Field Alerts Sample Clauses

Field Alerts. ELITE shall notify PRECISION DOSE immediately of any failure that meets Field Alert Report criteria. ELITE shall notify the District Office within three (3) working days of the failure for ELITE labeled Product. PRECISION DOSE is obligated to report any potential problems or issues with the Product to ELITE within 24 hours from the time such information is known.
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Field Alerts. Distributor shall be responsible for all processing of information related to any field alert report related to Product in the Territory, except for any Product quality or manufacturing defects not in the purview of the Distributor. Distributor shall be responsible for preparing all such applicable field alert reports and submit such reports to Prestwick for its review and subsequent filing with the applicable Governmental Authority in accordance with all applicable Laws.
Field Alerts. Product issues arising from stability data or other manufacturing issues that meet Field Alert Report criteria, once confirmation is received that such criteria is met, will be promptly communicated to Purchaser. Purchaser and Seller will jointly evaluate and prepare reports for filing by Seller, as required by law.
Field Alerts. The parties will exchange any information received by either party which may meet Field Alert Report criteria (21 CFR 314.81b1). Wherever possible the parties will discuss the necessity of filing a field alert report and collaborate in the submission thereof. CV will forward a copy of any such report
Field Alerts. BPI shall be responsible for all processing of information related to any NDA field alert report related to the Product in the Territory. Kos shall immediately (and in all cases in within time frames necessary to allow BPI and its Affiliates to comply with requirements under applicable Law) forward copies of all such information to BPI and shall otherwise cooperate with BPI to allow BPI and its Affiliates to comply with requirements under applicable Law. BPI shall be responsible for preparing all NDA field alert reports and submitting such reports to the FDA in accordance with all applicable Law and BPI shall submit a copy thereof to Kos at the time of submission to the FDA.
Field Alerts. Purpose This section defines the system for managing field alerts related to the Product. Procedure KING shall be the responsible party for any FDA contacts and for filing any field alerts. KING shall send copies of any field alerts to SUPPLIER. SUPPLIER shall notify KING within twenty-four (24) hours of discovery if any batch of Product could be subject to a field alert. Where a supplier manufacturing, packaging, or testing evaluation is required for a field alert report, _____________ commits to completing the required evaluation in a timely manner as the situation warrants. Section 7.0

Related to Field Alerts

  • API If the Software offers integration capabilities via an API, your use of the API may be subject to additional costs or Sage specific policies and terms and conditions (which shall prevail in relation to your use of the API). You may not access or use the API in any way that could cause damage to us or the Software, or in contravention of any applicable laws. We reserve the right in our sole discretion, to: (i) update any API from time to time; (ii) place limitations around your use of any API; and (iii) deny you access to any API in the event of misuse by you or to otherwise protect our legitimate interests.

  • PRODUCT MANUFACTURER'S SUPPLIERS Only those dealers/distributors listed by the manufacturer will be considered authorized to act on behalf of the Product Manufacturer.

  • Product Recalls The Company is not aware of any pattern or series of claims against the Company or any of its subsidiaries which reasonably could be expected to result in a generalized product recall relating to products sold by the Company or any of its subsidiaries, regardless of whether such product recall is formal, informal, voluntary or involuntary.

  • WHEXXXX xs xxxx of a plan of reorganization, RESTART PARTNERS II, L.P., a Delaware Limited Partnership ("Restart II"), may acquire an ownership interest in Elsinore Corporation ("Elsinore") or the Four Queens, Inc. ("FQI");

  • Probes Network hosts used to perform (DNS, EPP, etc.) tests (see below) that are located at various global locations.

  • Product ACCEPTANCE Unless otherwise provided by mutual agreement of the Authorized User and the Contractor, Authorized User(s) shall have thirty (30) days from the date of delivery to accept hardware products and sixty (60) days from the date of delivery to accept all other Product. Where the Contractor is responsible for installation, acceptance shall be from completion of installation. Failure to provide notice of acceptance or rejection or a deficiency statement to the Contractor by the end of the period provided for under this clause constitutes acceptance by the Authorized User(s) as of the expiration of that period. The License Term shall be extended by the time periods allowed for trial use, testing and acceptance unless the Commissioner or Authorized User agrees to accept the Product at completion of trial use. Unless otherwise provided by mutual agreement of the Authorized User and the Contractor, Authorized User shall have the option to run testing on the Product prior to acceptance, such tests and data sets to be specified by User. Where using its own data or tests, Authorized User must have the tests or representative set of data available upon delivery. This demonstration will take the form of a documented installation test, capable of observation by the Authorized User, and shall be made part of the Contractor’s standard documentation. The test data shall remain accessible to the Authorized User after completion of the test. In the event that the documented installation test cannot be completed successfully within the specified acceptance period, and the Contractor or Product is responsible for the delay, Authorized User shall have the option to cancel the order in whole or in part, or to extend the testing period for an additional thirty (30) day increment. Authorized User shall notify Contractor of acceptance upon successful completion of the documented installation test. Such cancellation shall not give rise to any cause of action against the Authorized User for damages, loss of profits, expenses, or other remuneration of any kind. If the Authorized User elects to provide a deficiency statement specifying how the Product fails to meet the specifications within the testing period, Contractor shall have thirty (30) days to correct the deficiency, and the Authorized User shall have an additional sixty (60) days to evaluate the Product as provided herein. If the Product does not meet the specifications at the end of the extended testing period, Authorized User, upon prior written notice to Contractor, may then reject the Product and return all defective Product to Contractor, and Contractor shall refund any monies paid by the Authorized User to Contractor therefor. Costs and liabilities associated with a failure of the Product to perform in accordance with the functionality tests or product specifications during the acceptance period shall be borne fully by Contractor to the extent that said costs or liabilities shall not have been caused by negligent or willful acts or omissions of the Authorized User’s agents or employees. Said costs shall be limited to the amounts set forth in the Limitation of Liability Clause for any liability for costs incurred at the direction or recommendation of Contractor.

  • Manufacturer A firm that operates or maintains a factory or establishment that produces on the premises, the materials or supplies obtained by the Contractor. Regular Dealer - A firm that owns, operates, or maintains a store, warehouse, or other establishment in which the materials or supplies required for the performance of the contract are bought, kept in stock, and regularly sold to the public in the usual course of business. A regular dealer engages in, as its principal business and in its own name, the purchase and sale or lease of the products in question. A regular dealer in such bulk items as steel, cement, gravel, stone, and petroleum products need not keep such products in stock, if it owns and operates distribution equipment for the products. Brokers and packagers are not regarded as manufacturers or regular dealers within the meaning of this section. North Carolina Unified Certification Program (NCUCP) - A program that provides comprehensive services and information to applicants for DBE certification, such that an applicant is required to apply only once for a DBE certification that will be honored by all recipients of USDOT funds in the state and not limited to the Department of Transportation only. The Certification Program is in accordance with 49 CFR Part 26. United States Department of Transportation (USDOT) - Federal agency responsible for issuing regulations (49 CFR Part 26) and official guidance for the DBE program. Forms and Websites Referenced in this Provision DBE Payment Tracking System - On-line system in which the Contractor enters the payments made to DBE subcontractors who have performed work on the project. xxxxx://xxxx.xxx.xxxxx.xx.xx/Vendor/PaymentTracking/ DBE-IS Subcontractor Payment Information - Form for reporting the payments made to all DBE firms working on the project. This form is for paper bid projects only. xxxx://xxx.xxxxx.xxx/doh/forms/files/DBE-IS.xls RF-1 DBE Replacement Request Form - Form for replacing a committed DBE. xxxx://xxxxxxx.xxxxx.xxx/projects/construction/Construction%20Forms/DBE%20MBE%20WBE %20Replacement%20Request%20Form.pdf SAF Subcontract Approval Form - Form required for approval to sublet the contract. xxxx://xxxxxxx.xxxxx.xxx/projects/construction/Construction%20Forms/Subcontract%20Approval %20Form%20Rev.%202012.zip JC-1 Joint Check Notification Form - Form and procedures for joint check notification. The form acts as a written joint check agreement among the parties providing full and prompt disclosure of the expected use of joint checks. xxxx://xxxxxxx.xxxxx.xxx/projects/construction/Construction%20Forms/Joint%20Check%20Notif ication%20Form.pdf Letter of Intent - Form signed by the Contractor and the DBE subcontractor, manufacturer or regular dealer that affirms that a portion of said contract is going to be performed by the signed DBE for the amount listed at the time of bid. xxxx://xxxxxxx.xxxxx.xxx/letting/LetCentral/Letter%20of%20Intent%20to%20Perform%20as%20 a%20Subcontractor.pdf

  • Product Sales Subject to Sections 10.3(c) and 10.3(d), Licensee agrees that it will not sell, offer for sale, or assist third parties (including Affiliates) in selling Product except for the sale and offer for sale of (A) TAF Product, TAF Combination Product, TDF Product and TDF Combination Product for use in the Field and in the countries of the TDF-TAF Territory, (B) COBI Product and COBI Combination Product for use in the Field and in the countries of the COBI Territory, and (C) EVG Product, EVG Combination Product and Quad Product for use in the Field and in the countries of the EVG-Quad Territory.

  • Manufacturing (a) The Supplier shall without limitation be responsible, at no additional cost to the Purchaser, for: sourcing and procuring all raw materials for the Products; obtaining all necessary approvals, permits and licenses for the manufacturing of the Products; providing sufficient qualified staff and workers to perform the obligations under this Purchase Agreement; implementing and maintaining effective inventory and production control procedures with respect to the Products; and handling other matters as reasonably requested by the Purchaser from time to time.

  • Discontinued Products If a product or model is discontinued by the manufacturer, Contractor may substitute a new product or model if the replacement product meets or exceeds the specifications and performance of the discontinued model and if the discount is the same or greater than the discontinued model.

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