No Safety Notices. (i) Except as disclosed in the Registration Statement, the General Disclosure Package and the Prospectus, there have been no recalls, warnings, safety alerts or other notifications or notice of action required or made to regulatory authorities, healthcare professionals, laboratories, or patients, relating to any alleged or potential performance or accuracy failure(s) of testing services offered, or lack of safety, or regulatory compliance of Company products or services or any items used in connection therewith (“Safety Notices”) and (ii) to the Company’s knowledge, there are no facts that would be reasonably likely to result in (x) a Safety Notice with respect to the Company’s products or services, (y) a change in labeling of any the Company’s respective products or services, or (z) a termination or suspension of marketing or testing of any the Company’s products or services.
Appears in 2 contracts
Samples: Underwriting Agreement (MDxHealth SA), Underwriting Agreement (MDxHealth SA)
No Safety Notices. (i) Except as disclosed in the Registration Statement, the General Time of Sale Disclosure Package and the Prospectus, there have been no recalls, warnings, “safety alerts or other notifications or notice of action required or made to regulatory authorities, healthcare professionals, laboratories, or patients, relating to any alleged or potential performance or accuracy failure(s) of testing services offered, or lack of safety, or regulatory compliance of Company products or services or any items used in connection therewith (“Safety Notices”) and (ii) to the Company’s knowledge, there are no facts that would be reasonably likely to result in (x) a Safety Notice with respect to the Company’s products or services, (y) a change in labeling of any the Company’s respective products or services, or (z) a termination or suspension of marketing or testing of any the Company’s products or services.
Appears in 1 contract
Samples: Purchase Agreement (MDxHealth SA)
No Safety Notices. (iA) Except as disclosed in the Registration Statement, in the General Time of Sale Disclosure Package and in the Prospectus, to the Company’s knowledge, there have been no recalls, field notifications, field corrections, market withdrawals or replacements, warnings, “dear doctor” letters, investigator notices, safety alerts or other notifications or notice of action required or made to regulatory authorities, healthcare professionals, laboratories, or patients, relating to any an alleged or potential performance or accuracy failure(s) of testing services offered, or lack of safety, efficacy, or regulatory compliance of Company the Company’s products or services or any items used in connection therewith (“Safety Notices”) and (iiB) to the Company’s knowledge, there are no facts that would be reasonably likely to result in (x1) a Safety Notice with respect to the Company’s products or services, (y2) a change in labeling of any the Company’s respective products or services, or (z3) a termination or suspension of marketing or testing of any the Company’s products or services.
Appears in 1 contract
No Safety Notices. (i) Except as disclosed in the Registration Statement, the General Time of Sale Disclosure Package and the Prospectus, there have been no recalls, field notifications, field corrections, market withdrawals or replacements, warnings, “dear doctor” letters, investigator notices, safety alerts or other notifications or notice of action required or made to regulatory authorities, healthcare professionals, laboratories, or patients, relating to any an alleged or potential performance or accuracy failure(s) of testing services offered, or lack of safety, efficacy, or regulatory compliance of Company the Company’s products or services or any items used in connection therewith (“Safety Notices”) ), except as would not reasonably be expected to have a Material Adverse Effect, and (ii) to the Company’s knowledge, there are no facts that would be reasonably likely to result in (x) a Safety Notice with respect to the Company’s products or services, (y) a change in labeling of any the Company’s respective products or services, or (z) a termination or suspension of marketing or testing of any the Company’s products or services.
Appears in 1 contract