Acceptance Activities Sample Clauses

Acceptance Activities. 1. Supplier shall maintain processes to ensure goods and/or services conform to Align requirements, including as appropriate, incoming, in- process and final acceptance activities. Records of acceptance activities shall be maintained. Records shall include the acceptance activity performed, date performed, the results, the individual conducting the acceptance activity and the equipment used. Supplier shall provide a Certificate of Conformance and/or Analysis for each lot or batch of product shipped, or for the service provided.
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Acceptance Activities. 1.1 For each Test Stage the Test Strategy shall set out the Stage Entry Criteria and Stage Exit Criteria and acceptance procedures. This may be subject to elaboration in the specific Contractor’s Test Approaches and
Sample 1
Acceptance Activities. 14.1. For each lot of Customized Insulet Devices, Insulet shall require [*] to conduct identification, sampling and testing in accordance with the Lot Release Procedures in Appendix B. A lot of Customized Insulet Devices Manufactured by [*] that, based on the performance of and results from the Lot Release Procedures and comparison to release criteria set forth in the Lot Release Procedures in Appendix B, is appropriate for release by [*] (each an “In-Process Conforming Lot”). In-Process Conforming Lots will proceed to sterilization in accordance with the Sterilization/[*] Procedures. For each In-Process Conforming Lot that completes the Sterilization/[*] Procedures, and is shipped to Insulet, Insulet will perform lot qualification testing per Lot release procedure in Appendix B. The lot passes acceptance criteria and Insulet release requirement will become Conforming Lot, and prior to ship to Amgen, Insulet will provide to Amgen electronic versions of the DHRs (Device History Record) and a Certificate of Conformance that will contain the following information:
Sample 1
Acceptance Activities. Supplier shall maintain processes to ensure Products or Services conform to MDT requirements, including as appropriate, incoming, in-process and final acceptance activities. Records of acceptance activities shall be maintained. Records shall include the acceptance activity performed, date performed, the results, the individual conducting the acceptance activity and the equipment used. Where required by MDT, Supplier shall provide a Certificate of Conformance and/or Analysis for each lot or batch of product shipped, or for the service provided. CHANGE CONTROL. Any process changes, design changes or deviations considered by the Supplier and/or sub-tier must be submitted to MDT for review and must include a detailed description of the change and its effects to the Products and/or Services characteristics. AUDITS/INSPECTIONS Supplier agrees that MDT, any government, notified body, commission, board, regulatory agency, court or other instrumentality having any jurisdiction over all aspects of the design, manufacturing and distribution of the Products ("Authority"), shall have access to and the right to inspect or audit any pertinent Product manufacturing or quality processes, and associated documentation or records. The Supplier may specifically be subject to scheduled or unannounced audits (per EU Recommendation 2013/473/EU). During unannounced audits, the Supplier must allow the Authority to witness the testing of Product samples, and/or if requested, provide samples of Product for independent testing by the Authority. If issues or findings are identified during an audit that potentially impact product or service quality, performance or availability, Supplier shall promptly notify MDT and agree to cooperate regarding communications with FDA, regulatory, or government authority. LABELING, PACKAGING, HANDLING & STORAGE Supplier shall ensure that packaging and shipping containers are of adequate design and construction to protect product from damage, deterioration or alteration during handling, storage and distribution. Expiration dates and any required storage conditions shall be clearly recorded on the labelling, packaging and shipping documents. Supplier shall create and store labels and perform labelling operations in a way that prevents an incorrect label from being used. SHIPMENT Supplier shall have systems in place to control shipment of Products so that only Products approved for release are shipped. Supplier shall ensure that no obsolete, rejected, expi...
Sample 1

Related to Acceptance Activities

  • Activities Except with the prior written consent of the Board, Executive will not during his employment with the Company undertake or engage in any other employment, occupation or business enterprise, other than ones in which Executive is a passive investor. Executive may engage in civic and not-for-profit activities so long as such activities do not materially interfere with the performance of his duties hereunder.

  • Restricted Activities The Executive agrees that some restrictions on his activities during and after his employment are necessary to protect the goodwill, Confidential Information and other legitimate interests of the Company and its Affiliates:

  • Leasing Activities Manager shall be the exclusive leasing agent of the Project, and shall perform all leasing functions relating to the Project. As provided in Article IX hereof, Manager shall be paid for such leasing activities in conformity with Schedule 5 to this Agreement, which amounts shall be in addition to the compensation otherwise payable to Manager hereunder. Without limiting the generality of the foregoing, Manager's leasing function includes the following:

  • Outside Activities Subject to the Articles of Incorporation and any agreements entered into by the General Partner or its Affiliates with the Partnership or a Subsidiary, any officer, director, employee, agent, trustee, Affiliate or stockholder of the General Partner shall be entitled to and may have business interests and engage in business activities in addition to those relating to the Partnership, including business interests and activities substantially similar or identical to those of the Partnership. Neither the Partnership nor any of the Limited Partners shall have any rights by virtue of this Agreement in any such business ventures, interest or activities. None of the Limited Partners nor any other Person shall have any rights by virtue of this Agreement or the partnership relationship established hereby in any such business ventures, interests or activities, and the General Partner shall have no obligation pursuant to this Agreement to offer any interest in any such business ventures, interests and activities to the Partnership or any Limited Partner, even if such opportunity is of a character which, if presented to the Partnership or any Limited Partner, could be taken by such Person.

  • Affiliate Activities The Borrowers and Holdings acknowledge that each Agent and each Arranger (and their respective Affiliates) is a full service securities firm engaged, either directly or through affiliates, in various activities, including securities trading, investment banking and financial advisory, investment management, principal investment, hedging, financing and brokerage activities and financial planning and benefits counseling for both companies and individuals. In the ordinary course of these activities, any of them may make or hold a broad array of investments and actively trade debt and equity securities (or related derivative securities) and/or financial instruments (including bank loans) for their own account and for the accounts of customers and may at any time hold long and short positions in such securities and/or instruments. Such investment and other activities may involve securities and instruments of Holdings and its Affiliates, as well as of other entities and persons and their Affiliates which may (i) be involved in transactions arising from or relating to the engagement contemplated hereby and by the other Loan Documents, (ii) be customers or competitors of Holdings and its Affiliates or (iii) have other relationships with Holdings and its Affiliates. In addition, it may provide investment banking, underwriting and financial advisory services to such other entities and persons. It may also co-invest with, make direct investments in, and invest or co-invest client monies in or with funds or other investment vehicles managed by other parties, and such funds or other investment vehicles may trade or make investments in securities of Holdings and its Affiliates or such other entities. The transactions contemplated hereby and by the other Loan Documents may have a direct or indirect impact on the investments, securities or instruments referred to in this clause.

  • Regulated Activities The Company shall not itself, nor shall it cause, permit or allow the Bank or any other of its Subsidiaries to (i) engage in any business or activity not permitted by all applicable laws and regulations, except where such business or activity would not reasonably be expected to have a Material Adverse Effect on the Company, the Bank and/or such of its Subsidiaries or (ii) make any loan or advance secured by the capital stock of another bank or depository institution, or acquire the capital stock, assets or obligations of or any interest in another bank or depository institution, in each case other than in accordance with applicable laws and regulations and safe and sound banking practices.

  • Permitted Activities The Executive shall devote his entire business time, attention and energies to the Business of the Employer and shall not during the Term be engaged (whether or not during normal business hours) in any other business or professional activity, whether or not such activity is pursued for gain, profit or other pecuniary advantage; but this shall not be construed as preventing the Executive from:

  • Competitive Activities During the term of this Agreement, Consultant will not, directly or indirectly, in any individual or representative capacity, engage or participate in or provide services to any business that is competitive with the types and kinds of business being conducted by Company.

  • Regulatory Activities Beginning on the Effective Date and to the extent UGNX remains the Lead Development Party with respect to a particular territory, subject to and in accordance with the terms and conditions of this Agreement and the requirements of Applicable Laws, UGNX, shall: (a) use Commercially Reasonable Efforts to file (or have filed) all Regulatory Filings with respect to the Licensed Products in the Field in order to obtain Marketing Approvals in each country in the Territory and the European Territory (or to obtain the European Centralized Approval in the European Core Territory) and in order to obtain Pricing and/or Reimbursement Approvals in the Profit Share Territory; (b) respond in a timely fashion to requests for data and information from Regulatory Authorities with respect to the Licensed Products in the Field in the Territory and the European Territory; and (c) meet with officials of the Regulatory Authorities at such times as may be requested by such Regulatory Authorities with respect to the Core Development Activities (“Regulatory Activities”), provided that KHK will have primary responsibility for obtaining, and UGNX shall provide all assistance reasonably requested by KHK, in relation to Pricing and/or Reimbursement Approvals for the Licensed Products in the Field in the European Territory. For the avoidance of doubt, UGNX will be responsible for obtaining, and KHK will provide all assistance reasonably requested by UGNX, in relation to Pricing and/or Reimbursement Approvals, if any, for the Licensed Products in the Field in the Profit Share Territory as part of the UGNX Core Development Activities, it being understood that the costs incurred by UGNX in connection with such activities will be shared equally (50/50). All such Regulatory Activities will be conducted in a manner consistent with the Core Development Plan and coordinated by the JSC in accordance with Article 3. Without limiting the applicability of the foregoing and the remainder of this Article 5, UGNX shall interface with the applicable Regulatory Authority(ies) and, through the JDC, shall keep KHK reasonably informed of all material events and developments occurring in the course of the Regulatory Activities, including scheduled UGNX regulatory strategy discussions and meetings with Regulatory Authorities in the Territory and the European Territory relating to the Licensed Products in the Field.

  • ADDITIONAL ACTIVITIES I agree that during the period of my employment by the Company I will not, without the Company's express written consent, engage in any employment or business activity which is competitive with, or would otherwise conflict with, my employment by the Company. I agree further that for the period of my employment by the Company and for one (l) year after the date of termination of my employment by the Company I will not induce any employee of the Company to leave the employ of the Company.

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