Compliance with Laws; Regulatory Matters. (a) The Company and each of its Subsidiaries is in compliance in all material respects with all Law and Orders applicable to the Company and its Subsidiaries. Notwithstanding the foregoing, no representation or warranty is made in this Section 4.22 with respect to (a) compliance with the Exchange Act, to the extent such compliance is covered in Section 4.6 and Section 4.9, (b) intellectual property and related matters, which are covered in Section 4.17, (c) applicable laws with respect to Taxes, which are covered in Section 4.18, (d) ERISA and other employee benefit-related matters, which are covered in Section 4.19, (e) labor law matters, which are covered in Section 4.20, or (f) Environmental Laws, which are covered in Section 4.23. (b) Without limiting the generality of Section 4.22(a), none of the Company or any of its Subsidiaries, nor, to the Knowledge of the Company, any director, officer, agent, employee or other Person acting on behalf of the Company or any of the Company's Subsidiaries has, in the course of its actions for, or on behalf of, the Company or any Company Subsidiary (i) used any corporate funds for any unlawful contribution, gift, entertainment or other unlawful expenses relating to political activity, (ii) made any direct or indirect unlawful payment to any foreign or domestic government official or employee from corporate funds, (iii) violated any provision of the U.S. Foreign Corrupt Practices Act of 1977, as amended, or (iv) made any unlawful bribe, rebate, payoff, influence, payment, kickback or other unlawful payment to any foreign or domestic government official or employee. (c) The Company, each of its Subsidiaries, and each of their respective businesses are being and have been operated, and each service or other product provided by the Company or any of its Subsidiaries (each such service or other product, a "Company Service") is being and has been developed, produced, marketed, distributed, tested, and provided, in compliance with all applicable Laws regarding healthcare or life sciences matters, including but not limited to the U.S. Federal Food, Drug and Cosmetic Act, the Public Health Service Act, the Health Insurance Portability and Accountability Act of 1996, all applicable rules and regulations of the U.S. Food and Drug Administration ("FDA"), the Drug Enforcement Administration ("DEA") and the U.S. Department of Health and Human Services ("HHS"), and any similar legal provisions in any foreign jurisdiction, including the EU Data Protection Directive 95/46/EC and national implementations thereof. (d) The Company and each of its Subsidiaries possess all Permits required by the FDA, DEA, HHS, and any other applicable Governmental Entity responsible for the regulation of healthcare or life sciences activities (each, a "Healthcare Regulatory Authority"), including all filings, submissions, authorizations, approvals, clearances, registrations, certifications, licenses, permits, and accreditations that are necessary for the Company and its Subsidiaries to conduct their business as presently conducted (each, a "Healthcare Regulatory Permit"). Each of the Healthcare Regulatory Permits is (i) in good standing, valid and enforceable, and (ii) in full and timely compliance with all filing, maintenance, and fee requirements. (e) Except as set forth in Section 4.22 of the Company Disclosure Letter, no Healthcare Regulatory Authority or other Person has provided any FDA Form 483, warning letter, untitled letter, Section 305 notice, or any other notice or communication to the Company or any of its Subsidiaries (i) stating that they were or are in violation of any Law or Healthcare Regulatory Permit, or (ii) threatening to revoke, suspend, deem invalid, or refuse to renew any of the Healthcare Regulatory Permits held by the Company or any of its Subsidiaries, nor is the Company or any of its Subsidiaries aware of any facts that could reasonably give rise to such a communication, notice, audit, investigation or inquiry. (f) The Company and each of its Subsidiaries have cooperated fully with, and have prepared, submitted, and implemented in a timely and complete manner all responses, corrective action plans, and other requirements required to be prepared and submitted by the Company or any of its Subsidiaries in response to all inspections, investigations, audits, examinations, orders, agreements, and Legal Proceedings performed or initiated by any Healthcare Regulatory Authority, or by any client, partner, or contracting party of the Company or any of its Subsidiaries or any Person acting on behalf thereof, other than currently outstanding action plans that are not material pursuant to the ordinary course client audits. (g) The Company, its Subsidiaries, all laboratory facilities owned, leased, operated, or employed by the Company or its Subsidiaries, and all Company Services are being and have been operated or provided in compliance with, and have not received any notice of violation of, the FDA's current good laboratory practices regulations, the FDA's current good manufacturing practices regulations, the Clinical Laboratory Improvement Amendments of 1988, the FDA's current good clinical practices regulations, the HHS "Common Rule" (45 C.F.R. Part 46), as amended, and all similar Laws. No Healthcare Regulatory Authority has commenced, or threatened to commence, any action to reject, terminate, suspend, or place on clinical hold any proposed or ongoing clinical trial (i) conducted by, or on behalf of, the Company or any Company Subsidiary, or (ii) in connection with which any Company Service was utilized. (h) Neither the Company, any of its Subsidiaries, nor any officer, director, employee or agent of the Company or any of its Subsidiaries, has (i) made an untrue statement of a material fact or a fraudulent statement to any Healthcare Regulatory Authority, or failed to disclose a material fact required to be disclosed to any Healthcare Regulatory Authority, (ii) been convicted of any crime or engaged in any conduct for which such Person could be excluded from participating in the federal health care programs under Section 1128 of the Social Security Act of 1935, as amended, or any similar Law, (iii) is or has been excluded from participation in any state or federal healthcare program, as defined in 42 USC Section 1320a-7b(f), or (iv) contracted with any employee, contractor, agent, vendor or vendor's affiliate knowing that the contracting party is excluded from participation in any state or federal healthcare program. (i) No individual or company for whom the Company or any of its Subsidiaries has conducted research is or has been subject to the FDA's Application Integrity Policy, or otherwise is under investigation or has been investigated by any Healthcare Regulatory Authority in any domestic or foreign jurisdiction, with regard to the integrity of data provided by the Company or any of its Subsidiaries.
Appears in 1 contract
Samples: Merger Agreement (Bioclinica Inc)
Compliance with Laws; Regulatory Matters. (a) 4.6.1. The Company is not in breach or violation of, or default under, its Constitutive Documents. The Company is, and each since its formation has been, in material compliance with all Applicable Laws and Judgments of any Governmental Authority applicable to it or to the conduct by the Company of its Subsidiaries is business, or the ownership or use of any of its assets and properties, including the Leased Properties. The Company has not received, since its formation, a written or, to its knowledge, oral notice or other communication alleging a material violation by the Company of any Applicable Law of any Governmental Authority applicable to its businesses or operations. No event has occurred nor does any circumstance exist that would reasonably be expected to give rise to an obligation on the part of the Company to undertake, or to bear all or any portion of the cost of, any material remedial action of any nature.
4.6.2. The Products are currently and at all times have been researched, developed, tested, labeled, manufactured, stored, imported, exported, promoted, marketed, sold and distributed, as applicable, by the Company, and to the knowledge of the Company, on behalf of the Company and by or on behalf of any Representative of the Company, in compliance in all material respects with all Law Applicable Laws, including the FD&C Act; the Public Health Service Act (“PHSA”); Applicable Laws governing interactions with healthcare professionals; analogous laws promulgated by foreign, federal, state, provincial or local Governmental Authorities; and Orders applicable any regulations adopted by Regulatory Authorities thereunder (including, as applicable, those requirements relating to cGMP, GLP, GCP, investigational use, and pre-market approval).
4.6.3. The Company, and to the Company and its Subsidiaries. Notwithstanding the foregoing, no representation or warranty is made in this Section 4.22 with respect to (a) compliance with the Exchange Act, to the extent such compliance is covered in Section 4.6 and Section 4.9, (b) intellectual property and related matters, which are covered in Section 4.17, (c) applicable laws with respect to Taxes, which are covered in Section 4.18, (d) ERISA and other employee benefit-related matters, which are covered in Section 4.19, (e) labor law matters, which are covered in Section 4.20, or (f) Environmental Laws, which are covered in Section 4.23.
(b) Without limiting the generality of Section 4.22(a), none of the Company or any of its Subsidiaries, nor, to the Knowledge knowledge of the Company, each Institution, has generated, prepared, maintained and retained all material information, data and biological materials that are required to be generated, prepared, maintained or retained by the Company and each Institution, as applicable, with respect to Products pursuant to, and materially in accordance with, GCP, GLP, cGMP and other Applicable Laws in the U.S. and, with respect to any directoractivities conducted outside the U.S., officerthe Applicable Laws in such jurisdiction. As of the date hereof, agentthe Company has not received written notice of and, employee to the knowledge of the Company, as of the date hereof the Company has not received any other notice of, any pending or threatened Action from the FDA or any other Regulatory Authority or Governmental Authority alleging that any operation or activity of the Company is in violation of the FD&C Act, the PHSA or any analogous Applicable Laws promulgated by applicable Governmental Authorities outside the U.S.
4.6.4. The Company has made available to Buyer a complete and correct copy of all Regulatory Filings submitted to any Regulatory Authority by the Company or in the Company’s possession. All Regulatory Filings submitted to any Regulatory Authority by or on behalf of the Company, and to the knowledge of the Company, each Institution, were true and correct in all material respects.
4.6.5. All preclinical research, clinical studies, and other studies and tests conducted by or on behalf of the Company, and to the knowledge of the Company, by or on behalf of each Institution with respect to Products, have been conducted, as applicable, in material compliance with research protocols, GLP, GCP, and all Applicable Laws, including the FD&C Act (and any regulations adopted thereunder). No preclinical research, clinical study or other Person acting study or test conducted by or on behalf of the Company, and to the knowledge of the Company, by or on behalf of each Institution, with respect to the Products has been terminated or suspended prior to completion. The Company, and to the knowledge of the Company, each Institution, has not, as of the date hereof, received any notice that any Regulatory Authority, investigator, or any relevant institutional review board, independent ethics committee or any other similar body has (i) refused to approve any clinical study, or any substantial amendment to a protocol for any clinical study, conducted or proposed to be conducted by or on behalf of the Company or any of the Company's Subsidiaries hasInstitution, in the course of its actions foror (ii) initiated, or threatened to initiate, any action to suspend any clinical study conducted by or on behalf of, of the Company or any Company Subsidiary (i) used any corporate funds for any unlawful contribution, gift, entertainment or other unlawful expenses relating to political activity, (ii) made any direct or indirect unlawful payment to any foreign or domestic government official or employee from corporate funds, (iii) violated any provision of the U.S. Foreign Corrupt Practices Act of 1977Institution, as amendedapplicable, or (iv) made suspend or terminate any unlawful bribe, rebate, payoff, influence, payment, kickback or other unlawful payment to any foreign or domestic government official or employee.
(c) The Company, each of its Subsidiaries, and each of their respective businesses are being and have been operated, and each service or other product provided IND sponsored by the Company or any Institution, as applicable, or otherwise restrict or delay the preclinical or nonclinical research on or clinical study of its Subsidiaries (each such service any Product.
4.6.6. As of the date hereof, neither the Company nor, to the knowledge of the Company, any Institution, has received notice of any pending or threatened investigation or Action from the FDA, the U.S. Department of Health and Human Services Office of Inspector General, the U.S. Department of Justice, or any other productfederal, a "Company Service") state, local, or foreign Governmental Authority alleging that the Company, or any Institution as relates to the Products, is being and has been developedin violation in any material respect of any Applicable Law, producedincluding the FD&C Act, marketedthe PHSA or any similar state, distributed, testedlocal or foreign equivalents to any of the foregoing.
4.6.7. The Company, and providedto the knowledge of the Company, each Institution in compliance relation to the Company and the Products, has complied in all material respects with all applicable Laws security and privacy standards regarding healthcare or life sciences matters, including but not limited to the U.S. Federal Food, Drug protected health information and Cosmetic Act, the Public Health Service Act, personal data under (i) the Health Insurance Portability and Accountability Act of 1996, all applicable rules as amended by the Health Information Technology for Economic and regulations Clinical Health Act of the U.S. Food and Drug Administration ("FDA"), the Drug Enforcement Administration ("DEA") and the U.S. Department of Health and Human Services ("HHS"), and any similar legal provisions in any foreign jurisdiction2009, including the regulations promulgated thereunder, (ii) EU Regulation 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data (the General Data Protection Directive 95/46/EC Regulation) and all national implementations implementing legislation thereof.
(d) The Company and each of its Subsidiaries possess all Permits required by the FDA, DEA, HHS, and any other applicable Governmental Entity responsible for the regulation of healthcare or life sciences activities (each, a "Healthcare Regulatory Authority"), including all filings, submissions, authorizations, approvals, clearances, registrations, certifications, licenses, permits, and accreditations that are necessary for the Company and its Subsidiaries to conduct their business as presently conducted (each, a "Healthcare Regulatory Permit"). Each of the Healthcare Regulatory Permits is (i) in good standing, valid and enforceable, and (iiiii) in full and timely compliance with all filingany applicable national, maintenancestate, and fee requirementsprovincial or local privacy laws.
(e) Except as set forth in Section 4.22 of 4.6.8. Neither the Company Disclosure Letternor, no Healthcare Regulatory Authority or other Person has provided any FDA Form 483, warning letter, untitled letter, Section 305 notice, or any other notice or communication to the Company or any knowledge of its Subsidiaries (i) stating that they were or are in violation of any Law or Healthcare Regulatory Permit, or (ii) threatening to revoke, suspend, deem invalid, or refuse to renew any of the Healthcare Regulatory Permits held by the Company or any of its Subsidiaries, nor is the Company or any of its Subsidiaries aware of any facts that could reasonably give rise to such a communication, notice, audit, investigation or inquiry.
(f) The Company and each of its Subsidiaries have cooperated fully with, and have prepared, submitted, and implemented in a timely and complete manner all responses, corrective action plans, and other requirements required to be prepared and submitted by the Company or any of its Subsidiaries in response to all inspections, investigations, audits, examinations, orders, agreements, and Legal Proceedings performed or initiated by any Healthcare Regulatory Authority, or by any client, partner, or contracting party of the Company or any of its Subsidiaries or any Person acting on behalf thereof, other than currently outstanding action plans that are not material pursuant to the ordinary course client audits.
(g) The Company, its Subsidiaries, all laboratory facilities owned, leased, operated, or employed by the Company or its Subsidiaries, and all Company Services are being and have been operated or provided in compliance with, and have not received any notice of violation of, the FDA's current good laboratory practices regulations, the FDA's current good manufacturing practices regulations, the Clinical Laboratory Improvement Amendments of 1988, the FDA's current good clinical practices regulations, the HHS "Common Rule" (45 C.F.R. Part 46), as amended, and all similar Laws. No Healthcare Regulatory Authority has commenced, or threatened to commence, any action to reject, terminate, suspend, or place on clinical hold any proposed or ongoing clinical trial (i) conducted by, or on behalf of, the Company or any Company Subsidiary, or (ii) in connection with which any Company Service was utilized.
(h) Neither the Company, any of its Subsidiaries, nor any officer, director, employee Company Personnel or agent of the Company or any of its Subsidiaries, Affiliate has (i) made an untrue any materially false statement of a on, or material fact or a fraudulent statement omission from, any notifications, applications, approvals, reports and other submission to any Healthcare Regulatory AuthorityGovernmental Authority or in any material legal proceeding; or (ii) committed any act, made any statement or failed to disclose make any statement that would reasonably be expected to provide a material fact required basis for the FDA to be disclosed invoke its policy with respect to “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” or for the FDA or any Healthcare Regulatory Authority, (ii) other Governmental Authority to invoke any similar policy. Neither the Company nor any Company Personnel has been convicted of any crime or engaged in any conduct for which that has resulted, or would reasonably be expected to result, in debarment or exclusion under Applicable Laws, including 21 U.S.C. §335a and 42 U.S.C. §1320a-7. No Actions that would reasonably be expected to result in such Person could be excluded from participating in the federal health care programs under Section 1128 a debarment or exclusion of the Social Security Act Company are pending or, to the knowledge of 1935the Company, threatened, against the Company or, to the knowledge of the Company, any Company Personnel.
4.6.9. The Company, and, to the knowledge of the Company, each Institution as amendedrelates to the Products, has not received any warning letter or untitled letter, report of inspectional observations, including FDA Form 483s, establishment inspection reports, notices of violation, clinical holds, enforcement notices or other documents or notifications from any Regulatory Authority or other Governmental Authority, or any institutional review board, independent ethics committee or similar Lawbody, (iii) is or has been excluded from participation in any state or federal healthcare program, as defined in 42 USC Section 1320a-7b(f), or (iv) contracted alleging a lack of compliance with any employee, contractor, agent, vendor or vendor's affiliate knowing that the contracting party is excluded from participation in any state or federal healthcare program.
(i) No individual or company for whom the Applicable Laws. The Company or any of its Subsidiaries has conducted research is or has not been subject to a corporate integrity agreement, deferred prosecution agreement, consent decree, monitoring agreement, settlement agreement or other similar agreements or orders mandating or prohibiting future or past activities.
4.6.10. The Company, and to the FDA's Application Integrity Policyknowledge of the Company, each Institution, has not marketed, advertised, distributed (for commercialization purposes), sold, or otherwise is under investigation commercialized any Product.
4.6.11. The Company has provided or has been investigated by any Healthcare Regulatory Authority in any domestic or foreign jurisdictionmade available to Buyer true, complete and correct copies of all adverse information with regard respect to the integrity safety and efficacy of Products relating to activities performed by or on behalf of the Company, and to the knowledge of the Company, by or on behalf of any Institution.
4.6.12. The Company has provided Buyer with the opportunity to review all written preclinical (including research), clinical and other material experimental data provided in the Company’s possession relating to the Products or the exploitation thereof relating to activities performed by or on behalf of the Company Company, and to the knowledge of the Company, by or on behalf of any of its SubsidiariesInstitution, and has not intentionally concealed from Buyer any such data.
4.6.13. To the Company’s knowledge, there are no safety, efficacy, or regulatory issues that would materially preclude Buyer or the Surviving Corporation from exploiting Products in compliance with Applicable Laws.
Appears in 1 contract
Compliance with Laws; Regulatory Matters. (a) The Company Fortis is, and each in the [*] has been, in material compliance with all applicable Laws and Judgments of any Governmental Entity applicable to it or to the conduct by Fortis of its Subsidiaries business, or the ownership or use of any of its assets and properties. Fortis has not received, since its incorporation, a written or, to its knowledge, oral notice or communication alleging a possible material violation by Fortis of any applicable Law or Judgment of any Governmental Entity applicable to its businesses or operations. [*] = Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) would likely cause competitive harm to the company if publicly disclosed. 129433662_24
(b) The Products at all times have been developed, tested, labeled, manufactured, and stored, as applicable, by or on behalf of Fortis in compliance in all material respects with all Law and Orders applicable Laws in the U.S., including the FFDCA or any regulations adopted thereunder by any Regulatory Entity (including, as applicable, those requirements relating to the Company FDA’s current GMP, GLP, and its Subsidiaries. Notwithstanding the foregoingGCP), no representation or warranty is made in this Section 4.22 and, with respect to (a) compliance with any activities conducted in the Exchange ActEU, the EMA. Fortis has generated, prepared, maintained and retained all material information, data and biological materials that are required to the extent such compliance is covered in Section 4.6 and Section 4.9be generated, (b) intellectual property and related mattersprepared, which are covered in Section 4.17, (c) applicable laws maintained or retained by Fortis with respect to TaxesProducts pursuant to, which are covered and in Section 4.18accordance in all material respects with, (d) ERISA GCP, GLP, GMP and other employee benefit-related mattersapplicable Laws. Fortis has not received written or, which are covered [*], oral notice of any pending or threatened Action from the FDA or any other Regulatory Entity alleging that any operation or activity of Fortis is in Section 4.19, (e) labor law matters, which are covered in Section 4.20, or (f) Environmental Laws, which are covered in Section 4.23.
(b) Without limiting the generality of Section 4.22(a), none violation of the Company FFDCA or any of its Subsidiaries, nor, to analogous applicable Laws promulgated by applicable Governmental Entities outside the Knowledge of the Company, any director, officer, agent, employee or other Person acting on behalf of the Company or any of the Company's Subsidiaries has, in the course of its actions for, or on behalf of, the Company or any Company Subsidiary (i) used any corporate funds for any unlawful contribution, gift, entertainment or other unlawful expenses relating to political activity, (ii) made any direct or indirect unlawful payment to any foreign or domestic government official or employee from corporate funds, (iii) violated any provision of the U.S. Foreign Corrupt Practices Act of 1977, as amended, or (iv) made any unlawful bribe, rebate, payoff, influence, payment, kickback or other unlawful payment to any foreign or domestic government official or employee.U.S.
(c) The CompanyFortis has made available to FibroGen a true, each complete and correct copy of its Subsidiariesall material Regulatory Materials submitted to any Regulatory Entity by Fortis or in Fortis’ possession. All Regulatory Materials submitted to any Regulatory Entity by Fortis were true and accurate in all material respects as of the date of submission to such Regulatory Entity.
(d) To the extent required by applicable Laws, all preclinical studies and tests and Clinical Trials conducted by Fortis with respect to Products have been, and each if still pending are being, conducted in material compliance with research protocols, GLP, GCP, and all applicable Laws in the U.S., including the FFDCA (or any regulations adopted thereunder), and, with respect to any activities conducted in the EU, the EMA. [*], all preclinical studies and tests and Clinical Trials conducted on behalf of their respective businesses Fortis with respect to Products have been, or if pending, are being and have been operatedconducted in material compliance with research protocols, GLP, GCP, and each service or other product provided by all applicable Laws in the Company U.S., including the FFDCA (or any regulations adopted thereunder), and, with respect to any activities conducted in the EU, the EMA. No preclinical study or test or Clinical Trial conducted by or on behalf of its Subsidiaries (each such service Fortis with respect to Products has been terminated or other productsuspended prior to completion, and no Regulatory Entity or clinical investigator that has participated or is participating in, or institutional review board that has or has had jurisdiction over, a "Company Service"preclinical study or test or Clinical Trial conducted by or on behalf of Fortis with respect to Products has commenced, or, [*], threatened to initiate, any action to place a clinical hold order on, or otherwise terminate or suspend or refuse to commence, any proposed or ongoing investigation or study or Clinical Trial conducted or proposed to be conducted by or on behalf of Fortis with respect to Products.
(e) Fortis has not received any written notice that any Regulatory Entity, or any relevant institutional review board, independent ethics committee or any other similar body has initiated, or threatened to initiate, any action to (i) suspend any Clinical Trial conducted by or on behalf of Fortis, or suspend or terminate any IND sponsored by Fortis or otherwise restrict or delay the preclinical or nonclinical research on or clinical study, in each case, of any Product, or (ii) recall, suspend or otherwise restrict the manufacture of any Product.
(f) Xxxxxx has not received any written notice that any relevant institutional review board or independent ethics committee has refused to approve (i) any Clinical Trial conducted or proposed to be conducted by or on behalf of Fortis or (ii) any substantial amendment to a protocol for any Clinical Trial conducted or proposed to be conducted by or on behalf of Fortis, in each case with respect to any Product.
(g) Fortis is being not subject to any investigation that is pending and of which Fortis has been developednotified in writing or, produced[*], marketed, distributed, tested, and providedwhich has been threatened, in compliance each case by (i) the FDA or (ii) the Department of Health and Human Services Office of Inspector General or Department of Justice pursuant to the Federal Healthcare Program Anti-Kickback Statute (42 U.S.C. §1320a-7b(b)) or the Federal False Claims Act (31 U.S.C. §3729).
(h) Fortis has complied in all material respects with all applicable Laws security and privacy standards regarding healthcare or life sciences matters, including but not limited protected health information relating to the U.S. Federal Food, Drug and Cosmetic Act, the Public Health Service Act, Products under (i) the Health Insurance Portability and Accountability Act of 1996, all applicable rules as amended by the Health Information Technology for Economic and regulations Clinical Health Act of the U.S. Food and Drug Administration ("FDA"), the Drug Enforcement Administration ("DEA") and the U.S. Department of Health and Human Services ("HHS"), and any similar legal provisions in any foreign jurisdiction2009, including the EU Data Protection Directive 95/46/EC and national implementations thereof.
(d) The Company and each of its Subsidiaries possess all Permits required by the FDA, DEA, HHS, and any other applicable Governmental Entity responsible for the regulation of healthcare or life sciences activities (each, a "Healthcare Regulatory Authority"), including all filings, submissions, authorizations, approvals, clearances, registrations, certifications, licenses, permits, and accreditations that are necessary for the Company and its Subsidiaries to conduct their business as presently conducted (each, a "Healthcare Regulatory Permit"). Each of the Healthcare Regulatory Permits is (i) in good standing, valid and enforceable, regulations promulgated thereunder and (ii) in full and timely compliance with all filing, maintenance, and fee requirementsany applicable state privacy laws.
(ei) Except as All manufacturing operations conducted by or for the benefit of Fortis with respect to the Products have been and are being conducted in material compliance with applicable Laws, including, to the extent applicable, GMP. [*] = Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) would likely cause competitive harm to the company if publicly disclosed. 129433662_24
(j) Neither Fortis nor, [*], any Fortis Personnel or Affiliate has committed any act, made any statement or failed to make any statement that would reasonably be expected to provide a basis for the FDA or any other Regulatory Entity to invoke its policy with respect to “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” or any such similar policies set forth in Section 4.22 of the Company Disclosure Letter, no Healthcare Regulatory Authority or other Person has provided any FDA Form 483, warning letter, untitled letter, Section 305 notice, or any other notice or communication to the Company or any of its Subsidiaries (i) stating that they were or are in violation of any Law or Healthcare Regulatory Permit, or (ii) threatening to revoke, suspend, deem invalid, or refuse to renew any of the Healthcare Regulatory Permits held by the Company or any of its Subsidiaries, nor is the Company or any of its Subsidiaries aware of any facts that could reasonably give rise to such a communication, notice, audit, investigation or inquiry.
(f) The Company and each of its Subsidiaries have cooperated fully with, and have prepared, submitted, and implemented in a timely and complete manner all responses, corrective action plans, and other requirements required to be prepared and submitted by the Company or any of its Subsidiaries in response to all inspections, investigations, audits, examinations, orders, agreements, and Legal Proceedings performed or initiated by any Healthcare Regulatory Authority, or by any client, partner, or contracting party of the Company or any of its Subsidiaries or any Person acting on behalf thereof, other than currently outstanding action plans that are not material pursuant to the ordinary course client audits.
(g) The Company, its Subsidiaries, all laboratory facilities owned, leased, operated, or employed by the Company or its Subsidiaries, and all Company Services are being and have been operated or provided in compliance with, and have not received any notice of violation of, the FDA's current good laboratory practices regulations, the FDA's current good manufacturing practices regulations, the Clinical Laboratory Improvement Amendments of 1988, the FDA's current good clinical practices regulations, the HHS "Common Rule" (45 C.F.R. Part 46), as amended, and all similar applicable Laws. No Healthcare Regulatory Authority has commencedNeither Fortis nor, or threatened to commence[*], any action to reject, terminate, suspend, or place on clinical hold any proposed or ongoing clinical trial (i) conducted by, or on behalf of, the Company or any Company Subsidiary, or (ii) in connection with which any Company Service was utilized.
(h) Neither the Company, any of its Subsidiaries, nor any officer, director, employee or agent of the Company or any of its Subsidiaries, Fortis Personnel has (i) made an untrue statement of a material fact or a fraudulent statement to any Healthcare Regulatory Authority, or failed to disclose a material fact required to be disclosed to any Healthcare Regulatory Authority, (ii) been convicted of any crime or engaged in any conduct for that has resulted, or would reasonably be expected to result, in debarment or exclusion under applicable Laws, including 21 U.S.C. §335a and 42 U.S.C. §1320a-7. No Actions that would reasonably be expected to result in such a debarment or exclusion of Fortis are pending or, [*], threatened, against Fortis or, [*], any Fortis Personnel.
(k) There are no Actions pending with respect to which such Person could be excluded from participating Fortis has been served and, [*], there are no other Actions pending, in the federal health care programs under Section 1128 each case, with respect to an alleged violation by Fortis of the Social Security FFDCA (or any regulations adopted thereunder), the Controlled Substances Act of 19351970, as amended, or any similar Law, (iii) is or has been excluded from participation in other applicable Laws promulgated by any state or federal healthcare program, as defined in 42 USC Section 1320a-7b(f), or (iv) contracted with Regulatory Entity that applies to the regulatory status of any employee, contractor, agent, vendor or vendor's affiliate knowing that the contracting party is excluded from participation in any state or federal healthcare programProduct.
(il) No individual Fortis has not received any warning letter or company for whom the Company untitled letter, report of inspectional observations, including FDA Form 483s, establishment inspection reports, notices of violation, clinical holds, enforcement notices or other documents from any Regulatory Entity, or any institutional review board, independent ethics committee or similar body, alleging a lack of its Subsidiaries compliance by Fortis with any applicable Laws.
(m) Fortis has conducted research is or has been subject to the FDA's Application Integrity Policynot marketed, advertised, distributed, sold, or otherwise is under investigation commercialized any Product.
(n) Fortis has made available to FibroGen all material written preclinical, clinical and other experimental data in Fortis’ possession relating to Products or the exploitation thereof relating to activities performed by or on behalf of Fortis, and has not concealed or withheld from FibroGen any such data.
(o) [*], there are no safety, efficacy, or regulatory issues, other than the information that has previously been investigated by any Healthcare Regulatory Authority made available to FibroGen, that would preclude FibroGen or the Surviving Corporation from exploiting the Products in any domestic or foreign jurisdiction, compliance with regard to the integrity of data provided by the Company or any of its Subsidiariesapplicable Laws.
Appears in 1 contract
Compliance with Laws; Regulatory Matters. (a) The Company is not in breach or violation of, or default under, and each has never been in breach or violation of, or default under its Constitutive Documents. The Company and the Parent are, and since their formation have been, in material compliance with all applicable Laws and Judgments of its Subsidiaries is any Governmental Entity applicable to them or to the conduct by the Company or the Parent of their respective business, or the ownership or use of any of their respective assets and properties, including the Leased Properties. Neither the Company nor the Parent have received, since their formation, a written or, to the Company’s knowledge and the Parent’s knowledge, oral notice or other communication alleging a possible violation by the Company or the Parent of any applicable Law or Judgment of any Governmental Entity applicable to their respective businesses or operations. No event has occurred nor, to the Company’s knowledge or the Parent’s knowledge, does any circumstance exist, that would reasonably be expected to give rise to any obligation on the part of the Company or the Parent to undertake, or to bear all or any portion of the cost of, any material remedial action of any nature.
(b) The Company’s engineered microbes and product candidates are being, and at all times have been, developed, tested, labeled, manufactured, stored, imported, exported and distributed, as applicable, in compliance in all material respects with all Law applicable Laws, including the FFDCA (including, as applicable, those requirements relating to GMP, GLP, GCP, investigational use, pre-market approval and Orders applicable applications to the market a new pharmaceutical product and all Laws referred to in EudraLex Volume 10 (Guidelines for Clinical Trials)). The Company and its Subsidiaries. Notwithstanding the foregoingAffiliates have generated, no representation prepared, maintained and retained all materials that are required to be generated, prepared, maintained or warranty is made in this Section 4.22 retained with respect to (a) compliance with the Exchange ActCompany’s engineered microbes and product candidates pursuant to, to the extent such compliance is covered and in Section 4.6 and Section 4.9accordance with, (b) intellectual property and related mattersGMP, which are covered in Section 4.17GLP, (c) applicable laws with respect to Taxes, which are covered in Section 4.18, (d) ERISA GCP and other employee benefit-related matters, which are covered in Section 4.19, (e) labor law matters, which are covered in Section 4.20, or (f) Environmental applicable Laws, which are covered in Section 4.23.
(b) Without limiting the generality of Section 4.22(a), none of the Company or any of its Subsidiaries, nor, to the Knowledge of the Company, any director, officer, agent, employee or other Person acting on behalf of the Company or any of the Company's Subsidiaries has, in the course of its actions for, or on behalf of, the Company or any Company Subsidiary (i) used any corporate funds for any unlawful contribution, gift, entertainment or other unlawful expenses relating to political activity, (ii) made any direct or indirect unlawful payment to any foreign or domestic government official or employee from corporate funds, (iii) violated any provision of the U.S. Foreign Corrupt Practices Act of 1977, as amended, or (iv) made any unlawful bribe, rebate, payoff, influence, payment, kickback or other unlawful payment to any foreign or domestic government official or employee.
(c) The Company, each of its Subsidiaries, and each of their respective businesses are being and have been operated, and each service or other product provided by the Company or any of its Subsidiaries (each such service or other product, a "Company Service") is being and has been developed, produced, marketed, distributed, tested, and provided, in compliance with all applicable Laws regarding healthcare or life sciences matters, including but not limited to the U.S. Federal Food, Drug and Cosmetic Act, the Public Health Service Act, the Health Insurance Portability and Accountability Act of 1996, all applicable rules and regulations of the U.S. Food and Drug Administration ("FDA"), the Drug Enforcement Administration ("DEA") and the U.S. Department of Health and Human Services ("HHS"), and any similar legal provisions in any foreign jurisdiction, including the EU Data Protection Directive 95/46/EC and national implementations thereof.
(d) The Company and each of its Subsidiaries possess all Permits required by the FDA, DEA, HHS, and any other applicable Governmental Entity responsible for the regulation of healthcare or life sciences activities (each, a "Healthcare Regulatory Authority"), including all filings, submissions, authorizations, approvals, clearances, registrations, certifications, licenses, permits, and accreditations that are necessary for the Company and its Subsidiaries to conduct their business as presently conducted (each, a "Healthcare Regulatory Permit"). Each of the Healthcare Regulatory Permits is (i) in good standing, valid and enforceable, and (ii) in full and timely compliance with all filing, maintenance, and fee requirements.
(e) Except as set forth in Section 4.22 of the Company Disclosure Letter, no Healthcare Regulatory Authority or other Person has provided any FDA Form 483, warning letter, untitled letter, Section 305 notice, or any other notice or communication to the Company or any of its Subsidiaries (i) stating that they were or are in violation of any Law or Healthcare Regulatory Permit, or (ii) threatening to revoke, suspend, deem invalid, or refuse to renew any of the Healthcare Regulatory Permits held by the Company or any of its Subsidiaries, nor is the Company or any of its Subsidiaries aware of any facts that could reasonably give rise to such a communication, notice, audit, investigation or inquiry.
(f) The Company and each of its Subsidiaries have cooperated fully with, and have prepared, submitted, and implemented in a timely and complete manner all responses, corrective action plans, and other requirements required to be prepared and submitted by the Company or any of its Subsidiaries in response to all inspections, investigations, audits, examinations, orders, agreements, and Legal Proceedings performed or initiated by any Healthcare Regulatory Authority, or by any client, partner, or contracting party of the Company or any of its Subsidiaries or any Person acting on behalf thereof, other than currently outstanding action plans that are not material pursuant to the ordinary course client audits.
(g) The Company, its Subsidiaries, all laboratory facilities owned, leased, operated, or employed by the Company or its Subsidiaries, and all Company Services such materials are being true, correct and have been operated or provided in compliance with, and have not received any notice of violation of, the FDA's current good laboratory practices regulations, the FDA's current good manufacturing practices regulations, the Clinical Laboratory Improvement Amendments of 1988, the FDA's current good clinical practices regulations, the HHS "Common Rule" (45 C.F.R. Part 46), as amended, and all similar Lawscomplete. No Healthcare Regulatory Authority has commenced, or threatened to commence, any action to reject, terminate, suspend, or place on clinical hold any proposed or ongoing clinical trial (i) conducted by, or on behalf of, the Company or any Company Subsidiary, or (ii) in connection with which any Company Service was utilized.
(h) Neither the Company, any of its Subsidiaries, nor any officer, director, employee or agent of the Company or any of its Subsidiaries, has (i) made an untrue statement of a material fact or a fraudulent statement to any Healthcare Regulatory Authority, or failed to disclose a material fact required to be disclosed to any Healthcare Regulatory Authority, (ii) been convicted of any crime or engaged in any conduct for which such Person could be excluded from participating in the federal health care programs under Section 1128 of the Social Security Act of 1935, as amended, or any similar Law, (iii) is or has been excluded from participation in any state or federal healthcare program, as defined in 42 USC Section 1320a-7b(f), or (iv) contracted with any employee, contractor, agent, vendor or vendor's affiliate knowing that the contracting party is excluded from participation in any state or federal healthcare program.
(i) No individual or company for whom the Company or any of its Subsidiaries has conducted research is or has been subject to the FDA's Application Integrity Policy, or otherwise is under investigation or has been investigated by any Healthcare Regulatory Authority in any domestic or foreign jurisdiction, with regard to the integrity of data provided by the Company or any of its Subsidiaries.Neither
Appears in 1 contract
Compliance with Laws; Regulatory Matters. (a) Except as set forth in Schedule 5.8(a) hereto, the Company is, and since January 1, 2015 has been, in compliance in all material respects with each Law that is or was applicable to it or to the conduct by the Company of its business, or the ownership or use of any of its Assets and Properties, including the Federal Food, Drug, and Cosmetic Act, the Public Health Service Act, and the Animal Welfare Act, as applicable, and their applicable implementing regulations. No event has occurred or circumstance exists that (with or without the lapse of time) (i) would reasonably be expected to constitute or result in a violation by the Company, or a failure on the part of the Company, to comply in any material respects with any Law, or (ii) would reasonably be expected to give rise to any obligation on the part of the Company to undertake or to bear all or any portion of the cost of, any material remedial action of any nature.
(b) The Company has obtained all necessary and applicable material Permits (i) required by any Regulatory Authority to authorize the design, development, preclinical and clinical testing, manufacture and labeling of the Company Products in jurisdictions where it presently conducts such activities with respect to each Company Product, or (ii) that are otherwise required to entitle the Company to own or lease, operate and use its Assets and Properties and conduct its business and operations as presently conducted. Schedule 5.8(b) hereto sets forth a complete and correct list of its Subsidiaries all material Permits held by the Company as of the date of this Agreement, true and complete copies of which have been provided to the Purchaser. The Company is in compliance in all material respects with (i) all terms and conditions of each such Permit, and (ii) all applicable Laws regarding registration, license and certification for each site at which a Company Product is manufactured and labeled. All manufacturing operations performed by or on behalf of the Company have been and are being conducted in all material respects in compliance with the Good Manufacturing Practice (cGMP) regulations of the FDA at 21 C.F.R. Parts 210, 211, and 600-680 and counterpart regulations in all other countries where compliance is required, in each case to the extent applicable. The Company is in compliance in all material respects with all Law applicable reporting requirements for all Permits held by it.
(c) All preclinical studies, and Orders other studies and tests conducted by or, to the knowledge of the Company, on behalf of the Company have been, and if still pending are being, conducted in material compliance with research protocols and all applicable Laws, including the Good Laboratory Practice (cGLP) regulations of the FDA at 21 C.F.R. Part 58, and the Animal Welfare Act and similar foreign laws, if applicable.
(d) Except as set forth in Schedule 5.8(d) hereto, the Company has not received any written notice or other written communication from the FDA or any other Regulatory Authority alleging any violation of any Laws by the Company. The Company is not subject to any obligation arising under an administrative or regulatory action, inspection, warning letter, notice of violation letter, or other written notice, response or commitment made to or with the FDA or any comparable Regulatory Authority with respect to a violation of Law, and, to the Knowledge of the Company, no such proceedings have been threatened.
(e) All filings with and submissions to the FDA and any similar Regulatory Authority made by the Company with regard to the Company Products, whether written or electronically delivered, were true, accurate and its Subsidiaries. Notwithstanding complete in all material respects as of the foregoingdate made, no representation or warranty is made in this Section 4.22 with respect to (a) compliance with the Exchange Actand, to the extent required to be updated, have been updated to be true, accurate and complete in all material respects as of the date of such compliance is covered in Section 4.6 and Section 4.9, (b) intellectual property and related matters, which are covered in Section 4.17, (c) applicable laws with respect to Taxes, which are covered in Section 4.18, (d) ERISA and other employee benefit-related matters, which are covered in Section 4.19, (e) labor law matters, which are covered in Section 4.20, or update.
(f) Environmental Laws, which are covered in Section 4.23.
(b) Without limiting the generality of Section 4.22(a), none of Neither the Company or any of its Subsidiaries, nor, to the Knowledge of the Company, any directorof its officers, officeremployees or agents has been convicted of any crime that has resulted, agentor would reasonably be expected to result, employee in debarment under applicable Law, including 21 U.S.C. Section 335a. No claims, actions, proceedings or investigations that would reasonably be expected to result in debarment are pending or, to the Knowledge of the Company, threatened against the Company or any of its respective officers, employees or agents.
(g) Neither the Company nor any of its directors, officers, employees, agents, distributors, or any other Person associated with or acting on behalf of the Company or any of the Company's Subsidiaries has, is in the course of its actions forviolation of, or on behalf ofsince January 1, the Company or any Company Subsidiary 2013 has (i) used any corporate funds for any unlawful contribution, gift, entertainment or other unlawful expenses relating to political activity, (ii) made any direct or indirect unlawful payment to any foreign or domestic government official or employee from corporate funds, (iii) violated any provision of the U.S. Foreign Corrupt Practices Act of 1977, as amended1977 (the “FCPA”) or any applicable Law enacted in any jurisdiction in connection with or arising under the OECD Convention Combating Bribery of Foreign Public Officials in International Business Transactions (the “OECD Convention”), or (ivii) made made, offered to make, promised to make or authorized the payment or giving of, directly or indirectly, any unlawful bribe, rebate, payoff, influence, influence payment, kickback or other unlawful payment or gift of money or anything of value prohibited under any applicable Law addressing matters comparable to those addressed by the FCPA or the OECD Convention implementing legislation concerning such payments or gifts in any foreign or domestic government official or employee.
jurisdiction (c) The any such payment, a “Prohibited Payment”). Since January 1, 2013, neither the Company, each of its Subsidiaries, and each of their respective businesses are being and have been operated, and each service or other product provided by the Company or any of its Subsidiaries (each such service or other product, a "Company Service") is being and has been developed, produced, marketed, distributed, tested, and provided, in compliance with all applicable Laws regarding healthcare or life sciences matters, including but not limited nor to the U.S. Federal Food, Drug and Cosmetic Act, the Public Health Service Act, the Health Insurance Portability and Accountability Act of 1996, all applicable rules and regulations of the U.S. Food and Drug Administration ("FDA"), the Drug Enforcement Administration ("DEA") and the U.S. Department of Health and Human Services ("HHS"), and any similar legal provisions in any foreign jurisdiction, including the EU Data Protection Directive 95/46/EC and national implementations thereof.
(d) The Company and each of its Subsidiaries possess all Permits required by the FDA, DEA, HHS, and any other applicable Governmental Entity responsible for the regulation of healthcare or life sciences activities (each, a "Healthcare Regulatory Authority"), including all filings, submissions, authorizations, approvals, clearances, registrations, certifications, licenses, permits, and accreditations that are necessary for the Company and its Subsidiaries to conduct their business as presently conducted (each, a "Healthcare Regulatory Permit"). Each of the Healthcare Regulatory Permits is (i) in good standing, valid and enforceable, and (ii) in full and timely compliance with all filing, maintenance, and fee requirements.
(e) Except as set forth in Section 4.22 of the Company Disclosure Letter, no Healthcare Regulatory Authority or other Person has provided any FDA Form 483, warning letter, untitled letter, Section 305 notice, or any other notice or communication to the Company or any of its Subsidiaries (i) stating that they were or are in violation of any Law or Healthcare Regulatory Permit, or (ii) threatening to revoke, suspend, deem invalid, or refuse to renew any of the Healthcare Regulatory Permits held by the Company or any of its Subsidiaries, nor is the Company or any of its Subsidiaries aware of any facts that could reasonably give rise to such a communication, notice, audit, investigation or inquiry.
(f) The Company and each of its Subsidiaries have cooperated fully with, and have prepared, submitted, and implemented in a timely and complete manner all responses, corrective action plans, and other requirements required to be prepared and submitted by the Company or any of its Subsidiaries in response to all inspections, investigations, audits, examinations, orders, agreements, and Legal Proceedings performed or initiated by any Healthcare Regulatory Authority, or by any client, partner, or contracting party of the Company or any of its Subsidiaries or any Person acting on behalf thereof, other than currently outstanding action plans that are not material pursuant to the ordinary course client audits.
(g) The Company, its Subsidiaries, all laboratory facilities owned, leased, operated, or employed by the Company or its Subsidiaries, and all Company Services are being and have been operated or provided in compliance with, and have not received any notice of violation of, the FDA's current good laboratory practices regulations, the FDA's current good manufacturing practices regulations, the Clinical Laboratory Improvement Amendments of 1988, the FDA's current good clinical practices regulations, the HHS "Common Rule" (45 C.F.R. Part 46), as amended, and all similar Laws. No Healthcare Regulatory Authority has commenced, or threatened to commence, any action to reject, terminate, suspend, or place on clinical hold any proposed or ongoing clinical trial (i) conducted by, or on behalf of, the Company or any Company Subsidiary, or (ii) in connection with which any Company Service was utilized.
(h) Neither the Company’s Knowledge, any of its Subsidiariesrespective directors, nor any officerofficers, directoragents, employee employees, Subsidiaries or agent of the Company or any of its Subsidiaries, has (i) made an untrue statement of a material fact or a fraudulent statement to any Healthcare Regulatory Authority, or failed to disclose a material fact required to be disclosed to any Healthcare Regulatory Authority, (ii) been convicted of any crime or engaged in any conduct for which such Person could be excluded from participating in the federal health care programs under Section 1128 of the Social Security Act of 1935, as amended, or any similar Law, (iii) is or has been excluded from participation in any state or federal healthcare program, as defined in 42 USC Section 1320a-7b(f), or (iv) contracted with any employee, contractor, agent, vendor or vendor's affiliate knowing that the contracting party is excluded from participation in any state or federal healthcare program.
(i) No individual or company for whom the Company or any of its Subsidiaries has conducted research is or Affiliates has been subject to the FDA's Application Integrity Policy, or otherwise is under any investigation or has been investigated by any Healthcare Regulatory Authority in any domestic or foreign jurisdiction, Governmental Entity with regard to the integrity of data provided by the Company or any of its SubsidiariesProhibited Payment.
Appears in 1 contract
Compliance with Laws; Regulatory Matters. (a) The Company Fortis is, and each in the [*] has been, in material compliance with all applicable Laws and Judgments of any Governmental Entity applicable to it or to the conduct by Fortis of its Subsidiaries is business, or the ownership or use of any of its assets and properties. Fortis has not received, since its incorporation, a written or, to its knowledge, oral notice or communication alleging a possible material violation by Fortis of any applicable Law or Judgment of any Governmental Entity applicable to its businesses or operations.
(b) The Products at all times have been developed, tested, labeled, manufactured, and stored, as applicable, by or on behalf of Fortis in compliance in all material respects with all Law and Orders applicable Laws in the U.S., including the FFDCA or any regulations adopted thereunder by any Regulatory Entity (including, as applicable, those requirements relating to the Company FDA’s current GMP, GLP, and its Subsidiaries. Notwithstanding the foregoingGCP), no representation or warranty is made in this Section 4.22 and, with respect to (a) compliance with any activities conducted in the Exchange ActEU, the EMA. Fortis has generated, prepared, maintained and retained all material information, data and biological materials that are required to the extent such compliance is covered in Section 4.6 and Section 4.9be generated, (b) intellectual property and related mattersprepared, which are covered in Section 4.17, (c) applicable laws maintained or retained by Fortis with respect to TaxesProducts pursuant to, which are covered and in Section 4.18accordance in all material respects with, (d) ERISA GCP, GLP, GMP and other employee benefit-related mattersapplicable Laws. Fortis has not received written or, which are covered [*], oral notice of any pending or threatened Action from the FDA or any other Regulatory Entity alleging that any operation or activity of Fortis is in Section 4.19, (e) labor law matters, which are covered in Section 4.20, or (f) Environmental Laws, which are covered in Section 4.23.
(b) Without limiting the generality of Section 4.22(a), none violation of the Company FFDCA or any of its Subsidiaries, nor, to analogous applicable Laws promulgated by applicable Governmental Entities outside the Knowledge of the Company, any director, officer, agent, employee or other Person acting on behalf of the Company or any of the Company's Subsidiaries has, in the course of its actions for, or on behalf of, the Company or any Company Subsidiary (i) used any corporate funds for any unlawful contribution, gift, entertainment or other unlawful expenses relating to political activity, (ii) made any direct or indirect unlawful payment to any foreign or domestic government official or employee from corporate funds, (iii) violated any provision of the U.S. Foreign Corrupt Practices Act of 1977, as amended, or (iv) made any unlawful bribe, rebate, payoff, influence, payment, kickback or other unlawful payment to any foreign or domestic government official or employee.U.S.
(c) The CompanyFortis has made available to FibroGen a true, each complete and correct copy of its Subsidiariesall material Regulatory Materials submitted to any Regulatory Entity by Fortis or in Fortis’ possession. All Regulatory Materials submitted to any Regulatory Entity by Fortis were true and accurate in all material respects as of the date of submission to such Regulatory Entity.
(d) To the extent required by applicable Laws, all preclinical studies and tests and Clinical Trials conducted by Fortis with respect to Products have been, and each if still pending are being, conducted in material compliance with research protocols, GLP, GCP, and all applicable Laws in the U.S., including the FFDCA (or any regulations adopted thereunder), and, with respect to any activities conducted in the EU, the EMA. [*], all preclinical studies and tests and Clinical Trials conducted on behalf of their respective businesses Fortis with respect to Products have been, or if pending, are being and have been operatedconducted in material compliance with research protocols, GLP, GCP, and each service or other product provided by all applicable Laws in the Company U.S., including the FFDCA (or any regulations adopted thereunder), and, with respect to any activities conducted in the EU, the EMA. No preclinical study or test or Clinical Trial conducted by or on behalf of its Subsidiaries (each such service Fortis with respect to Products has been terminated or other productsuspended prior to completion, and no Regulatory Entity or clinical investigator that has participated or is participating in, or institutional review board that has or has had jurisdiction over, a "Company Service") is being and preclinical study or test or Clinical Trial conducted by or on behalf of Fortis with respect to Products has commenced, or, [*], threatened to initiate, any action to place a clinical hold order on, or otherwise terminate or suspend or refuse to commence, any proposed or ongoing investigation or study or Clinical Trial conducted or proposed to be conducted by or on behalf of Fortis with respect to Products. [*] = Certain confidential information contained in this document, marked by brackets, has been developedomitted because it is both (i) not material and (ii) would likely cause competitive harm to the company if publicly disclosed.
(e) Fortis has not received any written notice that any Regulatory Entity, producedor any relevant institutional review board, marketedindependent ethics committee or any other similar body has initiated, distributedor threatened to initiate, testedany action to (i) suspend any Clinical Trial conducted by or on behalf of Fortis, and providedor suspend or terminate any IND sponsored by Fortis or otherwise restrict or delay the preclinical or nonclinical research on or clinical study, in compliance each case, of any Product, or (ii) recall, suspend or otherwise restrict the manufacture of any Product.
(f) Fortis has not received any written notice that any relevant institutional review board or independent ethics committee has refused to approve (i) any Clinical Trial conducted or proposed to be conducted by or on behalf of Fortis or (ii) any substantial amendment to a protocol for any Clinical Trial conducted or proposed to be conducted by or on behalf of Fortis, in each case with respect to any Product.
(g) Fortis is not subject to any investigation that is pending and of which Fortis has been notified in writing or, [*], which has been threatened, in each case by (i) the FDA or (ii) the Department of Health and Human Services Office of Inspector General or Department of Justice pursuant to the Federal Healthcare Program Anti-Kickback Statute (42 U.S.C. §1320a-7b(b)) or the Federal False Claims Act (31 U.S.C. §3729).
(h) Fortis has complied in all material respects with all applicable Laws security and privacy standards regarding healthcare or life sciences matters, including but not limited protected health information relating to the U.S. Federal Food, Drug and Cosmetic Act, the Public Health Service Act, Products under (i) the Health Insurance Portability and Accountability Act of 1996, all applicable rules as amended by the Health Information Technology for Economic and regulations Clinical Health Act of the U.S. Food and Drug Administration ("FDA"), the Drug Enforcement Administration ("DEA") and the U.S. Department of Health and Human Services ("HHS"), and any similar legal provisions in any foreign jurisdiction2009, including the EU Data Protection Directive 95/46/EC and national implementations thereof.
(d) The Company and each of its Subsidiaries possess all Permits required by the FDA, DEA, HHS, and any other applicable Governmental Entity responsible for the regulation of healthcare or life sciences activities (each, a "Healthcare Regulatory Authority"), including all filings, submissions, authorizations, approvals, clearances, registrations, certifications, licenses, permits, and accreditations that are necessary for the Company and its Subsidiaries to conduct their business as presently conducted (each, a "Healthcare Regulatory Permit"). Each of the Healthcare Regulatory Permits is (i) in good standing, valid and enforceable, regulations promulgated thereunder and (ii) in full and timely compliance with all filing, maintenance, and fee requirementsany applicable state privacy laws.
(ei) Except as All manufacturing operations conducted by or for the benefit of Fortis with respect to the Products have been and are being conducted in material compliance with applicable Laws, including, to the extent applicable, GMP.
(j) Neither Fortis nor, [*], any Fortis Personnel or Affiliate has committed any act, made any statement or failed to make any statement that would reasonably be expected to provide a basis for the FDA or any other Regulatory Entity to invoke its policy with respect to “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” or any such similar policies set forth in Section 4.22 of the Company Disclosure Letter, no Healthcare Regulatory Authority or other Person has provided any FDA Form 483, warning letter, untitled letter, Section 305 notice, or any other notice or communication to the Company or any of its Subsidiaries (i) stating that they were or are in violation of any Law or Healthcare Regulatory Permit, or (ii) threatening to revoke, suspend, deem invalid, or refuse to renew any of the Healthcare Regulatory Permits held by the Company or any of its Subsidiaries, nor is the Company or any of its Subsidiaries aware of any facts that could reasonably give rise to such a communication, notice, audit, investigation or inquiry.
(f) The Company and each of its Subsidiaries have cooperated fully with, and have prepared, submitted, and implemented in a timely and complete manner all responses, corrective action plans, and other requirements required to be prepared and submitted by the Company or any of its Subsidiaries in response to all inspections, investigations, audits, examinations, orders, agreements, and Legal Proceedings performed or initiated by any Healthcare Regulatory Authority, or by any client, partner, or contracting party of the Company or any of its Subsidiaries or any Person acting on behalf thereof, other than currently outstanding action plans that are not material pursuant to the ordinary course client audits.
(g) The Company, its Subsidiaries, all laboratory facilities owned, leased, operated, or employed by the Company or its Subsidiaries, and all Company Services are being and have been operated or provided in compliance with, and have not received any notice of violation of, the FDA's current good laboratory practices regulations, the FDA's current good manufacturing practices regulations, the Clinical Laboratory Improvement Amendments of 1988, the FDA's current good clinical practices regulations, the HHS "Common Rule" (45 C.F.R. Part 46), as amended, and all similar applicable Laws. No Healthcare Regulatory Authority has commencedNeither Fortis nor, or threatened to commence[*], any action to reject, terminate, suspend, or place on clinical hold any proposed or ongoing clinical trial (i) conducted by, or on behalf of, the Company or any Company Subsidiary, or (ii) in connection with which any Company Service was utilized.
(h) Neither the Company, any of its Subsidiaries, nor any officer, director, employee or agent of the Company or any of its Subsidiaries, Fortis Personnel has (i) made an untrue statement of a material fact or a fraudulent statement to any Healthcare Regulatory Authority, or failed to disclose a material fact required to be disclosed to any Healthcare Regulatory Authority, (ii) been convicted of any crime or engaged in any conduct for that has resulted, or would reasonably be expected to result, in debarment or exclusion under applicable Laws, including 21 U.S.C. §335a and 42 U.S.C. §1320a-7. No Actions that would reasonably be expected to result in such a debarment or exclusion of Fortis are pending or, [*], threatened, against Fortis or, [*], any Fortis Personnel.
(k) There are no Actions pending with respect to which such Person could be excluded from participating Fortis has been served and, [*], there are no other Actions pending, in the federal health care programs under Section 1128 each case, with respect to an alleged violation by Fortis of the Social Security FFDCA (or any regulations adopted thereunder), the Controlled Substances Act of 19351970, as amended, or any similar Law, (iii) is or has been excluded from participation in other applicable Laws promulgated by any state or federal healthcare program, as defined in 42 USC Section 1320a-7b(f), or (iv) contracted with Regulatory Entity that applies to the regulatory status of any employee, contractor, agent, vendor or vendor's affiliate knowing that the contracting party is excluded from participation in any state or federal healthcare programProduct.
(l) Fortis has not received any warning letter or untitled letter, report of inspectional observations, including FDA Form 483s, establishment inspection reports, notices of violation, clinical holds, enforcement notices or other documents from any Regulatory Entity, or any institutional review board, independent ethics committee or similar body, alleging a lack of compliance by Fortis with any applicable Laws.
(m) Fortis has not marketed, advertised, distributed, sold, or commercialized any Product.
(n) Fortis has made available to FibroGen all material written preclinical, clinical and other experimental data in Fortis’ possession relating to Products or the exploitation thereof relating to activities performed by or on behalf of Fortis, and has not concealed or withheld from FibroGen any such data.
(o) [*], there are no safety, efficacy, or regulatory issues, other than the information that has previously been made available to FibroGen, that would preclude FibroGen or the Surviving Corporation from exploiting the Products in compliance with applicable Laws. [*] = Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) No individual or company for whom the Company or any of its Subsidiaries has conducted research is or has been subject not material and (ii) would likely cause competitive harm to the FDA's Application Integrity Policy, or otherwise is under investigation or has been investigated by any Healthcare Regulatory Authority in any domestic or foreign jurisdiction, with regard to the integrity of data provided by the Company or any of its Subsidiariescompany if publicly disclosed.
Appears in 1 contract
Compliance with Laws; Regulatory Matters. (a) The Company is, and each of its Subsidiaries since January 1, 2011 has been, in material compliance with, and is not in compliance in all material respects with all violation of, any applicable Law and Orders applicable to the Company and its Subsidiaries. Notwithstanding the foregoing, no representation or warranty is made in this Section 4.22 with respect to the conduct of the Business, or the ownership or operation of its properties or assets.
(i) None of the Company or, to the Company’s Knowledge, any of its officers, directors, Employees or agents, including third party contractors (collectively, “Representatives”) has been debarred or suspended from participation in any activities or programs related to pharmaceutical product candidates or pharmaceutical products pursuant to 21 U.S.C. Section 335a (a) compliance with the Exchange Act, to the extent such compliance is covered in Section 4.6 and Section 4.9, or (b) intellectual property and related matters, which are covered in Section 4.17(“Debarred”), (cii) applicable laws with respect to Taxes, which are covered in Section 4.18, (d) ERISA and other employee benefit-related matters, which are covered in Section 4.19, (e) labor law matters, which are covered in Section 4.20, or (f) Environmental Laws, which are covered in Section 4.23.
(b) Without limiting the generality of Section 4.22(a), none of the Company does not employ or is a party to a Contract with any of its Subsidiaries, norperson who is, to the Knowledge of the Company, Debarred and (iii) to the Knowledge of the Company, the Company has not employed or been a party to a Contract with any directorperson who, officerduring the time when such person was employed by the Company, agentwas Debarred.
(c) Each of the product candidates of the Company (including the Key Product Candidate) is, employee among other things, being developed, tested, manufactured and stored, as applicable, by the Company, and to the Knowledge of the Company, by the Representatives, in material compliance with the FDA Act and/or applicable Law, regulations and guidances issued by the FDA and/or other Governmental Bodies, including Governmental Bodies in foreign jurisdictions, as applicable. No product candidate (including the Key Product Candidate) developed, manufactured, tested, or held by the Company has been recalled, withdrawn, suspended or discontinued (whether voluntarily or otherwise). No proceedings (whether completed or pending) seeking the recall, withdrawal, suspension or seizure of any such product candidate or pre-market approvals or marketing authorizations are pending, or to the Knowledge of the Company, threatened, against the Company, nor have any such proceedings been pending at any time.
(d) All reports, documents, claims, notices and other submissions required to be filed, maintained, or furnished to the FDA or other Person acting Governmental Body by the Company have been so filed, maintained or furnished and were complete and correct in all respects on the date filed (or were corrected in or supplemented by a subsequent filing), except for any such reports, documents, claims or notices the failure of which to so file, maintain or furnish would not have a Company Material Adverse Effect.
(e) The Company has made available to Parent each annual report filed by the Company with the FDA and any similar Governmental Body with respect to any product candidates (including the Key Product Candidate) of the Company that is the subject of clinical investigations, if any. The Company has made available to Parent all material information in its possession about adverse drug experiences obtained or otherwise received by the Company from any source, including information derived from clinical investigations, and reports in the scientific literature, and unpublished scientific papers relating to any product candidate (including the Key Product Candidate) manufactured, tested, or held by the Company.
(f) The Company has made available to Parent as of the date hereof (i) complete and correct copies of each investigational new drug application filed with the FDA and each similar regulatory filing made by or on behalf of the Company with any other Governmental Body, including all supplements and amendments thereto with respect to each product candidate (including the Key Product Candidate), in each case, if any (ii) all material correspondence sent to and received from the FDA and similar foreign Governmental Bodies by the Company that concerns or any would reasonably be expected to impact a product candidate (including the Key Product Candidate) of the Company's Subsidiaries has, in if any and (iii) all existing written records relating to all material discussions and all meetings between the course of its actions forCompany and the FDA or similar foreign Governmental Bodies with respect to each product candidate (including the Key Product Candidate), if any.
(g) The clinical trials, animal studies and other preclinical tests that have been and are being conducted by, or on behalf of, the Company, if any, have been and are being conducted in all material respects in accordance with all applicable Law, regulations and requirements of the FDA and similar foreign Governmental Bodies. The Company has not received any written notice from the FDA or any other Governmental Body requiring the termination or suspension or material modification of any animal study, preclinical study or clinical trial being conducted by or on behalf of the Company. Neither the FDA nor any other applicable Governmental Body nor any clinical investigator that has participated or is participating in, or institutional review board that has or has had jurisdiction over, a clinical trial conducted by or on behalf of the Company Subsidiary has commenced or, to the Knowledge of the Company, threatened in writing to initiate, any action to place a clinical hold order on, or otherwise terminate, delay, suspend or materially restrict, any proposed or ongoing clinical trial conducted or proposed to be conducted by or on behalf of the Company in respect of any product candidate (including the Key Product Candidate). Schedule 4.18(g) lists all clinical trial investigatory sites with respect to the Key Product Candidate, identifying as to each such site whether the Company has conducted a regulatory and quality assessment and audit of such site. Each such site has been, and is in material compliance with applicable Law, regulations, and requirements of the FDA or similar foreign Governmental Body.
(h) Schedule 4.18(h) lists all pharmaceutical investigational product manufacturing sites with respect to the Key Product Candidate. Each site has been, and is in compliance with applicable Law, regulations, and requirements of the FDA or similar foreign Governmental Body, and has not received any 483s or other notices of violations issued by the FDA, or other Governmental Body. The Company is not a party to any corporate integrity agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with, or imposed by, any Governmental Body.
(i) used any corporate funds for any unlawful contributionThe Company has not, gift, entertainment or other unlawful expenses relating and to political activity, (ii) made any direct or indirect unlawful payment to any foreign or domestic government official or employee from corporate funds, (iii) violated any provision the Knowledge of the U.S. Foreign Corrupt Practices Act Company, none of 1977its Representatives, as amendedhas committed an act, made a statement, or failed to make a statement that, would reasonably be expected to provide a basis for the FDA to invoke its policy respecting “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy set forth in 56 Fed. Reg. 46191 (ivSeptember 10, 1991) made and any unlawful bribeamendments thereto (the “FDA Ethics Policy”). The Company is not the subject of any pending or, rebateto the Knowledge of the Company, payoff, influence, payment, kickback or other unlawful payment threatened investigation pursuant to any foreign or domestic government official or employeethe FDA Ethics Policy.
(cj) The Company, each of its SubsidiariesCompany is in compliance with, and each of their respective businesses are being and have been operatedsince January 1, and each service or other product provided by the Company or any of its Subsidiaries (each such service or other product, a "Company Service") is being and 2011 has been developed, produced, marketed, distributed, tested, and providedcomplied with, in compliance with all material respects, all applicable Laws security and privacy standards regarding healthcare or life sciences matters, including but not limited to the U.S. Federal Food, Drug and Cosmetic Act, the Public Health Service Act, protected health information under (i) the Health Insurance Portability and Accountability Act of 1996, all as amended by the Health Information Technology for Economic and Clinical Health Act of 2009, including the regulations promulgated thereunder and (ii) any applicable rules state privacy Laws.
(k) To the Knowledge of the Company, there are no investigations, lawsuits, or regulatory proceedings, pending or threatened, brought by or before the FDA, the Centers for Medicare and regulations Medicaid Services, the U.S. Office of Inspector General of the U.S. Food Health and Drug Administration ("FDA")Human Services, the Drug Enforcement Administration ("DEA") and or the U.S. Department of Health and Human Services ("HHS")Justice in which the Company is or will be made the defendant or respondent, and nor are there any similar legal provisions adverse judgments, decrees, or orders, currently in any foreign jurisdiction, including effect that have been issued by such Governmental Bodies against the EU Data Protection Directive 95/46/EC and national implementations thereofCompany.
(dl) The Company and each of its Subsidiaries possess all Permits required by the FDA, DEA, HHS, and any other applicable Governmental Entity responsible for the regulation of healthcare or life sciences activities (each, a "Healthcare Regulatory Authority"), including all filings, submissions, authorizations, approvals, clearances, registrations, certifications, licenses, permits, and accreditations that are necessary for the Company and its Subsidiaries to conduct their business as presently conducted (each, a "Healthcare Regulatory Permit"). Each of the Healthcare Regulatory Permits is does not participate in (i) Medicare (42 U.S.C. §1395 et seq.), (ii) Medicaid (42 U.S.C. § 1396 et seq.), or other governmental payment program; and no income or revenue of the Company is derived from any of the foregoing.
(m) The Company is in good standingmaterial compliance with, valid and enforceablesince January 1, 2011 has complied with, in all material respects, all applicable Laws of all Governmental Bodies, or any self-regulating organization, regarding privacy, security and/or data protection (collectively, “Privacy Laws”). The Company has maintained, enforced and complied with in all material respects written privacy, security and data protection policies (the “Privacy Policies”) with respect to any Proprietary Information providing for, without limitation: (i) clear and conspicuous disclosure of the Company’s privacy, security and data protection practices, including collection, storage, use and disclosure of, and provision of access and corrections to any Proprietary Information, and (ii) in full and timely compliance with all filingprotection from loss, maintenancemisappropriation, disclosure or corruption of, and fee requirements.
(e) Except as set forth in Section 4.22 of unauthorized access to any Proprietary Information. Neither this Agreement nor the Company Disclosure Letter, no Healthcare Regulatory Authority Transactions violate or other Person has provided any FDA Form 483, warning letter, untitled letter, Section 305 notice, or any other notice or communication to will violate the Company or any of its Subsidiaries (i) stating that they were or are in violation terms and conditions of any Law Privacy Policies, any applicable Privacy Laws or Healthcare Regulatory Permit, or (ii) threatening to revoke, suspend, deem invalid, or refuse to renew any of the Healthcare Regulatory Permits held by the Company or any of its Subsidiaries, nor is the Company or any of its Subsidiaries aware privacy rights of any facts that could reasonably give rise to such a communication, notice, audit, investigation or inquiry.
(f) The Company and each Person. To the Knowledge of its Subsidiaries have cooperated fully with, and have prepared, submitted, and implemented in a timely and complete manner all responses, corrective action plans, and other requirements required to be prepared and submitted by the Company or any of its Subsidiaries in response to all inspections, investigations, audits, examinations, orders, agreements, and Legal Proceedings performed or initiated by any Healthcare Regulatory Authority, or by any client, partner, or contracting party of the Company or any of its Subsidiaries or any Person acting on behalf thereof, other than currently outstanding action plans that are not material pursuant to the ordinary course client audits.
(g) The Company, its Subsidiaries, all laboratory facilities owned, leased, operated, or employed by the Company or its Subsidiaries, and all Company Services are being and have been operated or provided in compliance with, and have not received any notice of violation of, the FDA's current good laboratory practices regulations, the FDA's current good manufacturing practices regulations, the Clinical Laboratory Improvement Amendments of 1988, the FDA's current good clinical practices regulations, the HHS "Common Rule" (45 C.F.R. Part 46), as amended, and all similar Laws. No Healthcare Regulatory Authority has commenced, or threatened to commence, any action to reject, terminate, suspend, or place on clinical hold any proposed or ongoing clinical trial (i) conducted by, or on behalf of, the Company or any Company Subsidiary, or (ii) in connection with which any Company Service was utilized.
(h) Neither the Company, any of its Subsidiaries, nor any officer, director, employee or agent of the Company or any of its Subsidiaries, has (i) made an untrue statement of a material fact or a fraudulent statement to any Healthcare Regulatory Authority, or failed to disclose a material fact required to be disclosed to any Healthcare Regulatory Authority, (ii) been convicted of any crime or engaged in any conduct for which such Person could be excluded from participating in the federal health care programs under Section 1128 of the Social Security Act of 1935, as amended, or any similar Law, (iii) is or has been excluded from participation in any state or federal healthcare program, as defined in 42 USC Section 1320a-7b(f), or (iv) contracted with any employee, contractor, agent, vendor or vendor's affiliate knowing that the contracting party is excluded from participation in any state or federal healthcare program.
(i) No individual or company for whom the Company or any of its Subsidiaries has conducted research is or no Proprietary Information has been subject to the FDA's Application Integrity Policyany breach, misappropriation, unauthorized disclosure, or otherwise is under investigation unauthorized access or has been investigated use by any Healthcare Regulatory Authority in any domestic or foreign jurisdiction, with regard to the integrity of data provided by the Company or any of its SubsidiariesPerson.
Appears in 1 contract
