Common use of Certain Communications Clause in Contracts

Certain Communications. Except as described in the Registration Statement, the Time of Sale Prospectus and the Prospectus, the Company: (i) since its incorporation in July 2018, has not received any FDA Form 483, written notice of adverse finding, warning letter, untitled letter or other written correspondence or notice from any governmental or regulatory authority alleging or asserting material noncompliance with any applicable Health Care Laws (as defined below) or the terms of any Permits, except in each case as would not, individually or in the aggregate, reasonably be expected to result in a Material Adverse Change; (ii) has not received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any governmental or regulatory authority or third party alleging that any product candidate, operation, or activity is in violation of any Health Care Laws or Permits and has no knowledge that any such governmental or regulatory authority or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding, except in each case as would not, individually or in the aggregate, reasonably be expected to result in a Material Adverse Change; (iii) (a) has filed, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Health Care Laws or Permits, (b) except as would not, individually or in the aggregate, reasonably be expected to result in a Material Adverse Change, all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and correct and not misleading in all material respects on the date filed (or were corrected or supplemented by a subsequent submission), and (c) is not aware of any reasonable basis for any material liability with respect to such filings; and (iv) has not, and to the knowledge of the Company, the Company’s officers, employees and agents have not, made any untrue statement of a material fact or fraudulent statement to any governmental or regulatory authority or failed to disclose a material fact required to be disclosed to any governmental or regulatory authority.

Certain Communications. Except as described in the Registration Statement, the Time of Sale Prospectus Statement and the Prospectus, the CompanyCompany and each subsidiary: (i) since its the Company’s incorporation in July 2018, has not received any FDA Form 483, written notice of adverse finding, warning letter, untitled letter or other written correspondence or notice from any governmental or regulatory authority alleging or asserting material noncompliance with any applicable Health Care Laws (as defined below) or the terms of any Permits, except in each case as would not, individually or in the aggregate, reasonably be expected to result in a Material Adverse Change; (ii) has not received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any governmental or regulatory authority or third party alleging that any product candidate, operation, or activity is in violation of any Health Care Laws or Permits and has no knowledge that any such governmental or regulatory authority or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding, except in each case as would not, individually or in the aggregate, reasonably be expected to result in a Material Adverse Change; (iii) (a) has filed, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Health Care Laws or Permits, (b) except as would not, individually or in the aggregate, reasonably be expected to result in a Material Adverse Change, all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and correct and not misleading in all material respects on the date filed (or were corrected or supplemented by a subsequent submission), and (c) is not aware of any reasonable basis for any material liability with respect to such filings; and (iv) has not, and to the knowledge of the Company, the Company’s officers, employees and agents have not, made any untrue statement of a material fact or fraudulent statement to any governmental or regulatory authority or failed to disclose a material fact required to be disclosed to any governmental or regulatory authority.