MRDx® BCR-ABL Test Assay Kit Terms of Sale 

These terms and conditions, as well as any Genoptix, Inc. (“Genoptix”) quote and supplemental terms included with the MRDx® BCR-ABL Test Assay Kit (the “Kit”), comprise the entire agreement (“Agreement”) between you and Genoptix. No modification, addition to, or waiver of any terms of this Agreement shall be effective unless in writing and signed by an authorized representative of Genoptix. This Agreement is effective upon Genoptix’s acceptance of your order. 

Kits are shipped F.O.B. origin and all responsibility and costs of shipping and delivery shall be borne by you. Title and risk of loss shall pass to you at the F.O.B. point. Claims for shortage of Kits or for loss or damage shall be waived unless you promptly report such shortage, loss or damage to Genoptix. 

Orders cannot be changed or canceled once they have been placed unless Genoptix approves such change or cancellation in writing, and you may be held responsible for any charges relating to such change or cancellation. Returns must be approved in writing by Genoptix. 

Your use of the Kits is limited to diagnostic services for your resident patient population only. Use of the Kit outside of the FDA Authorized Intended Use is expressly prohibited. 

You may not transfer, distribute or resell Kits or any component of the Kit. 

Genoptix’s sale of the Kits pursuant to this Agreement does not convey to you any license, expressly or by implication, to manufacture, duplicate or otherwise copy or reproduce any component within the Kit. 

Prices may change at any time without notice and do not include taxes or similar fees that may apply. If you are exempt from any taxes, you must provide a tax exemption certificate of Genoptix. 

Unless otherwise agreed upon in writing, payment is due to Genoptix within thirty (30) days from the invoice date. Past due payments are subject to a one and one-half percent (1.5%) late fee or the highest rate permitted by law. Genoptix reserves the right to require full or partial payment in advance if Genoptix deems necessary in its sole discretion. 

Genoptix is a reseller of Kits, and as such it does not provide any warranties. Genoptix will provide to you any transferable manufacturer’s standard warranties for the Kits. NO WARRANTIES, EXPRESS OR IMPLIED, ARE GIVEN IN RESPECT OF KITS, AND ANY IMPLIED WARRANTY OF MERCHANABILITY OR FITNESS FOR ANY PURPOSE IS HEREBY EXPRESSLY DISCLAIMED. 

You shall hold this Agreement including Kit prices in strict confidence. You may not, without Genoptix’s prior written consent, use or disclose any data, designs, or other information belonging to or supplied by or on behalf of Genoptix. 

You agree to indemnify and hold harmless Genoptix, its subsidiaries, consultants and affiliates, and their respective successors and assigns, from and against all claims, loss, damage or expense, and any other liabilities whatsoever, including without limitation, reasonable attorney’s fees, arising from or by reason of any actual or claimed damages, and/or injuries, or any litigation based thereon, which may be incurred by you with respect to any part of the Kits, including defective design, material, latent or patent, or workmanship, and such obligation shall survive acceptance of the goods and payment therefor by you. 

Genoptix will not be responsible for any delays caused by labor troubles, accidents, fires, invasion, riots, civil commotion, war, acts of God, government regulations or restrictions and any other causes beyond Genoptix’s reasonable control. 

Genoptix’s exercise of any option or its failure to exercise any rights hereunder shall not constitute a waiver of its rights to damages for breach of contract and shall not constitute a waiver of any subsequent failure, delay, or breach by you. 

You agree to comply with all federal, state and local laws, ordinances rules and regulations relating to this Agreement. 

You shall not assign any rights or obligations under this Agreement without first obtaining Genoptix’s written permission. Any such assignment without the written consent of Genoptix shall, at Genoptix’s option, be void. 

This Agreement shall be governed by and construed according to the laws of California, without regard to conflict of law principles. 

FDA Authorized Intended Use Statement of the Product. The MolecularMD MRDx BCR-ABL Test is an in vitro diagnostic test for the quantitative detection of BCR-ABL1 transcripts (e13a2/b2a2 and/or e14a2/b3a2) and the ABL1 endogenous control mRNA in peripheral blood specimens from patients previously diagnosed with t(9;22) positive chronic myeloid leukemia (CML). The ratio of BCR-ABL1 to ABL1 is calculated and reported on the WHO International Scale. The test utilizes quantitative, real-time reverse transcription polymerase chain reaction performed on the Applied Biosystems 7500 Fast Dx instrument. The MolecularMD MRDx BCR-ABL Test is intended to measure BCR-ABL mRNA transcript levels in patients diagnosed with t(9;22) positive CML during monitoring of treatment with Tyrosine Kinase Inhibitors (TKIs). The device is also intended to be used in the serial monitoring for BCR-ABL mRNA transcript levels as an aid in identifying CML patients in the chronic phase being treated with nilotinib who may be candidates for treatment discontinuation and for monitoring of treatment-free remission. The test does not differentiate between e13a2 or e14a2 fusion transcripts and does not monitor other rare fusion transcripts resulting from t(9;22). The test is not intended for the diagnosis of CML. 

Limited Use Label License Agreement. Use of this product signifies the agreement of any Purchaser (“End User”) of the MolecularMD MRDx® BCR-ABL Test to the following terms: 

1. The MolecularMD MRDx® BCR-ABL Test may be used solely in accordance with the MolecularMD MRDx® BCR-ABL Test Package Insert and for use with components contained in the kit only. 

2. The MolecularMD MRDx® BCR-ABL Test may be used solely for providing Diagnostic Services meaning a human diagnostic testing service sold or offered for sale by End Users limited to the FDA Authorized Intended Use of the Product for patient clinical reference testing ordered by a physician. Use in research and/or clinical trial testing is expressly prohibited. 

3. Use of the MolecularMD MRDx® BCR-ABL Test by End Users is limited to Diagnostic Services for their own Resident Patient Population; use for Diagnostics Services to other entities is prohibited. Independent advertising or soliciting Diagnostic Services for purposes other than serving the End User’s Resident Patient Population is prohibited. 

4. The MolecularMD MRDx® BCR-ABL Test Assay Kit and its components are licensed for one-time use and may not be reused, refurbished, or resold. 

5. MolecularMD grants no license under any of its intellectual property to use or incorporate the enclosed components of the Kit with any components not included within the Kit except as described in the MolecularMD MRDx® BCR-ABL Test Package Insert. 

6. MolecularMD specifically disclaims any other licenses, expressed or implied other than those expressly stated. 

7. Other than expressly stated licenses, MolecularMD makes no warranty that this Kit and/or its use(s) do not infringe the rights of third-parties. 

8. The End User of the MolecularMD MRDx® BCR-ABL Test Assay Kit agrees not to take or permit anyone else to take any steps that could lead to or facilitate any acts prohibited above. 

Updated August 27, 2018