GENERAL TERMS AND CONDITIONS OF SALE FOR CLINICAL SERVICES

1. Terms of sale

• General Terms: Following are the terms and conditions of sale (the “Terms”) offered by M Diagnostics Pte. Ltd. (the “Provider”) to the purchaser of Clinical Services (the “Buyer”).
• Clinical Services: For the purpose of this term and conditions of sale, Clinical Services shall mean the following:
  1. GASTROClear^TM testing services relating to the performance of the MiRXES GASTROClear^TM test by the Provider on appropriate samples submitted by the Buyer.
  2. APEX^TM Tissue testing services related to the performance of the MiRXES APEX^TM Tissue test by the Provider on the appropriate samples submitted by the Buyer.
• Effective Date: The Terms are deemed to be in effect upon the Buyer’s acceptance of the contract as evidenced by means including but not limited to issuance of a Purchase Order by the Buyer, provision of a copy of the Provider’s order form or quotation duly executed by the Buyer, signing of a Service Agreement or other forms or written acknowledgement by the Buyer accepting the terms of the quotation issued by the Provider.
• Amendments: The Provider may, from time to time and at its sole discretion, amend this General Terms and Conditions of Sale. Such amendments shall be deemed to be effective after fourteen (14) days from the provision of written notice to the Buyer.

2. Price, Ordering and Payment

• Validity: Subject to the term of any valid quotations issued by the Provider or prior written agreements between the Buyer and Provider, the Provider reserves the right, at its sole discretion, to revise the prices or type of Clinical Services provided.
• Taxes and Fees: Unless otherwise stated, the prices exclude any taxes or duties payable for the sale, delivery or use of any Clinical Services, which shall be paid for by the Buyer.
• Cancellations or Changes: In the event of changes or cancellation of order(s), the Buyer shall, as soon as practicable, contact the Provider via the sales enquiry hotline or email. Any cancellation, changes or refunds shall be at the Provider’s sole discretion. For the avoidance of doubt, the Provider shall not be obligated to cancel any order once such order or instructions has been received from the Buyer . The Provider reserves the right to invoice the Buyer for the cost incurred up to the date of the cancellation, or additional charges resultant from the changes. The payment of which shall be governed by the Terms herein.
• Turnaround Times: The Provider shall notify the Buyer of the applicable turnaround times for the Clinical Services. Provider reserves the right to revise the turnaround times for any Clinical Services by providing notice in writing to the Buyer. The Provider shall not be responsible for delays resultant from incomplete or inaccurate information provided on the order form nor for delays caused by sample issues not caused by the Provider including but not limited to incorrectly collected or stored samples. The Provider’s stated turnaround times are dependent on current laboratory capacity, and delays may be experienced during periods of extreme demand. In addition, in a small proportion of cases, test results may be inconclusive and require re-testing, which can extend the time to confirm a result.
• Re-Testing (where applicable): In the event that a clinical test returns an inconclusive result, the Provider shall, as soon as practicable, inform the Buyer of the same. In the event of such an inconclusive test result, the Provider shall not be obligated to repeat the clinical test. Buyer may, at its own cost, request for the test to be repeated on the affected sample (if sufficient sample is available) or re-sample the affected subject and arrange for pick-up of the sample for re-testing. For the avoidance of doubt, any re-runs or testing of re-sampling at the request of the Buyer shall be chargeable as a new test.
• Payment: The Provider shall invoice the Buyer pursuant to the price and payment terms provided in the applicable quotation or as otherwise agreed in writing between the parties.
• Late Payment: Upon non-payment of any past-due invoice issued by the Provider, the Provider reserves the right to discontinue the supply of Clinical Services to the Buyer until the balance is paid in full. The Provider shall also be entitled, without limiting any other rights it may have, to charge interest on the outstanding amount at the rate of 1.5 percent (1.5%) per month from the due date until the outstanding amount is paid in full. 

3. Logistics Schedule

• Sample shipment: Unless otherwise agreed, all clinical samples (local and overseas) are expected to be shipped to the Provider’s sample receiving counter with accordance to any relevant laws and regulations. The Provider will only assume responsibility of the clinical samples upon receiving and registering the samples, at which point, the Provider will inform the Buyer on receipt of the clinical samples.
• GASTROClear^TM Sample pick-up: Sample pick-ups from clinics shall be arranged in accordance with the operating hours provided by the Provider. The Buyer and the Provider shall mutually agree on sample pick-up process that will ensure that GASTROClear^TM sample reach the destinated lab within 2 hours of blood draw. Sample collections can be arranged by contacting Provider’s hotline at (+65) 6950 5868
• APEX^TM Tissue Sample pick-up: Sample pick-ups from clinics shall be arranged in accordance with the operating hours provided by the Provider. The Buyer and the Provider shall mutually agree on sample pick-up process that will ensure that the sample reach the destinated lab within 48 hours of initiation of sample collection. Sample collections can be arranged by contacting Provider’s hotline at (+65) 6950 3210

4. Warranty

• Subject to all the terms and conditions set out herein, the Provider warrants that the Clinical Services will be completed in a professional, workmanlike manner, with a commercially reasonable degree of skill and care, and in compliance with applicable specifications, statutory and regulatory requirements.
• Exclusions: The foregoing warranties do not apply to the extent a non-conformance is due to (i) abuse, misuse, neglect, negligence, accident, improper storage of samples by the Buyer prior to receipt of the samples by the Provider; (ii) provision of incorrect instructions or any mislabeling by the Buyer; or (iii) Force Majeure Events, or (vi) use with a third party’s goods or services (unless expressly stated in writing by the Provider such third party’s goods or services is suitable for use with the Clinical Services).

5. Intellectual Property

• Ownership: The ownership of all intellectual property rights in relation to the Clinical Services, including all modifications or improvements shall remain the Provider’s sole and exclusive property. Notwithstanding the above, all medical data and information generated from the Clinical Services, including the patient data and test results, shall be owned by the Buyer.

6. Limitation of Liability

• To the maximum extent permitted by law, the Provider shall not be liable for any indirect, special, incidental, punitive, multiple or consequential damages (including without limitation damages for loss of use of facilities or equipment, revenue, data, profits or goodwill) that might be incurred or that may arise from Clinical Services.
• Notwithstanding Clause 6.1, the Provider’s maximum aggregate liability arising out of or in connection with the Clinical Services, is limited to the total amount paid by the Buyer for the specific Clinical Services purchased that gave rise to the liability.
• The Provider shall not be liable for any losses, damages, cost and liabilities arising out of or caused by the Buyer’s (i) breach of the Terms; (ii) inaccurate or unauthorised representation or warranty to the Provider; (iii) failure to conform to local laws and regulations; and (iv) willful act or misconduct, omission, or any other wrongful act or omission.
• The Buyer shall bear sole responsibility for obtaining any and all necessary approvals and permissions required before the provision of the samples to the Provider. It shall be the sole responsibility of the Buyer to ensure that the use of any data generated and received from the Clinical Services is compliant with all applicable laws, regulations and governmental policies and are suitable for the Buyer’s intended use. The Buyer shall indemnify the Provider against any and all costs and losses that may be sustained or incurred in relation to any breach of these responsibilities.

7. Assay Information
   • GASTROClear^TM: This assay evaluates the expression of 12 circulating human miRNA associated with gastric cancer. The test performance characteristics was independently determined by the Provider. The Provider is licensed by the Ministry of Health (Singapore) as a Clinical Laboratory under the Healthcare Services Act to perform high-complexity testing. GASTROClear^TM assay performance may be altered based on factors such as excessive blood cell lysis before processing, sampling during treatment. Possible sources of errors can result from trace contamination, rare technical errors, miRNA variants that interfere with analysis. This test is not intended to provide a definitive diagnosis of stomach cancer and is not a substitute for gastro-endoscopy. Individuals with high-risk classification should be followed up by a healthcare professional. The interpretation and clinical annotations provided are intended solely for use by a medical professional and do not constitute medical advice by the Provider and the manufacturer. The clinical recommendation within the report is at the sole discretion of the physician. The clinical recommendation does not take into consideration of other risk factors such as genetic predispositions, other medical conditions, drug interactions, environmental and lifestyle factors. Decisions regarding prescriptions and treatment should not be solely based on this test and the information contained in this report. The stomach cancer risk classification may be updated over time with on-going clinical studies and trials. Information contained within this report is dependent on the date of generation and/or database version used to generate the report.
   • APEX^TM Tissue: This assay assesses somatic mutations in solid tumors across hotspots of 50 genes. The test performance characteristics was independently determined by the Provider. The Provider is licensed by the Ministry of Health (Singapore) as a Clinical Laboratory under the Healthcare Services Act to perform high-complexity testing. APEX^TM Tissue assay performance may be altered based on factors such as inappropriate tissue sample processing, tissue sample do not meet sample requirement criteria and/or mishandling during sample transportation. Possible sources of errors can result from trace contamination, and/or rare technical errors that interfere with analysis. Mutations assessed include SNVs and indels, amplifications and fusions. These genes are implicated in the signaling pathways in cancer development from published literature and public databases. Reported mutations are tiered by clinical significance, adapted from joint consensus recommendations by the Association for Molecular Pathology, American Society of Clinical Oncology, and College of American Pathologists (Li, et al., 2017). This report is intended to be used by oncologists, to guide therapy selection. Information contained within this report is dependent on the date of generation and/or database version used to generate the report.

8. Miscellaneous

• Confidentiality: The Parties agree to keep confidential any non-public information (including but not limited to any protocol, assay design, oligonucleotide sequences or performance data), software algorithms or commercial information (including but not limited to market, customer or pricing information) received from the Provider in the process of discussions, negotiations or other communications in relation to the Clinical Services.
• Personal Data Protection: The Parties shall comply with any applicable personal data protection legislations and guidelines with regards to any and all personal data collected and/or held in connection with the use of the Clinical Services.
• Where personal data is required by the Provider for the Clinical Services, Buyer shall undertake that (i) it would have, prior to disclosing such personal data to the Provider, obtained the appropriate informed consent from the individuals whose personal data are being disclosed; and (ii) any personal data disclosed by it are accurate and complete.
• Use of names: No Party shall make, or permit any person to make, any public announcement, communication or circular using the other Party’s names or trademarks without the prior written approval of the other Party.
• Force Majeure: The Provider shall not be responsible for any failure or delay in performing any of the Provider’s obligations, if delayed, hindered, interfered with or prevented by floods, riots, fires, strikes, freight embargoes, act of God, acts of war or hostilities of any nature, change of laws or regulations of government of either party or any similar cause beyond the reasonable control of the party affected (“Force Majeure Event”) provided that the Provider shall give prompt notice of the nature of the Force Majeure Event to Buyer.
• Termination: The Provider reserves the right to terminate this Agreement in the event of any breaches of the terms of this Agreement or in the event of overdue payments by the Buyer.
• Governing Law: The rights and obligations by the Parties hereunder shall be governed by, and construed in accordance with, the laws of the Republic of Singapore.

T&C for Clinical Services v1, effective 5 April 2022.