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. 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.
Sample 1
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.”)
Sample 1
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.
Sample 1
Production and Supply. Hwasung will be solely responsible for the design, manufacturing, quality control, and localization of products for the Vietnamese market. Hwasung will ensure timely supply and maintain product standards. Marketing and Promotion: Hwasung will independently develop marketing and sales strategies for Vietnam and will handle the promotion of products through online and offline channels.
Sample 1
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. Section 2.1 of the Supply Agreement shall be amended by adding the following additional sentence to the end of Section 2.1: “For the avoidance of doubt, the Parties acknowledge and agree that the Minimum Annual Purchase Commitment (which, for the avoidance of doubt, applies to the purchase of the Production Instrument and not to the purchase of the Production Radium Instrument) shall expire in calendar year 2016 and shall not apply to any calendar year thereafter during the Term of the Agreement.” Additionally, Section 2 of the Supply Agreement shall be amended by adding a new Section 2.2 thereto as follows:
Sample 1
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. (b) Guilford or its designate shall forward orders to Nordion Europe's address of Zoning Industriel - B-6220, Fleurus, Belgium, setting out the recipient, shipping address, protocol number, IND or European equivalent number, radioactive license number of the Product, quantity and other applicable instructions and information. Nordion Europe shall process such orders and ship the requested Product ex-Works Nordion Europe's facility in Fleuris, Belguim by mutually agreed routings and carriers, appropriately packaged and documented, within 48 hours of such order therefor as set forth on Schedule D attached hereto. Upon Nordion Europe's request, Guilford will obtain and provide to Nordion Europe, prior to shipment by Nordion Europe, documentation evidencing proper legal authority for the receipt and possession of the Product by the recipient. (c) Nordion Europe will manufacture and deliver to the clinical sites Product in batches ("Batches") of a minimum of [ * ] vials ("Vials"). Each Vial shall constitute one dose of Product suitable for administration at the clinical site, meeting the radioactivity (5 mCi) and other Specifications at "Reference" (i.e., noon, Central European Time on the day immediately following the day of Product synthesis). Prior to (and where appropriate, following) each shipment, Nordion Europe shall test each Batch in accordance with the protocol set f...
Sample 1
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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. 5.2 Subject to clause 6 the Licensee will use the Licensed Material in accordance with the reasonable instructions of DVSA and will observe any reasonable directions given by DVSA as to the representation and disposition of the Licensed Material on Products and on packaging for Products. 5.3 The Licensee will from time to time and upon reasonable request supply DVSA with a sample of each of the Products and such information as DVSA may reasonably require regarding Products which the Licensee is currently manufacturing or offering for sale. 5.4 The Licensee will from time to time and upon reasonable request give or arrange for DVSA or their representatives during usual business hours full and free access for the purposes of inspection and testing to any premises where Products are produced and/or stored. 5.5 The Licensee will undertake quality control inspections on Products as are reasonably required by DVSA from time to time and will keep true and accurate records of the manufacture and quality control procedures specified by DVSA and make such records available to DVSA upon demand. 5.6 The Licensee will during the term of this Licence Agreement use its reasonable endeavours to extend the sale of the Products worldwide. 5.7 If the Licensed Material is used for Research or Education, a copy of the Product will be delivered up to DVSA immediately it is published. 5.8 In the event that any of the provisions of this clause 5 are not complied with, in relation to any Products, all such Products will be destroyed or otherwise disposed of in accordance with any reasonable directions given to the Licensee by DVSA. The Licensee shall be allowed a reasonable time to carry out such directions and DVSA may at their discretion require sworn evidence of such destruction. 5.9 The Licensee will notify DVSA when the Product goes out of print or if they stop making the Product available.
Sample 1
Production and Supply 
Sample 1Sample 2

Related to Production and Supply

  • Manufacturing and Supply (a) Depomed shall supply Product for use in conducting Depomed’s development activities for Product in the Field and in the Territory as set forth in Exhibit D. (b) During the four-year period beginning on the Effective Date (the “Supply Period”), Depomed shall supply and package (or have supplied and packaged) Product pursuant to this Section 4.8. Depomed will use commercially reasonable efforts to enter into a long-term Product supply agreement with [***] days after the Effective Date (the “Depomed Supply Agreement”) that will be freely assignable to Solvay or its Affiliates, successors or assigns at any time. In addition, Depomed and Solvay will negotiate and enter into a Product supply agreement with business terms substantially similar to the Depomed Supply Agreement concurrently with the execution and delivery by Depomed and [***] of the Depomed Supply Agreement (the “Solvay Supply Agreement”, and, together with the Depomed Supply Agreement, the “Supply Agreements”). The Supply Agreements will, together, contain the following provisions (among others mutually agreeable to the Parties): (i) Under the Solvay Supply Agreement, Depomed will agree to supply Solvay with its requirements of finished, packaged Product during the Supply Period; (ii) All manufacturing and records will be performed and maintained in accordance with specifications, cGMP and Applicable Law; (iii) Depomed will provide reasonable assistance to Solvay in the event Solvay wishes to qualify a backup Product manufacturer; (iv) Depomed shall [***]; (v) Solvay will pay Depomed the following amounts in connection with all activities performed by or on behalf of Depomed associated with Product manufacture and supply (other than activities specified on Exhibit D) (A) [***]% of Depomed’s out-of-pocket costs incurred in connection with such manufacture and supply of Product to Solvay, and (B) a labor charge equal to the FTE Charges for all Depomed employees allocated to the manufacture and supply of Product to Solvay, not to exceed FTE Charges for an aggregate of [***] during any given calendar quarter (and Depomed shall provide to Solvay periodic reports detailing the FTE Charges for which Solvay must pay Depomed hereunder);

  • 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.

  • Introduction and Background The purpose of this Schedule 2 (Contract Services and Contract Supplies) is to set out the characteristics of the Contract Services and/or Contract Supplies (as the case may be) and Funding that the Provider will be required to make available to all Contracting Authorities in relation to Lot 1 and/or Lot 2 (as the case may be) and to provide a description of what the Contract Services and/or Contract Supplies (as the case may be) and Funding will entail.

  • Manufacture and Supply As between the Parties, Otsuka shall be responsible for, shall bear all costs associated with, and shall have all decision-making authority over, all Manufacturing Activities (subject to discussion of CMC matters with Acucela through the JDC or applicable Operating Team as discussed below); provided, that Otsuka shall supply Licensed Product to Acucela or its permitted subcontractors for use in clinical trials conducted in accordance with each Development Plan and, if applicable, Commercialization Plan (i.e., Phase 3b Clinical Trials or Post-Approval Studies, if any), free of charge and in such quantities as are agreed by the JDC or the JCC (as applicable) or are otherwise required to seek or obtain Regulatory Approval. In addition, if and after Acucela exercises an Opt-In Right under Section 3.1, Otsuka shall supply promotional samples of Licensed Product to Acucela for use in its performance of Co-Promotion, in such quantities and on such terms as are determined by the JCC. The cost of promotional samples of Licensed Product, which shall be included in Commercialization Costs, shall be established by the JCC based on Otsuka’s per-unit cost to manufacture such promotional samples (but, for the avoidance of doubt, Otsuka shall have no obligation to disclose any information relating to its manufacturing costs), but in no event shall such promotional sample cost exceed * per promotional sample unless mutually agreed otherwise by the Parties. Acucela’s and its permitted subcontractors’ obligations to conduct Development activities, and upon Acucela’s exercise of its Opt-in Right pursuant to Section 3.1, to conduct Development and Commercialization activities, shall be expressly conditioned upon Otsuka fulfilling its Licensed Product supply obligations as set forth in the Development Plan or the Commercialization Plan, as applicable. To the extent that Otsuka reasonably believes is necessary for performance of Development or Commercialization, Otsuka agrees to keep Acucela reasonably informed from time to time, through the JDC, JCC or applicable Operating Team, regarding the general status of Manufacturing Activities related to the Licensed Product (including Other Indication Product(s), as applicable) and from time to time shall update Acucela on any foreseeable delays and/or other material issues relating to Manufacturing the Licensed Product (including Other Indication Product(s), as applicable). Through the JDC or applicable Operating Team, Otsuka and Acucela shall confer and discuss CMC matters, and Otsuka agrees to consider suggestions of Acucela regarding CMC matters.

  • Supply Agreement Seller and Buyer, or their Affiliates, shall have executed the Supply Agreement.

  • Course Curriculum, Instruction, and Grading X. Xxxx College courses offered as dual credit, regardless of where they are taught, follow the same syllabus, course outline, textbook, grading method, and other academic policies as the courses outlined in the Hill College catalog. B. Approved courses being taught for dual credit must follow the approved master syllabus of the discipline and of Hill College. C. Textbooks should be identical to those approved for use by Hill College. Should an instructor propose an alternative textbook, the textbook must be approved in advance by the appropriate instructional department of Hill College and the Vice President of Instruction. Other instructional materials for dual credit/concurrent courses must be identical or at an equivalent level to materials used by Hill College. D. Courses which result in college‐level credit will follow the standard grading practices of Hill College, as identified by college policy and as identified in the appropriately approved course syllabus. The grades used in college records are A (excellent), B (above average), C (average), D (below average), F (failure), I (incomplete), W (withdrawn), WC (withdrawn COVID). The lowest passing grade is D. Grade point averages are computed by assigning values to each grade as follows: A = 4 points, B = 3 points, C = 2 points, D = 1 point, and F = 0 points. Grading criteria may be devised by Hill College and the ISD to allow faculty the opportunity to award high school credit only or high school and college credit depending upon student performance. E. Faculty, who are responsible for teaching dual credit/concurrent classes, are responsible for keeping appropriate records, certifying census date rosters, providing interim grade reports, certifying final grade reports at the end of the semester, certifying attendance, and providing other reports and information as may be required by Hill College and/or the School District.

  • 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. (b) The Supplier shall not change any process, material, component, packaging or manufacturing location without the Purchaser’s express prior written approval.

  • 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.

  • Introduction and Purpose Introduction • Neighbourhood Development Plans • Neighbourhood Development Orders

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