Assay Procedure Clause Samples
The Assay Procedure clause defines the specific methods and protocols to be used for testing and analyzing samples or materials within an agreement. It typically outlines the standards, equipment, and conditions under which assays must be performed, and may specify who is responsible for conducting the tests and how results are to be reported. By clearly establishing these procedures, the clause ensures consistency, reliability, and mutual understanding of testing outcomes, thereby reducing disputes over the validity of assay results.
Assay Procedure. (A) All Assays shall be carried out in accordance with Good Industry Practice and the requirements of the relevant Offtake Agreement.
(B) For each Lot where the Offtaker is a Related Party of the relevant Seller Group Member or the Refinery is owned, leased or otherwise controlled by a Seller Group Member or any of their Affiliates then any Assay in respect of such Lot must be carried out in accordance with Good Industry Practice by a reputable third party laboratory approved by the Purchaser in writing, acting reasonably. The costs and expenses of all such Assays shall be borne by the Seller and ProjectCo.
Assay Procedure. MERCK shall take and retain, for [***] ([***]) years (or such longer period as required by the Specified Regulatory Requirements) following Manufacture, samples of Materials, Clinical Product, Marketed Product and MERCK Product from each Lot, in an amount equal to [***] ([***]) times the amount needed to perform full quality control testing (such testing to include at least that described in the applicable Specifications), and shall specify the identifiable and traceable information regarding the Material, and dates of Manufacture thereof.
Assay Procedure. The assay which is analysed automati- cally is based on OrisTM Cell Migration To identify compounds which change cell migration behaviour and thereby might modifify PHACTR1 activity, leading to novel hit compounds against CAD, 780 compounds from a marketed drug library were screened.Compounds were screened at 10 μM in duplicates, across a total of 20 Assay technologyand ▇▇▇▇▇▇ ▇▇▇▇▇ EnSight Multimode reader. In this assay plates for 60 hours. The z prime value generally exceeded 0.3 of the plates shown as Z primes. a cell free area is created by inserting a silicon stopper into a well of a 96-well plate before seeding of smooth muscle cells. By removing the stopper a cell free area is generated (grey area, Fig.
Assay Procedure. ARIAD shall take and retain, for such period as may be required by applicable law of the countries set forth on Appendix A, samples of API from each Batch sufficient to perform at least full duplicate quality control testing (such testing to include at least that described in the Specification), and shall specify the identifiable and traceable information regarding the raw material, and dates of manufacture and packaging thereof. Additionally, ARIAD shall take and retain sufficient quantities of each Batch of API sufficient to perform at least full duplicate quality control testing (such testing to include at least that described in the Specification) (each such retained quantity, a “Sample”) and shall specify the identifiable and traceable information regarding the raw material, and dates of manufacture and packaging of such Sample, such Sample to be delivered to MEDINOL, upon MEDINOL’s written request, in order to implement analytical or other controls required by FDA or other Regulatory Authorities of the countries listed on Appendix A, or performance of quality control testing by MEDINOL or its designee; the cost of which Sample shall be invoiced to MEDINOL. In the event that MEDINOL elects to perform quality control testing of any Sample of the API, ARIAD shall provide reasonable assistance to MEDINOL by providing copies of requisite documentation describing ARIAD’s assay procedures (in addition to the quality control records described in the preceding sentence) and by making ARIAD personnel reasonably available to train, at MEDINOL’s request, MEDINOL’s personnel on the methods for performing such assays. MEDINOL agrees that ARIAD shall be designated as a “Qualified Supplier” of API after confirming as a result of MEDINOL’s acceptance testing that three (3) different Batches of API each having been made from a different batch of starting materials, conform to the warranty set forth in Section 5.1.
Assay Procedure. ARIAD shall take and retain, for [***] ([***]) years (or such longer period as required by the Specified Regulatory Requirements) following Manufacture samples of API, Materials and Clinical Product from each Batch or Lot, as applicable, in an amount equal to [***] ([***]) times the amount needed to perform full quality control testing (such testing to include at least that described in the applicable Specifications), and shall specify the identifiable and traceable information regarding the Material, and dates of Manufacture thereof.