Product Validation Sample Clauses

Product Validation. Please provide a clear description of the quality assurance programmes in place for the manufacture of each of the proposed articles, and in particular, the steps taken to ensure that the assay cut-off values remain within the required tolerance. Quality assurance reports for the past 3 years should be provided. Suppliers are to produce evidence in support of assurance claimed for each testing product.
Sample 1
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Product Validation. Bidders will be required to provide evidence in support of the levels of assurance claimed for each testing product. The best evidence comprises independent papers published in the scientific literature, related to specific testing products. Results should be given both for spiked oral fluid samples and for clinical samples. Bidders should also describe fully the quality assurance procedures in place for the manufacture of each of the proposed articles and in particular the steps taken to ensure that the assay cut-off values remain within the required tolerance. Quality assurance reports for the past three years manufacture of proposed articles should be submitted.
Sample 1
Product Validation. Bidders will be required to provide evidence in support of the levels of assurance claimed for each testing product. The best evidence comprises independent papers published in the scientific literature, related to specific testing products. Results should be given both for spiked urine samples and for clinical samples. Bidders should also describe fully the quality assurance procedures in place for the manufacture of each of the proposed articles and in particular the steps taken to ensure that the assay cut-off values remain within the required tolerance. Quality assurance reports for the past three years manufacture of proposed articles should be submitted. NOMS RSG will conduct on-going independent quality assurance on a regular basis. The quality assurance process may identify aspects of product performance or procedures that would benefit from improvement. Where such improvements serve to bring procedures up to the level set out in this specification the provider will be required to make those improvements without additional cost to the Prison or NOMS. Product Origin For all testing products proposed there will be a clear and full statement of product composition, origin and manufacturer. This will include a statement for all the component parts (of the testing product) including the antibodies and will include the final assembly of the testing product. A clear statement must be given on copyright ownership of each component part and of final testing product. A clear statement should be given of any potential challenges to copyright or challenges to copyright pending.
Sample 1
Product Validation. It is understood and agreed by the parties hereto that all processes affecting the purported identity, strength, or quality of the Product being manufactured, assembled and/or packaged shall be qualified and maintained in a validated state. ALCON shall be notified in advance of such validations and the protocols describing these validations shall be reviewed by ALCON’s Quality Assurance Department prior to the commencement of any validation and in accordance with Article I, Section 1.04. ALCON shall assess any intended product validation protocols based on the potential risk and will not unreasonably withhold or delay consent. Copies of validation reports and data will be made available to ALCON by the SELLER in the event such documentation is needed to support Product applications or dossiers.
Sample 1
Product Validation. RxElite shall pay in addition to the above, by wire transfer, all necessary costs for process validation batches necessary for the approval in each respective country , and this product will be sold under the profit share terms of this agreement, once approval has been finalized in each country. Additional development fees for further country filings shall be agreed upon by both parties and paid to Core Tech from RxElite as due for each country filing.
Sample 1
Product Validation. Upon receipt and installation of the new system, Customers should perform a basic test of all main functional areas within the confines of their specific environment that includes the facility’s trained personnel, specific hardware, and specific procedures. Validation experts contend that the extent to which a user tests application software should be based on the degree of risk associated with each function. To assist our customers in validating the software application, IDM has developed a document referred to as the Validation Tool. The Validation Tool includes a list of the risk-related functional areas designed within the software, and a series of suggested steps to test each of these defined areas. In addition, a series of workflow scenarios are provided to test the integration of the major functional areas found in the system. IDM support is available to assist with validation questions and concerns. These suggested test steps are not intended to be all-inclusive. Users are responsible for validating the software in accordance with their own Standard Operating Procedures (SOPs), in order to ensure that the software is operating as intended within their own environment. Product Configuration During this phase, IDM will work with customer personnel to determine a final, global configuration for full deployment.
Sample 1

Related to Product Validation

  • Product Testing Upon request, Customer shall provide Operator a laboratory report for each Product delivery by Customer or Customer’s supplier. Operator will not be obligated to receive Contaminated Product for throughput across the Berths, nor will Operator be obligated to accept Product that fails to meet the quality specifications set forth in the arrival notice.

  • 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.

  • Commercialization Intrexon shall have the right to develop and Commercialize the Reverted Products itself or with one or more Third Parties, and shall have the right, without obligation to Fibrocell, to take any such actions in connection with such activities as Intrexon (or its designee), at its discretion, deems appropriate.

  • 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.

  • Clinical Studies The animal and other preclinical studies and clinical trials conducted by the Company or on behalf of the Company were, and, if still pending are, to the Company’s knowledge, being conducted in all material respects in compliance with all Applicable Laws and in accordance with experimental protocols, procedures and controls generally used by qualified experts in the preclinical study and clinical trials of new drugs and biologics as applied to comparable products to those being developed by the Company; the descriptions of the results of such preclinical studies and clinical trials contained in the Registration Statement and the Prospectus are accurate and complete in all material respects, and, except as set forth in the Registration Statement and the Prospectus, the Company has no knowledge of any other clinical trials or preclinical studies, the results of which reasonably call into question the clinical trial or preclinical study results described or referred to in the Registration Statement and the Prospectus when viewed in the context in which such results are described; and the Company has not received any written notices or correspondence from the FDA, the EMA, or any other domestic or foreign governmental agency requiring the termination, suspension or modification of any preclinical studies or clinical trials conducted by or on behalf of the Company that are described in the Registration Statement and the Prospectus or the results of which are referred to in the Registration Statement and the Prospectus.

  • 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.

  • 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.

  • Development of Products (a) During the term of this Agreement, ViewRay may from time to time seek services from PEKO with respect to the development of certain Products that can be incorporated into the ViewRay Renaissance™ MRI-guided radiation therapy system. For each Program to be undertaken by PEKO pursuant to this Agreement, the parties will prepare a “Work Statement” and agree to said “Work Statement” in substantially the form attached as Attachment 1. Each Work Statement will describe: (i) the (i) services that PEKO will be responsible for providing to ViewRay and the deliverables that PEKO will be responsible for delivering to ViewRay (“Deliverable(s)”), (ii) delivery schedule for the Deliverables, (iii) pricing terms, (iv) work plan for the Program, and (v) ViewRay’s responsibilities in connection with the Program. Each Work Statement will be prepared based upon the requirements and information provided to PEKO by ViewRay. A separate Work Statement will be required for each Program; and each Work Statement will become subject to this Agreement only when mutually agreed and signed by ViewRay and PEKO.

  • Licensed Product “Licensed Product” shall mean any article, composition, apparatus, substance, chemical material, method, process or service whose manufacture, use, or sale is covered or claimed by a Valid Claim within the Patent Rights. For clarity, a “Licensed Product” shall not include other product or material that (a) is used in combination with Licensed Product, and (b) does not constitute an article, composition, apparatus, substance, chemical material, method, process or service whose manufacture, use, or sale is covered or claimed by a Valid Claim within the Patent Rights.

  • Manufacture 2.1. The LED(s) on the LED module shall be equipped with suitable fixation elements.

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