Product Changes definition

Product Changes as defined in Section 4.2.
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.
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 Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for confidential treatment and have been filed separately with the Securities and Exchange Commission. Confidential Treatment Requested by Kiniksa Pharmaceuticals, Ltd. 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.

Examples of Product Changes in a sentence

  • 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.

  • Notwithstanding the foregoing, if any such Product Changes in clause (c) are applicable to Products in both the Kiniksa Field and in the Regeneron Field, then, prior to the receipt of U.S. Marketing Approval, [***], unless otherwise agreed to by the Parties.

  • ALLERGAN shall be diligent in its efforts to obtain Manufacturing Authorization in the country of Manufacture to any Product Changes, with the support of GSK, in order to ensure that ALLERGAN may implement such Product Changes as soon as possible.

  • 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.

  • In addition, within [***] days following the end of each Quarter in which Kiniksa incurs any Out-of-Pocket Expenses with respect to filing any updates to the U.S. BLA associated with any Product Changes after the U.S. BLA Transfer Date, Kiniksa shall deliver electronically to Regeneron a written “flash” report setting forth Kiniksa’s good faith estimate of such amounts.

  • 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.

  • At any time and from time to time while this Agreement remains in force, Transamerica may request that Allmerica Financial enhance, modify or otherwise change the Policy Forms ("Product Changes") or develop new variable life insurance products ("New Products"), including New Products to be developed for sale in New York State.

  • GSK shall be diligent in its efforts to obtain approvals from a Regulatory Authority of amendments to Marketing Authorizations in the Territory to any Product Changes, with the support of ALLERGAN, in order to ensure that ALLERGAN may implement such Product Changes as soon as possible.

  • Class D Product Changes are design improvements, component changes, or other minor improvements not sufficiently significant as to require a Class B classification.

  • Supplier agrees to perform and administer all "Product Changes" in accordance with Xxxx Communications Research document GR 209 CORE, Issue 2, January 1996, titled "Generic Requirements for Product Change Notices", which is incorporated herein by reference.


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.
Product Changes shall be administered in accordance with Xxxx Communications Research document GR 209 CORE, Issue 2, January 1996, titled "Generic Requirements for Product Change Notices," which is incorporated herein by reference. Supplier may make changes to MATERIAL, modify drawings, or make changes to manufacturing specifications, provided the changes, modifications, or substitutions DO NOT have an impact on the performance, reliability, Form, Fit, or Function of the MATERIAL without prior notification to Company. Supplier shall maintain written records of all such changes, and make these records available for Company's review upon request. For such changes or modifications which DO have an impact on performance, reliability, Form, Fit, or Function, Supplier shall identify each such change or modification in accordance with the classifications contained in the above Xxxx Communications Research document via a Product Change Notification (PCN) form. The Company shall immediately acknowledge receipt of the PCN to the address/contact as stated on the PCN form and shall have thirty (30) calendar days to advise Supplier if the proposed change or modification is unacceptable. If Company notifies Supplier as required herein, that the proposed change or modification is unacceptable, Supplier shall not implement such change or modification. Company may reject any MATERIAL offered by Supplier which has been changed or modified in a manner unacceptable to Company. If Company has not notified Supplier that the change or modification is unacceptable within thirty (30) calendar days following issuance of the Change Notification, Supplier shall implement the change or modification as described in the Change Notification. If during the review of a proposed PCN, which has a classification of either A or AC, issued by Supplier during the Warranty period of the affected MATERIAL, the Company determines that implementation of the PRODUCT CHANGE will cause the Company to incur "unreasonable expenses" such as, but not limited to, expenses resulting from escorting Supplier's personnel to numerous Company locations containing affected MATERIAL or repeated product changes to the same item of MATERIAL within a one (1) year time period, the Company shall so notify Supplier, in writing, prior to the implementation of such PRODUCT CHANGE. Upon such notification, the Company and Supplier shall jointly determine the implementation procedure which will utilize the Supplier's and/or Company's personn...
Product Changes. We may upgrade or alter the Product Hardware or Software at any time.
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 [****].
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.
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.

Related to Product Changes

  • Product Schedule means PTC’s standard order form entitled “PTC Product Schedule” (including all schedules, attachments and other document(s) specifically referenced therein) or such alternative order form as may be submitted by Customer and accepted by PTC, in each case that specifies (i) the Licensed Products and/or Services ordered; and (ii) for Licensed Products, the installation address (including the Designated Country) and the Licence Term.

  • Product Labeling means, with respect to a Licensed Product in a country or other jurisdiction in the Territory, (a) the Regulatory Authority-approved full prescribing information for such Licensed Product for such country or other jurisdiction, including any required patient information, and (b) all labels and other written, printed, or graphic matter upon a container, wrapper, or any package insert utilized with or for such Licensed Product in such country or other jurisdiction.

  • Alternative nicotine product means any vaping product, whether or not it includes nicotine, including electronic smoking devices, that can be ingested into the body by chewing, smoking, absorbing, dissolving, inhaling, or by any other means. ‘Alternative nicotine product’ does not include:

  • 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.

  • Diagnostic clinical procedures manual means a collection of written procedures that describes each method (and other instructions and precautions) by which the licensee performs diagnostic clinical procedures; where each diagnostic clinical procedure has been approved by the authorized user and includes the radiopharmaceutical, dosage, and route of administration.

  • Back Ordered Products If product is not expected to ship within the time provided to the TIPS Member by the Vendor, the Member is to be notified within 3 business days and appropriate action taken based on customer request. The TIPS Vendor Agreement Signature Page is inserted here.

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

  • New Products means any product which is not an Enhanced Product or 2 Existing Product but which is substantially similar to an Existing Product with respect to design and function and possesses reasonable performance improvements. If Company desires to purchase an Enhanced or New Product(s) from Supplier, Company shall so notify Supplier and provide Supplier the opportunity to manufacture such Enhanced or New Product(s), subject to the following conditions and procedures.

  • Product Backlog means a list of those Stories that do not form part of the current Sprint Plan at that time and which are to form the subject of a future Sprint, either in the current Release at that time or a subsequent Release;

  • Existing Product means any formulation of the same product category and form sold, supplied, manufactured, or offered for sale in California prior to the following dates, or any subsequently introduced identical formulation:

  • Covered Products means Your Applications, Libraries, Passes, Safari Extensions, Safari Push Notifications, and/or FPS implementations developed under this Agreement.

  • Manufacturing Process means any process for—

  • Product Specifications means the specifications, features and/or terms of any "Contract" (as defined in the LME Rules) listed for trading on the LME, as described in the LME Rules;

  • New Product means the Synology-branded hardware product and Synology-branded accessories contained in the original packaging Customer bought from an authorized Synology distributor or reseller. You may see our “New Product” at Product Support Status.

  • Monitoring Indicator means a measure of HSP performance that may be monitored against provincial results or provincial targets, but for which no Performance Target is set;

  • Development Schedule shall have the meaning set forth in Section 1.1.

  • Covered Product The consumer product that You purchased concurrently with and is covered by this Agreement.

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

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

  • Commercialization Plan has the meaning set forth in Section 6.2.

  • Commercialization or “Commercialize” means activities directed to marketing, promoting, research and development as required, manufacturing for sale, offering for sale, distributing, importing or selling a product, including sub-licensing or sub-contracting of these activities.

  • Clinical Studies means Xxxxx 0, Xxxxx 0, Xxxxx 0, Xxxxx 3, and such other tests and studies in human subjects that are required by Applicable Law, or otherwise recommended by the Regulatory Authorities, to obtain or maintain Regulatory Approvals for a Licensed Product for one (1) or more indications, including tests or studies that are intended to expand the Product Labeling for such Licensed Product with respect to such indication.

  • Third Party Components means software and interfaces, licensed by RIM from a third party for incorporation into a RIM software product, or for incorporation into firmware in the case of RIM hardware products, and distributed as an integral part of that RIM product under a RIM brand, but shall not include Third Party 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;

  • Collaboration Product means a pharmaceutical product containing or comprising Compound in any dosage form alone, or in combination with, one or more other pharmaceutically active ingredients, and any and all Improvements thereto.