SOLVAY'S MANUFACTURING COMMITMENT Sample Clauses

SOLVAY'S MANUFACTURING COMMITMENT. Solvay shall manufacture Bulk Product under this Agreement in conformity with the Specification, in a duly licensed facility as required by the United States Food and Drug Administration and equivalent European Union regulatory agencies, and in compliance with applicable laws and regulations and Good Manufacturing Practices, as prescribed from time to time by these appropriate regulatory agencies. Each shipment of Bulk Product hereunder shall have been subjected to a quality control inspection by Solvay in accordance with the Specification and with Solvay's then current quality control standards and systems, which shall be at least as stringent as those agreed in writing between Millennium and Solvay. Solvay shall not make any change to its manufacturing process for the Bulk Product (as it exists as of the Effective Date) which would affect the regulatory approvals for the Bulk Product in the United States or the European Union (and to the extent applicable, of Member States of the European Union) without first obtaining the prior written approval of Millennium. Solvay shall number each shipment with a vendor lot number that is traceable to Key Raw Materials, Bulk Product Intermediates and/or other components used to manufacture such Bulk Product and shall maintain all appropriate validation documentation as reasonably specified by Millennium and agreed by Solvay, or as required by appropriate regulatory authorities. Such manufacturing and validation information shall be communicated to Millennium pursuant to Section 3.4 of the License Agreement. Solvay shall permit Millennium and/or representatives of appropriate regulatory agencies to review periodically Solvay's Bulk Product manufacturing facilities and testing procedures at reasonable times with a Solvay representative present, and to obtain copies of batch records for Bulk Product in order to assure compliance with the requirements of this Article 6.1.
Sample 1
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SOLVAY'S MANUFACTURING COMMITMENT. Solvay shall manufacture Bulk Product under this Agreement in conformity with the Specification, in a duly licensed facility as required by the United States Food and Drug Administration and equivalent European Union regulatory agencies, and in compliance with applicable laws and regulations and Good Manufacturing Practices, as prescribed from time to time by these appropriate regulatory agencies. Each shipment of Bulk Product hereunder shall have been subjected to a quality control inspection by Solvay in accordance with the Specification and with Solvay's then-current quality control standards and systems, which shall be consistent with those agreed between COR and Solvay. Solvay shall number each shipment with a vendor lot number that is traceable to Key Raw Materials, Bulk Product Intermediates and/or other components used to manufacture such Bulk Product and shall maintain all appropriate validation documentation as reasonably specified by COR and agreed by Solvay, or as required by appropriate regulatory authorities. Such manufacturing and validation information shall be communicated to COR pursuant to Section 3.4 of the License Agreement. Solvay shall permit COR and/or representatives of appropriate regulatory agencies to review periodically Solvay's Bulk Product manufacturing facilities and testing procedures at reasonable times with a Solvay representative present, and to obtain copies of batch records for Bulk Product in order to assure compliance with the requirements of this Article 6.0.
Sample 1
SOLVAY'S MANUFACTURING COMMITMENT. Solvay shall manufacture Bulk Drug Substance under this Agreement in conformity with the Specification, in a duly licensed facility as required by the United States Food and Drug Administration and other Regulatory Authorities, and in compliance with the Quality Agreement and all Applicable Laws, including GMPs and other regulations prescribed from time to time by these appropriate Regulatory Authorities. ##### Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions.
Sample 1

Related to SOLVAY'S MANUFACTURING COMMITMENT

  • 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 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. [*****]

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

  • 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.

  • 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 [***].

  • 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.

  • Manufacturing Agreement Each of the Sellers (as applicable) shall have executed and delivered to the Buyer the Manufacturing Agreement with respect to the portion of the Business conducted at the applicable Facility.

  • Commercialization Plans As soon as practicable after formation of the JCC (following Acucela’s exercise of an Opt-In Right under Section 3.1), the JCC shall prepare and approve the initial Commercialization Plan for Commercialization of the Licensed Product for the Initial Indication in the Initial Formulation (and, if applicable, any New Formulation or Other Indication Product) in the Territory. The Parties shall use Commercially Reasonable Efforts to ensure that such initial Commercialization Plan for Commercialization of the Licensed Product for the Initial Indication in the Initial Formulation is consistent with the general Commercialization Plan outline set forth in Exhibit C attached hereto and incorporated herein (the “General Commercialization Plan Outline”). The JCC shall prepare and approve a separate Commercialization Plan for Commercialization of Licensed Product for the Initial Indication in the Initial Formulation in the Territory and for Commercialization of each Other Indication Product and New Formulation (if any) in the Territory, and shall update and amend each Commercialization Plan not less than annually or more frequently as needed to take into account changed circumstances or completion, commencement or cessation of Commercialization activities not contemplated by the then-current Commercialization Plan. Amendments and revisions to the Commercialization Plan shall be reviewed and discussed, in advance, by the JCC, and Otsuka agrees to consider proposals and suggestions made by Acucela regarding amendments and revisions to the Commercialization Plan. Any amendment or revision to the Commercialization Plan that provides for an increase or decrease in the number of FTEs for any Phase 3b Clinical Trials or Post-Approval Studies as compared to the previous version of the Commercialization Plan, or that provides for addition or discontinuation of tasks or activities as compared to the previous version of the Commercialization Plan, or that moves forward the timetable for activities reflected in the Commercialization Plan, shall provide for a reasonable ramp-up or wind-down period, as applicable, to accommodate a smooth and orderly transition of Commercialization activities to the amended or revised Commercialization Plan. Each Commercialization Plan shall identify the goals of Commercialization contemplated thereunder and shall address Commercialization (including Co-Promotion) activities related to the Licensed Product (including, if applicable, any Other Indication Product), including:

  • Manufacturing and Supply Genentech shall be responsible for manufacturing and supplying Licensed Products for clinical use and commercial sale in the Genentech Field.

  • 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

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