Manufacturing for ROW Administration Sample Clauses

Manufacturing for ROW Administration. Prior to Regulatory Approval of Licensed Product in any country in the ROW, Celgene will provide to the JGC a Manufacturing plan for the ROW in form and substance at least as detailed as the applicable section of the U.S. Commercialization Plan (including covering the applicable three-year time period) (the “ROW Post-Approval Manufacturing Plan”). Celgene (itself or by or through any others, including any Affiliates or Sublicensees) will not materially deviate from the then current ROW Post-Approval Manufacturing Plan when Manufacturing Licensed Product for Commercialization for ROW Administration without first notifying the JGC in writing and providing an updated ROW Post-Approval Manufacturing Plan.
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Related to Manufacturing for ROW Administration

  • REGULATORY ADMINISTRATION SERVICES BNY Mellon shall provide the following regulatory administration services for each Fund and Series:  Assist the Fund in responding to SEC examination requests by providing requested documents in the possession of BNY Mellon that are on the SEC examination request list and by making employees responsible for providing services available to regulatory authorities having jurisdiction over the performance of such services as may be required or reasonably requested by such regulatory authorities;  Assist with and/or coordinate such other filings, notices and regulatory matters and other due diligence requests or requests for proposal on such terms and conditions as BNY Mellon and the applicable Fund on behalf of itself and its Series may mutually agree upon in writing from time to time; and

  • 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 [***].

  • Contract for Services The parties intend this Agreement to be a contract for the provision of services and not a contract for the sale of goods. To the fullest extent permitted by law, the provisions of the Uniform Commercial Code (UCC), the Uniform Computer Information Transaction Act (UCITA), the United Nations Convention on Contracts for the International Sale of Goods, and any substantially similar legislation as may be enacted, shall not apply to this Agreement.

  • Subcontracting for Medicaid Services Notwithstanding any permitted subcontracting of services to be performed under this Agreement, Party shall remain responsible for ensuring that this Agreement is fully performed according to its terms, that subcontractor remains in compliance with the terms hereof, and that subcontractor complies with all state and federal laws and regulations relating to the Medicaid program in Vermont. Subcontracts, and any service provider agreements entered into by Party in connection with the performance of this Agreement, must clearly specify in writing the responsibilities of the subcontractor or other service provider and Party must retain the authority to revoke its subcontract or service provider agreement or to impose other sanctions if the performance of the subcontractor or service provider is inadequate or if its performance deviates from any requirement of this Agreement. Party shall make available on request all contracts, subcontracts and service provider agreements between the Party, subcontractors and other service providers to the Agency of Human Services and any of its departments as well as to the Center for Medicare and Medicaid Services.

  • Quality Assurance Program An employee shall be entitled to leave of absence without loss of earnings from her or his regularly scheduled working hours for the purpose of writing examinations required by the College of Nurses of Ontario arising out of the Quality Assurance Program.

  • Manufacturing (a) The Supplier shall without limitation be responsible, at no additional cost to the Purchaser, for: sourcing and procuring all raw materials for the Products; obtaining all necessary approvals, permits and licenses for the manufacturing of the Products; providing sufficient qualified staff and workers to perform the obligations under this Purchase Agreement; implementing and maintaining effective inventory and production control procedures with respect to the Products; and handling other matters as reasonably requested by the Purchaser from time to time. (b) The Supplier shall not change any process, material, component, packaging or manufacturing location without the Purchaser’s express prior written approval.

  • Office of Supplier Diversity The State of Florida supports its diverse business community by creating opportunities for woman-, veteran-, and minority-owned small business enterprises to participate in procurements and contracts. The Department encourages supplier diversity through certification of woman-, veteran-, and minority-owned small business enterprises and provides advocacy, outreach, and networking through regional business events. For additional information, please contact the Office of Supplier Diversity (OSD) at xxxxxxx@xxx.xxxxxxxxx.xxx.

  • Project Administration The Contractor shall provide project administration for all Subcontractors, vendors, suppliers, and others involved in implementing the Work and shall coordinate administration efforts with those of the A/E and ODR in accordance with these Uniform General and Supplementary Conditions and provisions of Division 1 Specifications, and as outlined in the Pre- construction Conference.

  • Commercialization Reports Throughout the term of this Agreement and during the Sell-Off Period, and within thirty (30) days of December 31st of each year, Company will deliver to University written reports of Company’s and Sublicensees’ efforts and plans to develop and commercialize the innovations covered by the Licensed Rights and to make and sell Licensed Products. Company will have no obligation to prepare commercialization reports in years where (a) Company delivers to University a written Sales Report with active sales, and (b) Company has fulfilled all Performance Milestones. In relation to each of the Performance Milestones each commercialization report will include sufficient information to demonstrate achievement of those Performance Milestones and will set out timeframes and plans for achieving those Performance Milestones which have not yet been met.

  • Administration Services When a medical prescription drug is administered by infusion, the administration of the prescription drug may be covered separately from the prescription drug. See Infusion Therapy - Administration Services in the Summary of Medical Benefits for benefit limits and the amount you pay. Prescription drugs that are self-administered are not covered as a medical benefit but may be covered as a pharmacy benefit. Please see Pharmacy Prescription Drugs and Diabetic Equipment or Supplies – Pharmacy Benefits section above for additional information. For some medical prescription drugs, after the first administration, coverage may be limited to certain locations (for example, a designated outpatient or ambulatory service facility, physician’s office, or your home), provided the location is appropriate based on your medical status. For a list of medical prescription drugs that are subject to this Site of Care Program, visit our website. Preauthorization may be required to determine medical necessity as well as appropriate site of care. If we deny your request for preauthorization, or you disagree with our determination for the appropriate site of care, you can submit a medical appeal. See Appeals in Section 5 for information on how to file a medical appeal.

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