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

  • For clarity, Takeda shall not have the right to terminate this Agreement pursuant to Section 12.2 for Orexigen’s failure to complete the Delivery of Launch Supplies (as provided in Section 7.2.1 of this Agreement) or any other failure to supply, and Takeda’s sole remedy for any such failure shall be the remedies set forth in paragraphs 2 and 3 of this Exhibit.

  • 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.

  • 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.

  • 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).

  • For clarity, except for termination of this Agreement pursuant to Section 13.2 as a consequence of Takeda’s exercise of its rights under Section 4.2 of the Collaboration Agreement or pursuant to Section 3.6.1 of this Agreement, Takeda shall not have the right to terminate this Agreement or the Collaboration Agreement for Orexigen’s failure to achieve Delivery of Launch Supplies as set forth in Section 3.4, or for any other failure by Orexigen to supply the Product in accordance with this Agreement.

  • Notwithstanding anything to the contrary in this Agreement, the first [***] ([***]) Batches of the Product delivered to Takeda following Delivery of Launch Supplies shall, at the time of delivery to Takeda, have [***] for which no more than [***] ([***]) months shall have elapsed since the date of Manufacture.

  • 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 […***…].

  • 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.

  • Orexigen guarantees delivery of Launch Supplies to Takeda by the delivery date specified in Takeda’s purchase order issued to Orexigen at least [***] months prior to such delivery date; provided, however, that if any delay in delivery of Launch Supplies is caused by Takeda, then such delivery date shall be extended for each day such delivery may be delayed.

  • 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.


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.

  • Product Schedule means the “Product Schedule” that forms part of the Contract.

  • 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 any one or more of the following petroleum oils, or a mixture or combination of these oils, to be used without further processing except blending by mechanical means:

  • 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 the Cover Sheet.

  • 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 reasonably homogenous cannabis product in its final packaged form created using the same standard operating procedures and the same formulation.

  • Technical Specifications A specification in a document defining the characteristics of a product or a service, such as the quality levels, the environmental and climate performance levels, the design for all needs, including accessibility for people with disabilities, and the evaluation of conformity, of product performance, of the use of the product, safety or dimensions, as well as requirements applicable to the product as regards the name by which it is sold, terminology, symbols, testing and test methods, packaging, marking or labelling, instructions for use, the production processes and methods at every stage in the life cycle of the supply or service, as well as the evaluation and conformity procedures;

  • 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 who is 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 stage of the construction of the vehicle, system, component or separate technical unit 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);