Product Changes definition

Product Changes as defined in Section 4.2.
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Product Changes means any changes, improvements, alterations, modifications, new generations, and substitutions to or of the Products or the Products' labelling to include content, size, adhesive, ink, bottles or seals.
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Product Changes means changes to the dose, formulation, delivery, or form of any Product, or other changes to the method of Manufacturing of any Product for Commercialization in the Kiniksa Field in the Territory as compared to the dose, formulation, delivery, or form of such Product in the Existing Product Formulation, or other changes to the method of Manufacturing agreed by the Parties under any Supply Agreement or Quality Agreement.
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Examples of Product Changes in a sentence

  • Examples of such possible actions include, but are not limited to, the following: Product recall or disuse; Dosage modification; Clinical trial suspension; Restrictions on distribution (including scheduling/rescheduling of the Product); Changes in indication; Urgent safety restrictions; Any changes to the local product information or packaging due to safety reasons; Failure to obtain a MA renewal; MA withdrawal or suspension; and/or Discontinuation of production or import.

  • For the avoidance of doubt, Qorvo may discontinue any Instrument in its sole discretion so long as Qorvo complies with this Section 7.6 (Product Changes).

  • Notwithstanding the foregoing, SMI shall not make any Product Changes that disqualify Products for sale under any regulatory or other approval governing the sale or distribution of Products within any portion of the Territory.

  • Product Changes: ▇▇▇▇▇-▇▇▇▇▇ is constantly working to improve products.

  • So long as Regeneron is Manufacturing the Product under a Supply Agreement, Regeneron shall use Commercially Reasonable Efforts to implement (or have implemented) any Product Changes required under Applicable Law in the Territory.

  • Subject to Section 7 (Product Changes), each Order will be billed at the quoted price for sixty (60) calendar days from the date of such quote, and thereafter at the price in effect at the time of shipment.

  • Prior the U.S. BLA Transfer Date, Regeneron shall prepare any necessary supplementary Registration Filings for the Product in the Kiniksa Field in the Territory with respect to any Product Changes and provide such Registration Filings to Kiniksa for its review and comment reasonably in advance of the filing thereof (and use good faith efforts to incorporate any such comments), and Regeneron shall be responsible for filing such Registration Filings with respect to such Product Changes.

  • After the U.S. BLA Transfer Date, Kiniksa, in consultation with Regeneron, shall prepare any necessary supplementary Registration Filings for the Product in the Kiniksa Field in the Territory with respect to any Product Changes, and Kiniksa shall be responsible for filing such Registration Filings with respect to any such Product Changes and shall file any updates to the U.S. BLA that may be associated with any such Product Changes.

  • Subject to Section 7 (Product Changes), each Order will be billed at the quoted price for ten (10) calendar days from the date of such quote, and thereafter at the price in effect at the time of shipment.

  • Regeneron shall use Commercially Reasonable Efforts to implement (or have implemented) all Product Changes requested by Kiniksa to the extent approved by Regeneron, such approval not to be unreasonably withheld, conditioned, or delayed.


More Definitions of Product Changes

Product Changes. Except for the Required Changes defined in Section 11.1.2 below, Schering shall not make or allow to be made any changes to the Product, Specifications, Manufacturing or Packaging that would require variations to the Marketing Authorization or notification in any country of the Territory, without the prior written consent of Pharmion, such consent not to be unreasonably withheld or delayed. Schering will use Commercially Reasonable Efforts to ensure that the timing of Schering's notice to Pharmion of any such change shall permit adequate time for Pharmion to make any necessary regulatory filings and obtain any necessary approval of the corresponding variation to the Marketing Authorization thereof from Agencies prior to the change being implemented.
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Product Changes shall be administered in accordance with ▇▇▇▇ Communications Research document GR 209 CORE, Issue 2, January 1996, titled "Generic Requirements for Product Change Notices," which is incorporated herein by reference.
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Product Changes means any material changes, improvements, alterations, modifications, upgrades, new generations, and substitutions to or of the Products or the Products' labeling relating to the form, fit, function, or appearance of the Products. Product Changes shall be deemed to (a) include Product software fixes, updates, and upgrades which, when incorporated, result in variations from the original operational specifications and designs; and (b) exclude Product software fixes, updates, and minor upgrades (as set forth in Section 3.9) that merely affect the speed or efficiency of the Products or constitute minor error or "bug" fixes.
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Product Changes means those mechanical, electrical or Specification changes, changes in suppliers or subcontractors, made to or with respect to the Evergreen-Products or the manufacture process which, if made, could affect the schedule, performance, quality, reliability, availability, serviceability, appearance, dimensions, tolerances, safety or costs. EverQ is, [****], allowed to make Product Changes that do not affect customer interests pursuant to the Contracts. Product changes which may affect the performance, quality, reliability, serviceability, appearance, dimensions and the tolerances, safety of Evergreen-Products and affecting customer interests pursuant to the Contracts only become effective if approved by Evergreen, nevertheless such approval shall only be denied on a reasonable basis. Evergreen shall use its commercially reasonable efforts to provide for respective adjustment clauses [****].
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Product Changes. We may upgrade or alter the Product Hardware or Software at any time.
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Product Changes means those mechanical, electrical or Specification changes, changes in suppliers or subcontractors, made to or with respect to the Products or the manufacture process which, if made, could affect the schedule, performance, quality, reliability, availability, serviceability, appearance, dimensions, tolerances, safety or costs. EverQ is, [****], allowed to make Product Changes that do not affect customer interests in existing Product Sales Transactions. Product Changes affecting customer interests in existing Product Sales Transactions only become effective if approved by Evergreen, nevertheless such approval shall only be denied on a reasonable basis. Evergreen shall use its reasonable efforts to provide for respective adjustment clauses [****]. Should Q-Cells and/or REC develop a proprietary product design that provides cost and/or product advantages the Parties will negotiate in good faith to enable said design to be manufactured and sold under the terms of this Agreement.
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Related to Product Changes

  • Product Schedule means a product schedule documenting the specific terms and conditions applying to a Product as may be amended, updated or replaced from time to time (and includes any Electronic Platform Schedules);

  • Product Labeling means, with respect to a particular pharmaceutical product and a particular country, (a) the full prescribing information for the product approved by the applicable Regulatory Authorities in such country, including any required patient information; and (b) all labels and other written, printed or graphic matter physically upon a container, wrapper or any package insert utilized with or for the product in such country.

  • Alternative nicotine product means any noncombustible product containing nicotine that is intended 766 for human consumption, whether chewed, absorbed, dissolved, or ingested by any other means. 767 "Alternative nicotine product" does not include any nicotine vapor product, tobacco product, or product 768 regulated as a drug or device by the U.S. Food and Drug Administration (FDA) under Chapter V (21 769 U.S.C. § 351 et seq.) of the Federal Food, Drug, and Cosmetic Act.

  • Manufacturing Site means a location where a manufacturing

  • Detailed manufacturing or process data means technical data that describe the steps, sequences, and conditions of manufacturing, processing or assembly used by the manufacturer to produce an item or component or to perform a process.