Production File Changes Sample Clauses

Production File Changes. 5.4.1. Initiated by Com21 From time to time during the Term, Com21 may issue a change request by giving an Engineering Change Order ("ECO") to Manufacturer that states one or more changes to a Production File or the Manufacturing Specifications. Com21's ECO shall specify whether Com21's requested change is a Class 1 ECO or Class 2 ECO. A "Class 1 ECO" is an engineering change that must be implemented within Twenty Four (24) hours after receipt of notice and before additional Products are delivered to Com21. A "Class 2 ECO" is an engineering change that will be implemented at a mutually agreeable time. Manufacturer shall, without additional charge to Com21 and within the time specified in the ECO but generally not more than two (2) business days from Com21's issuance of the ECO, provide information regarding factors that may affect implementation of the changes described in the ECO. This shall include any special costs associated with implementation or special research required to validate the proposed change, and any cost impact on the Product. If, after receiving Manufacturer's response, Com21 wishes to implement the changes described in the ECO, Com21 shall issue a Final or Released ECO to Manufacturer. 5.4.2. Initiated by Manufacturer If Manufacturer wishes to initiate a change to a Production File or the Manufacturing Specifications, Manufacturer shall furnish to Com21 a proposed change notice ("Proposed Change Notice") together with information regarding factors that may affect implementation, and cost associated with implementation (one-time and on-going). Manufacturer shall supplement the Proposed Change Notice with such additional information as Com21 may reasonably request at any time ("Supplemental Information"). Com21 shall not be deemed to have completed its assessment, and shall be under no obligation to respond to a Proposed Change Notice, until Com21 has received and analyzed the Proposed Change Notice, the Supplemental Information, and such other information regarding the business, financial and technical particulars as Com21 may in its sole discretion deem necessary or advisable. Com21 may decline any Proposed Change Notice in Com21's absolute discretion. If Com21 wishes to implement an engineering change as described in Manufacturer's Proposed Change Notice, Com21 shall issue a Final ECO to Manufacturer. For change requests initiated by Manufacturer, Manufacturer will be responsible for all tooling and other costs incurred and will reimbu...
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Production File Changes 

Related to Production File Changes

  • Product Changes Vocera shall have the right, in its absolute discretion, without liability to End User, to update to provide new functionality or otherwise change the design of any Product or to discontinue the manufacture or sale of any Product. Vocera shall notify End User at least 90 days prior to the delivery of any Product which incorporates a change that adversely affects form, fit or function (“Material Change”). Vocera shall also notify End User at least 90 days prior to the discontinuance of manufacture of any Product. Notification will be made as soon as reasonably practical for changes associated with regulatory or health and safety issues.

  • Development Reports Beginning six months after Effective Date and ending on the date of first commercial sale of a Licensed Product in the United States, LICENSEE shall report to Cornell progress covering LICENSEE's (and Affiliate's and Sublicensee's) activities and efforts in the development of rights granted to LICENSEE under this Agreement for the preceding six months. The report shall include, but not be limited to, activities and efforts to develop and test all Licensed Products and obtain governmental approvals necessary for marketing the same. Such semi-annual reports shall be due within sixty days (60) of the reporting period and shall use the form as provided herein as Appendix C.

  • Development Records Each Party shall maintain complete, current and accurate records of all Development activities conducted by it hereunder, and all data and other information resulting from such activities. Such records shall fully and properly reflect all work done and results achieved in the performance of the Development activities in good scientific manner appropriate for regulatory and patent purposes. Each Party shall document all non-clinical studies and Clinical Trials in formal written study reports according to Applicable Laws and national and international guidelines (e.g., ICH, cGCP, cGLP, and cGMP).

  • Program Changes Contractor agrees to inform the County of any alteration in program or service delivery at least thirty (30) days prior to the implementation of the change, or as soon as reasonably feasible.

  • Commercialization Reports Throughout the term of this Agreement and during the Sell-Off Period, and within thirty (30) days of December 31st of each year, Company will deliver to University written reports of Company’s and Sublicensees’ efforts and plans to develop and commercialize the innovations covered by the Licensed Rights and to make and sell Licensed Products. Company will have no obligation to prepare commercialization reports in years where (a) Company delivers to University a written Sales Report with active sales, and (b) Company has fulfilled all Performance Milestones. In relation to each of the Performance Milestones each commercialization report will include sufficient information to demonstrate achievement of those Performance Milestones and will set out timeframes and plans for achieving those Performance Milestones which have not yet been met.

  • Contract Database Metadata Elements Title: Xxxxxxx-Xxx Xxxxx Central School District and Xxxxxxx-Xxx Xxxxx Teachers Association (2007)

  • Updates and Upgrades Contractor grants to the Eligible User a non-exclusive, non-transferable license to use upgrades and updates provided by Contractor during the Contract Period. Upgrades and updates are subject to the terms of this Contract. The Eligible User reserves the right to accept updates and upgrades at its discretion and to determine if such updates comply with the requirements in the Contract scope of work.

  • Technical Specifications The Technical Specifications furnished on the CD are intended to establish the standards for quality, performance and technical requirements for all labor, workmanship, material, methods and equipment necessary to complete the Work. When specifications and drawings are provided or referenced by the County, these are to be considered part of the Scope of Work, and to be specifically documented in the Detailed Scope of Work. For convenience, the County supplied specifications, if any, and the Technical Specifications furnished on the CD.

  • Project Changes Project changes prior to bid opening shall be made by addendum to plans and specifications. Changes after bid opening shall be made by change order. The Local Government shall submit all addenda and all change orders to the Department for an eligibility determination. After execution of all construction, equipment and materials contracts, the Project contingency may be reduced.

  • Updates “Updates” are changes that do not require a change to the established Centralized Contract terms and conditions. Updates may include: Centralized Contract changes and updates made in accordance with the previously approved pricing formula (e.g. discount from list price); adding new products or services within the established, previously approved pricing structure; lowering pricing of products or services already on Contract, deleting products or services available through the Centralized Contract, adding product or service that do not fall under the previously established price structure or discounts under the Contract, re-bundled products, and other updates not listed above that are deemed to be in the best interest of the State and do not result in a change to the established Centralized Contract terms and conditions. Updates must be submitted to OGS for review, and must be accompanied by a justification of reasonableness of price if the change results in a change in pricing methodology. OGS will notify Contractor in writing if approved.

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