No Safety Notices. (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 subsidiaries’ product candidates (“Safety Notices”) and (ii) 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’ product candidates, or (y) a material change in labeling of any of the Company’s or its subsidiaries’ product candidates or (z) a termination or suspension of marketing or testing of any of the Company’s or its subsidiaries’ product candidates.
Appears in 4 contracts
Samples: Underwriting Agreement (Tarsus Pharmaceuticals, Inc.), Underwriting Agreement (Tarsus Pharmaceuticals, Inc.), Underwriting Agreement (Tarsus Pharmaceuticals, Inc.)
No Safety Notices. (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 subsidiaries’ product candidates products (“Safety Notices”) ), except as would not, singly or in the aggregate, reasonably be expected to result in a Material Adverse Effect and (ii) 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’ product candidatesproducts, or (y) a material change in labeling of any of the Company’s or its subsidiaries’ product candidates products or (z) a termination or suspension of marketing or testing of any of the Company’s or its subsidiaries’ product candidatesproducts.
Appears in 3 contracts
Samples: Underwriting Agreement (SONDORS Inc.), Underwriting Agreement (SONDORS Inc.), Underwriting Agreement (SONDORS Inc.)
No Safety Notices. (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 subsidiaries’ product candidates products (“Safety Notices”) and (ii) 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’ product candidatesproducts, or (y) a material change in labeling of any of the Company’s or its subsidiaries’ product candidates products or (z) a termination or suspension of marketing or testing of any of the Company’s or its subsidiaries’ product candidates.
Appears in 2 contracts
Samples: Sales Agreement (Orphazyme a/S), Underwriting Agreement (Orphazyme a/S)
No Safety Notices. (i) There have been no recalls, field notifications, field corrections, market withdrawals or replacements, warnings, “dear doctor” letters, investigator notices, safety alerts or other written notice of action relating to an alleged lack of safety, efficacy, or regulatory compliance of the Company’s or its subsidiaries’ product candidates products (“Safety Notices”) and (ii) 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’ product candidatesproducts, or (y) a material change in labeling of any of the Company’s or its subsidiaries’ product candidates products or (z) a termination or suspension of marketing marketing, testing or testing distribution of any of the Company’s or its subsidiaries’ product candidatesproducts.
Appears in 1 contract
Samples: Underwriting Agreement (Rotech Healthcare Holdings Inc.)
No Safety Notices. (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 of action relating to an alleged lack of safety, efficacy, or regulatory compliance of the Company’s or its subsidiaries’ product candidates (“Safety Notices”) and (ii) there are no facts that would be reasonably likely to result in (x) a material Safety Notice with respect to the Company’s or its subsidiaries’ product candidates, or (y) a material change in labeling of any of the Company’s or its subsidiaries’ product candidates or (z) a termination or suspension of marketing or testing of any of the Company’s or its subsidiaries’ product candidates.
Appears in 1 contract
Samples: Tarsus Pharmaceuticals, Inc.
No Safety Notices. (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 subsidiaries’ product candidates products (“Safety Notices”) and (ii) 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’ product candidatesproducts, or (y) a material change in labeling of any of the Company’s or its subsidiaries’ product candidates products or (z) a termination or suspension of marketing or testing of any of the Company’s or its subsidiaries’ product candidatesproducts.
Appears in 1 contract