Common use of FDA Regulatory Matters Clause in Contracts

FDA Regulatory Matters. (a) Each Credit Party has all Permits issued or allowed by the FDA or any comparable governmental authority (including but not limited to new drug applications, abbreviated new drug applications, biologics license applications, investigational new drug applications, over-the-counter drug monograph, device pre-market approval applications, device pre-market notifications, investigational device exemptions, product recertifications, manufacturing approvals and authorizations, CX Xxxxx, pricing and reimbursement approvals, labeling approvals or their foreign equivalent, controlled substance registrations, and wholesale distributor permits (hereinafter “Healthcare Permits”) that are required to conduct its business as currently conducted, or as proposed to be conducted. To the knowledge of Borrowers, neither the FDA nor any comparable governmental authority is considering limiting, suspending, or revoking such Permits or changing the marketing classification or labeling or other significant parameter affecting the products of a Credit Party. To the knowledge of Borrowers, there is no false or misleading information or significant omission in any product application or other submission to the FDA or any comparable governmental authority. Each Credit Party has fulfilled and performed their obligations under each Permit, and no event has occurred or condition or state of facts exists which would constitute a breach or default under, or would cause revocation or termination of, any such Permit. To the knowledge of Borrowers, any third party that is a manufacturer or contractor for a Credit Party is in compliance with all Permits required by the FDA or comparable governmental authority and all Healthcare Laws insofar as they reasonably pertain to the manufacture of product components or products regulated as medical devices and marketed or distributed by a Credit Party.

FDA Regulatory Matters. (a) Each Credit Party Borrower has all Permits issued or allowed by the FDA U.S. Food and Drug Administration (“FDA”) or any comparable governmental authority (including but not limited to new drug applications, abbreviated new drug applications, biologics license applications, investigational new drug applications, over-the-counter drug monograph, device pre-market approval applications, device pre-market notifications, investigational device exemptions, product recertifications, manufacturing approvals and authorizations, CX Xxxxx, pricing and reimbursement approvals, labeling approvals or their foreign equivalent, controlled substance registrations, and wholesale distributor permits (hereinafter “Healthcare Permits”) that are required to conduct its business as currently conducted, or as proposed to be conducted. To the knowledge of BorrowersBorrower, neither the FDA nor any comparable governmental authority is considering limiting, suspending, or revoking such Permits or changing the marketing classification or labeling or other significant parameter affecting the products of a Credit Partythe Borrower. To the knowledge of BorrowersBorrower, there is no false or misleading information or significant omission in any product application or other submission to the FDA or any comparable governmental authority. Each Credit Party The Borrower has fulfilled and performed their obligations under each Permit, and no event has occurred or condition or state of facts exists which would constitute a breach or default under, or would cause revocation or termination of, any such Permit. To the knowledge of BorrowersBorrower, any third party that is a manufacturer or contractor for a Credit Party the Borrower is in compliance with all Permits required by the FDA or comparable governmental authority and all Healthcare Public Health Laws insofar as they reasonably pertain to the manufacture of product components or products regulated as medical devices and marketed or distributed by a Credit Partythe Borrower.

FDA Regulatory Matters. (a) Each Credit Party Borrower has all Permits issued or allowed by the FDA U.S. Food and Drug Administration (“FDA”) or any comparable governmental authority (including but not limited to new drug applications, abbreviated new drug applications, biologics license applications, investigational new drug applications, over-the-counter drug monograph, device pre-market approval applications, device pre-market notifications, investigational device exemptions, product recertifications, manufacturing approvals and authorizations, CX XX Xxxxx, pricing and reimbursement approvals, labeling approvals or their foreign equivalent, controlled substance registrations, and wholesale distributor permits (hereinafter “Healthcare Permits”) that are required to conduct its business as currently conducted, or as proposed to be conducted. To the knowledge of BorrowersBorrower, neither the FDA nor any comparable governmental authority is considering limiting, suspending, or revoking such Permits or changing the marketing classification or labeling or other significant parameter affecting the products of a Credit Partythe Borrower. To the knowledge of BorrowersBorrower, there is no false or misleading information or significant omission in any product application or other submission to the FDA or any comparable governmental authority. Each Credit Party The Borrower has fulfilled and performed their obligations under each Permit, and no event has occurred or condition or state of facts exists which would constitute a breach or default under, or would cause revocation or termination of, any such Permit. To the knowledge of BorrowersBorrower, any third party that is a manufacturer or contractor for a Credit Party the Borrower is in compliance with all Permits required by the FDA or comparable governmental authority and all Healthcare Public Health Laws insofar as they reasonably pertain to the manufacture of product components or products regulated as medical devices and marketed or distributed by a Credit Partythe Borrower.

FDA Regulatory Matters. (a) Each Credit Party has all Permits issued or allowed by the FDA U.S. Food and Drug Administration (“FDA”) or any comparable governmental authority (including but not limited to new drug applications, abbreviated new drug applications, biologics license applications, investigational new drug applications, over-the-counter drug monograph, device pre-market approval applications, device pre-market notifications, investigational device exemptions, product recertifications, manufacturing approvals and authorizations, CX XX Xxxxx, pricing and reimbursement approvals, labeling approvals or their foreign equivalent, controlled substance registrations, and wholesale distributor permits (hereinafter “Healthcare Permits”) that are required to conduct its business as currently conducted, or as proposed to be conducted. To the knowledge of Borrowers, neither the FDA nor any comparable governmental authority is considering limiting, suspending, or revoking such Permits or changing the marketing classification or labeling or other significant parameter affecting the products of a Credit Party. To the knowledge of Borrowers, there is no false or misleading information or significant omission in any product application or other submission to the FDA or any comparable governmental authority. Each Credit Party has fulfilled and performed their obligations under each Permit, and no event has occurred or condition or state of facts exists which would constitute a breach or default under, or would cause revocation or termination of, any such Permit. To the knowledge of Borrowers, any third party that is a manufacturer or contractor for a Credit Party is in compliance with all Permits required by the FDA or comparable governmental authority and all Healthcare Public Health Laws insofar as they reasonably pertain to the manufacture of product components or products regulated as medical devices and marketed or distributed by a Credit Party.