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 products (“Safety Notices”), except as would not, singly or in the aggregate, reasonably be expected to result in 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 material change in labeling of any of the Company’s products, or (z) a termination or suspension of marketing or testing of any of the Company’s products, except, in each of cases (x), (y) or (z) such as would not, singly or in the aggregate, reasonably be expected to have a Material Adverse Effect.
Appears in 10 contracts
Samples: Underwriting Agreement (Vapotherm Inc), Underwriting Agreement (Vapotherm Inc), Underwriting Agreement (Outset Medical, 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 products or its subsidiaries’ product candidates (“Safety Notices”), except as would notnot reasonably be expected to, singly or in the aggregate, reasonably be expected to result in 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 material change in labeling of any of the Company’s productsits subsidiaries’ product candidates, or (zy) a termination or suspension of marketing or testing of any of the Company’s productsor its subsidiaries’ product candidates, except, in each of cases (x), (y) or (zy) such as would notnot reasonably be expected to, singly or in the aggregate, reasonably be expected to have result in a Material Adverse Effect.
Appears in 5 contracts
Samples: Underwriting Agreement (Inozyme Pharma, Inc.), Underwriting Agreement (Lyra Therapeutics, Inc.), Underwriting Agreement (Inozyme Pharma, 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 products product candidates (“Safety Notices”), except as would notnot reasonably be expected to, singly or in the aggregate, reasonably be expected to result in 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 product candidates or services, (y) a material change in labeling of any of the Company’s products, or (z) a termination or suspension of marketing or testing of any of the Company’s productsproduct candidates, except, in each of cases (x), (y) or (zy) such as would notnot reasonably be expected to, singly or in the aggregate, reasonably be expected to have result in a Material Adverse Effect.
Appears in 5 contracts
Samples: Agency Agreement (Galera Therapeutics, Inc.), Underwriting Agreement (Galera Therapeutics, Inc.), Underwriting Agreement (Centrexion Therapeutics Corp)
No Safety Notices. (iA) 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 (“Safety Notices”), except as would not, singly or in the aggregate, reasonably be expected to result in a Material Adverse Effect, and (iiB) to the knowledge of 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 servicesits subsidiaries’ products, (y2) a material change in labeling of any of the Company’s or its subsidiaries’ products, or (z3) a termination or suspension of marketing or testing of any of the Company’s or its subsidiaries’ products, except, in each of cases (x1), (y2) or (z3) such as would not, singly or in the aggregate, reasonably be expected to have result in a Material Adverse Effect.
Appears in 4 contracts
Samples: Underwriting Agreement (Axonics, Inc.), Underwriting Agreement (Axonics Modulation Technologies, Inc.), Underwriting Agreement (Axonics Modulation Technologies, 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’ products and product candidates (“Safety Notices”), except as would notnot reasonably be expected to, singly or in the aggregate, reasonably be expected to result in 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 or its subsidiaries’ products or services, (y) a material change in labeling of any of the Company’s productsand product candidates, or (zy) a termination or suspension of marketing or testing of any of the Company’s productsor its subsidiaries’ products and product candidates, except, in each of cases (x), (y) or (zy) such as would notnot reasonably be expected to, singly or in the aggregate, reasonably be expected to have result in a Material Adverse Effect.
Appears in 3 contracts
Samples: Terms Agreement (Protalix BioTherapeutics, Inc.), Terms Agreement (Protalix BioTherapeutics, Inc.), Terms Agreement (Protalix BioTherapeutics, Inc.)
No Safety Notices. (i) There Except as disclosed in the Registration Statement, the Pricing 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”), except as would not, singly or in the aggregate, reasonably be expected to result in 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 material change in labeling of any of the Company’s productsproducts or services, or (z) a termination or suspension of marketing or testing of any of the Company’s productsproducts or services, except, in each of cases (x), (y) or (z) such as would not, singly or in the aggregate, not reasonably be expected to have a Material Adverse Effect.
Appears in 3 contracts
Samples: Intersect ENT, Inc., Intersect ENT, Inc., Intersect ENT, 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 products (“Safety Notices”), except as would not, singly or in the aggregate, reasonably be expected to result in a Material Adverse Effect, and (ii) to the Company’s and its subsidiary’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 material change in labeling of any of the Company’s products, or (z) a termination or suspension of marketing or testing of any of the Company’s products, except, in each of cases (x), (y) or (z) such as would not, singly or in the aggregate, not reasonably be expected to have a Material Adverse Effect.
Appears in 3 contracts
Samples: Underwriting Agreement (Exact Sciences Corp), Underwriting Agreement (Exact Sciences Corp), Underwriting Agreement (Entellus Medical 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’ products (“Safety Notices”), except as would not, singly or in the aggregate, reasonably be expected to result in a Material Adverse Effect, 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 servicesits subsidiaries’ products, or (y) a material change in labeling of any of the Company’s products, or its subsidiaries’ products or (z) a termination or suspension of marketing or testing of any of the Company’s or its subsidiaries’ products, except, in each of cases (x), (y) or and (z) such as would not, singly or in the aggregate, reasonably be expected to have a Material Adverse Effect.
Appears in 2 contracts
Samples: Equity Distribution Agreement (CVRx, Inc.), Underwriting Agreement (CVRx, Inc.)
No Safety Notices. (i) There Except as described in the Registration Statement, the Preliminary Prospectus 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”), except as would not, singly or in the aggregate, reasonably be expected to result in 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 material change in labeling of any of the Company’s products, or (z) a termination or suspension of marketing or testing of any of the Company’s products, except, in each of cases (x), (y) or (z) such as would not, singly or in the aggregate, reasonably be expected to have a Material Adverse Effect.
Appears in 2 contracts
Samples: Underwriting Agreement (Movano Inc.), Underwriting Agreement (Movano 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’ products (“Safety Notices”), ) except as would not, singly or in the aggregate, reasonably be expected to result in have a Material Adverse Effect, Effect and (ii) to the Company’s knowledge, there are no facts that would be reasonably likely to result in (x) such a Safety Notice with respect to the Company’s products or servicesits subsidiaries’ products, or (y) a material adverse change in labeling of any of the Company’s or its subsidiaries’ products, or (z) a termination or suspension of marketing or testing or distribution of any of the Company’s or its subsidiaries’ products, except, in each of cases (x), (y) or (z) such as would not, singly or in the aggregate, reasonably be expected to have a Material Adverse Effect.
Appears in 2 contracts
Samples: Underwriting Agreement (Paragon 28, Inc.), Underwriting Agreement (Paragon 28, Inc.)
No Safety Notices. (iA) 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 its Subsidiaries’ product candidates (“Safety Notices”), except as would notnot reasonably be expected to, singly or in the aggregate, reasonably be expected to result in a Material Adverse Effect, and (iiB) 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 material change in labeling of any of the Company’s productsits Subsidiaries’ product candidates, or (zy) a termination or suspension of marketing or testing of any of the Company’s productsor its Subsidiaries’ product candidates, except, in each of cases (x), (y) or (zy) such as would notnot reasonably be expected to, singly or in the aggregate, reasonably be expected to have result in a Material Adverse Effect.
Appears in 1 contract
No Safety Notices. Except as would not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect: (i) There and except as disclosed in the Registration Statements, the Time of Sale Disclosure Package and the Prospectus, during the last five (5) years, there have been no post-market 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”), except as would not, singly or in the aggregate, reasonably be expected to result in a Material Adverse Effect, ) and (ii) to the Company’s knowledge, there are no facts that would be reasonably likely to result in (x) such a Safety Notice with respect to the Company’s products or servicesproducts, (y) a material change in labeling of any of the Company’s productsrespective products or services, or (z) a termination or suspension of marketing or testing of any of the Company’s products, except, in each of cases (x), (y) or (z) such as would not, singly or in the aggregate, reasonably be expected to have a Material Adverse Effect.
Appears in 1 contract
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’ products and product candidates (“Safety Notices”), except as would notnot reasonably be expected to, singly or in the aggregate, reasonably be expected to result in 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 or its subsidiaries’ products or services, (y) a material change in labeling of any of the Company’s productsand product candidates, or (zy) a termination or suspension of marketing or testing of any of the Company’s productsor its subsidiaries’ products and product candidates, except, in each of cases (x), (y) or (zy) such as would notnot reasonably be expected to, singly or in the aggregate, reasonably be expected to have result in a Material Adverse Effect.
Appears in 1 contract
Samples: Underwriting Agreement (Protalix BioTherapeutics, Inc.)
No Safety Notices. Except as would not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect: (i) There and except as disclosed in the Registration Statement, the Time of Sale Disclosure Package and the Prospectus, during the last five (5) years, there have been no post-market 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”), except as would not, singly or in the aggregate, reasonably be expected to result in a Material Adverse Effect, ) and (ii) to the Company’s knowledge, there are no facts that would be reasonably likely to result in (x) such a Safety Notice with respect to the Company’s products or servicesproducts, (y) a material change in labeling of any of the Company’s productsrespective products or services, or (z) a termination or suspension of marketing or testing of any of the Company’s products, except, in each of cases (x), (y) or (z) such as would not, singly or in the aggregate, reasonably be expected to have a Material Adverse Effect.
Appears in 1 contract
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 notices of action relating to an alleged lack of safety, efficacy, or regulatory compliance of the Company’s products (“Safety Notices”), except as would not, singly or in the aggregate, reasonably be expected to result in 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 material change in labeling of any of the Company’s products, or (z) a termination or suspension of marketing or testing of any of the Company’s products, except, in each of cases (x), (y) or (z) such as would not, singly or in the aggregate, reasonably be expected to have a Material Adverse Effect.
Appears in 1 contract
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 products (“Safety Notices”), except as would not, singly or in the aggregate, reasonably be expected to result in a Material Adverse EffectChange, 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 material change in labeling of any of the Company’s products, or (z) a termination or suspension of marketing or testing of any of the Company’s products, except, in each of cases (x), (y) or (z) such as would not, singly or in the aggregate, reasonably be expected to have a Material Adverse EffectChange.
Appears in 1 contract
Samples: Vapotherm Inc
No Safety Notices. (i) There Except as disclosed in the Registration Statement, the Pricing 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”), except as would not, singly or in the aggregate, reasonably be expected to result in 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 servicesservices of the Company or its subsidiaries, (y) a material change in labeling of any of the Company’s productsproducts or services of the Company or its subsidiaries, or (z) a termination or suspension of marketing or testing of any of the Company’s productsproducts or services of the Company or its subsidiaries, except, in each of cases (x), (y) or (z) such as would not, singly or in the aggregate, reasonably be expected to not have a Material Adverse Effect.
Appears in 1 contract
Samples: ECPM Holdings, LLC