Launch Supplies definition

Launch Supplies means the [***] of Contrave in finished package form, by dosage strength, including samples and trade Product, [***] in the United States, which at the time of delivery, will have a minimum of [***] ([***])[***] remaining shelf life and will comply with the terms of this Exhibit 4.1 or, if in effect, the Manufacturing Services Agreement. [***], and Takeda will have solely the additional remedies set forth in paragraph 3 of this Exhibit.
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Launch Supplies means the full quantity of Product in finished bulk form (30 gallon HDPE drums or in such other finished bulk form as agreed to by the Parties), by dosage strength, ordered by Takeda for commercial launch of Product in the Territory, which at the time of Delivery (of Launch Supplies), will have a minimum of nine (9) months remaining shelf life and will comply with the terms of the Manufacturing Services Agreement.
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Launch Supplies means a quantity of Licensed Product sufficient for the commercial launch of such Licensed Product in the U.S. for the Initial Indication, as agreed by the Parties in accordance with the terms of the Supply Agreement. *** Certain information on this page has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.
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Examples of Launch Supplies in a sentence

  • The Parties shall work together in good faith to enter into a mutually acceptable quality agreement with respect to the Manufacture of the Product prior to shipment of Launch Supplies.

  • Santarus further agrees to commercially launch a Licensed Product for the Initial Indication in the U.S. within one hundred twenty (120) days following receipt of all necessary Regulatory Approvals to market and sell such Licensed Product in the U.S. for the Initial Indication (subject to prior timely receipt of adequate Launch Supplies from Pharming and provided that all Manufacturing Approvals are in place and effective).

  • Subject to Isis’ obligation to manufacture and supply API for the commercial launch of the Product pursuant to Section 5.3 (Clinical and Launch Supplies) and the Supply Agreement, Genzyme will be responsible for securing commercial quantities of API and finished drug product for the Product.

  • A further 28 papers use empirical data to undertake some form of modeling.

  • Prior to shipment of the Launch Supplies, and thereafter not more than [***] per Calendar Year or as otherwise agreed by the Parties, and subject to the terms of the applicable agreement between Orexigen and its Third Party Manufacturers, Orexigen shall, at Takeda’s request, conduct GMP audits of the Third Party Manufacturers and, if applicable, exercise such other audit rights that Orexigen may have under such agreements, and shall disclose to Takeda the complete results of such audits.

  • For Launch Supplies, Takeda will issue a Firm Order at least [***] ([***]) months prior to the Launch Supplies Delivery Date, and Orexigen may invoice the estimated Transfer Price when Orexigen completes Delivery of Launch Supplies.

  • Milestone Event Payment Regulatory Approval in the Territory $ 20 million The later to occur of (i) Delivery of Launch Supplies; or (ii) Regulatory Approval in the Territory $ 10 million First Commercial Sale in the Territory $ 70 million For purposes of this Section 7.2.1, “Delivery of Launch Supplies” shall be deemed to occur if and only […***…].

  • Through the latter half of this financial year, the early research and development work on the PAD was commenced and the Company’s collaboration with AllVascular Pty Limited in animal trials started.

  • If Orexigen fails to achieve Delivery of Launch Supplies by the Launch Supplies Delivery Date, then Takeda will have solely the remedies set forth in Section 3.6.1(a) and (b) and the following remedy: Takeda shall not be obligated to pay the Ten Million Dollar ($10,000,000) second milestone event payment under the heading “Development Milestones” set forth in Section 7.2.1 of the Collaboration Agreement and Orexigen shall forfeit receipt of such payment.

  • Notwithstanding anything to the contrary contained in this Agreement, in order to achieve Delivery of Launch Supplies, Orexigen shall deliver the Launch Supplies to Takeda by the Launch Supplies Delivery Date.


More Definitions of Launch Supplies

Launch Supplies means the [***] of Contrave in finished bulk form (30 gallon HDPE drums or in such other finished bulk form as agreed to by the Parties), by dosage strength, [***] in the United States, which at the time of delivery, will have a minimum of [***] remaining shelf life and will comply with the terms of this Exhibit 4.1 or, if in effect, the Manufacturing Services Agreement. [***], and Takeda will have solely the additional remedies set forth in paragraph 3 of this Exhibit.’
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Related to Launch Supplies

  • Bulk Product means Licensed Product supplied in a form other than Finished Product which can be converted into Finished Product.

  • Manufacturing Services means the manufacturing, quality control, quality assurance, stability testing, packaging, and related services, as set forth in this Agreement, required to manufacture Product or Products using the Active Materials, Components, and Xxxx Back Items;

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

  • Drug Substance means an active ingredient that is intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease or to affect the structure or any function of the human body, but does not include intermediates used in the synthesis of such ingredient.

  • 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.

  • Clinical Supply Agreement has the meaning set forth in Section 4.2.

  • Purchase Order (PO) means a written offer made by a purchaser to a supplier formally stating the terms and conditions of a proposed transaction.

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

  • Network Supply Point or "NSP" means any Point of Connection between:

  • Launch means the intentional ignition of the first-stage motor(s) of the Launch Vehicle intended to place or try to place a Launch Vehicle (which may or may not include any Transfer Vehicle, Payload or crew) from Earth:

  • Contract Quantity means the quantity of Delivered Energy expected to be delivered by Seller during each Contract Year as set forth in Section 3.1(e).

  • Contract Manufacturer means a company that produces goods under contract for another company under the label or brand name of that company.

  • Purchase Order means the form or format a Customer uses to make a purchase under the Contract (e.g., a formal written purchase order, electronic purchase order, procurement card, contract or other authorized means).

  • Product means any deliverable under the Contract, which may include commodities, services, technology or software.

  • MSAA Indicator Technical Specifications document means, as the context requires, either or both of the document entitled “Multi-Sector Service Accountability Agreement (MSAA) 2019-20 Indicator Technical Specifications November 5, 2018 Version 1.3” and the document entitled “Multi-Sector Service Accountability Agreement (MSAA) 2019-20 Target and Corridor-Setting Guidelines” as they may be amended or replaced from time to time;

  • Medical equipment supplier means any person, as defined in § 1-230, engaged in the delivery to the ultimate consumer, pursuant to the lawful order of a practitioner, of hypodermic syringes and needles, medicinal oxygen, Schedule VI controlled devices, those Schedule VI controlled substances with no medicinal properties that are used for the operation and cleaning of medical equipment, solutions for peritoneal dialysis, and sterile water or saline for irrigation.

  • Final Product means a product that is not used in producing other products and is built and intended for use outdoors, provided the final product has not deteriorated or has otherwise become a potential source of contaminants.

  • Technical Specifications means the detailed requirements for the Work furnished by the Architect and set forth in Book 3 of the Contract Documents.

  • Satellite Manufacturer means, with respect to any Satellite, the prime contractor and manufacturer of such Satellite.

  • Framework Suppliers means the suppliers (including the Supplier) appointed under this Framework Agreement or agreements on the same or similar terms to this Framework Agreement as part of this Framework;

  • Product Manufacturer means the entity that assembles the component parts to manufacture the final Product;

  • Manufacturer means the person or body responsible to the approval authority for all aspects of the type approval process and for ensuring conformity of production. It is not essential that the person or body is directly involved in all stages of the construction of the vehicle which is the subject of the approval process.

  • Manufactured end product means any end product in product and service codes (PSCs) 1000-9999, except—

  • Third Party Supplier means a third party manufacturer and/or licensor of Products.

  • licensed water supplier means a company which is the holder for the time being of a water supply licence under Section 17A(1) of the 1991 Act(f);

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