Product Changes definition

Product Changes as defined in Section 4.2.
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Product Changes means any material changes, improvements, alterations, modifications, new applications, and additional specifications to or of the Products or the Products' labeling.
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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 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.
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Examples of Product Changes in a sentence

  • Product Changes – Both product design changes and new product opportunities can give the policyholder more choices.

  • It is therefore necessary that each submittal to SEI include sufficient product description information, which is achieved by a complete components and materials listing to uniquely and unambiguously identify the product model in question (see Section 14: Product Changes).

  • Lukens, Anticompetitive Product Changes in the Pharmaceutical Industry, 41 RUTGERS L.J. 1 (2009); Matthew Avery & Mary Nguyen, The Roadblock for Generic Drugs: Declaratory Judgment Jurisdiction for Later Generic Challengers, 15 N.C. J.L. & TECH.

  • With regard to PHMSA’s Advisory Bulletin and associated Guidance to Operators Regarding Flow Reversals, Product Changes and Conversion to Service dated September 18, 2014, the advisory bulletin is based upon 49 CFR parts 192 and 195 and lessons-learned/ findings from inspections of operator facilities for construction, operations, maintenance, and integrity management and, therefore, is still applicable.

  • MA, MAPD and PDP Plan and Product Changes Enrolled Medicare members may elect to choose different plan options and Products from one year to the next or even in the same year.

  • Action Item: Product Changes Regarding Water LossesSteve Bitar: The next item will take a little bit of time if you can indulge me.

  • Product Changes Xxxxxx Industries reserves the right to discontinue or make changes to an existing product.

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

  • Costs associated with any subsequent Default Rate Product Changes will be charged to the Member.

  • Medicare Product Changes Medicare members may elect to choose different Medicare Product options and Medicare Products from one year to the next or even in the same year.


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 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...
Sample 1
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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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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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 the facilities where a Compound is Manufactured by or on behalf of a Party, as such Manufacturing Site may change from time to time in accordance with Section 8.7.

  • 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, customer is to be notified within 3 business days and appropriate action taken based on customer request. Vice-President of O 3/28/19 Xxxxxxxx Xxxxxx perations erations The Interlocal Purchasing System (TIPS Cooperative) Supplier Response Bid Information Contact Information Ship to Information Bid Creator Xxxx Xxxxxx General Address Region VIII Education Address Counsel/Procurement Service Center Compliance Officer 0000 XX Xxxxxxx 000 Email xxxx.xxxxxx@xxxx-xxx.xxx North Contact Phone (000) 000-0000 Pittsburg, TX 75686 Fax Contact Xxxxxxx Xxxxxxx, Department Contracts Compliance Building Bid Number 190101 Specialist Title Safety Equipment, Supplies Floor/Room and Services Department Telephone Bid Type RFP Building Fax Issue Date 1/7/2019 08:01 AM (CT) Email Close Date 2/15/2019 03:00:00 PM (CT) Floor/Room Telephone +0 (000) 000-0000 Fax +0 (000) 000-0000 Email xxxx@xxxx-xxx.xxx Supplier Information Company Northern Imports (Work Wear Safety Shoes) Address 6318 Airport Freeway Suite C Fort Worth, TX 76117 Contact Department Building Floor/Room Telephone (000) 000-0000 Fax (000) 000-0000 Email Submitted 2/13/2019 11:58:28 AM (CT) Total $0.00 By submitting your response, you certify that you are authorized to represent and bind your company. Signature Xxxxxx X Xxxxxxxx Email xxxxx.xxxxxxxx@xxxxxxxxxxxxx.xxx Supplier Notes Work Wear Safety Shoes has enjoyed our vendor relationship with TIPS Coop and the governmental agencies that have used the TIPS Coop to make safety boot purchases. By submitting this bid we seek to strengthen and grow our business with the TIPS Coop. Thank you for the business! Xxxxxx X Xxxxxxxx Bid Notes Bid Activities Bid Messages Bid Attributes Please review the following and respond where necessary # Name Note Response 1 Yes - No Disadvantaged/Minority/Women Business Enterprise - D/M/WBE (Required by some participating governmental entities) Vendor certifies that their firm is a D/M/WBE?Vendor must upload proof of certification to the ”Response Attachments” D/M/WBE CERTIFICATES section. NO 2 Yes - No Historically Underutilized Business - HUB (Required by some participating governmental entities) Vendor certifies that their firm is a HUB as defined by the State of Texas at xxxxx://xxxxxxxxxxx.xxxxx.xxx/purchasing/vendor/hub/ No or in a HUBZone as defined by the US Small Business Administration at xxxxx://xxx.xxx.xxx/offices/headquarters/ohp Proof of one or both may be submitted. Vendor must upload proof of certification to the “Response Attachments” HUB CERTIFICATES section.

  • 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 those Manufacturing, performance, quality - control release, and Fill/Finish specifications for Drug Substance or Licensed Product in the Territory, which are initially as set forth in the applicable Regulatory Approval for a Licensed Product, as such specifications may be amended from time to time pursuant to the terms of this Agreement.

  • 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, 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.

  • 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 human clinical trials for a Licensed Product and any other tests and studies for a Licensed Product in human subjects.

  • 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.