Testing of Products. Stellartech shall use its best efforts to design, construct and comprehensively test the Thermage Generator and Thermage Disposable Devices in accordance with the Development Program. Stellartech will use best efforts to ensure that the Products, once the clinical phase is completed, will (i) be tested by an internationally recognized testing agency, such as TUV, and in accordance with IEC601 requirements, as applicable and (ii) pass any such testing and be suitable for approval by all U.S. and foreign regulatory agencies having jurisdiction over medical devices. During the term of the Development Program, Stellartech, agrees to promptly provide Thermage with a copy of all sections of any report received from any testing agency relating to a Thermage Generator or Thermage Disposable Device. Stellartech shall be compensated for its services rendered under this Paragraph 2.3 in accordance with Paragraph 2.4, below.
Testing of Products. Shenzhen Yi Jia shall test, or cause to be tested, each batch of the Products manufactured pursuant to this Agreement before delivery to Aspire. Such testing shall be performed at Shenzhen Yi Jia’s facility. The quality control requirements for such testing shall be established as part of the Specifications and shall contain such quality control procedures as are necessary to insure that the Product meets the Specifications and has a shelf life (such as batteries) not less than the shelf life set forth in the Specifications.
Testing of Products. After an open call for tender for testing of high chairs by an accredited laboratory, SGS at Aix-en Provence was chosen as the laboratory which had to perform testing on the samples extracted from the market. The laboratory has been an expert for many years in the field of child safety. It is accredited by COFRAC in accordance with ISO 17025 for all activities regarding children’s products testing and approved by the French Ministry of Industry to deliver Type Examinations in accordance with the Decree 91-1292 on child care articles. It was agreed by the market surveillance authorities that all samples had to be tested according to EN 14988:2006+A1:2012. However, whenever there was a failure on the restraint system and lateral protection, the laboratory had to also perform similar tests in line with EN 14988:2006. This provided market surveillance authorities with enough information to be able to not only risk assess the product itself but also to determine the type of measures taken on the respective samples. It was also considered that some high chairs may have a function as a reclined cradle, by simple reclining of the backrest or by the addition of a spare component. For this function, compliance with relevant standard EN12790: 2009 was checked. Additional testing was carried out as well,when the respective high chair could be considered as a reclined cradle too. In that case, they were tested according to EN 12790:2009 (standard for reclined cradles) A protocol was developed to anticipate additional provisions laid down in the Decision published by the EU in March 2013 concerning certain seats for children; in particular special attention was given to requirements related to packaging, the identification of the manufacturer and importer (including contact details: name and address), entanglement hazards and stuffing materials that could constitute choking hazards and also purchase information.
Testing of Products. 7.1. Eye-Grain will perform testing/quality control of Products prior to delivery, in a place, time, manner, and to the extent deemed appropriate by Eye-Grain in its sole discretion, and when applicable, in accordance with ISO 9001 standards.
Testing of Products. LICENSEE shall periodically send its Products to an independent Marijuana Testing Facility licensed by the State of Colorado and applicable local licensing authorities, at its sole cost, to confirm that LICENSEE'S are of the quality stated by LICENSEE and otherwise comply with applicable law.
Testing of Products. Alder will supply Product-specific reagents and reference standards (including CoA and expiry/retest date) to SANDOZ. SANDOZ shall store the Process Transfer Materials (see definition in CMA) at the proper labeled storage condition in qualified equipment. The introduction of a new lot of critical reagent or reference standard for qualified or validated assays must go through Change Control (Section 2.11). • SANDOZ will be responsible for the compliance of the cGMPs for the BDS Manufacture in alignment with the BDS Specifications, and will carry out complete in-process and release testing according to the agreed test documents. In-process testing results will be documented in BDS batch records with comparison to the allowable range, as appropriate. The Certificate of Analysis (CoA) for the release testing must comply with internationally harmonized requirements for Batch certification. including: [***] A CoA for each individual Batch of Product must be issued and provided to Alder. [***]
Testing of Products. LD Technology shall test, or cause to be tested, each batch of the Products manufactured pursuant to this Agreement before delivery to Nature’s Best. Such testing shall be performed at LD Technology’s facility. The requirements for such testing shall be established as part of the Specifications.
Testing of Products. ACCEPTOR assumes full responsibility for the testing of PRODUCT. ACCEPTOR and/or its approved contractors shall carry out all tests of PRODUCT as specified in the corresponding agreed documents and the responsibility list. Testing shall be performed by laboratories approved by ACCEPTOR and that meet Center for Medicare and Medicaid Services, where applicable.
Testing of Products. ACCEPTOR and/or its approved contractors will carry out appropriate testing according to the test documents as listed in ENCLOSURE C. The testing of PRODUCTS must be performed according to properly transferred methods if applicable, which has been qualified (early phase) or fully validated (process validation, registration stability) as appropriate, by properly trained or qualified technicians using qualified or calibrated tools as necessary. ACCEPTOR and/or its approved contractors shall prepare the complete analytical documentation which is required for the release of the PRODUCT. The Certificate of Analysis ( CoA) and/or testing records must include: [***] Out of Specification Results Out of Specification investigations will be handled according to ACCEPTOR current standard operation procedure for deviations. ACCEPTOR and/or its approved contractors undertake to investigate any suspect result. Any unusual result will be reported for comments to MAGENTA together with an outline of the planned investigation. If a PRODUCT fails one of the safety tests performed before release, then the materials cannot be injected into humans unless otherwise agreed on by the ACCEPTOR Medical Director, Principal Investigator, Program Coordinator/Supervisor. ACCEPTOR QA, MAGENTA QA and the FDA. MAGENTA must be informed of such decision within one (1) working day. Confirmed out of specification results must be reported to MAGENTA within one (1) working day after occurrence. After completion of the investigation, the OOS final report will be handed over to MAGENTA with the batch records. Initial OOS results due to laboratory failure will be mentioned as comment in the final CoA or analytical report. Furthermore, ACCEPTOR and/or its approved contractors agrees to inform any Out-of-Expectation (OOE) result, i.e. an individual finding or final result which does lie within the stipulated specification, but strongly deviates from expectations, to MAGENTA within five (5) working days after observation by ACCEPTOR.
Testing of Products
