No Safety Notices. (i) Except as disclosed in the Registration Statement, the 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 notice of action relating to an alleged lack of safety, efficacy, or regulatory compliance of the Company’s products (“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 15 contracts
Samples: Purchase Agreement (POINT Biopharma Global Inc.), Purchase Agreement (Apollo Endosurgery, Inc.), Underwriting Agreement (Leap Therapeutics, Inc.)
No Safety Notices. (i) Except as disclosed in the Registration Statement, the Time of Sale Disclosure Package Statement 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 notice of action relating to an alleged lack of safety, efficacy, or regulatory compliance of the Company’s products (“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 9 contracts
Samples: Equity Distribution Agreement (Co-Diagnostics, Inc.), Equity Distribution Agreement (POINT Biopharma Global Inc.), Equity Distribution Agreement (Inhibikase Therapeutics, Inc.)
No Safety Notices. (i) Except as disclosed in the Registration Statement, the Time of Sale Disclosure Package Statement 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 notice of action relating to an alleged lack of safety, efficacy, or regulatory compliance of the Company’s products (“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 of the Company’s respective products or services, or (z) a termination or suspension of marketing or testing of any of the Company’s products or services.
Appears in 4 contracts
Samples: Sales Agreement (Larimar Therapeutics, Inc.), Sales Agreement (Larimar Therapeutics, Inc.), Sales Agreement (Surrozen, Inc./De)
No Safety Notices. Except as would not, singly or in the aggregate, have a Material Adverse Effect: (i) Except as disclosed in the Registration Statement, the 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 notice of action relating to an alleged lack of safety, efficacy, or regulatory compliance of the Company’s or its Subsidiaries’ products or services (collectively, “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 or its Subsidiaries’ products or services, or (y) a material change in labeling of any of the Company’s respective or its Subsidiaries’ products or services, or (z) a termination or suspension of marketing marketing, testing or testing distribution of any of the Company’s or its Subsidiaries’ products or services.
Appears in 3 contracts
Samples: Securities Purchase Agreement (Eloxx Pharmaceuticals, Inc.), Securities Purchase Agreement (Sonendo, Inc.), Securities Purchase Agreement (Sonendo, Inc.)
No Safety Notices. (iA) Except as disclosed in the Registration Statement, the 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 notice of action relating to an alleged lack of safety, efficacy, or regulatory compliance of the Company’s Company or the Subsidiaries’ products (“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 Company or any of the Subsidiaries’ products or services, (y2) a change in labeling of any of the Company’s or the Subsidiaries’ respective products or services, or (z3) a termination or suspension of marketing or testing of any of the Company’s or the Subsidiaries’ respective products or services.
Appears in 3 contracts
Samples: Underwriting Agreement (Progenity, Inc.), Purchase Agreement (Progenity, Inc.), Purchase Agreement (Progenity, Inc.)
No Safety Notices. (i) Except as disclosed in the Registration Statement, the 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 notice of action relating to an alleged lack of safety, efficacy, or regulatory compliance of the Company’s products (“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 and its subsidiaries’ products or services, (y) a change in labeling of any the Company’s and its subsidiaries’ respective products or services, or (z) a termination or suspension of marketing or testing of any the Company’s and its subsidiaries’ products or services.
Appears in 3 contracts
Samples: Underwriting Agreement (CareDx, Inc.), Underwriting Agreement (CareDx, Inc.), Purchase Agreement (CareDx, Inc.)
No Safety Notices. (i) Except as disclosed in the Registration Statement, the Time of Sale Disclosure Package and the Prospectus, and except in each case as would not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect, (i) there have been no recalls, field notifications, field corrections, market withdrawals or replacements, warnings, “dear doctor” letters, investigator notices, safety alerts or other notice of action relating to an alleged lack of safety, efficacy, or regulatory compliance of the Company’s or its subsidiary’s products (“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 or its subsidiary’s products or services, (y) a change in labeling of any the Company’s or its subsidiary’s respective products or services, or (z) a termination or suspension of marketing or testing of any the Company’s or its subsidiary’s respective products or services.
Appears in 2 contracts
Samples: Underwriting Agreement (Aziyo Biologics, Inc.), Underwriting Agreement (Aziyo Biologics, Inc.)
No Safety Notices. (i) Except as disclosed in the Registration Statement, the 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 notice of action relating to an alleged lack of safety, efficacy, or regulatory compliance of the Company’s products (“Safety Notices”) and (ii) to the Company’s knowledge, there are no facts that would reasonably be reasonably likely expected to result in (x) a Safety Notice with respect to the Company’s products or services, (y) a change in labeling of any of 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 (Nyxoah SA), Purchase Agreement (Nyxoah SA)
No Safety Notices. (iA) Except as disclosed in the Registration Statement, the Time of Sale Disclosure Package Statement 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 notice of action relating to an alleged lack of safety, efficacy, or regulatory compliance of the Company’s Company or the Subsidiaries’ products (“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 Company or any of the Subsidiaries’ products or services, (y2) a change in labeling of any of the Company’s or the Subsidiaries’ respective products or services, or (z3) a termination or suspension of marketing or testing of any of the Company’s or the Subsidiaries’ respective products or services.
Appears in 2 contracts
Samples: Equity Distribution Agreement (Biora Therapeutics, Inc.), At Market Issuance Sales Agreement (Progenity, Inc.)
No Safety Notices. (i) Except as disclosed in the Registration Statement, the Time of Sale Disclosure Package and the ProspectusSEC Filings, there have been no recalls, field notifications, field corrections, market withdrawals or replacements, warnings, “dear doctor” letters, investigator notices, safety alerts or other notice of action relating to an alleged lack of safety, efficacy, or regulatory compliance of the Company’s products (“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: Common Stock Purchase Agreement (Beyond Air, Inc.), Common Stock Purchase Agreement (Beyond Air, Inc.)
No Safety Notices. (i) Except as disclosed in the Registration Statement, the Time of Sale Disclosure Package and the Prospectus, (i) there have been no recalls, field notifications, field corrections, market withdrawals or replacements, warnings, “dear doctor” letters, investigator notices, safety alerts or other notice of action relating to an alleged lack of safety, efficacy, or regulatory compliance of the Company’s products (“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 (Edap TMS Sa), Purchase Agreement (Edap TMS Sa)
No Safety Notices. (i) Except as disclosed in the Registration Statement, the Time of Sale Disclosure Package and the Prospectus, or as otherwise would not reasonably be expected to result in a Material Adverse Effect, there have been no recalls, field notifications, field corrections, market withdrawals or replacements, warnings, “dear doctor” letters, investigator notices, safety alerts or other notice of action relating to an alleged lack of safety, efficacy, or regulatory compliance of the Company’s products (“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 (Infinity Pharmaceuticals, Inc.)
No Safety Notices. (i) Except as disclosed in the Registration Statement, the Time of Sale Disclosure Package Statement 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 notice of action relating to an alleged lack of safety, efficacy, or regulatory compliance of the Company’s products (“Safety Notices”) and (ii) to the Company’s knowledge, there are no facts that would reasonably be reasonably likely expected to result in (x) a Safety Notice with respect to the Company’s products or services, (y) a change in labeling of any of 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: Sales Agreement (Nyxoah SA)
No Safety Notices. (iA) Except as disclosed in the Registration Statement, the Time of Sale Disclosure Package Statement and 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 notice of action relating to an alleged lack of safety, efficacy, or regulatory compliance of the Company’s products (“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, in the Time of Sale Disclosure Package and in 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 notice of action relating to an alleged lack of safety, efficacy, or regulatory compliance of the Company’s products (“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 (XBiotech Inc.)
No Safety Notices. (i) Except as disclosed in the Registration Statement, the Time of Sale Disclosure Package Statement 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 an any alleged or potential performance or accuracy failure(s) of testing services offered, or lack of safety, efficacy, or regulatory compliance of the Company’s 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: Sales Agreement (MDxHealth SA)
No Safety Notices. (i) Except as disclosed in the Registration Statement, the Time of Sale Disclosure Package and the ProspectusSEC Reports, there have been no recalls, field notifications, field corrections, market withdrawals or replacements, warnings, “dear doctor” letters, investigator notices, safety alerts or other notice of action relating to an alleged lack of safety, efficacy, or regulatory compliance of the Company’s products or product candidates (“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
No Safety Notices. (iA) Except as disclosed in the Registration Statement, the Time of Sale Disclosure Package and the Prospectus, there have been no recalls, field notifications, field corrections, market withdrawals or replacements, warningswithdrawals, “dear doctor” letters, investigator notices, safety alerts or other notice of action relating to an alleged lack of safety, efficacy, or regulatory compliance of the Company’s products (“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
Samples: Purchase Agreement (Cutera Inc)
No Safety Notices. (i) Except as disclosed in the Registration StatementStatements, the Time of Sale Disclosure Package and the ProspectusProspectuses, there have been no recalls, field notifications, field corrections, market withdrawals or replacements, warnings, “dear doctor” letters, investigator notices, safety alerts or other notice of action relating to an alleged lack of safety, efficacy, or regulatory compliance of the Company’s products (“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: Underwriting Agreement (Zynex Inc)
No Safety Notices. (i) Except as disclosed in the Registration Statement, the 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 notice of action relating to an alleged lack of safety, efficacy, or regulatory compliance of the Company’s products (“Safety Notices”) and (ii) to the Company’s knowledge, there are no facts currently present 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 of the Company’s products or servicesproducts.
Appears in 1 contract
No Safety Notices. (iA) Except as disclosed in the Registration Statement, the Time of Sale Disclosure Package Statement and the Prospectus, there have been no recalls, field notifications, field corrections, market withdrawals or replacements, warningswithdrawals, “dear doctor” letters, investigator notices, safety alerts or other notice of action relating to an alleged lack of safety, efficacyeffectiveness, or regulatory compliance of the Company’s products (“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 servicesproducts, (y2) a change in labeling of any the Company’s respective products or servicesproducts, 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 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 notice of action relating to an alleged lack of safety, efficacy, or regulatory compliance of the Company’s products (“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, except as would not reasonably be expected, individually or in the aggregate, to result in a Material Adverse Effect.
Appears in 1 contract
No Safety Notices. (i) Except as disclosed described in the Registration Statement, the Time of Sale General Disclosure Package and the Prospectus, (i) there have been no material recalls, field notifications, field corrections, market withdrawals or replacements, warnings, “dear doctor” letters, investigator notices, safety alerts or other notice notices of action relating to an alleged lack of safety, efficacy, or regulatory compliance of the Company’s products (“Safety Notices”) since January 1, 2015, and (ii) to the knowledge of the Company’s knowledge, there are no material complaints with respect to the Company products that are currently unresolved. To the knowledge of the Company, there are no facts that would be reasonably likely to result in (xi) a material Safety Notice with respect to the Company’s products or servicesproducts, (yii) a material change in labeling of any the Company’s respective products or services, products; or (ziii) a termination or suspension of marketing or testing of any the Company’s products or servicesproducts.
Appears in 1 contract
Samples: Underwriting Agreement (Avedro Inc)