoming years. Not later than thirty (30) days after the filing of the first application for Regulatory Approval of a Product in the Copromotion Territory and thereafter on or before September 30 of each calendar year, the MSC shall prepare an annual commercialization plan and budget (the "Annual Commercialization Plan and Budget"), which plan is based on the then current Copromotion Territory Commercialization Plan and includes a comprehensive market development, marketing, sales, supply and distribution strategy, including an overall budget for anticipated marketing, promotion and sales efforts in the upcoming calendar year (the first such Annual Development Plan and Budget shall cover the remainder of the calendar year in which such Product is anticipated to be approved plus the first full calendar year thereafter). The Annual Commercialization Plan and Budget will specify which Target Markets and distribution channels each Party shall devote its respective Promotion efforts towards, the personnel and other resources to be devoted by each Party to such efforts, the number and positioning of Details to be performed by each Party, as well as market and sales forecasts and related operating expenses, for the Product in each country of the Copromotion Territory, and budgets for projected Pre-Marketing Expenses, Sales and Marketing Expenses and Post-Approval Research and Regulatory Expenses. In preparing and updating the Copromotion Territory Commercialization Plan and each Annual Commercialization Plan and Budget, the MSC will take into consideration factors such as market conditions, regulatory issues and competition.

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