Production and Supply Sample Clauses

Production and Supply. The Company intends to begin manufacturing the TCS-1 System on a commercial basis within the current fiscal year. The Company will be dependent on arrangements with its subcontractors for the manufacture and assembly of the principal components incorporated into the TCS-1 System (see BUSINESS "Agreements With Subcontractors", below). It will therefore be substantially dependent on the ability of such subcontractors to satisfy performance and quality specifications and to dedicate sufficient production capacity for all TCS-1 System scheduled delivery dates. The Company believes that all of its subcontractors have the requisite manufacturing capabilities and the willingness to dedicate sufficient amounts of their manufacturing capacity to allow the Company to meet all TCS-1 System delivery dates, currently scheduled or expected to be scheduled within the next two years. However, no assurance can be given that this will in fact be the case and failure on the part of the Company's subcontractors in these regards would adversely affect the Company's ability to manufacture and deliver TCS-1 Systems on a timely and competitive basis. In such event the Company would have to replace or supplement its present subcontractors. There can be no assurance that should it be necessary to do so, the Company would be able to find capable replacements for its subcontractors on a timely basis and on terms beneficial to the Company, if at all; The Company's inability to do so would have a material adverse effect on its business (see BUSINESS: "Production and Supply"). Components of the TCS-1 Systems, which are not manufactured by the Company's subcontractors specifically for the TCS-1 System, will be purchased, either directly by the Company or indirectly through its subcontractors from third-party manufacturers. The Company believes that numerous alternative sources of supply for all such components are readily available. Technological Changes To date, the market for tire disintegration equipment has not, to the best of management's knowledge, been characterized by rapid changes in technology. However, there can be no assurance that new products or technologies, presently unknown to the Company, will not, at any time in the future and without warning, render the Company's tire disintegration technology less competitive or even obsolete. Moreover, the technology upon which the Company's tire disintegration system is based, could be susceptible to being analyzed and reconstructe...
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Production and Supply. 5.1 The Licensee may sub-contract the manufacture, marketing, distribution and sale of Products and such manufacture, marketing, distribution and sale may take place worldwide provided that the Licensee will use its best endeavours to ensure that any such sub-contractor does nothing to place the Licensee in breach of this Licence Agreement and that the Licensee will remain liable to DVSA for any breach of the Licence Agreement arising from any act omission or neglect by any such sub-contractor.
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Production and Supply. (a) Product Manufacturing Forecast. By not later than the Effective Date ------------------------------ of this Agreement and thereafter on the [*] business day of each month, beginning [*], for * Portions of this exhibit have been omitted pursuant to a request for confidential treatment filed with the Securities and Exchange Commission. The omitted portions of this exhibit have been filed separately with the SEC. the remainder of the Term, the Parties shall issue a rolling "Product ------- Manufacturing Forecast" which shall establish, on a monthly basis, for ---------------------- the remainder of the Term, the number of Runs to be performed and the quantity of Bulk Drug reasonably expected to be manufactured, released and supplied to Immunex, within the ranges set forth in Exhibit A --------- hereto. The Product Manufacturing Forecast shall be used for joint planning purposes and shall be nonbinding unless otherwise specified herein, and may be amended by the Parties from time to time as the Parties deem appropriate. Beginning [*] or such other date as agreed upon by the Parties in writing, each Product Manufacturing Forecast shall be binding for the first [*] months, and non-binding for the remainder of the Term, as further described below. Beginning with the initial binding Product Manufacturing Forecast, the forecasts for Bulk Drug within the first [*] months of each such rolling Product Manufacturing Forecast shall constitute a Bulk Drug Commitment and shall be binding upon the Parties and cannot be changed except upon mutual written consent of the Parties (or except upon mutual agreement of the Parties under Section 3.9 or Section 4.5 hereof, which ----------- ----------- agreement shall not, without the consent of Genentech, affect any Runs that are in process [*]), and the [*]-month period shall be that period which commences on the first day of the month immediately following the month in which the Product Manufacturing Forecast is issued. By way of example only, when the rolling Product Manufacturing Forecast for [*], is issued, the [*]-month period covered by such forecast shall commence on [*], and shall end on [*]. The Bulk Drug Commitment shall include approximate harvest dates for each Commercial Run.
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Production and Supply. During the Term of this Agreement, STRATEC agrees to make and sell and deliver to Gen-Probe, for resale and/or placement throughout the Territory, Products meeting the Product Specifications, under the terms and conditions set forth herein. STRATEC’s shall not sell Panther Instruments to any party other than Gen-Probe. Gen-Probe shall have the exclusive right, both during the Term and after the expiration or earlier termination of this Agreement, to market and sell the Products purchased hereunder from STRATEC and to repair and service, or have repaired and serviced, all such Products. Subject to the rights and obligations of the parties under Section 5.10 and Article 12 of this Agreement, Gen-Probe agrees to buy exclusively from STRATEC during the initial Term of this Agreement a minimum quantity of [***] units of the Production Instrument following CE-marking of the Panther Instrument and [***] units of the Production Instrument following U.S. FDA 510(k) clearance of the Panther Instrument. Upon successful completion of the parties’ activities under the Development Agreement, Gen-Probe shall use its best commercial efforts to obtain CE-marking and FDA approval for the Panther instrument and STRATEC shall reasonably cooperate with Gen-Probe in connection with such efforts. (Gen-Probe’s obligation as described in the two preceding sentences is hereafter referred to as the “Minimum Aggregate Purchase Commitment”). Beginning with the first full calendar year of supply of Production Instruments, following CE-marking of the Panther Instrument the total number of instruments to be taken in each calendar year of the Initial Term shall not be less than [***] Production Instruments. Beginning with the first full calendar year of supply of Production Instruments following U.S. FDA 510(k) clearance, the total number of instruments to be taken in each calendar year of the Initial Term shall not be less than [***] Production Instruments. (Gen-Probe’s annual purchase obligations are collectively referred to as the “Minimum Annual Purchase Commitment.”)
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Production and Supply. For the avoidance of doubt, the parties acknowledge and agree that Section 2.1 of the Supply Agreement, as amended hereby, shall apply to the manufacture and supply of Radium Instruments hereunder as if set forth in its entirety herein with such changes thereto as are necessary to make such Section applicable to the manufacture and supply of Radium Instruments.
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Production and Supply. Genor and Licensee hereby agree that under contract manufacturing (CMO) mode, Licensee or its affiliates or sublicensees shall procure and Genor shall supply clinical trial materials and/or commercial product the Licensed Product for development and commercialization in the Sublicensed Territory. Specific CMO agreements and/or orders shall be signed between Genor and Licensee or its affiliates or sublicensees each time such procurement and supply is needed. Genor shall make its best efforts to fulfil Licensee or its affiliates or sublicensees’s such demands, while Licensee or its affiliates or sublicensees shall notify Genor beforehand allowing enough time for production planning and execution.
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Production and Supply. (a) During the term of this Agreement, Guilford agrees to purchase from Nordion Europe, and Nordion Europe agrees to produce and supply, Guilford's entire requirement of Product for the European Phase II Clinical Trial, which Guilford agrees will not be less than [ * ] Batches (as defined below) of [ * ] Vials (as defined below) each. Nordion Europe warrants that all such Product supplied by Nordion Europe shall meet the specifications set forth in Schedule D attached hereto as delivered at the clinical sites (the "Specifications") and further represents and warrants that the Specifications and the methodologies used to synthesize the Product for use in European Phase II Clinical Trials shall meet all European regulatory requirements in order to conduct such clinical trials and to support Guilford's (or its designee's) application for approval to market the Product in Europe. Nordion Europe will use its commercially reasonable best efforts to supply Product in the quantities, at the times and at the locations designated by Guilford in connection with the European Phase II Clinical Trials.
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Production and Supply 
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Related to Production and Supply

  • Manufacturing and Supply Genentech shall be responsible for manufacturing and supplying Licensed Products for clinical use and commercial sale in the Genentech Field.

  • Equipment and Supplies Independent Contractor, at Independent Contractor's sole expense, shall provide all equipment, tools and supplies necessary to perform the Service.

  • Supply Agreements For a period of three years from the consummation of the IPO, Odetics shall not unilaterally terminate or assign its guarantee obligation with respect to any supply agreement pursuant to which it has guaranteed the performance by ATL of ATL's obligations, unless such suppliers have consented to the termination or assignment of such guarantee.

  • Manufacture and Supply Subject to the terms and conditions of this Agreement, Collaboration Products shall be manufactured and supplied for preclinical and clinical testing and for commercial sale upon the following terms and conditions:

  • Supply Agreement The Supply Agreement shall have been executed on behalf of the Seller and delivered to the Purchaser.

  • Development of Products (a) During the term of this Agreement, ViewRay may from time to time seek services from PEKO with respect to the development of certain Products that can be incorporated into the ViewRay Renaissance™ MRI-guided radiation therapy system. For each Program to be undertaken by PEKO pursuant to this Agreement, the parties will prepare a “Work Statement” and agree to said “Work Statement” in substantially the form attached as Attachment 1. Each Work Statement will describe: (i) the (i) services that PEKO will be responsible for providing to ViewRay and the deliverables that PEKO will be responsible for delivering to ViewRay (“Deliverable(s)”), (ii) delivery schedule for the Deliverables, (iii) pricing terms, (iv) work plan for the Program, and (v) ViewRay’s responsibilities in connection with the Program. Each Work Statement will be prepared based upon the requirements and information provided to PEKO by ViewRay. A separate Work Statement will be required for each Program; and each Work Statement will become subject to this Agreement only when mutually agreed and signed by ViewRay and PEKO.

  • Clinical Supply Takeda will provide to Licensee[***] the amount of TAK-385 Licensed Compound or TAK-385 Licensed Products needed by Licensee to complete all Clinical Trials contemplated by the TAK-385 Development Plan (estimated by Licensee as of the Effective Date to be [***]), solely to the extent that Takeda can supply such TAK-385 [***] = Portions of this exhibit have been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment requested under 17 C.F.R. Sections 200.80(b)(4) and 230.406. Licensed Compound or TAK-385 Licensed Products (a) from its supply of TAK-385 Licensed Compound or TAK-385 Licensed Products in existence as of the Effective Date and which supply can be used for its intended purposes without further re-processing (the “Initial Clinical Supply”) and (b) after retaining the amount needed by Takeda for Clinical Trials in the Takeda Territory. Takeda will also provide to Licensee, at [***] any additional supplies of TAK-385 Licensed Compound or TAK-385 Licensed Products in excess of the Initial Clinical Supply needed by Licensee to complete all Clinical Trials contemplated by the TAK-385 Development Plan. Within [***] days after the Effective Date, the Parties will enter into a manufacturing and supply agreement (the “Takeda Clinical Manufacturing and Supply Agreement”), which will govern the terms and conditions of the Manufacturing and supply of the TAK-385 Licensed Compound and TAK-385 Licensed Products (including the Initial Clinical Supply) by Takeda to Licensee for Development purposes, including the exact quantities and the timelines for delivery. The Parties will negotiate the terms and conditions of such Takeda Clinical Manufacturing and Supply Agreement in good faith for a period of [***] days (as may be extended upon agreement of the Parties). As part of the negotiation related to the Takeda Clinical Manufacturing and Supply Agreement, the Parties shall discuss in good faith the ability of Takeda to supply to Licensee [***]. If the Parties have not entered into a definitive agreement within such negotiation period, then the final terms and conditions of such agreement will be resolved in accordance with Section 8.2 (Arbitration for Failure to Agree).

  • 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.

  • Development Services During the term of this Agreement, the Provider agrees to provide to or on behalf of the Port the professional services and related items described in Exhibit A (collectively, the “Development Services”) in accordance with the terms and conditions of this Agreement. The Provider specifically agrees to include at least one Port representative in any economic development negotiations or discussions in which the Provider is involved concerning (i) a port-related business prospect or (ii) a business transaction which will ultimately require Port involvement, financial or otherwise.

  • Product Supply The Parties shall reasonably cooperate and assist each other in transferring ownership of Product drug product and/or Product drug substance (such material, CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED. collectively, the “Product Lots”) set forth in Exhibit A attached hereto as promptly as reasonably practicable following the Effective Date; provided, however, that neither Party shall be required to pay money to any Third Party, commence any litigation with, or offer or grant any accommodation (financial or otherwise) to any Third Party. Such Product Lots shall be delivered EXW (Ex Works) (Incoterms 2010) AMGEN, Thousand Oaks, California. Any expense for shipment shall be borne by AKERO (including any import or export duties or taxes). Subject to the terms of this Section 5.4 and Section 6.2 (Additional AMGEN Warranties), AMGEN transfers the Product Lots to AKERO “as is”, and makes no other representation to AKERO in connection therewith. The Parties have entered into a Quality Agreement substantially in the form attached hereto as Exhibit F, dated as of the date hereof, governing the quality of the Product Lots to be supplied pursuant to this Section 5.4. For the avoidance of doubt, Product Lots consisting of drug product as set forth in Exhibit A supplied pursuant to this Section 5.4 shall be labeled for their intended clinical use as set forth in Exhibit A and the labeling of any Product drug product manufactured after the Effective Date shall be the responsibility of AKERO. Except for the Licensed Materials and such Product Lots to be transferred to AKERO, AKERO shall be responsible for, and shall bear the cost of, obtaining (whether by manufacturing or causing to be manufactured) research, clinical and commercial supplies of the Product. From and after the Effective Date, AKERO shall be responsible for all costs and expenses in connection with the storage of, and any stability studies performed on, the Product Lots.

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