FDA Regulatory Matters. (a) Borrower has all Permits issued or allowed by the 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, XX Xxxxx, pricing and reimbursement approvals, labeling approvals or their foreign equivalent, controlled substance registrations, and wholesale distributor permits (hereinafter “Permits”) that are required to conduct its business as currently conducted, or as proposed to be conducted. To the knowledge of Borrower, 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 the Borrower. To the knowledge of Borrower, 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. 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 Borrower, any third party that is a manufacturer or contractor for the Borrower is in compliance with all Permits required by the FDA or comparable governmental authority and all 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 the Borrower.
Appears in 1 contract
Samples: Credit, Security and Guaranty Agreement (Alphatec Holdings, Inc.)
FDA Regulatory Matters. (a) Borrower has all Permits issued or allowed by the 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, XX CX Xxxxx, pricing and reimbursement approvals, labeling approvals or their foreign equivalent, controlled substance registrations, and wholesale distributor permits (hereinafter “Permits”) that are required to conduct its business as currently conducted, or as proposed to be conducted. To the knowledge of Borrower, 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 the Borrower. To the knowledge of Borrower, 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. 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 Borrower, any third party that is a manufacturer or contractor for the Borrower is in compliance with all Permits required by the FDA or comparable governmental authority and all 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 the Borrower.
(b) All products designed, developed, manufactured, prepared, assembled, packaged, tested, labeled, distributed or marketed by or on behalf of Borrower that are subject to the jurisdiction of the FDA or a comparable governmental authority have been and are being designed, developed, tested, manufactured, prepared, assembled, packaged, distributed, labeled and marketed in compliance with the Healthcare Laws and all other applicable Laws, statutes, ordinances, rules and regulations (each a “Requirement of Law”), including, without limitation, clinical and non-clinical evaluation, product approval or clearance, good manufacturing practices, labeling, advertising and promotion, record-keeping, establishment registration and device listing, reporting of recalls, and adverse event reporting, and have been and are being tested, investigated, designed, developed, manufactured, prepared, assembled, packaged, labeled, distributed, marketed, and sold in compliance with all applicable Requirements of Law.
(c) Borrower is not subject to any obligation arising under an administrative or regulatory action, proceeding, or inspection by a governmental authority, including the FDA, warning letter, notice of violation letter, consent decree, request for information or other notice, response or commitment made to or with the FDA or any comparable governmental authority. There is no act, omission, event, or circumstance of which Borrower has knowledge that would reasonably be expected to give rise to or lead to any civil, criminal or administrative action, suit, demand, claim, complaint, hearing, investigation, demand letter, warning letter, proceeding or request for information pending against Borrower and, to Borrower’s knowledge, Borrower has no liability (whether actual or contingent) for failure to comply with any Public Health Laws. There has not been any violation of any Public Health Laws by Borrower in its product development efforts, submissions, record keeping and reports to the FDA or any other comparable governmental authority that could reasonably be expected to require or lead to investigation, corrective action or enforcement, regulatory or administrative action that could reasonably be expected to have a Material Adverse Effect. To the knowledge of Borrower, there are no civil or criminal proceedings relating to Borrower or any officer, director or employee of Borrower that involve a matter within or related to the FDA’s any other comparable governmental authority’s jurisdiction.
(d) As of the Closing Date, Borrower is not undergoing any inspection related to any activities or products of the Borrower that are subject to Healthcare Laws, or any other governmental authority investigation.
(e) During the period of six calendar years immediately preceding the Closing Date, Borrower has not introduced into commercial distribution any products manufactured by or on behalf of Borrower or distributed any products on behalf of another manufacturer that were upon their shipment by Borrower adulterated or misbranded in violation of 21 U.S.C. § 331. Borrower has not received any notice or communication from the FDA or comparable governmental authority alleging material noncompliance with any Requirement of Law. No product has been seized, withdrawn, recalled, detained, or subject to a suspension (other than in the ordinary course of business) of research, manufacturing, distribution or commercialization activity, and there are no facts or circumstances reasonably likely to cause (i) the seizure, denial, withdrawal, recall, detention, public health notification, safety alert or suspension of manufacturing or other activity relating to any product; (ii) a change in the labeling of any product suggesting a compliance issue or risk; or (iii) a termination, seizure or suspension of manufacturing, researching, distributing or marketing of any product. No proceedings in the United States or any other jurisdiction seeking the withdrawal, recall, revocation, suspension, import detention, or seizure of any product are pending or threatened against Borrower.
(f) Neither Borrower nor any of its respective officers, directors, employees, agents or contractors (i) have been excluded or debarred from any federal healthcare program (including without limitation Medicare or Medicaid) or any other federal program or (ii) have received notice from the FDA or any other comparable governmental authority with respect to debarment or disqualification of any person that could reasonably be expected to have a Material Adverse Effect. Neither Borrower nor any of its respective officers, directors, employees, agents or contractors have been convicted of any crime or engaged in any conduct for which (x) debarment is mandated or permitted by 21 U.S.C. § 335a or (y) such person or entity could be excluded from participating in the federal health care programs under Section 1128 of the Social Security Act or any similar law. No officer and to the knowledge of Borrower, no employee or agent of a Borrower, has (aa) made any untrue statement of material fact or fraudulent statement to the FDA or any other comparable governmental authority; (bb) failed to disclose a material fact required to be disclosed to the FDA or any other comparable governmental authority; or (cc) committed an act, made a statement, or failed to make a statement that would reasonably be expected to provide the basis for the FDA or any other comparable governmental authority to invoke its policy respecting “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities,” as set forth in 56 Fed. Reg. 46191 (September 10, 1991).
(g) Borrower has not granted rights to design, develop, manufacture, produce, assemble, distribute, license, prepare, package, label, market or sell its products to any other person nor is it bound by any agreement that affects Borrower’s exclusive right to design, develop, manufacture, produce, assemble, distribute, license, prepare, package, label, market or sell its products.
(h) Except as set forth on Schedule 8.2(h), (i) Borrower and its respective contract manufacturers are, and have been for the past six calendar years, in compliance with, and each of its products in current commercial distribution is designed, manufactured, prepared, assembled, packaged, labeled, stored, installed, serviced, and processed in compliance with, the Quality System Regulation set forth in 21 C.F.R. Part 820, or comparable quality management system, including, but not limited to, ISO 13485, as applicable, (ii) Borrower is in compliance with the written procedures, record-keeping and reporting requirements required by the FDA or any comparable governmental authority pertaining to the reporting of adverse events and recalls involving any of Borrower’s products, including, as the case may be, Medical Device Reporting set forth in 21 C.F.R. Part 803 and Reports of Corrections and Removals set forth in 21 C.F.R. Part 806, (iii) Borrower’s products are and have been labeled, promoted, and advertised in accordance with their Permit or within the scope of an exemption from obtaining such Permit, and (iv) Borrower’s establishments are registered with the FDA, as applicable, and each product of a Borrower, if any, is listed with the FDA under the applicable FDA registration and listing regulations for medical devices.
Appears in 1 contract
Samples: Credit, Security and Guaranty Agreement (Alphatec Holdings, Inc.)
FDA Regulatory Matters. (a) Borrower Each Credit Party has all Permits issued or allowed by the U.S. Food and Drug Administration (“FDA”) 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, XX 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 BorrowerBorrowers, 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 the Borrowera Credit Party. To the knowledge of BorrowerBorrowers, 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. The Borrower 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 BorrowerBorrowers, any third party that is a manufacturer or contractor for the Borrower a Credit Party is in compliance with all Permits required by the FDA or comparable governmental authority and all Public Health 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.
(b) All products designed, developed, manufactured, prepared, assembled, packaged, tested, labeled, distributed or marketed by or on behalf of each Credit Party that are subject to the jurisdiction of the FDA or a comparable governmental authority have been and are being designed, developed, tested, manufactured, prepared, assembled, packaged, distributed, labeled and marketed in compliance with the Healthcare Laws, including, without limitation, clinical and non-clinical evaluation, product approval or clearance, good manufacturing practices, labeling, advertising and promotion, record-keeping, establishment registration and device listing, reporting of recalls, and adverse event reporting, and have been and are being tested, investigated, designed, developed, manufactured, prepared, assembled, packaged, labeled, distributed, marketed, and sold in compliance with all applicable Requirements of Law.
(c) Each Credit Party is not subject to any obligation arising under an administrative or regulatory action, proceeding, or inspection by a governmental authority, including the FDA, warning letter, notice of violation letter, consent decree, request for information or other notice, response or commitment made to or with the FDA or any comparable governmental authority. There is no act, omission, event, or circumstance of which Borrowers have knowledge that would reasonably be expected to give rise to or lead to any civil, criminal or administrative action, suit, demand, claim, complaint, hearing, investigation, demand letter, warning letter, proceeding or request for information pending against Borrowers and, to Borrowers’ knowledge, Borrowers have no liability (whether actual or contingent) for failure to comply with any Healthcare Laws. There has not been any violation of any Healthcare Laws by Borrowers in their product development efforts, submissions, record keeping and reports to the FDA or any other comparable governmental authority that could reasonably be expected to require or lead to investigation, corrective action or enforcement, regulatory or administrative action that could reasonably be expected to have a Material Adverse Effect. To the knowledge of Borrowers, there are no civil or criminal proceedings relating to Borrowers or any officer, director or employee of Borrowers that involve a matter within or related to the FDA’s any other comparable governmental authority’s jurisdiction.
(d) As of the Closing Date, Borrowers are not undergoing any inspection related to any activities or products of the Borrowers that are subject to Healthcare Laws, or any other governmental authority investigation.
(e) During the period of six calendar years immediately preceding the Closing Date, Borrowers have not introduced into commercial distribution any products manufactured by or on behalf of Borrowers or distributed any products on behalf of another manufacturer that were upon their shipment by Borrowers adulterated or misbranded in violation of 21 U.S.C. § 331. Borrowers have not received any notice or communication from the FDA or comparable governmental authority alleging material noncompliance with any Healthcare Law. No product has been seized, withdrawn, recalled, detained, or subject to a suspension (other than in the Ordinary Course of Business) of research, manufacturing, distribution or commercialization activity, and there are no facts or circumstances reasonably likely to cause (i) the seizure, denial, withdrawal, recall, detention, public health notification, safety alert or suspension of manufacturing or other activity relating to any product; (ii) a change in the labeling of any product suggesting a compliance issue or risk; or (iii) a termination, seizure or suspension of manufacturing, researching, distributing or marketing of any product. No proceedings in the United States or any other jurisdiction seeking the withdrawal, recall, revocation, suspension, import detention, or seizure of any product are pending or threatened against any Borrower.
(f) Neither Borrowers nor any of their respective officers, directors, employees, agents or contractors (i) have been excluded or debarred from any federal healthcare program (including without limitation Medicare or Medicaid) or any other federal program or (ii) have received notice from the FDA or any other comparable governmental authority with respect to debarment or disqualification of any person that could reasonably be expected to have a Material Adverse Effect. Neither Borrowers nor any of their respective officers, directors, employees, agents or contractors have been convicted of any crime or engaged in any conduct for which (x) debarment is mandated or permitted by 21 U.S.C. § 335a or (y) such person or entity could be excluded from participating in the federal health care programs under Section 1128 of the Social Security Act or any similar law. No officer and to the knowledge of any Borrower, no employee or agent of a Borrower, has (aa) made any untrue statement of material fact or fraudulent statement to the FDA or any other comparable governmental authority; (bb) failed to disclose a material fact required to be disclosed to the FDA or any other comparable governmental authority; or (cc) committed an act, made a statement, or failed to make a statement that would reasonably be expected to provide the basis for the FDA or any other comparable governmental authority to invoke its policy respecting “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities,” as set forth in 56 Fed. Reg. 46191 (September 10, 1991).
(g) Borrowers have not granted rights to design, develop, manufacture, produce, assemble, distribute, license, prepare, package, label, market or sell its products to any other person nor is it bound by any agreement that affects Borrowers’ exclusive right to design, develop, manufacture, produce, assemble, distribute, license, prepare, package, label, market or sell its products.
(h) Except as set forth on Schedule 8.2(h), (i) Borrowers and their respective contract manufacturers are, and have been for the past six calendar years, in compliance with, and each of its products in current commercial distribution is designed, manufactured, prepared, assembled, packaged, labeled, stored, installed, serviced, and processed in compliance with, the Quality System Regulation set forth in 21 C.F.R. Part 820, or comparable quality management system, including, but not limited to, ISO13485, as applicable, (ii) Borrowers are in compliance with the written procedures, record-keeping and reporting requirements required by the FDA or any comparable governmental authority pertaining to the reporting of adverse events and recalls involving any of Borrowers’ products, including, as the case may be, Medical Device Reporting set forth in 21 C.F.R. Part 803 and Reports of Corrections and Removals set forth in 21 C.F.R. Part 806, (iii) Borrowers’ products are and have been labeled, promoted, and advertised in accordance with their Permit or within the scope of an exemption from obtaining such Permit, and (iv) Borrowers’ establishments are registered with the FDA, as applicable, and each product of Borrowers, if any, is listed with the FDA under the applicable FDA registration and listing regulations for medical devices.
(i) Lender agrees that any breach of the terms of this Section 8.2 as a result of any action or inaction on the part of Structure Medical shall not be a breach of this Section 8.2 by Borrowers.
Appears in 1 contract
Samples: Credit, Security and Guaranty Agreement (Alphatec Holdings, Inc.)
FDA Regulatory Matters. (a) Borrower Each Credit Party has all Permits issued or allowed by the U.S. Food and Drug Administration (“FDA”) 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, XX 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 BorrowerBorrowers, 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 the Borrowera Credit Party. To the knowledge of BorrowerBorrowers, 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. The Borrower 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 BorrowerBorrowers, any third party that is a manufacturer or contractor for the Borrower a Credit Party is in compliance with all Permits required by the FDA or comparable governmental authority and all Public Health 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.
(b) All products designed, developed, manufactured, prepared, assembled, packaged, tested, labeled, distributed or marketed by or on behalf of each Credit Party that are subject to the Borrowerjurisdiction of the FDA or a comparable governmental authority have been and are being designed, developed, tested, manufactured, prepared, assembled, packaged, distributed, labeled and marketed in compliance with the Healthcare Laws, including, without limitation, clinical and non-clinical evaluation, product approval or clearance, good manufacturing practices, labeling, advertising and promotion, record-keeping, establishment registration and device listing, reporting of recalls, and adverse event reporting, and have been and are being tested, investigated, designed, developed, manufactured, prepared, assembled, packaged, labeled, distributed, marketed, and sold in compliance with all applicable Requirements of Law.
Appears in 1 contract
Samples: Credit, Security and Guaranty Agreement (Alphatec Holdings, Inc.)
FDA Regulatory Matters. (a) Borrower Each Credit Party has all Permits issued or allowed by the 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, XX Xxxxx, pricing and reimbursement approvals, labeling approvals or their foreign equivalent, controlled substance registrations, and wholesale distributor permits (hereinafter “Permits”) that are required to conduct its business as currently conducted, or as proposed to be conducted. To the knowledge of BorrowerBorrowers, 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 the Borrowera Credit Party. To the knowledge of BorrowerBorrowers, 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. The Borrower 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 BorrowerBorrowers, any third party that is a manufacturer or contractor for the Borrower a Credit Party is in compliance with all Permits required by the FDA or comparable governmental authority and all 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.
(b) All products designed, developed, manufactured, prepared, assembled, packaged, tested, labeled, distributed or marketed by or on behalf of each Credit Party that are subject to the jurisdiction of the FDA or a comparable governmental authority have been and are being designed, developed, tested, manufactured, prepared, assembled, packaged, distributed, labeled and marketed in compliance with the Healthcare Laws and all other applicable Laws, statutes, ordinances, rules and regulations (each a “Requirement of Law”), including, without limitation, clinical and non-clinical evaluation, product approval or clearance, good manufacturing practices, labeling, advertising and promotion, record-keeping, establishment registration and device listing, reporting of recalls, and adverse event reporting, and have been and are being tested, investigated, designed, developed, manufactured, prepared, assembled, packaged, labeled, distributed, marketed, and sold in compliance with all applicable Requirements of Law.
(c) Each Credit Party is not subject to any obligation arising under an administrative or regulatory action, proceeding, or inspection by a governmental authority, including the FDA, warning letter, notice of violation letter, consent decree, request for information or other notice, response or commitment made to or with the FDA or any comparable governmental authority. There is no act, omission, event, or circumstance of which Borrowers have knowledge that would reasonably be expected to give rise to or lead to any civil, criminal or administrative action, suit, demand, claim, complaint, hearing, investigation, demand letter, warning letter, proceeding or request for information pending against Borrowers and, to Borrowers’ knowledge, Borrowers have no liability (whether actual or contingent) for failure to comply with any Public Health Laws. There has not been any violation of any Public Health Laws by Borrowers in their product development efforts, submissions, record keeping and reports to the FDA or any other comparable governmental authority that could reasonably be expected to require or lead to investigation, corrective action or enforcement, regulatory or administrative action that could reasonably be expected to have a Material Adverse Effect. To the knowledge of Borrowers, there are no civil or criminal proceedings relating to Borrowers or any officer, director or employee of Borrowers that involve a matter within or related to the FDA’s any other comparable governmental authority’s jurisdiction.
(d) As of the Closing Date, Borrowers are not undergoing any inspection related to any activities or products of the Borrowers that are subject to Healthcare Laws, or any other governmental authority investigation.
(e) During the period of six calendar years immediately preceding the Closing Date, Borrowers have not introduced into commercial distribution any products manufactured by or on behalf of Borrowers or distributed any products on behalf of another manufacturer that were upon their shipment by Borrowers adulterated or misbranded in violation of 21 U.S.C. § 331. Borrowers have not received any notice or communication from the FDA or comparable governmental authority alleging material noncompliance with any Requirement of Law. No product has been seized, withdrawn, recalled, detained, or subject to a suspension (other than in the Ordinary Course of Business) of research, manufacturing, distribution or commercialization activity, and there are no facts or circumstances reasonably likely to cause (i) the seizure, denial, withdrawal, recall, detention, public health notification, safety alert or suspension of manufacturing or other activity relating to any product; (ii) a change in the labeling of any product suggesting a compliance issue or risk; or (iii) a termination, seizure or suspension of manufacturing, researching, distributing or marketing of any product. No proceedings in the United States or any other jurisdiction seeking the withdrawal, recall, revocation, suspension, import detention, or seizure of any product are pending or threatened against Borrower.
(f) Neither Borrowers nor any of their respective officers, directors, employees, agents or contractors (i) have been excluded or debarred from any federal healthcare program (including without limitation Medicare or Medicaid) or any other federal program or (ii) have received notice from the FDA or any other comparable governmental authority with respect to debarment or disqualification of any person that could reasonably be expected to have a Material Adverse Effect. Neither Borrower nor any of its respective officers, directors, employees, agents or contractors have been convicted of any crime or engaged in any conduct for which (x) debarment is mandated or permitted by 21 U.S.C. § 335a or (y) such person or entity could be excluded from participating in the federal health care programs under Section 1128 of the Social Security Act or any similar law. No officer and to the knowledge of Borrower, no employee or agent of a Borrower, has (aa) made any untrue statement of material fact or fraudulent statement to the FDA or any other comparable governmental authority; (bb) failed to disclose a material fact required to be disclosed to the FDA or any other comparable governmental authority; or (cc) committed an act, made a statement, or failed to make a statement that would reasonably be expected to provide the basis for the FDA or any other comparable governmental authority to invoke its policy respecting “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities,” as set forth in 56 Fed. Reg. 46191 (September 10, 1991).
(g) Borrowers have not granted rights to design, develop, manufacture, produce, assemble, distribute, license, prepare, package, label, market or sell its products to any other person nor is it bound by any agreement that affects Borrowers’ exclusive right to design, develop, manufacture, produce, assemble, distribute, license, prepare, package, label, market or sell its products.
(h) Except as set forth on Schedule 8.2(h), (i) Borrowers and their respective contract manufacturers are, and have been for the past six calendar years, in compliance with, and each of its products in current commercial distribution is designed, manufactured, prepared, assembled, packaged, labeled, stored, installed, serviced, and processed in compliance with, the Quality System Regulation set forth in 21 C.F.R. Part 820, or comparable quality management system, including, but not limited to, ISO 13485, as applicable, (ii) Borrowers are in compliance with the written procedures, record-keeping and reporting requirements required by the FDA or any comparable governmental authority pertaining to the reporting of adverse events and recalls involving any of Borrowers’ products, including, as the case may be, Medical Device Reporting set forth in 21 C.F.R. Part 803 and Reports of Corrections and Removals set forth in 21 C.F.R. Part 806, (iii) Borrowers’ products are and have been labeled, promoted, and advertised in accordance with their Permit or within the scope of an exemption from obtaining such Permit, and (iv) Borrowers’ establishments are registered with the FDA, as applicable, and each product of Borrowers, if any, is listed with the FDA under the applicable FDA registration and listing regulations for medical devices.
Appears in 1 contract
Samples: Credit, Security and Guaranty Agreement (Alphatec Holdings, Inc.)
