Other Regulatory Matters. (a) All of the Company Products have been manufactured, processed, packaged and held in accordance with the FDA’s HCT/P regulations at 21 C.F.R. Part 1271 or the FDA’s Quality System Regulation (“QSR”) at 21 C.F.R. Part 820, as applicable. All manufacturers of the Company Products that are required to be registered with the FDA under applicable Laws are so registered. All of the Company Products are appropriately listed in the FDA’s tissue products listing database or medical device listing database, as appropriate. To the Knowledge of the Company, all manufacturers of the Company Products have, prior to the Closing, manufactured products for the Company in accordance with applicable requirements of the HCT/P regulations or QSR, as applicable, in all material respects, and have, prior to the Closing, conducted business operations in compliance with the FDA Act and any applicable Laws relating to the manufacture of the Company Products. To the Knowledge of the Company, the marketing, sale and distribution of the Company Products is in compliance with the FDA Act. Company Products, that are HCT/Ps, other than its injectable or micronized amniotic membrane-derived products, qualify for marketing as a Section 361 HCT/Ps, and do not require the FDA premarket review or authorization. Premarket notification submissions or premarket approval applications and related documents and information for each of the Company Products that is a medical device have been filed, approved or cleared, and maintained in compliance with the FDA Act any other applicable Laws administered or promulgated by any other Governmental Authority. Neither the Company nor, to the Knowledge of the Company, any manufacturers of the Company Products, have received any warning or advisory letters from the FDA or received information from the FDA or other applicable Governmental Authority indicating that the Company Products are not in compliance with the FDA Act or any other applicable Laws. The Company does not possess information about the Company Products that would necessitate the filing of an adverse event report under the Public Health Service Act and the FDA’s regulations at 21 C.F.R. § 1271.350 or an FDA medical device report under the FDA Act and the FDA’s implementing regulations at 21 CFR Part 803, or that otherwise indicates that the Company Products are misbranded or adulterated within the meaning of the FDA Act, or otherwise may not be introduced into interstate commerce. (b) All operations of the Company have achieved and maintained all applicable quality certifications including all required ISO (International Organization for Standardization) certifications. Section 5.12(a) of the Disclosure Schedule lists each ISO and quality certification applicable to the Company. There is no pending or, to the Knowledge of the Company, threatened, Action to audit, repeal, fail to renew or challenge any such certification. (c) Except as set forth in Section 5.27(c) of the Disclosure Schedule, there have, within the past five (5) years, been no seizures conducted or threatened by the FDA or any other Governmental Authority, and no recalls, market withdrawals, field notifications, notifications of misbranding or adulteration, safety alerts conducted or adverse regulatory actions, requested or, to the Knowledge of the Company, threatened, by the FDA or by any other Governmental Authority, in each case relating to the Company or its business, assets or the Company Products. The Company has not been required by the FDA Act to file with the FDA any report concerning an adverse reaction or an adverse event or to file any other report or provide information to any product safety agency (other than the FDA), commission, board or other Governmental Authority of any jurisdiction, concerning actual or potential hazards with respect to any Company Product. Each Company Product complies with all material product safety standards of each applicable product safety agency, commission, board or other Governmental Authority. (d) The Company has inquired with all relevant suppliers of the Company and, no more than thirty (30) days prior to the Closing Date, received confirmation from all such suppliers that (i) the facilities at which the products are manufactured by such suppliers and sold to the Company are registered with the FDA, as required, (ii) such suppliers have not received any warning or advisory letters from the FDA or received information from the FDA or other applicable Governmental Authority indicating that any Company Products are not in compliance with the FDA Act or any applicable Law, and (iii) such suppliers do not possess information about any products sold to the Company that would necessitate the filing of an adverse event report under the Public Health Service Act and the FDA’s regulations at 21 C.F.R. § 1271.350 or an FDA medical device report under the FDA Act (and the FDA’s implementing regulations at 21 CFR Part 803) or would indicate that the products are misbranded or adulterated within the meaning of the FDA Act or otherwise may not be introduced into interstate commerce. The Company has not received any correspondence from, nor submitted any correspondence to, any Governmental Authority, discussing the legal marketing status, or the labeling or promotion, of any of the Company Products specifically, or generally of amniotic tissue or bone products. (e) Section 5.27(e) of the Disclosure Schedule lists all Company Products (by SKU), describes them by product category, provides a general description, shows the Company’s status with respect to each Company Product (e.g., “manufacturer”), and (i) for each Company Product commercialized, marketed or sold in the United States indicates whether the Company Product is distributed as a Section 361 HCT/P or, if not, provides the legal authority for marketing of the Company Product, or (ii) for each Company Product commercialized, marketed or sold outside the United States, specifies the applicable form of marketing authorization. (f) Each Company Product is, and at all relevant times has been, fit for the ordinary purposes for which it is intended to be used and conforms to any promises or affirmations of fact made in all regulatory filings pertaining thereto and made on the container or label for such Company Product or in connection with its sale. There is no design or manufacturing defect with respect to any Company Product. (g) The Company has not received any written notice that the Company has, and to the Knowledge of the Company there is no reasonable basis for, any Action against the Company for, any Liability arising out of any injury to any person or property as a result of a Company Product. (h) Section 5.27(h) of the Disclosure Schedule sets forth a complete and accurate listing of all preclinical and clinical studies, together with the dates and brief descriptions of such studies, previously or currently undertaken or sponsored by the Company with respect to any Company Product. All material information regarding the efficacy, safety and utility of the Company Products has been collected and maintained in accordance with accepted industry practices and will be readily accessible to Buyer after the Effective Time. All preclinical and clinical trials conducted, supervised or monitored by the Company have been conducted in compliance in all material respects with all applicable Laws, and the regulations and requirements of any Governmental Authority, including, but not limited to, FDA regulations at 21 C.F.R. Part 812, where applicable, and FDA “Good Laboratory Practices” at 21 C.F.R. Part 58. The Company has consistently obtained and maintained any Institutional Review Board (“IRB”) approvals of clinical trials conducted, supervised, or monitored by the Company as required by law, and has been in full compliance with any applicable requirements of 21 C.F.R. part 56. In no clinical trial conducted, supervised or monitored by the Company has IRB approval ever been suspended, terminated, put on clinical hold, or voluntarily withdrawn because of deficiencies attributed to the Company. No filing or submission to the FDA or any other Governmental Authority that is the basis for any approval or clearance contains any material omission or material false information. Any clinical trial involving a product regulated by the FDA as a medical device has been conducted in compliance with the FDA’s regulations concerning Investigational Device Exemptions, set forth at 21 C.F.R. Part 812. (i) The Company has heretofore provided to Buyer all material correspondence and contact information (including 483 inspection reports, untitled letters, warning letters, cease and desist letters, and consents) between the Company and the FDA or any other Governmental Authority regarding the Company Products, and, to the extent provided to the Company, between the FDA and other Governmental Authorities relating thereto.
Appears in 2 contracts
Samples: Merger Agreement, Merger Agreement (Organogenesis Holdings Inc.)
Other Regulatory Matters. (a) All The Company has not received any notice or other communication from any Governmental Body (i) contesting the uses of or the labeling and promotion of any of the Company Products have been manufactured, processed, packaged and held in accordance with the FDA’s HCT/P regulations at 21 C.F.R. Part 1271 or the FDA’s Quality System Regulation (“QSR”ii) at 21 C.F.R. Part 820, as applicable. All manufacturers otherwise alleging any violation of any Law by the Company Products that are required with respect to be registered with the FDA under applicable Laws are so registered. All of the any Company Products are appropriately listed in the FDA’s tissue products listing database or medical device listing database, as appropriate. To the Knowledge of the Company, all manufacturers of the Company Products have, prior to the Closing, manufactured products for the Company in accordance with applicable requirements of the HCT/P regulations or QSR, as applicable, in all material respects, and have, prior to the Closing, conducted business operations in compliance with the FDA Act and any applicable Laws relating to the manufacture of the Company Products. To the Knowledge of the Company, the marketing, sale and distribution of the Company Products is in compliance with the FDA Act. Company Products, that are HCT/Ps, other than its injectable or micronized amniotic membrane-derived products, qualify for marketing as a Section 361 HCT/Ps, and do not require the FDA premarket review or authorization. Premarket notification submissions or premarket approval applications and related documents and information for each of the Company Products that is a medical device have been filed, approved or cleared, and maintained in compliance with the FDA Act any other applicable Laws administered or promulgated by any other Governmental Authority. Neither the Company nor, to the Knowledge of the Company, any manufacturers of the Company Products, have received any warning or advisory letters from the FDA or received information from the FDA or other applicable Governmental Authority indicating that the Company Products are not in compliance with the FDA Act or any other applicable Laws. The Company does not possess information about the Company Products that would necessitate the filing of an adverse event report under the Public Health Service Act and the FDA’s regulations at 21 C.F.R. § 1271.350 or an FDA medical device report under the FDA Act and the FDA’s implementing regulations at 21 CFR Part 803, or that otherwise indicates that the Company Products are misbranded or adulterated within the meaning of the FDA Act, or otherwise may not be introduced into interstate commerceProduct.
(b) All operations of the Company There have achieved and maintained all applicable quality certifications including all required ISO been no field notifications or adverse regulatory actions taken (International Organization for Standardization) certifications. Section 5.12(a) of the Disclosure Schedule lists each ISO and quality certification applicable to the Company. There is no pending or, to the Knowledge of the Company, threatened) by any Governmental Body with respect to any of the Company Products and the Company has not, Action to auditeither voluntarily or at the request of any Governmental Body, repeal, fail to renew or challenge provided post-sale warnings regarding any such certificationCompany Product.
(c) Except All filings with and submissions to any Governmental Body made by the Company with regard to the Company Products, whether oral, written or electronically delivered, were true, accurate and complete as set forth in Section 5.27(c) of the Disclosure Scheduledate made, there haveand, within to the past five (5) yearsextent required to be updated, been no seizures conducted or threatened by as so updated remain true, accurate and complete as of the FDA or any other Governmental Authoritydate hereof, and no recallsdo not misstate any of the statements or information included therein, market withdrawals, field notifications, notifications of misbranding or adulteration, safety alerts conducted omit to state a fact necessary to make the statements therein not misleading.
(d) As to each Company Product subject to FDA regulation or adverse regulatory actions, requested orsimilar legal provisions in any foreign jurisdiction, to the Knowledge of the Company, threatenedeach such Company Product is being developed, by the manufactured, tested, packaged, labeled, marketed, sold, distributed or commercialized in material compliance with all applicable Laws and FDA or by any other Governmental Authorityrequirements, in each case including, but not limited to, those relating to investigational use, investigational device exemption, premarket notification, premarket approval, good clinical practices, good manufacturing practices, record keeping, filing of reports, and patient privacy and medical record security. To the Company or its businessKnowledge of the Company, assets or the Company Products. The Company has not been required by the FDA Act to file with the FDA any report concerning an adverse reaction or an adverse event or to file any other report or provide information to any product safety agency (other than the FDA), commission, board or other Governmental Authority of any jurisdiction, concerning actual or potential hazards with respect to any Company Product. Each Company Product complies with all material product safety standards of each applicable product safety agency, commission, board or other Governmental Authority.
(d) The Company has inquired with all relevant suppliers manufacturing facilities of the Company and, no more than thirty (30) days prior to the Closing Date, received confirmation from are operated in compliance in all such suppliers that (i) the facilities at which the products are manufactured by such suppliers and sold to the Company are registered material respects with the FDA, as required, (ii) such suppliers have not received any warning or advisory letters from the FDA or received information from the FDA or other applicable Governmental Authority indicating that any Company Products are not in compliance with the FDA Act or any applicable Law, and (iii) such suppliers do not possess information about any products sold to the Company that would necessitate the filing of an adverse event report under the Public Health Service Act and the FDA’s regulations Quality System Regulation requirements at 21 C.F.R. § 1271.350 or an FDA medical device report under the FDA Act (and the FDA’s implementing regulations at 21 CFR Part 803) or would indicate that the products are misbranded or adulterated within the meaning of the FDA Act or otherwise may not be introduced into interstate commerce. The Company has not received any correspondence from820, nor submitted any correspondence to, any Governmental Authority, discussing the legal marketing status, or the labeling or promotion, of any of the Company Products specifically, or generally of amniotic tissue or bone productsas applicable.
(e) Section 5.27(eAll preclinical and clinical trials conducted, supervised or monitored by the Company have been conducted in material compliance with all applicable Laws, and the regulations and requirements of any Governmental Body, including, but not limited to, FDA good clinical practice and good laboratory practice requirements. The Company has consistently obtained and maintained any necessary Institutional Review Board (“IRB”) approvals of the Disclosure Schedule lists all Company Products (clinical trials or modifications thereto, conducted, supervised, or monitored by SKU), describes them by product category, provides a general description, shows the Company’s status with respect to each Company Product (e.g.. In no clinical trial conducted, “manufacturer”), and (i) for each Company Product commercialized, marketed supervised or sold in the United States indicates whether monitored by the Company Product is distributed as a Section 361 HCT/P orhas IRB approval ever been suspended, if notterminated, provides the legal authority for marketing of the Company Productput on clinical hold, or (ii) for each Company Product commercialized, marketed or sold outside voluntarily withdrawn because of deficiencies attributed to the United States, specifies the applicable form of marketing authorizationCompany.
(f) Each Company Product is, and at all relevant times has been, fit for the ordinary purposes for which it is intended to be used and conforms to any promises or affirmations of fact made in all regulatory filings pertaining thereto and made on the container or label for such Company Product or in connection with its sale. There is no design or manufacturing defect with respect to any Company Product.
(gPart 2.16(f) The Company has not received any written notice that the Company has, and to the Knowledge of the Company there is no reasonable basis for, any Action against the Company for, any Liability arising out of any injury to any person or property as a result of a Company Product.
(h) Section 5.27(h) of the Disclosure Schedule sets forth a complete and accurate listing of all preclinical and clinical studies, together with the dates and brief descriptions of such studies, previously or currently undertaken or sponsored by the Company with respect to any Company Product. All material information regarding the efficacy, safety and utility of the Company Products has been collected and maintained in accordance with accepted industry practices and will be readily accessible to Buyer Parent after the Effective Time. All preclinical and clinical trials conducted, supervised or monitored by the Company have been conducted in compliance in all material respects with all applicable Laws, and the regulations and requirements of any Governmental Authority, including, but not limited to, FDA regulations at 21 C.F.R. Part 812, where applicable, and FDA “Good Laboratory Practices” at 21 C.F.R. Part 58. The Company has consistently obtained and maintained any Institutional Review Board (“IRB”) approvals of clinical trials conducted, supervised, or monitored by the Company as required by law, and has been in full compliance with any applicable requirements of 21 C.F.R. part 56. In no clinical trial conducted, supervised or monitored by the Company has IRB approval ever been suspended, terminated, put on clinical hold, or voluntarily withdrawn because of deficiencies attributed to the Company. No filing or submission to the FDA or any other Governmental Authority that is the basis for any approval or clearance contains any material omission or material false information. Any clinical trial involving a product regulated by the FDA as a medical device has been conducted in compliance with the FDA’s regulations concerning Investigational Device Exemptions, set forth at 21 C.F.R. Part 812.
(i) The Company has heretofore provided to Buyer Parent all material correspondence and contact information (including 483 inspection reports, untitled letters, warning letters, cease and desist letters, and consents) between the Company and the FDA or any other Governmental Authority Bodies regarding the Company Products, and, to the extent provided to the Company, between the FDA and other Governmental Authorities Bodies relating thereto.
Appears in 1 contract
Samples: Merger Agreement (Clarient, Inc)
Other Regulatory Matters. (a) All The Company has not received any notice or other communication from any Governmental Authority (i) contesting the uses of or the labeling and promotion of any of the Company Products have been manufactured, processed, packaged and held in accordance with the FDA’s HCT/P regulations at 21 C.F.R. Part 1271 or the FDA’s Quality System Regulation (“QSR”ii) at 21 C.F.R. Part 820, as applicable. All manufacturers otherwise alleging any violation of any Law by the Company Products that are required with respect to be registered with the FDA under applicable Laws are so registered. All of the Company Products are appropriately listed in the FDA’s tissue products listing database or medical device listing database, as appropriate. To the Knowledge of the Company, all manufacturers of the Company Products have, prior to the Closing, manufactured products for the Company in accordance with applicable requirements of the HCT/P regulations or QSR, as applicable, in all material respects, and have, prior to the Closing, conducted business operations in compliance with the FDA Act and any applicable Laws relating to the manufacture of the Company Products. To the Knowledge of the Company, the marketing, sale and distribution of the Company Products is in compliance with the FDA Act. Company Products, that are HCT/Ps, other than its injectable or micronized amniotic membrane-derived products, qualify for marketing as a Section 361 HCT/Ps, and do not require the FDA premarket review or authorization. Premarket notification submissions or premarket approval applications and related documents and information for each of the Company Products that is a medical device have been filed, approved or cleared, and maintained in compliance with the FDA Act any other applicable Laws administered or promulgated by any other Governmental Authority. Neither the Company nor, to the Knowledge of the Company, any manufacturers of the Company Products, have received any warning or advisory letters from the FDA or received information from the FDA or other applicable Governmental Authority indicating that the Company Products are not in compliance with the FDA Act or any other applicable Laws. The Company does not possess information about the Company Products that would necessitate the filing of an adverse event report under the Public Health Service Act and the FDA’s regulations at 21 C.F.R. § 1271.350 or an FDA medical device report under the FDA Act and the FDA’s implementing regulations at 21 CFR Part 803, or that otherwise indicates that the Company Products are misbranded or adulterated within the meaning of the FDA Act, or otherwise may not be introduced into interstate commerce.
(b) All operations of the Company There have achieved and maintained all applicable quality certifications including all required ISO been no field notifications or adverse regulatory actions taken (International Organization for Standardization) certifications. Section 5.12(a) of the Disclosure Schedule lists each ISO and quality certification applicable to the Company. There is no pending or, to the Knowledge of the Company, threatened, Action to audit, repeal, fail to renew or challenge any such certification.
(c) Except as set forth in Section 5.27(c) of the Disclosure Schedule, there have, within the past five (5) years, been no seizures conducted or threatened by the FDA or any other Governmental Authority, and no recalls, market withdrawals, field notifications, notifications of misbranding or adulteration, safety alerts conducted or adverse regulatory actions, requested or, to the Knowledge of the Company, threatened, by the FDA or by any other Governmental Authority, in each case relating to the Company or its business, assets or the Company Products. The Company has not been required by the FDA Act to file with the FDA any report concerning an adverse reaction or an adverse event or to file any other report or provide information to any product safety agency (other than the FDA), commission, board or other Governmental Authority of any jurisdiction, concerning actual or potential hazards with respect to any Company Product. Each Company Product complies with all material product safety standards of each applicable product safety agency, commission, board or other Governmental Authority.
(d) The Company has inquired with all relevant suppliers of the Company and, no more than thirty (30) days prior to the Closing Date, received confirmation from all such suppliers that (i) the facilities at which the products are manufactured by such suppliers and sold to the Company are registered with the FDA, as required, (ii) such suppliers have not received any warning or advisory letters from the FDA or received information from the FDA or other applicable Governmental Authority indicating that any Company Products are not in compliance with the FDA Act or any applicable Law, and (iii) such suppliers do not possess information about any products sold to the Company that would necessitate the filing of an adverse event report under the Public Health Service Act and the FDA’s regulations at 21 C.F.R. § 1271.350 or an FDA medical device report under the FDA Act (and the FDA’s implementing regulations at 21 CFR Part 803) or would indicate that the products are misbranded or adulterated within the meaning of the FDA Act or otherwise may not be introduced into interstate commerce. The Company has not received any correspondence from, nor submitted any correspondence to, any Governmental Authority, discussing the legal marketing status, or the labeling or promotion, of any of the Company Products specifically, or generally of amniotic tissue or bone products.
(e) Section 5.27(e) of the Disclosure Schedule lists all Company Products (by SKU), describes them by product category, provides a general description, shows the Company’s status with respect to each Company Product (e.g., “manufacturer”), and (i) for each Company Product commercialized, marketed or sold in the United States indicates whether the Company Product is distributed as a Section 361 HCT/P or, if has not, provides either voluntarily or at the legal authority for marketing request of the Company Productany Governmental Authority, or (ii) for each Company Product commercialized, marketed or sold outside the United States, specifies the applicable form of marketing authorization.
(f) Each Company Product is, and at all relevant times has been, fit for the ordinary purposes for which it is intended to be used and conforms to any promises or affirmations of fact made in all regulatory filings pertaining thereto and made on the container or label for such Company Product or in connection with its sale. There is no design or manufacturing defect with respect to provided post-sale warnings regarding any Company Product.
(gc) All filings with and submissions to any Governmental Authority made by the Company with regard to the Company Products, whether oral, written or electronically delivered, were true, accurate and complete as of the date made, and, to the extent required to be updated, as so updated remain true, accurate and complete as of the date hereof, and do not misstate any of the statements or information included therein, or omit to state a fact necessary to make the statements therein not misleading.
(d) As to each Company Product subject to FDA regulation or similar legal provisions in any foreign jurisdiction, each such Company Product is being developed, manufactured, tested, packaged, labeled, marketed, sold, distributed or commercialized in material compliance with all applicable Laws and FDA requirements, including, but not limited to, those relating to investigational use, investigational device exemption, premarket notification, premarket approval, good clinical practices, good manufacturing practices, record keeping, filing of reports, and patient privacy and medical record security. All manufacturing facilities of the Company are operated in compliance in all material respects with the FDA’s Quality System Regulation requirements at 21 C.F.R. Part 820, as applicable.
(e) All preclinical and clinical trials conducted, supervised or monitored by the Company have been conducted in material compliance with all applicable Laws, and the regulations and requirements of any Governmental Authority, including, but not limited to, FDA good clinical practice and good laboratory practice requirements. The Company has not received consistently obtained and maintained any written notice that necessary Institutional Review Board (“IRB”) approvals of clinical trials or modifications thereto, conducted, supervised, or monitored by the Company. In no clinical trial conducted, supervised or monitored by the Company hashas IRB approval ever been suspended, and terminated, put on clinical hold, or voluntarily withdrawn because of deficiencies attributed to the Knowledge Company.
(f) Section 3.23(f) of the Company there is no reasonable basis for, any Action against the Company for, any Liability arising out of any injury to any person or property as a result of a Company Product.
(h) Section 5.27(h) of the Disclosure Schedule sets forth a complete and accurate listing of all preclinical and clinical studies, together with the dates and brief descriptions of such studies, previously or currently undertaken or sponsored by the Company with respect to any Company Product. All material information regarding the efficacy, safety and utility of the Company Products has been collected and maintained in accordance with accepted industry practices and will be readily accessible to Buyer Parent after the Effective Time. All preclinical and clinical trials conducted, supervised or monitored by the Company have been conducted in compliance in all material respects with all applicable Laws, and the regulations and requirements of any Governmental Authority, including, but not limited to, FDA regulations at 21 C.F.R. Part 812, where applicable, and FDA “Good Laboratory Practices” at 21 C.F.R. Part 58. The Company has consistently obtained and maintained any Institutional Review Board (“IRB”) approvals of clinical trials conducted, supervised, or monitored by the Company as required by law, and has been in full compliance with any applicable requirements of 21 C.F.R. part 56. In no clinical trial conducted, supervised or monitored by the Company has IRB approval ever been suspended, terminated, put on clinical hold, or voluntarily withdrawn because of deficiencies attributed to the Company. No filing or submission to the FDA or any other Governmental Authority that is the basis for any approval or clearance contains any material omission or material false information. Any clinical trial involving a product regulated by the FDA as a medical device has been conducted in compliance with the FDA’s regulations concerning Investigational Device Exemptions, set forth at 21 C.F.R. Part 812.
(i) The Company has heretofore provided to Buyer Parent all material correspondence and contact information (including 483 inspection reports, untitled letters, warning letters, cease and desist letters, and consents) between the Company and the FDA or any other Governmental Authority regarding the Company Products, and, to the extent provided to the Company, between the FDA and other Governmental Authorities relating thereto.
Appears in 1 contract
Other Regulatory Matters. (a) All of the The Company Products have been manufactured, processed, packaged and held in accordance with the FDA’s HCT/P regulations at 21 C.F.R. Part 1271 or the FDA’s Quality System Regulation (“QSR”) at 21 C.F.R. Part 820, as applicable. All manufacturers of the does not Manufacture any Company Products that are required to be registered with the FDA under applicable Laws are so registered. All of the Company Products are appropriately listed in the FDA’s tissue products listing database or medical device listing database, as appropriateProduct other than TheraGauze. To the Knowledge of Company’s Knowledge, the Company is in compliance with all applicable FDA Laws and has obtained all required FDA registrations, approvals, clearances, authorizations, and/or has made all required notifications to the FDA that are necessary for the Company’s Manufacture, all manufacturers of the Company Products havePromotion, prior to the Closinguse, manufactured products for the Company in accordance with applicable requirements of the HCT/P regulations sale, or QSRdistribution, as applicable, in all material respects, and have, prior to the Closing, conducted business operations in compliance with the FDA Act and any applicable Laws relating to the manufacture of the Company Products. To the Knowledge of the Company, the marketing, sale and distribution of the Company Products is in compliance with the FDA Act. Company Products, that are HCT/Ps, other than its injectable or micronized amniotic membrane-derived products, qualify for marketing as a Section 361 HCT/Ps, and do not require the FDA premarket review or authorization. Premarket notification submissions or premarket approval applications and related documents and information for each of the Company Products that is a medical device have been filed, approved or cleared, and maintained in compliance with the FDA Act any other applicable Laws administered or promulgated by any other Governmental Authority. Neither the Company nor, to the Knowledge of the Company, any manufacturers of the Company Products, have received except where the failure to do so would not reasonably be expected to have, either individually or in the aggregate, a Material Adverse Effect, and (i) any warning FDA registrations, approvals, clearances, authorizations, and notifications required by the Company are currently valid and in full force, (ii) all such required FDA registrations, approvals, clearances, authorizations, and notifications, whether oral, written or advisory letters from electronically delivered, were true, accurate and complete in all material aspects as of the date made, and, to the extent required to be updated, as so updated remain true, accurate and complete in all material aspects as of the date hereof, and do not misstate any of the statements or information included therein, or omit to state a fact necessary to make the statements therein not misleading, and (iii) the FDA has not notified Company or, to the Company’s Knowledge, any Manufacturer of any threatened or received information from the FDA actual revocation or other applicable Governmental Authority indicating that the Company Products are not in compliance with the FDA Act or suspension of any other applicable Laws. The Company does not possess information about the Company Products that would necessitate the filing of an adverse event report under the Public Health Service Act and the FDA’s regulations at 21 C.F.R. § 1271.350 or an FDA medical device report under the FDA Act and the FDA’s implementing regulations at 21 CFR Part 803such required registration, approval, clearance, authorization, or that otherwise indicates that the Company Products are misbranded or adulterated within the meaning of the FDA Act, or otherwise may not be introduced into interstate commercenotification.
(b) All operations The Company has not received any notice or allegation of the Company have achieved and maintained all applicable quality certifications including all required ISO (International Organization for Standardization) certifications. Section 5.12(a) a violation of the Disclosure Schedule lists each ISO and quality certification applicable to the Company. There is no pending or, to the Knowledge or observation of the Company, threatened, Action to audit, repeal, fail to renew or challenge non-compliance with any such certification.
(c) Except as set forth in Section 5.27(c) of the Disclosure Schedule, there have, FDA Law within the past last five (5) years, been no seizures conducted whether in the form of inspection observations under an FDA Form 483, an FDA Establishment Inspection Report, an FDA Warning Letter or threatened Untitled Letter, post-sale warning, seizure, or any other form of administrative or judicial enforcement action by any Governmental Authority.
(c) To the Company’s Knowledge, the Company has submitted all reports and other information and records required to be submitted by the FDA Company to the FDA, the American Association of Tissue Banks, or any other Governmental AuthorityAuthority with respect to the Company Products; and, all such reports, information, and no recallsrecords, market withdrawalswhether oral, field notificationswritten or electronically delivered, notifications were true, accurate and complete in all material aspects as of misbranding or adulterationthe date made, safety alerts conducted or adverse regulatory actions, requested orand, to the Knowledge extent required to be updated, as so updated remain true, accurate and complete in all material respects as of the date hereof, and do not misstate any of the statements or information included therein, or omit to state a fact necessary to make the statements therein not misleading. To the Company’s Knowledge, threatened, by no circumstances have arisen that would require the FDA or by any other Governmental Authority, in each case relating Company to submit a Biological Product Deviation Report to the Company or its business, assets or the Company Products. The Company has not been required by the FDA Act to file with the FDA any report concerning an adverse reaction or an adverse event or to file any other report or provide information to any product safety agency (other than the FDA), commission, board or other Governmental Authority of any jurisdiction, concerning actual or potential hazards with respect to any Company Product. Each Company Product complies with all material product safety standards of each applicable product safety agency, commission, board or other Governmental Authority.
(d) The Company has inquired with all relevant suppliers of the Company and, no more than thirty (30) days prior to the Closing Date, received confirmation from all such suppliers that (i) the facilities at which the products are manufactured by such suppliers and sold to the Company are registered with the FDA, as required, (ii) such suppliers have not received conducted any warning or advisory letters from the FDA or received information from the FDA or other applicable Governmental Authority indicating that any Company Products are not in compliance with the FDA Act or any applicable Law, and (iii) such suppliers do not possess information about any products sold to the Company that would necessitate the filing of an adverse event report under the Public Health Service Act and the FDA’s regulations at 21 C.F.R. § 1271.350 or an FDA medical device report under the FDA Act (and the FDA’s implementing regulations at 21 CFR Part 803) or would indicate that the products are misbranded or adulterated within the meaning of the FDA Act or otherwise may not be introduced into interstate commerce. The Company has not received any correspondence fromRecall, nor submitted any correspondence to, has Company received requests or demands from any Governmental Authority, discussing the legal marketing statuscustomer, end user, or the labeling or promotion, of any of the Company Products specifically, or generally of amniotic tissue or bone products.
(e) Section 5.27(e) of the Disclosure Schedule lists all Company Products (by SKU), describes them by product category, provides other Person that a general description, shows the Company’s status with respect to each Company Product (e.g.should be Recalled, “manufacturer”), and (i) for each Company Product commercialized, marketed or sold in the United States indicates whether the Company Product is distributed as a Section 361 HCT/P or, if not, provides the legal authority for marketing of the Company Product, or (ii) for each Company Product commercialized, marketed or sold outside the United States, specifies the applicable form of marketing authorization.
(f) Each Company Product is, and at all relevant times has been, fit for the ordinary purposes for which it is intended to be used and conforms to any promises or affirmations of fact made in all regulatory filings pertaining thereto and made on the container or label for such Company Product or in connection with its sale. There is no design or manufacturing defect with respect to any Company Product.
(g) The Company has not received any written notice that the Company has, and to the Knowledge of the Company there is no reasonable basis for, any Action against the Company for, any Liability arising out of any injury to any person or property as a result of a Company Product.
(h) Section 5.27(h) of the Disclosure Schedule sets forth a complete and accurate listing of all preclinical and clinical studies, together with the dates and brief descriptions of such studies, previously or currently undertaken or sponsored by the Company with respect to any Company Product. All material information regarding the efficacy, safety and utility of the Company Products has been collected and maintained in accordance with accepted industry practices and will be readily accessible to Buyer after the Effective Time. All preclinical and clinical trials conducted, supervised or monitored by nor does the Company have been conducted in compliance in all material respects with all applicable Laws, and the regulations and requirements Knowledge of any Governmental Authority, including, but not limited to, FDA regulations at 21 C.F.R. Part 812, where applicable, and FDA “Good Laboratory Practices” at 21 C.F.R. Part 58. The Company has consistently obtained and maintained any Institutional Review Board (“IRB”) approvals of clinical trials conducted, supervised, or monitored by the Company as required by law, and has been in full compliance with any applicable requirements of 21 C.F.R. part 56. In no clinical trial conducted, supervised or monitored by the Company has IRB approval ever been suspended, terminated, put on clinical hold, or voluntarily withdrawn because of deficiencies attributed circumstance that could reasonably be expected to the Company. No filing or submission lead to the FDA or any other Governmental Authority that is the basis for any approval or clearance contains any material omission or material false information. Any clinical trial involving a product regulated by the FDA as a medical device has been conducted in compliance with the FDA’s regulations concerning Investigational Device Exemptions, set forth at 21 C.F.R. Part 812Recall.
(i) The Company has heretofore provided to Buyer all material correspondence and contact information (including 483 inspection reports, untitled letters, warning letters, cease and desist letters, and consents) between the Company and the FDA or any other Governmental Authority regarding the Company Products, and, to the extent provided to the Company, between the FDA and other Governmental Authorities relating thereto.
Appears in 1 contract
Samples: Contribution Agreement and Plan of Merger (Alliqua BioMedical, Inc.)
Other Regulatory Matters. (a) All The Company has not received any notice or other communication from any Governmental Authority (i) contesting the uses of or the labeling and promotion of any of the Company Products have been manufactured, processed, packaged and held in accordance with the FDA’s HCT/P regulations at 21 C.F.R. Part 1271 or the FDA’s Quality System Regulation (“QSR”ii) at 21 C.F.R. Part 820, as applicable. All manufacturers otherwise alleging any violation of any Law by the Company Products that are required with respect to be registered with the FDA under applicable Laws are so registered. All of the Company Products are appropriately listed in the FDA’s tissue products listing database or medical device listing database, as appropriate. To the Knowledge of the Company, all manufacturers of the Company Products have, prior to the Closing, manufactured products for the Company in accordance with applicable requirements of the HCT/P regulations or QSR, as applicable, in all material respects, and have, prior to the Closing, conducted business operations in compliance with the FDA Act and any applicable Laws relating to the manufacture of the Company Products. To the Knowledge of the Company, the marketing, sale and distribution of the Company Products is in compliance with the FDA Act. Company Products, that are HCT/Ps, other than its injectable or micronized amniotic membrane-derived products, qualify for marketing as a Section 361 HCT/Ps, and do not require the FDA premarket review or authorization. Premarket notification submissions or premarket approval applications and related documents and information for each of the Company Products that is a medical device have been filed, approved or cleared, and maintained in compliance with the FDA Act any other applicable Laws administered or promulgated by any other Governmental Authority. Neither the Company nor, to the Knowledge of the Company, any manufacturers of the Company Products, have received any warning or advisory letters from the FDA or received information from the FDA or other applicable Governmental Authority indicating that the Company Products are not in compliance with the FDA Act or any other applicable Laws. The Company does not possess information about the Company Products that would necessitate the filing of an adverse event report under the Public Health Service Act and the FDA’s regulations at 21 C.F.R. § 1271.350 or an FDA medical device report under the FDA Act and the FDA’s implementing regulations at 21 CFR Part 803, or that otherwise indicates that the Company Products are misbranded or adulterated within the meaning of the FDA Act, or otherwise may not be introduced into interstate commerce.
(b) All operations of the Company There have achieved and maintained all applicable quality certifications including all required ISO (International Organization for Standardization) certifications. Section 5.12(a) of the Disclosure Schedule lists each ISO and quality certification applicable to the Company. There is no pending or, to the Knowledge of the Company, threatened, Action to audit, repeal, fail to renew or challenge any such certification.
(c) Except as set forth in Section 5.27(c) of the Disclosure Schedule, there have, within the past five (5) years, been no seizures conducted or threatened by the FDA or any other Governmental Authority, and no recalls, market withdrawals, field notifications, notifications of misbranding or adulteration, safety alerts conducted or adverse regulatory actions, requested or, to the Knowledge of the Company, threatened, by the FDA or by any other Governmental Authority, in each case relating to the Company or its business, its assets or the Company Products.
(c) Certain Filings and Lists.
(i) Except as set forth in Section 3.26(c) of the Disclosure Schedules, if applicable, premarket notification submissions and related documents and information for each Company Product (510(k), abbreviated or special 510(k) submissions, Investigational Device Exception (“IDE”) submissions or similar submissions (e.g., relating to CE Markings)) have been filed, approved or cleared, and maintained in compliance with applicable Laws administered or promulgated by the FDA or other Governmental Authority, for sales in the United States or in any other country. The Company has not been required by the FDA Act to file filed and maintained its Tissue Establishment Registration in accordance with 21 CFR Part 1271 with the FDA as a processor and distributor of human cells, tissues and cellular- and tissue-based products (HCT/Ps). All preclinical and clinical studies that support any report concerning an adverse reaction such United States approval or an adverse event clearance of any Company Product have been conducted in compliance with 21 CFR Part 812 and “Good Laboratory Practices” (21 CFR Part 58). No filing or submission to file the FDA or any other report or provide information to any product safety agency (other than the FDA), commission, board or other Governmental Authority of that is the basis for any jurisdiction, concerning actual such approval or potential hazards with respect to clearance contains any Company Product. Each Company Product complies with all material product safety standards of each applicable product safety agency, commission, board omission or other Governmental Authoritymaterial false information.
(d) The Company has inquired with all relevant suppliers of the Company and, no more than thirty (30) days prior to the Closing Date, received confirmation from all such suppliers that (i) the facilities at which the products are manufactured by such suppliers and sold to the Company are registered with the FDA, as required, (ii) such suppliers have not received any warning or advisory letters from the FDA or received information from the FDA or other applicable Governmental Authority indicating that any Company Products are not in compliance with the FDA Act or any applicable Law, and (iii) such suppliers do not possess information about any products sold to the Company that would necessitate the filing of an adverse event report under the Public Health Service Act and the FDA’s regulations at 21 C.F.R. § 1271.350 or an FDA medical device report under the FDA Act (and the FDA’s implementing regulations at 21 CFR Part 803) or would indicate that the products are misbranded or adulterated within the meaning of the FDA Act or otherwise may not be introduced into interstate commerce. The Company has not received any correspondence from, nor submitted any correspondence to, any Governmental Authority, discussing the legal marketing status, or the labeling or promotion, of any of the Company Products specifically, or generally of amniotic tissue or bone products.
(e) Section 5.27(e3.26(c) of the Disclosure Schedule Schedules lists all Company Products (by SKU), describes them by product category, provides a general descriptiondescription and type of product that each is “regulated as” (e.g., Section 361), shows the Company’s status with respect to each Company Product (e.g., “manufacturer”), and indicates: (iA) for each which Company Product Products are commercialized, marketed, sold or placed in interstate commerce in the United States under an approved or cleared FDA authority (e.g., 510(k), abbreviated or special 510(k) or IDE), (B) which Company Products are commercialized, marketed or sold in the United States indicates whether the solely pursuant to a Tissue Establishment Registration, (C) which Company Product is distributed as a Section 361 HCT/P or, if not, provides the legal authority for marketing of the Company Product, or (ii) for each Company Product Products are commercialized, marketed or sold outside the United States, specifies the applicable form of marketing authorization.
(f) Each Company Product isStates under an approved or cleared authority from another Governmental Authority, and at all relevant times has been(C) which Company Products are not so commercialized, fit for the ordinary purposes for which it is intended marketed, sold or placed in interstate commerce under an approved or cleared authority or pursuant to be used a Tissue Establishment Registration, and conforms to any promises or affirmations of fact made in all regulatory filings pertaining thereto and made on the container or label for indicating why such Company Product Products are being so commercialized, marketed, sold or in connection with its saleplaced without such authority. There is no design or manufacturing defect with respect to any Company Product.
(g) The Company has not received any written notice that the Company has, and to the Knowledge of the Company there is no reasonable basis for, any Action against the Company for, any Liability arising out of any injury to any person or property as a result of a Company Product.
(h) Section 5.27(h3.26(c) of the Disclosure Schedule sets forth a complete also lists all 510(k)s, abbreviated or special 510(k) submissions, IDE submissions and accurate listing of all preclinical and clinical studiessimilar submissions (e.g., together with the dates and brief descriptions of such studies, previously or currently undertaken or sponsored by the Company with respect relating to any Company Product. All material information regarding the efficacy, safety and utility of the Company Products has been collected and maintained in accordance with accepted industry practices and will be readily accessible to Buyer after the Effective Time. All preclinical and clinical trials conducted, supervised or monitored by the Company have been conducted in compliance in all material respects with all applicable Laws, and the regulations and requirements of any Governmental Authority, including, but not limited to, FDA regulations at 21 C.F.R. Part 812, where applicable, and FDA “Good Laboratory Practices” at 21 C.F.R. Part 58. The Company has consistently obtained and maintained any Institutional Review Board (“IRB”CE Markings) approvals of clinical trials conducted, supervised, or monitored by the Company as required by law, and has been in full compliance with any applicable requirements of 21 C.F.R. part 56. In no clinical trial conducted, supervised or monitored by the Company has IRB approval ever been suspended, terminated, put on clinical hold, or voluntarily withdrawn because of deficiencies attributed related to the Company. No filing or submission to ’s business and currently pending with the FDA or any other Governmental Authority that is outside the basis for any approval or clearance contains any material omission or material false information. Any clinical trial involving a product regulated by the FDA as a medical device has been conducted in compliance with the FDA’s regulations concerning Investigational Device Exemptions, set forth at 21 C.F.R. Part 812United States.
(i) The Company has heretofore provided to Buyer all material correspondence and contact information (including 483 inspection reports, untitled letters, warning letters, cease and desist letters, and consents) between the Company and the FDA or any other Governmental Authority regarding the Company Products, and, to the extent provided to the Company, between the FDA and other Governmental Authorities relating thereto.
Appears in 1 contract
Other Regulatory Matters. (a) Parent has not received any notice or other communication from any Governmental Authority (i) contesting the uses of or the labeling and promotion of any of Parent Products or (ii) otherwise alleging any violation of any Law by Parent with respect to any Parent Products.
(b) There have been no field notifications or adverse regulatory actions taken (or, to the Knowledge of Parent, threatened) by any Governmental Authority with respect to any of Parent Products and Parent has not, either voluntarily or at the request of any Governmental Authority, provided post-sale warnings regarding any Parent Product.
(c) All filings with and submissions to any Governmental Authority made by Parent with regard to Parent Products, whether oral, written or electronically delivered, were true, accurate and complete as of the Company Products have been date made, and, to the extent required to be updated, as so updated remain true, accurate and complete as of the date hereof, and do not misstate any of the statements or information included therein, or omit to state a fact necessary to make the statements therein not misleading.
(d) As to each Parent Product subject to FDA regulation or similar legal provisions in any foreign jurisdiction, each such Parent Product is being developed, manufactured, processedtested, packaged packaged, labeled, marketed, sold, distributed or commercialized in material compliance with all applicable Laws and held FDA requirements, including, but not limited to, those relating to investigational use, investigational device exemption, premarket notification, premarket approval, good clinical practices, good manufacturing practices, record keeping, filing of reports, and patient privacy and medical record security. All manufacturing facilities of Parent are operated in accordance compliance in all material respects with the FDA’s HCT/P regulations at 21 C.F.R. Part 1271 or the FDA’s Quality System Regulation (“QSR”) requirements at 21 C.F.R. Part 820, as applicable. All manufacturers of the Company Products that are required to be registered with the FDA under applicable Laws are so registered. All of the Company Products are appropriately listed in the FDA’s tissue products listing database or medical device listing database, as appropriate. To the Knowledge of the Company, all manufacturers of the Company Products have, prior to the Closing, manufactured products for the Company in accordance with applicable requirements of the HCT/P regulations or QSR, as applicable, in all material respects, and have, prior to the Closing, conducted business operations in compliance with the FDA Act and any applicable Laws relating to the manufacture of the Company Products. To the Knowledge of the Company, the marketing, sale and distribution of the Company Products is in compliance with the FDA Act. Company Products, that are HCT/Ps, other than its injectable or micronized amniotic membrane-derived products, qualify for marketing as a Section 361 HCT/Ps, and do not require the FDA premarket review or authorization. Premarket notification submissions or premarket approval applications and related documents and information for each of the Company Products that is a medical device have been filed, approved or cleared, and maintained in compliance with the FDA Act any other applicable Laws administered or promulgated by any other Governmental Authority. Neither the Company nor, to the Knowledge of the Company, any manufacturers of the Company Products, have received any warning or advisory letters from the FDA or received information from the FDA or other applicable Governmental Authority indicating that the Company Products are not in compliance with the FDA Act or any other applicable Laws. The Company does not possess information about the Company Products that would necessitate the filing of an adverse event report under the Public Health Service Act and the FDA’s regulations at 21 C.F.R. § 1271.350 or an FDA medical device report under the FDA Act and the FDA’s implementing regulations at 21 CFR Part 803, or that otherwise indicates that the Company Products are misbranded or adulterated within the meaning of the FDA Act, or otherwise may not be introduced into interstate commerce.
(b) All operations of the Company have achieved and maintained all applicable quality certifications including all required ISO (International Organization for Standardization) certifications. Section 5.12(a) of the Disclosure Schedule lists each ISO and quality certification applicable to the Company. There is no pending or, to the Knowledge of the Company, threatened, Action to audit, repeal, fail to renew or challenge any such certification.
(c) Except as set forth in Section 5.27(c) of the Disclosure Schedule, there have, within the past five (5) years, been no seizures conducted or threatened by the FDA or any other Governmental Authority, and no recalls, market withdrawals, field notifications, notifications of misbranding or adulteration, safety alerts conducted or adverse regulatory actions, requested or, to the Knowledge of the Company, threatened, by the FDA or by any other Governmental Authority, in each case relating to the Company or its business, assets or the Company Products. The Company has not been required by the FDA Act to file with the FDA any report concerning an adverse reaction or an adverse event or to file any other report or provide information to any product safety agency (other than the FDA), commission, board or other Governmental Authority of any jurisdiction, concerning actual or potential hazards with respect to any Company Product. Each Company Product complies with all material product safety standards of each applicable product safety agency, commission, board or other Governmental Authority.
(d) The Company has inquired with all relevant suppliers of the Company and, no more than thirty (30) days prior to the Closing Date, received confirmation from all such suppliers that (i) the facilities at which the products are manufactured by such suppliers and sold to the Company are registered with the FDA, as required, (ii) such suppliers have not received any warning or advisory letters from the FDA or received information from the FDA or other applicable Governmental Authority indicating that any Company Products are not in compliance with the FDA Act or any applicable Law, and (iii) such suppliers do not possess information about any products sold to the Company that would necessitate the filing of an adverse event report under the Public Health Service Act and the FDA’s regulations at 21 C.F.R. § 1271.350 or an FDA medical device report under the FDA Act (and the FDA’s implementing regulations at 21 CFR Part 803) or would indicate that the products are misbranded or adulterated within the meaning of the FDA Act or otherwise may not be introduced into interstate commerce. The Company has not received any correspondence from, nor submitted any correspondence to, any Governmental Authority, discussing the legal marketing status, or the labeling or promotion, of any of the Company Products specifically, or generally of amniotic tissue or bone products.
(e) Section 5.27(e) of the Disclosure Schedule lists All preclinical and clinical trials conducted, supervised or monitored by Parent have been conducted in material compliance with all Company Products (by SKU), describes them by product category, provides a general description, shows the Company’s status with respect to each Company Product (e.g., “manufacturer”)applicable Laws, and (i) for each Company Product commercializedthe regulations and requirements of any Governmental Authority, marketed including, but not limited to, FDA good clinical practice and good laboratory practice requirements. Parent has consistently obtained and maintained any necessary IRB approvals of clinical trials or sold in the United States indicates whether the Company Product is distributed as a Section 361 HCT/P ormodifications thereto, if notconducted, provides the legal authority for marketing of the Company Productsupervised, or (ii) for each Company Product commercializedmonitored by Parent. In no clinical trial conducted, marketed supervised or sold outside the United Statesmonitored by Parent has IRB approval ever been suspended, specifies the applicable form terminated, put on clinical hold, or voluntarily withdrawn because of marketing authorizationdeficiencies attributed to Parent.
(f) Each Company Product is, and at all relevant times has been, fit for the ordinary purposes for which it is intended to be used and conforms to any promises or affirmations of fact made in all regulatory filings pertaining thereto and made on the container or label for such Company Product or in connection with its sale. There is no design or manufacturing defect with respect to any Company Product.
(g) The Company has not received any written notice that the Company has, and to the Knowledge of the Company there is no reasonable basis for, any Action against the Company for, any Liability arising out of any injury to any person or property as a result of a Company Product.
(h) Section 5.27(h) of the Parent Disclosure Schedule 4.18 sets forth a complete and accurate listing of all preclinical and clinical studies, together with the dates and brief descriptions of such studies, previously or currently undertaken or sponsored by the Company Parent with respect to any Company Parent Product. All material information regarding the efficacy, safety and utility of the Company Parent Products has been collected and maintained in accordance with accepted industry practices and will be readily accessible to Buyer Parent after the Effective Time. All preclinical and clinical trials conducted, supervised or monitored by the Company have been conducted in compliance in all material respects with all applicable Laws, and the regulations and requirements of any Governmental Authority, including, but not limited to, FDA regulations at 21 C.F.R. Part 812, where applicable, and FDA “Good Laboratory Practices” at 21 C.F.R. Part 58. The Company has consistently obtained and maintained any Institutional Review Board (“IRB”) approvals of clinical trials conducted, supervised, or monitored by the Company as required by law, and has been in full compliance with any applicable requirements of 21 C.F.R. part 56. In no clinical trial conducted, supervised or monitored by the Company has IRB approval ever been suspended, terminated, put on clinical hold, or voluntarily withdrawn because of deficiencies attributed to the Company. No filing or submission to the FDA or any other Governmental Authority that is the basis for any approval or clearance contains any material omission or material false information. Any clinical trial involving a product regulated by the FDA as a medical device has been conducted in compliance with the FDA’s regulations concerning Investigational Device Exemptions, set forth at 21 C.F.R. Part 812.
(i) The Company Parent has heretofore provided to Buyer the Company all material correspondence and contact information (including 483 inspection reports, untitled letters, warning letters, cease and desist letters, and consents) between the Company Parent and the FDA or any other Governmental Authority regarding the Company Parent Products, and, to the extent provided to the CompanyParent, between the FDA and other Governmental Authorities relating thereto.
Appears in 1 contract
Samples: Merger Agreement (Ruthigen, Inc.)
Other Regulatory Matters. (a) All The Company has not received any notice or other communication from any Governmental Authority (i) contesting the uses of or the labeling and promotion of any of the Company Products have been manufactured, processed, packaged and held in accordance with the FDA’s HCT/P regulations at 21 C.F.R. Part 1271 or the FDA’s Quality System Regulation (“QSR”ii) at 21 C.F.R. Part 820, as applicable. All manufacturers otherwise alleging any violation of any Law by the Company Products that are required with respect to be registered with the FDA under applicable Laws are so registered. All of the Company Products are appropriately listed in the FDA’s tissue products listing database or medical device listing database, as appropriate. To the Knowledge of the Company, all manufacturers of the Company Products have, prior to the Closing, manufactured products for the Company in accordance with applicable requirements of the HCT/P regulations or QSR, as applicable, in all material respects, and have, prior to the Closing, conducted business operations in compliance with the FDA Act and any applicable Laws relating to the manufacture of the Company Products. To the Knowledge of the Company, the marketing, sale and distribution of the Company Products is in compliance with the FDA Act. Company Products, that are HCT/Ps, other than its injectable or micronized amniotic membrane-derived products, qualify for marketing as a Section 361 HCT/Ps, and do not require the FDA premarket review or authorization. Premarket notification submissions or premarket approval applications and related documents and information for each of the Company Products that is a medical device have been filed, approved or cleared, and maintained in compliance with the FDA Act any other applicable Laws administered or promulgated by any other Governmental Authority. Neither the Company nor, to the Knowledge of the Company, any manufacturers of the Company Products, have received any warning or advisory letters from the FDA or received information from the FDA or other applicable Governmental Authority indicating that the Company Products are not in compliance with the FDA Act or any other applicable Laws. The Company does not possess information about the Company Products that would necessitate the filing of an adverse event report under the Public Health Service Act and the FDA’s regulations at 21 C.F.R. § 1271.350 or an FDA medical device report under the FDA Act and the FDA’s implementing regulations at 21 CFR Part 803, or that otherwise indicates that the Company Products are misbranded or adulterated within the meaning of the FDA Act, or otherwise may not be introduced into interstate commerce.
(b) All operations of the Company There have achieved and maintained all applicable quality certifications including all required ISO been no field notifications or adverse regulatory actions taken (International Organization for Standardization) certifications. Section 5.12(a) of the Disclosure Schedule lists each ISO and quality certification applicable to the Company. There is no pending or, to the Knowledge of the Company, threatened, Action to audit, repeal, fail to renew or challenge any such certification.
(c) Except as set forth in Section 5.27(c) of the Disclosure Schedule, there have, within the past five (5) years, been no seizures conducted or threatened by the FDA or any other Governmental Authority, and no recalls, market withdrawals, field notifications, notifications of misbranding or adulteration, safety alerts conducted or adverse regulatory actions, requested or, to the Knowledge of the Company, threatened, by the FDA or by any other Governmental Authority, in each case relating to the Company or its business, assets or the Company Products. The Company has not been required by the FDA Act to file with the FDA any report concerning an adverse reaction or an adverse event or to file any other report or provide information to any product safety agency (other than the FDA), commission, board or other Governmental Authority of any jurisdiction, concerning actual or potential hazards with respect to any Company Product. Each Company Product complies with all material product safety standards of each applicable product safety agency, commission, board or other Governmental Authority.
(d) The Company has inquired with all relevant suppliers of the Company and, no more than thirty (30) days prior to the Closing Date, received confirmation from all such suppliers that (i) the facilities at which the products are manufactured by such suppliers and sold to the Company are registered with the FDA, as required, (ii) such suppliers have not received any warning or advisory letters from the FDA or received information from the FDA or other applicable Governmental Authority indicating that any Company Products are not in compliance with the FDA Act or any applicable Law, and (iii) such suppliers do not possess information about any products sold to the Company that would necessitate the filing of an adverse event report under the Public Health Service Act and the FDA’s regulations at 21 C.F.R. § 1271.350 or an FDA medical device report under the FDA Act (and the FDA’s implementing regulations at 21 CFR Part 803) or would indicate that the products are misbranded or adulterated within the meaning of the FDA Act or otherwise may not be introduced into interstate commerce. The Company has not received any correspondence from, nor submitted any correspondence to, any Governmental Authority, discussing the legal marketing status, or the labeling or promotion, of any of the Company Products specifically, or generally of amniotic tissue or bone products.
(e) Section 5.27(e) of the Disclosure Schedule lists all Company Products (by SKU), describes them by product category, provides a general description, shows the Company’s status with respect to each Company Product (e.g., “manufacturer”), and (i) for each Company Product commercialized, marketed or sold in the United States indicates whether the Company Product is distributed as a Section 361 HCT/P or, if has not, provides either voluntarily or at the legal authority for marketing request of the Company Productany Governmental Authority, or (ii) for each Company Product commercialized, marketed or sold outside the United States, specifies the applicable form of marketing authorization.
(f) Each Company Product is, and at all relevant times has been, fit for the ordinary purposes for which it is intended to be used and conforms to any promises or affirmations of fact made in all regulatory filings pertaining thereto and made on the container or label for such Company Product or in connection with its sale. There is no design or manufacturing defect with respect to provided post-sale warnings regarding any Company Product.
(gc) All filings with and submissions to any Governmental Authority made by the Company with regard to the Company Products, whether oral, written or electronically delivered, were true, accurate and complete as of the date made, and, to the extent required to be updated, as so updated remain true, accurate and complete as of the date hereof, and do not misstate any of the statements or information included therein, or omit to state a fact necessary to make the statements therein not misleading.
(d) As to each Company Product subject to FDA regulation or similar legal provisions in any foreign jurisdiction, each such Company Product is being developed, manufactured, tested, packaged, labeled, marketed, sold, distributed or commercialized in material compliance with all applicable Laws and FDA requirements, including, but not limited to, those relating to investigational use, investigational device exemption, premarket notification, premarket approval, good clinical practices, good manufacturing practices, record keeping, filing of reports, and patient privacy and medical record security. All manufacturing facilities of the Company are operated in compliance in all material respects with the FDA’s Quality System Regulation requirements at 21 C.F.R. Part 820, as applicable.
(e) All preclinical and clinical trials conducted, supervised or monitored by the Company have been conducted in material compliance with all applicable Laws, and the regulations and requirements of any Governmental Authority, including, but not limited to, FDA good clinical practice and good laboratory practice requirements. The Company has not received consistently obtained and maintained any written notice that necessary Institutional Review Board (“IRB”) approvals of clinical trials or modifications thereto, conducted, supervised, or monitored by the Company. In no clinical trial conducted, supervised or monitored by the Company hashas IRB approval ever been suspended, and terminated, put on clinical hold, or voluntarily withdrawn because of deficiencies attributed to the Knowledge of the Company there is no reasonable basis for, any Action against the Company for, any Liability arising out of any injury to any person or property as a result of a Company ProductCompany.
(hf) Section 5.27(h) of the Company Disclosure Schedule 3.25(f) sets forth a complete and accurate listing of all preclinical and clinical studies, together with the dates and brief descriptions of such studies, previously or currently undertaken or sponsored by the Company with respect to any Company Product. All material information regarding the efficacy, safety and utility of the Company Products has been collected and maintained in accordance with accepted industry practices and will be readily accessible to Buyer Parent after the Effective Time. All preclinical and clinical trials conducted, supervised or monitored by the Company have been conducted in compliance in all material respects with all applicable Laws, and the regulations and requirements of any Governmental Authority, including, but not limited to, FDA regulations at 21 C.F.R. Part 812, where applicable, and FDA “Good Laboratory Practices” at 21 C.F.R. Part 58. The Company has consistently obtained and maintained any Institutional Review Board (“IRB”) approvals of clinical trials conducted, supervised, or monitored by the Company as required by law, and has been in full compliance with any applicable requirements of 21 C.F.R. part 56. In no clinical trial conducted, supervised or monitored by the Company has IRB approval ever been suspended, terminated, put on clinical hold, or voluntarily withdrawn because of deficiencies attributed to the Company. No filing or submission to the FDA or any other Governmental Authority that is the basis for any approval or clearance contains any material omission or material false information. Any clinical trial involving a product regulated by the FDA as a medical device has been conducted in compliance with the FDA’s regulations concerning Investigational Device Exemptions, set forth at 21 C.F.R. Part 812.
(i) The Company has heretofore provided to Buyer Parent all material correspondence and contact information (including 483 inspection reports, untitled letters, warning letters, cease and desist letters, and consents) between the Company and the FDA or any other Governmental Authority regarding the Company Products, and, to the extent provided to the Company, between the FDA and other Governmental Authorities relating thereto.
Appears in 1 contract
Samples: Merger Agreement (Ruthigen, Inc.)
Other Regulatory Matters. (a) All The Company and each Subsidiary has not received any notice or other communication from any Governmental Authority (i) contesting the uses of or the labeling and promotion of any of the Company Products have been manufactured, processed, packaged and held in accordance with the FDA’s HCT/P regulations at 21 C.F.R. Part 1271 or the FDA’s Quality System Regulation (“QSR”ii) at 21 C.F.R. Part 820, as applicable. All manufacturers otherwise alleging any violation of any Law by the Company Products that are required or any Subsidiary with respect to be registered with the FDA under applicable Laws are so registered. All of the Company Products are appropriately listed in the FDA’s tissue products listing database or medical device listing database, as appropriate. To the Knowledge of the Company, all manufacturers of the Company Products have, prior to the Closing, manufactured products for the Company in accordance with applicable requirements of the HCT/P regulations or QSR, as applicable, in all material respects, and have, prior to the Closing, conducted business operations in compliance with the FDA Act and any applicable Laws relating to the manufacture of the Company Products. To the Knowledge of the Company, the marketing, sale and distribution of the Company Products is in compliance with the FDA Act. Company Products, that are HCT/Ps, other than its injectable or micronized amniotic membrane-derived products, qualify for marketing as a Section 361 HCT/Ps, and do not require the FDA premarket review or authorization. Premarket notification submissions or premarket approval applications and related documents and information for each of the Company Products that is a medical device have been filed, approved or cleared, and maintained in compliance with the FDA Act any other applicable Laws administered or promulgated by any other Governmental Authority. Neither the Company nor, to the Knowledge of the Company, any manufacturers of the Company Products, have received any warning or advisory letters from the FDA or received information from the FDA or other applicable Governmental Authority indicating that the Company Products are not in compliance with the FDA Act or any other applicable Laws. The Company does not possess information about the Company Products that would necessitate the filing of an adverse event report under the Public Health Service Act and the FDA’s regulations at 21 C.F.R. § 1271.350 or an FDA medical device report under the FDA Act and the FDA’s implementing regulations at 21 CFR Part 803, or that otherwise indicates that the Company Products are misbranded or adulterated within the meaning of the FDA Act, or otherwise may not be introduced into interstate commerce.
(b) All operations of the Company There have achieved and maintained all applicable quality certifications including all required ISO been no field notifications or adverse regulatory actions taken (International Organization for Standardization) certifications. Section 5.12(a) of the Disclosure Schedule lists each ISO and quality certification applicable to the Company. There is no pending or, to the Knowledge of the Company, threatened, Action to audit, repeal, fail to renew or challenge any such certification.
(c) Except as set forth in Section 5.27(c) of the Disclosure Schedule, there have, within the past five (5) years, been no seizures conducted or threatened by the FDA or any other Governmental Authority, and no recalls, market withdrawals, field notifications, notifications of misbranding or adulteration, safety alerts conducted or adverse regulatory actions, requested or, to the Knowledge of the Company, threatened, by the FDA or by any other Governmental Authority, in each case relating to the Company or its business, assets or the Company Products. The Company has not been required by the FDA Act to file with the FDA any report concerning an adverse reaction or an adverse event or to file any other report or provide information to any product safety agency (other than the FDA), commission, board or other Governmental Authority of any jurisdiction, concerning actual or potential hazards with respect to any Company Product. Each Company Product complies with all material product safety standards of each applicable product safety agency, commission, board or other Governmental Authority.
(d) The Company has inquired with all relevant suppliers of the Company and, no more than thirty (30) days prior to the Closing Date, received confirmation from all such suppliers that (i) the facilities at which the products are manufactured by such suppliers and sold to the Company are registered with the FDA, as required, (ii) such suppliers have not received any warning or advisory letters from the FDA or received information from the FDA or other applicable Governmental Authority indicating that any Company Products are not in compliance with the FDA Act or any applicable Law, and (iii) such suppliers do not possess information about any products sold to the Company that would necessitate the filing of an adverse event report under the Public Health Service Act and the FDA’s regulations at 21 C.F.R. § 1271.350 or an FDA medical device report under the FDA Act (and the FDA’s implementing regulations at 21 CFR Part 803) or would indicate that the products are misbranded or adulterated within the meaning of the FDA Act or otherwise may not be introduced into interstate commerce. The Company has not received any correspondence from, nor submitted any correspondence to, any Governmental Authority, discussing the legal marketing status, or the labeling or promotion, of any of the Company Products specifically, or generally of amniotic tissue or bone products.
(e) Section 5.27(e) of the Disclosure Schedule lists all Company Products (by SKU), describes them by product category, provides a general description, shows the Company’s status with respect to each Company Product (e.g., “manufacturer”), and (i) for each Company Product commercialized, marketed or sold in the United States indicates whether the Company Product is distributed as a Section 361 HCT/P or, if and each Subsidiary has not, provides either voluntarily or at the legal authority for marketing request of the Company Productany Governmental Authority, or (ii) for each Company Product commercialized, marketed or sold outside the United States, specifies the applicable form of marketing authorization.
(f) Each Company Product is, and at all relevant times has been, fit for the ordinary purposes for which it is intended to be used and conforms to any promises or affirmations of fact made in all regulatory filings pertaining thereto and made on the container or label for such Company Product or in connection with its sale. There is no design or manufacturing defect with respect to provided post-sale warnings regarding any Company Product.
(gc) The Company has not received All filings with and submissions to any written notice that Governmental Authority made by the Company hasor any Subsidiary with regard to the Company Products, whether oral, written or electronically delivered, were true, accurate and complete as of the date made, and, to the extent required to be updated, as so updated remain true, accurate and complete as of the date hereof, and do not misstate any of the statements or information included therein, or omit to state a fact necessary to make the Knowledge statements therein not misleading.
(d) As to each Company Product subject to FDA regulation or similar legal provisions in any foreign jurisdiction, each such Company Product is being developed, manufactured, tested, packaged, labeled, marketed, sold, distributed or commercialized in material compliance with all applicable Laws and FDA requirements, including, but not limited to, those relating to investigational use, investigational device exemption, premarket notification, premarket approval, good clinical practices, good manufacturing practices, record keeping, filing of reports, and patient privacy and medical record security. All manufacturing facilities of the Company there is no reasonable basis forand any applicable Subsidiary are operated in compliance in all material respects with the FDA’s Quality System Regulation requirements at 21 C.F.R. Part 820, any Action against the Company for, any Liability arising out of any injury to any person or property as a result of a Company Productapplicable.
(he) All preclinical and clinical trials conducted, supervised or monitored by the Company or any Subsidiary have been conducted in material compliance with all applicable Laws, and the regulations and requirements of any Governmental Authority, including, but not limited to, FDA good clinical practice and good laboratory practice requirements. The Company and each Subsidiary has consistently obtained and maintained any necessary Institutional Review Board (“IRB”) approvals of clinical trials or modifications thereto, conducted, supervised, or monitored by the Company or any Subsidiary. In no clinical trial conducted, supervised or monitored by the Company or any Subsidiary has IRB approval ever been suspended, terminated, put on clinical hold, or voluntarily withdrawn because of deficiencies attributed to the Company or any Subsidiary.
(f) Section 5.27(h3.26(f) of the Company Disclosure Schedule sets forth a complete and accurate listing of all preclinical and clinical studies, together with the dates and brief descriptions of such studies, previously or currently undertaken or sponsored by the Company or any Subsidiary with respect to any Company ProductProduct since January 1, 2014. All material information regarding the efficacy, safety and utility of the Company Products has been collected and maintained in accordance with accepted industry practices and will be readily accessible to Buyer Parent after the Effective Time. All preclinical and clinical trials conducted, supervised or monitored by the Company have been conducted in compliance in all material respects with all applicable Laws, and the regulations and requirements of any Governmental Authority, including, but not limited to, FDA regulations at 21 C.F.R. Part 812, where applicable, and FDA “Good Laboratory Practices” at 21 C.F.R. Part 58. The Company has consistently obtained and maintained any Institutional Review Board (“IRB”) approvals of clinical trials conducted, supervised, or monitored by the Company as required by law, and has been in full compliance with any applicable requirements of 21 C.F.R. part 56. In no clinical trial conducted, supervised or monitored by the Company has IRB approval ever been suspended, terminated, put on clinical hold, or voluntarily withdrawn because of deficiencies attributed to the Company. No filing or submission to the FDA or any other Governmental Authority that is the basis for any approval or clearance contains any material omission or material false information. Any clinical trial involving a product regulated by the FDA as a medical device has been conducted in compliance with the FDA’s regulations concerning Investigational Device Exemptions, set forth at 21 C.F.R. Part 812.
(i) The Company has heretofore provided to Buyer Parent all material correspondence and contact information (including 483 inspection reports, untitled letters, warning letters, cease and desist letters, and consents) between the Company or any Subsidiary and the FDA or any other Governmental Authority regarding the Company Products, and, to the extent provided to the CompanyCompany or any Subsidiary, between the FDA and other Governmental Authorities relating thereto.
Appears in 1 contract
