Custom Arrays. Upon Affymetrix confirming receipt of complete Buyer Target Sequences and related information for each new Custom Probe Array design, Affymetrix will use reasonable efforts to design, layout, produce masks, and manufacture the initial lot of Custom Probe Arrays for each such custom design as follows: (i) within 12 weeks if Buyer orders only one Custom Probe Array design; (ii) within fourteen (14) weeks for up to four (4) custom designs; and (iii) for more than four (4) custom designs, according to the schedule quoted to Buyer and/or its Affiliates at the time they order such Custom Probe Array designs. Where Buyer and/or its Affiliates have ordered more than one custom design, Affymetrix reserves the right to provide the initial lots of Custom Probe Arrays for each such design at separate times, at Affymetrix' sole discretion, subject to the maximum time periods described in the previous sentence; in such case, the order that the initial lots of each such design will be provided relative to such other designs will be determined by a priority list submitted by Buyer at the time it orders the designs or, if no such list is submitted, in Affymetrix’ discretion. In no event shall Affymetrix be obligated to supply more than twelve (12) custom designs per year. Delivery times for all additional lots of Custom Probe Arrays ordered pursuant to this letter will be quoted at the time Affymetrix receives a firm order for such products and shall not exceed four (4) weeks from the date of such order. Buyer acknowledges that implementation of any deviations for a particular custom design may increase the time period between order placement and delivery of Custom Probe Arrays based on any such design. All such time extensions for a particular custom design will be discussed with Buyer prior to start of such design. All Custom Probe Arrays must be ordered and purchased in whole-lot increments.
Custom Arrays. Several of the commercial arrays contain a high number of variants, making a fast turnaround time and interpretation challenging. Additionally, these arrays will include variants which may not be of direct interest in a clinical setting as panels often include all known PGx variants regardless of the level of evidence supporting their clinical utility. This has driven many institutions to develop their own custom clinical array with a more focused set of clinically actionable variants. Typically, these custom arrays are performed using single gene-based testing covering only the variants with direct clinical applicability yet limiting broad applicability. To be able to test a broad set of variants while maintaining a rapid turnaround time, companies have developed customizable arrays. One example frequently used for clinical PGx is the OpenArray (Thermofisher scientific). This array can detect between 12 and 240 variants using standard TaqMan technology [35]. Selected TaqMan assays are spotted on a chip based on the clients need. Each chip contains xxxxx for the patient samples; in each of these xxxxx, through-holes are present which contain the assays desired. This format allows for a thorough characterization of a few genes as well as for a broader approach focused on a panel of common variants in multiple genes. This array has been used in clinical implementation studies as well. For example, in the INGENIOUS study it was used to interrogate a panel of 43 variants in 14 genes [36]. A 2 similar approach was used by the Ubiquitous pharmacogenomics (U-PGx) consortium. The U-PGx consortium’s initiated the PREPARE study aimed at collecting evidence of the clinical utility of a pre-emptive PGx panel consisting of 58 SNVs in 14 pharmacogenes [34]. The panel covers the most common variants in all actionable genes included in the DPWG guidelines [37] and is analyzed with KASP technology using the SNPline (LGC) [38].
Custom Arrays. Except for the sale of Custom Arrays to RDG under Section 3.1, before shipment to RDG of additional Custom Arrays for development by RDG of Content for Catalogue Arrays CBMX and RDG will negotiate a commercially reasonable price in good faith. 5.1.4.1.5
