Document Generated Sample Clauses

Document Generated. 2023-07-01
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Document Generated. 2023-10-22 as the Treaty establishing the European Economic Community (The Treaty of Rome) then becoming Treaty establishing the European Community. Its title is now Treaty on the functioning of the European Union.
Document Generated. 2020-12-18

Related to Document Generated

  • Water Supply The system may or may not meet state and local requirements. It is the right and responsibility of Buyer to determine the compliance of the system with state and local requirements. [For additional information on this subject, request the “Water Supply and Waste Disposal Notification” form.]

  • Environmental Services 1. Preparation of Environmental Documentation (CEQA/NEPA) including but not limited to the following: a. Initial Study b. Categorical Exemption (CE) c. Notice of Exemption (XXX) d. Negative Declaration (ND) e. Mitigated Negative Declaration (MND) f. Notice of Preparation (NOP) g. Environmental Impact Report (EIR) i. Initial Document (Screen Check/Administrative Draft) ii. Addendum iii. Supplemental

  • Radiation Therapy/Chemotherapy Services This plan covers chemotherapy and radiation services. This plan covers respiratory therapy services. When respiratory services are provided in your home, as part of a home care program, durable medical equipment, supplies, and oxygen are covered as a durable medical equipment service.

  • Commercial Supply i) Not later than ** before the anticipated first commercial sale of the Licensed Product in the Licensed Territory, the Parties shall commence good faith negotiations of a commercial supply agreement that shall govern the supply of Commercial Product to SymBio (the “Commercial Supply Agreement”), with a goal of entering into the Commercial Supply Agreement no later than ** prior to the anticipated first commercial sale of the Licensed Product in the Licensed Territory. Pursuant to the Commercial Supply Agreement, Onconova shall be obligated, by itself or through its Third Party contract manufacturer, to supply to SymBio, and SymBio shall be required to purchase, all quantities of the Commercial Product required by SymBio to commercialize the Licensed Product in the Licensed Territory. Such Commercial Supply Agreement shall be consistent with the terms set forth in this Article 5, and shall include customary and reasonable terms and conditions commonly accepted in the pharmaceutical industry for supply of similar products at similar scale. Without limiting the foregoing, the Commercial Supply Agreement shall contain rights for SymBio to audit the Actual Unit Cost periodically, an obligation for the Parties to enter into a quality agreement, backup rights for SymBio to manufacture Licensed Products and rights for SymBio to inspect facilities used to manufacture Commercial Product. ii) Pursuant to the Commercial Supply Agreement, Onconova shall supply SymBio with the Commercial Product meeting the relevant Specifications, at a price equal to the “Xxxx Up,” which shall be defined as Onconova’s Actual Unit Cost for the Commercial Product plus **, provided that (i) in no event shall the Xxxx Up exceed **, and further provided that in no event shall the sum of the price for supply of the Commercial Product to SymBio and the royalty payable pursuant to Section 15 with respect to the Commercial Product exceed **. The foregoing calculations shall be based on the average Japan Net Selling Price and U.S. Net Selling Price calculated for all units of Commercial Product sold in the calendar quarter preceding the calendar quarter in which Onconova invoices SymBio for Commercial Product. With respect to any supply of Commercial Product prior to the period during which the U.S. Net Selling Price and/or Japan Net Selling Price can be calculated, the Parties shall use an estimated U.S. Net Selling Price and/or Japan Net Selling Price, as applicable, for purposes of calculating the Xxxx Up.

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