Finished US Goods definition

Finished US Goods mean kits containing the Product labeled and ready for distribution and sale to end-users in the United States, as contemplated by the definition for such term in the Supply Agreement; provided, however, that for purposes of this Agreement, such term shall also include any single such kit containing one of the constituent parts of the Product. *** CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.
Finished US Goods mean either (i) packages (“Packages”) of two (2) Kits (one In-111 Zevalin Kit and one Y-90 Zevalin Kit) labeled and ready for distribution and sale to end-users in the United States, with each such Package representing as of the Effective Date certain non-radioactive ingredients necessary to produce one (1) treatment to a patient of the Product (i.e., a single dose of Indium-111 Ibritumomab Tiuxetan (referred to on the Current Prescribing Information as In-111 Zevalin) and Yttrium-90 Ibritumomab Tiuxetan (referred to on the Current Prescribing Information as Y-90 Zevalin)), or (ii) individual Kits (either In-111 Zevalin Kits or Y-90 Zevalin Kits) labeled and ready for distribution and sale to end-users in the United States, all as more particularly described on Exhibit A. Exhibit A, like the Current Prescribing Information, also notes required materials, in addition to Rituxan® (Rituximab), that are not part of the Product, not supplied with the Kits or not available from Manufacturer or pursuant to this Agreement.

Examples of Finished US Goods in a sentence

  • Buyer shall promptly notify Manufacturer of all complaints concerning Finished US Goods sold to Buyer pursuant to this Agreement, and Manufacturer shall investigate all such complaints related to the manufacture of Finished US Goods by Manufacturer and provide a written report to Buyer.

  • SENSITIVITY ANALYSISFor the case of Cb = 0, landslide width is predicted to vary with slope, soil bulk density, relative degree of saturation, and friction angle.

  • If Buyer wishes to refuse acceptance on this basis, Buyer shall, within such 30-day period, inform Manufacturer in writing of Buyer’s refusal to accept the shipment and the reason therefore (i.e., by identifying the manner in which the manufacture of Finished US Goods in such shipment is not in conformity with applicable cGMPs Requirements and the Specifications).

  • After the Closing, CTI shall (i) promptly deliver to the Company any Customer Orders received after the Closing Date and any payments received from third parties for Finished US Goods ordered and purchased from the Company after the Closing Date, and (ii) exercise commercially reasonable efforts to refer all inquiries that it receives with respect to the Product in the United States (other than with respect to the Excluded Assets or the Pre-Closing Liabilities) to the Company.

  • At all times from the Effective Date through that date which is five (5) years after the expiration date for the Finished US Goods supplied to Buyer hereunder, Buyer and Manufacturer shall each maintain (or, in the instance of Manufacturer, self-insure for) product liability insurance in an amount of not less than Fifteen Million Dollars ($15,000,000) annual aggregate, including retention.

  • For the avoidance of doubt, the parties agree that, except pursuant to the provisions of Section 5.8 or this Section 5.9, Buyer may not return any Finished US Goods to Manufacturer.

  • Manufacturer shall conduct or have conducted stability studies at least one (1) time each year (to the extent annual testing is required by the FDA or the Regulatory Applications/Approvals) for at least one (1) batch of Finished US Goods from each site where Finished US Goods are manufactured.

  • Upon Buyer’s written request, Manufacturer shall provide Buyer with up to one half (1/2) (in the aggregate) of the original amount of the retained samples of Finished US Goods.

  • In the event that Buyer believes that a recall, withdrawal or field correction is necessary with respect to any Finished US Goods provided under this Agreement, Buyer shall so notify Manufacturer and both parties shall cooperate to determine the appropriate action to take.

  • Buyer shall not be obligated to pay Manufacturer for, and Manufacturer shall be responsible for all costs associated with the delivery and destruction of, such Bulk Product and Finished US Goods.

Related to Finished US Goods

  • Finished Goods means completed goods which require no additional processing or manufacturing to be sold to third party customers by the Loan Parties in the ordinary course of business.

  • Finished Products means the fully assembled and shrink-wrapped Licensed Products, each including a Game Cartridge, Game Cartridge label and Printed Materials.

  • Finished Services means complete end-to-end services offered by Qwest to wholesale customers or retail End User Customers. Finished Services do not include Unbundled Network Elements or combinations of Unbundled Network Elements. Finished Services include Access Services, private lines, retail services, and resold services.

  • Finished Product means a cannabis product in its final form to be sold at a retail premises.

  • the Products means all products and associated documentation to be supplied under this Contract;

  • Dangerous Goods means Goods which are officially classified as hazardous as well as Goods which are or may become of a dangerous, inflammable, radioactive noxious or damaging nature.

  • Tobacco product manufacturer means an entity that after the date of enactment of this Act directly (and not exclusively through any affiliate):

  • Eligible Products collectively means certain Dell and Dell EMC hardware, software product(s) and services related to the Dell Technologies Client Solutions Group (“CSG”) and Infrastructure Solutions Group (“ISG”) lines of business in the product categories (each an “Eligible Product Category”). A detailed list of Eligible Products in each eligible Product Category may be found at: https://www.dellemc.com/resources/en-sg/auth/asset/quick-reference-

  • Eligible Finished Goods Inventory means Eligible Inventory consisting of finished goods available for sale (as determined in a manner acceptable to the Administrative Agent in its Permitted Discretion and consistent with past practices).

  • Customer Equipment means hardware, software, systems, cabling and facilities provided by you and used in conjunction with the Equipment that we supply to you in order to receive the Services;

  • Tobacco products means cigars, cigarettes, cheroots, stogies, periques, granulated, plug cut, crimp cut, ready rubbed, and other smoking tobacco, snuff, snuff flour, moist snuff, cavendish, ping and twist tobacco, fine-cut and other chewing tobaccos, shorts, refuse scraps, clippings, cuttings and sweepings of tobacco, and other kinds and forms of tobacco, prepared in such manner as to be suitable for chewing or smoking in a pipe or otherwise, or both for chewing and smoking.

  • Household goods means personal effects and property used or to be used in a dwelling when a part of the equipment or supply of that dwelling. Household goods do not include property moving from a factory or store, unless the property was purchased by the householder with intent to use the property in his or her dwelling, the property is transported at the request of the householder, and the householder pays the carrier's transportation charges either directly or indirectly.

  • Your Products means products developed or to be developed by or for You that include an Intel Component executing the Materials. 2.

  • Hemp products means all products made from industrial hemp,

  • Raw Materials means all raw materials, supplies, components and packaging necessary to manufacture and ship the Product in accordance with the Specifications, as provided in Exhibit A, but not including the API.

  • Products means information resources technologies that are, or are related to, EIR.

  • Manufacturing site means the facilities where a Compound is Manufactured by or on behalf of a Party, as such Manufacturing Site may change from time to time in accordance with Section 8.7.

  • shipped includes removal from the work sites by ship or any other means;

  • API means the American Petroleum Institute.

  • Supplier Equipment means the Supplier's hardware, computer and telecoms devices, equipment, plant, materials and such other items supplied and used by the Supplier (but not hired, leased or loaned from the Customer) in the performance of its obligations under this Call Off Contract;

  • Manufacturing Facility means buildings and structures, including machinery and equipment, the primary purpose of which is or will be the manufacture of tangible goods or materials or the processing of such goods or materials by physical or chemical change.

  • Product Inventory means all inventory owned as of the Closing by Seller or any Affiliate thereof of finished Product that is in conformance with the Specifications and has an expiration date of October 1, 2016 or later, regardless of whether such inventory is held at a location or facility of Seller or any Affiliate (or of any other Person on behalf of Seller or any Affiliate, including in any of Seller’s warehouses, manufacturers, suppliers, distributors or consignees) or in transit to or from Seller or any Affiliate (or any such other Person).

  • Refined Products means gasoline, diesel fuel, jet fuel, asphalt and asphalt products, and other refined products of crude oil.

  • GOODS / MATERIALS means any of the articles, materials, machinery, equipments, supplies, drawing, data and other property and all services including but not limited to design, delivery, installation, inspection, testing and commissioning specified or required to complete the order.

  • Contract for Goods means any contract, purchase order or agreement for the purchase of goods awarded by the city and whose cost is to be paid from funds belonging to or administered by the city; provided that a “contract” does not include: (i) a delegate agency contract; (ii) a lease of real property;

  • Cannabis products means cannabis that has undergone a process whereby the plant material has been transformed into a concentrate, including, but not limited to, concentrated cannabis, or an edible or topical product containing cannabis or concentrated cannabis and other ingredients.