Common use of Compliance with Laws; Regulatory Matters Clause in Contracts

Compliance with Laws; Regulatory Matters. 4.6.1. The Company is not in breach or violation of, or default under, its Constitutive Documents. The Company is, and 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 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 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 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 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 activities conducted outside the U.S., the Applicable Laws in such jurisdiction. As of the date hereof, the Company has not received written notice of and, 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 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 Institution, or (ii) initiated, or threatened to initiate, any action to suspend any clinical study conducted by or on behalf of the Company or any Institution, as applicable, or suspend or terminate any 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 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 federal, state, local, or foreign Governmental Authority alleging that the Company, or any Institution as relates to the Products, is in violation in any material respect of any Applicable Law, including the FD&C Act, the PHSA or any similar state, local or foreign equivalents to any of the foregoing. 4.6.7. The Company, and to the knowledge of the Company, each Institution in relation to the Company and the Products, has complied in all material respects with all applicable security and privacy standards regarding protected health information and personal data under (i) the Health Insurance Portability and Accountability Act of 1996, as amended by the Health Information Technology for Economic and Clinical Health Act of 2009, 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 Regulation) and all national implementing legislation thereof, and (iii) any applicable national, state, provincial or local privacy laws. 4.6.8. Neither the Company nor, to the knowledge of the Company, any Company Personnel or Affiliate has (i) made any materially false statement on, or material omission from, any notifications, applications, approvals, reports and other submission to any Governmental Authority or in any material legal proceeding; or (ii) committed any act, made any statement or failed to make any statement that would reasonably be expected to provide a basis for the FDA to invoke its policy with respect to “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” or for the FDA or any 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 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 the Company are pending or, to the knowledge of the 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 relates 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 body, alleging a lack of compliance with any Applicable Laws. The Company 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 knowledge of the Company, each Institution, has not marketed, advertised, distributed (for commercialization purposes), sold, or commercialized any Product. 4.6.11. The Company has provided or made available to Buyer true, complete and correct copies of all adverse information with respect to the 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 in the Company’s possession relating to the Products or the exploitation thereof 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, 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.

Compliance with Laws; Regulatory Matters. 4.6.1. The Company is not in breach or violation of, or default under, its Constitutive Documents. The Company (a) Each Seller is, and since its formation during the past two (2) years has been, in compliance in all material compliance respects with all Applicable Laws and Judgments of any Governmental Authority each Law that is or was applicable to it or to the conduct by such Seller of the Company of its businessBusiness, or the ownership or use of any of its assets and propertiesincluded in the Purchased Assets. To the Knowledge of Sellers, 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 no event has occurred nor does or circumstance related to or affecting the Business exists that (with or without the lapse of time) (i) would constitute or result in a violation by any circumstance exist that Seller, or a failure on the part of any Seller, to comply in any material respect with any Law, or (ii) would reasonably be expected to give rise to an any obligation on the part of the Company any Seller to undertake, or to bear all or any portion of the cost of, any material remedial action of any nature. 4.6.2(b) The Governmental Permits include all necessary and applicable material permits, approvals, clearances, authorizations, licenses and registrations required by any Governmental Authority to be held by the Sellers to permit the manufacture, labeling, sale, distribution and promotion of the Business Products in jurisdictions where the Sellers currently conduct such activities (the “Activities to Date”) with respect to each Business Product, or that are otherwise required to entitle the Sellers to own or lease, operate and use the Purchased Assets and conduct the Business as presently conducted. Subject to Section 6.13, Schedule 3.6(b) hereto sets forth a complete and correct list of all material Governmental Permits held by the Sellers for use primarily in the Business, true and complete copies of which have been made available to the Purchasers. The Products Sellers are currently in compliance in all material respects with (i) all terms and conditions of each Governmental Permit, and (ii) all applicable Laws regarding registration, license, certification for each site at all times have been researched, developed, testedwhich a Business Product is manufactured, labeled, manufacturedsold, storedor distributed. To the Knowledge of Sellers, importedsubject to Section 6.13, exported, promoted, marketed, sold and distributed, as applicable, by the Company, and all material Governmental Permits are freely assignable or transferable to the knowledge of the CompanyPurchasers, on behalf of the Company and without notice to, or approval or consent of, any Governmental Authority. All manufacturing operations performed by or on behalf of any Representative the Business have been during the past two (2) years and are being conducted in all material respects in compliance with the Quality System Regulations of the CompanyFDA and, to the extent applicable to the Sellers, material compliance with counterpart regulations in the European Union and all other countries where the Business Products are marketed and such compliance is required. The Sellers are in compliance in all material respects with all 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 applicable reporting requirements for all Governmental Authorities; and any regulations adopted by Regulatory Authorities thereunder (including, as applicable, those requirements relating to cGMP, GLP, GCP, investigational use, and pre-market approval)Permits. 4.6.3. (c) The Company, and to the knowledge of the Company, each Institution, has generated, prepared, maintained and retained all material information, data and biological materials that Sellers 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 activities conducted outside the U.S., the Applicable Laws in such jurisdiction. As of the date hereof, the Company has not received written notice of and, 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 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 Institution, or (ii) initiated, or threatened to initiate, any action to suspend any clinical study conducted by or on behalf of the Company or any Institution, as applicable, or suspend or terminate any 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 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 federal, state, local, or foreign Governmental Authority alleging that the Company, or any Institution as relates to the Products, is in violation in any material respect of any Applicable Law, including the FD&C Act, the PHSA or any similar state, local or foreign equivalents to any of the foregoing. 4.6.7. The Company, and to the knowledge of the Company, each Institution in relation to the Company and the Products, has complied in all material respects with all FDA and non-United States equivalent agencies and similar state and local Laws applicable security to the maintenance, compilation and privacy standards regarding protected health information and personal data under (i) the Health Insurance Portability and Accountability Act filing of 1996, as amended by the Health Information Technology for Economic and Clinical Health Act of 2009reports, including the regulations promulgated thereunderadverse event reports, (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 Business Products. Schedule 3.6(c) hereto sets forth, as of personal data and on the free movement date of this Agreement, a list of all medical device reports (as such data (the General Data Protection Regulationterm is used in 21 C.F.R. Part 803) and all national implementing legislation thereof, and (iii) any applicable national, state, provincial equivalent reports filed or local privacy laws. 4.6.8. Neither the Company nor, to the knowledge of the Company, any Company Personnel or Affiliate has (i) made any materially false statement on, or material omission from, any notifications, applications, approvals, reports and other submission to any Governmental Authority or in any material legal proceeding; or (ii) committed any act, made any statement or failed to make any statement that would reasonably be expected to provide a basis for submitted with the FDA to invoke its policy and all non-United States equivalent agencies with respect to “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” or for the Business Products. (d) The Sellers have not received any written communication from the FDA or any other Governmental Authority to invoke any similar policy. Neither (i) contesting the Company nor any Company Personnel has been convicted pre-market clearance or approval of, or the labeling and promotion of any crime or engaged in any conduct that has resultedBusiness Products, or would reasonably be expected (ii) otherwise alleging any material violation of any Laws by the Sellers related 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 the operation of the Company are pending Business. (e) There have been no recalls, field notifications or seizures ordered or adverse regulatory actions taken (or, to the knowledge Knowledge of the CompanySellers, threatened) by the FDA or any other Governmental Authority with respect to any Business Products, against including any facilities where any Business Products are produced, processed, packaged or stored, and within the Company orfive (5) years preceding the date hereof the Sellers have not, either voluntarily or at the request of any Governmental Authority, initiated or participated in a recall of any Business Product. (f) To the Knowledge of the Sellers, all filings with and submissions to the knowledge FDA and any similar Governmental Authority made by the Sellers with regard to the Business Products, whether oral, written or electronically delivered, were true, accurate and complete in all material respects as of the Company, any Company Personnel. 4.6.9. The Companydate made, and, to the knowledge extent required to be updated, have been updated to be true, accurate and complete in all material respects as of the Companydate of such update. (g) No Seller nor any of its directors, each Institution as relates officers or employees, nor, to the ProductsKnowledge of the Sellers, has not received any warning letter or untitled letterof Sellers’ agents, 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 Authoritydistributors, or any institutional review board, independent ethics committee other Person associated with or similar body, alleging a lack of compliance with any Applicable Laws. The Company 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 knowledge of the Company, each Institution, has not marketed, advertised, distributed (for commercialization purposes), sold, or commercialized any Product. 4.6.11. The Company has provided or made available to Buyer true, complete and correct copies of all adverse information with respect to the 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 acting on behalf of any InstitutionSeller has, in connection with the operation of the Business (i) violated or is in violation of any provision of the U.S. Foreign Corrupt Practices Act of 1977 (the “FCPA”), (ii) violated or is in violation of 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 (iii) made, offered to make, promised to make or authorized the payment or giving of, directly or indirectly, any bribe, rebate, payoff, 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 jurisdiction (any such payment, a “Prohibited Payment”). 4.6.12. The Company (h) No Seller nor, to the Knowledge of the Sellers, any of its directors, officers, agents, employees or Affiliates has provided Buyer been subject to any investigation by any Governmental Authority with regard to any Prohibited Payment made, or alleged to have been made, in connection with the opportunity to review all written preclinical (including research), clinical and other material experimental data in the Company’s possession relating to the Products or the exploitation thereof relating to activities performed by or on behalf operation of the Company, and to the knowledge of the Company, by or on behalf of any Institution, and has not intentionally concealed from Buyer any such dataBusiness. 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.

Compliance with Laws; Regulatory Matters. 4.6.1. The Company is not (a) Except as set forth in breach or violation ofSchedule 5.8(a) hereto, or default under, its Constitutive Documents. The the Company is, and since its formation January 1, 2015 has been, in compliance in all material compliance respects with all Applicable Laws and Judgments of any Governmental Authority 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 Assets and propertiesProperties, including the Leased Properties. The Company has not receivedFederal Food, since its formationDrug, a written orand Cosmetic Act, to its knowledgethe Public Health Service Act, oral notice or other communication alleging a material violation by and the Company of any Applicable Law of any Governmental Authority Animal Welfare Act, as applicable, and their applicable to its businesses or operationsimplementing regulations. No event has occurred nor does 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 circumstance exist that material respects with any Law, or (ii) would reasonably be expected to give rise to an any obligation on the part of the Company to undertake, undertake or to bear all or any portion of the cost of, any material remedial action of any nature. 4.6.2(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 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 Products are currently 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 all times which a Company Product is manufactured and labeled. All manufacturing operations performed by or on behalf of the Company have been researchedand 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, developed, tested, labeled, manufactured, stored, imported, exported, promoted, marketed, sold and distributed, as applicable, by the Company211, 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 applicable reporting requirements for all Permits held by it. (c) All preclinical studies, and other studies and tests conducted by or, to the knowledge of the Company, on behalf of the Company have been, and by or on behalf of any Representative of the Companyif still pending are being, conducted in material compliance in with research protocols and all material respects with all Applicable applicable Laws, including the FD&C Act; Good Laboratory Practice (cGLP) regulations of 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 any regulations adopted by Regulatory Authorities thereunder (including, as applicable, those requirements relating to cGMP, GLP, GCP, investigational useFDA at 21 C.F.R. Part 58, and pre-market approval)the Animal Welfare Act and similar foreign laws, if applicable. 4.6.3. The Company, and to the 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, (d) Except as applicable, with respect to Products pursuant to, and materially set forth in accordance with, GCP, GLP, cGMP and other Applicable Laws in the U.S. and, with respect to any activities conducted outside the U.S., the Applicable Laws in such jurisdiction. As of the date hereofSchedule 5.8(d) hereto, the Company has not received any written notice of and, to the knowledge of the Company, as of the date hereof the Company has not received any or other notice of, any pending or threatened Action written communication from the FDA or any other Regulatory Authority or Governmental Authority alleging that any operation or activity of the Company is in violation of any Laws by the FD&C Act, the PHSA or any analogous Applicable Laws promulgated by applicable Governmental Authorities outside the U.S. 4.6.4Company. The Company has made available to Buyer a complete and correct copy of all Regulatory Filings submitted 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 by with respect to a violation of Law, and, to the Company or in the Company’s possession. All Regulatory Filings submitted to any Regulatory Authority by or on behalf Knowledge of the Company, no such proceedings have been threatened. (e) All filings with and submissions to the knowledge of FDA and any similar Regulatory Authority made by the CompanyCompany with regard to the Company Products, each Institutionwhether written or electronically delivered, were true true, accurate and correct complete 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 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, respects as of the date hereofmade, 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 Institution, or (ii) initiated, or threatened to initiate, any action to suspend any clinical study conducted by or on behalf of the Company or any Institution, as applicable, or suspend or terminate any 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 any Product. 4.6.6. As of the date hereof, neither the Company norand, to the knowledge of the Companyextent required to be updated, any Institutionhave been updated to be true, has received notice of any pending or threatened investigation or Action from the FDA, the U.S. Department of Health accurate and Human Services Office of Inspector General, the U.S. Department of Justice, or any other federal, state, local, or foreign Governmental Authority alleging that the Company, or any Institution as relates to the Products, is in violation in any material respect of any Applicable Law, including the FD&C Act, the PHSA or any similar state, local or foreign equivalents to any of the foregoing. 4.6.7. The Company, and to the knowledge of the Company, each Institution in relation to the Company and the Products, has complied complete in all material respects with all applicable security and privacy standards regarding protected health information and personal data under (i) the Health Insurance Portability and Accountability Act of 1996, as amended by the Health Information Technology for Economic and Clinical Health Act of 2009, 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 date of such data (the General Data Protection Regulation) and all national implementing legislation thereof, and (iii) any applicable national, state, provincial or local privacy lawsupdate. 4.6.8. (f) Neither the Company nor, to the knowledge Knowledge of the Company, any Company Personnel of its officers, employees or Affiliate has (i) made any materially false statement on, or material omission from, any notifications, applications, approvals, reports and other submission to any Governmental Authority or in any material legal proceeding; or (ii) committed any act, made any statement or failed to make any statement that would reasonably be expected to provide a basis for the FDA to invoke its policy with respect to “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” or for the FDA or any other Governmental Authority to invoke any similar policy. Neither the Company nor any Company Personnel agents has been convicted of any crime or engaged in any conduct that has resulted, or would reasonably be expected to result, in debarment or exclusion under Applicable Lawsapplicable Law, including 21 U.S.C. §335a and 42 U.S.C. §1320a-7Section 335a. No Actions claims, actions, proceedings or investigations that would reasonably be expected to result in such a debarment or exclusion of the Company are pending or, to the knowledge Knowledge of the Company, threatened, threatened against the Company oror any of its respective officers, to the knowledge of the Company, any Company Personnelemployees or agents. 4.6.9. The Company(g) Neither the Company nor any of its directors, andofficers, to the knowledge of the Companyemployees, each Institution as relates to the Productsagents, 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 Authoritydistributors, or any institutional review board, independent ethics committee other Person associated with or similar body, alleging a lack of compliance with any Applicable Laws. The Company 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 knowledge of the Company, each Institution, has not marketed, advertised, distributed (for commercialization purposes), sold, or commercialized any Product. 4.6.11. The Company has provided or made available to Buyer true, complete and correct copies of all adverse information with respect to the safety and efficacy of Products relating to activities performed by or acting on behalf of the CompanyCompany is in violation of, and or since January 1, 2013 has (i) violated any provision of the U.S. Foreign Corrupt Practices Act of 1977 (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 (ii) made, offered to make, promised to make or authorized the knowledge payment or giving of, directly or indirectly, any bribe, rebate, payoff, 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 jurisdiction (any such payment, a “Prohibited Payment”). Since January 1, 2013, neither the Company, by or on behalf of any Institution. 4.6.12. The Company has provided Buyer with the opportunity nor to review all written preclinical (including research), clinical and other material experimental data in the Company’s possession relating Knowledge, any of its respective directors, officers, agents, employees, Subsidiaries or Affiliates has been subject to the Products or the exploitation thereof relating any investigation by any Governmental Entity with regard to activities performed by or on behalf of the Company, and to the knowledge of the Company, by or on behalf of any Institution, and has not intentionally concealed from Buyer any such dataProhibited Payment. 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.

Compliance with Laws; Regulatory Matters. 4.6.1. The Company is not in breach or violation of, or default under, its Constitutive Documents. The Company (a) Fortis is, and since its formation in the [*] has been, in material compliance with all Applicable applicable Laws and Judgments of any Governmental Authority Entity applicable to it or to the conduct by the Company Fortis of its business, or the ownership or use of any of its assets and properties, including the Leased Properties. The Company Fortis has not received, since its formationincorporation, a written or, to its knowledge, oral notice or other communication alleging a possible material violation by the Company Fortis of any Applicable applicable Law or Judgment of any Governmental Authority Entity applicable to its businesses or operations. No event [*] = Certain confidential information contained in this document, marked by brackets, has occurred nor does any circumstance exist that been omitted because it is both (i) not material and (ii) would reasonably be expected likely cause competitive harm 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.company if publicly disclosed. 129433662_24 4.6.2. (b) The Products are currently and at all times have been researched, developed, tested, labeled, manufactured, and 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, Fortis in compliance in all material respects with all Applicable Lawsapplicable Laws in the U.S., 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 FFDCA or local Governmental Authorities; and any regulations adopted thereunder by any Regulatory Authorities thereunder Entity (including, as applicable, those requirements relating to cGMPthe FDA’s current GMP, GLP, and GCP), investigational useand, and pre-market approval). 4.6.3with respect to any activities conducted in the EU, the EMA. The Company, and to the knowledge of the Company, each Institution, Fortis 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, Fortis with respect to Products pursuant to, and materially in accordance in all material respects with, GCP, GLP, cGMP GMP and other Applicable Laws in the U.S. and, with respect to any activities conducted outside the U.S., the Applicable Laws in such jurisdictionapplicable Laws. As of the date hereof, the Company Fortis has not received written or, [*], oral notice of and, 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 Entity alleging that any operation or activity of the Company Fortis is in violation of the FD&C Act, the PHSA FFDCA or any analogous Applicable applicable Laws promulgated by applicable Governmental Authorities Entities outside the U.S. 4.6.4. The Company (c) Fortis has made available to Buyer FibroGen a true, complete and correct copy of all material Regulatory Filings Materials submitted to any Regulatory Authority Entity by the Company Fortis or in the Company’s Fortis’ possession. All Regulatory Filings Materials submitted to any Regulatory Authority Entity by or on behalf of the Company, and to the knowledge of the Company, each Institution, Fortis were true and correct accurate in all material respectsrespects as of the date of submission to such Regulatory Entity. 4.6.5. All (d) To the extent required by applicable Laws, all preclinical research, clinical studies, and other studies and tests and Clinical Trials conducted by or on behalf of the Company, and to the knowledge of the Company, by or on behalf of each Institution Fortis with respect to ProductsProducts have been, have been conductedand if still pending are being, as applicable, conducted in material compliance with research protocols, GLP, GCP, and all Applicable Lawsapplicable Laws in the U.S., including the FD&C Act FFDCA (and 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 Fortis with respect to Products have been, or if 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. No preclinical research, clinical study or other study or test or Clinical Trial conducted by or on behalf of the Company, and to the knowledge of the Company, by or on behalf of each Institution, Fortis with respect to the Products has been terminated or suspended prior to completion. The Company, 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 preclinical study or test or Clinical Trial conducted by or on behalf of Fortis with respect to the knowledge 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 the Company, each Institution, Fortis with respect to Products. (e) Fortis has not, as of the date hereof, not received any written notice that any Regulatory Authority, investigatorEntity, 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 Institution, or (ii) initiated, or threatened to initiate, any action to (i) suspend any clinical study Clinical Trial conducted by or on behalf of the Company or any Institution, as applicableFortis, or suspend or terminate any IND sponsored by the Company or any Institution, as applicable, Fortis or otherwise restrict or delay the preclinical or nonclinical research on or clinical study study, in each case, of any Product, or (ii) recall, suspend or otherwise restrict the manufacture of any Product. 4.6.6. As (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 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 date hereof, neither FDA or (ii) 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. General or Department of Justice, or any other federal, state, local, or foreign Governmental Authority alleging that the Company, or any Institution as relates Justice pursuant to the Products, is in violation in any material respect of any Applicable Law, including Federal Healthcare Program Anti-Kickback Statute (42 U.S.C. §1320a-7b(b)) or the FD&C Act, the PHSA or any similar state, local or foreign equivalents to any of the foregoingFederal False Claims Act (31 U.S.C. §3729). 4.6.7. The Company, and to the knowledge of the Company, each Institution in relation to the Company and the Products, (h) Fortis has complied in all material respects with all applicable security and privacy standards regarding protected health information and personal data relating to the Products under (i) the Health Insurance Portability and Accountability Act of 1996, as amended by the Health Information Technology for Economic and Clinical Health Act of 2009, including the regulations promulgated thereunder, thereunder and (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 Regulation) and all national implementing legislation thereof, and (iii) any applicable national, state, provincial or local state privacy laws. 4.6.8. Neither (i) All manufacturing operations conducted by or for the Company norbenefit of Fortis with respect to the Products have been and are being conducted in material compliance with applicable Laws, including, to the knowledge of 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 Companycompany if publicly disclosed. 129433662_24 (j) Neither Fortis nor, [*], any Company Fortis Personnel or Affiliate has (i) made any materially false statement on, or material omission from, any notifications, applications, approvals, reports and other submission to any Governmental Authority or in any material legal proceeding; or (ii) 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 for the FDA or any other Governmental Authority to invoke such similar policies set forth in any similar policyapplicable Laws. Neither the Company nor Fortis nor, [*], any Company Fortis Personnel has been convicted of any crime or engaged in any conduct that has resulted, or would reasonably be expected to result, in debarment or exclusion under Applicable 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 the Company Fortis are pending or, to the knowledge of the Company[*], threatened, against the Company Fortis or, to the knowledge of the Company[*], any Company Fortis Personnel. 4.6.9. The Company, (k) There are no Actions pending with respect to which Fortis has been served and, [*], there are no other Actions pending, in each case, with respect to an alleged violation by Fortis of the FFDCA (or any regulations adopted thereunder), the Controlled Substances Act of 1970, as amended, or any other applicable Laws promulgated by any Regulatory Entity that applies to the knowledge regulatory status of the Company, each Institution as relates to the Products, any Product. (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 or notifications from any Regulatory Authority or other Governmental AuthorityEntity, or any institutional review board, independent ethics committee or similar body, alleging a lack of compliance by Fortis with any Applicable applicable Laws. The Company 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 knowledge of the Company, each Institution, (m) Fortis has not marketed, advertised, distributed (for commercialization purposes)distributed, sold, or commercialized any Product. 4.6.11. The Company (n) Fortis has provided or made available to Buyer true, complete and correct copies of FibroGen all adverse information with respect to the 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 material written preclinical (including research)preclinical, clinical and other material experimental data in the Company’s Fortis’ possession relating to the Products or the exploitation thereof relating to activities performed by or on behalf of the Company, and to the knowledge of the Company, by or on behalf of any InstitutionFortis, and has not intentionally concealed or withheld from Buyer FibroGen any such data. 4.6.13. To the Company’s knowledge(o) [*], there are no safety, efficacy, or regulatory issues issues, other than the information that has previously been made available to FibroGen, that would materially preclude Buyer FibroGen or the Surviving Corporation from exploiting the Products in compliance with Applicable applicable Laws.

Compliance with Laws; Regulatory Matters. 4.6.1. The Company is not in breach or violation of, or default under, its Constitutive Documents. The Company (a) Fortis is, and since its formation in the [*] has been, in material compliance with all Applicable applicable Laws and Judgments of any Governmental Authority Entity applicable to it or to the conduct by the Company Fortis of its business, or the ownership or use of any of its assets and properties, including the Leased Properties. The Company Fortis has not received, since its formationincorporation, a written or, to its knowledge, oral notice or other communication alleging a possible material violation by the Company Fortis of any Applicable applicable Law or Judgment of any Governmental Authority Entity 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. (b) The Products are currently and at all times have been researched, developed, tested, labeled, manufactured, and 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, Fortis in compliance in all material respects with all Applicable Lawsapplicable Laws in the U.S., 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 FFDCA or local Governmental Authorities; and any regulations adopted thereunder by any Regulatory Authorities thereunder Entity (including, as applicable, those requirements relating to cGMPthe FDA’s current GMP, GLP, and GCP), investigational useand, and pre-market approval). 4.6.3with respect to any activities conducted in the EU, the EMA. The Company, and to the knowledge of the Company, each Institution, Fortis 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, Fortis with respect to Products pursuant to, and materially in accordance in all material respects with, GCP, GLP, cGMP GMP and other Applicable Laws in the U.S. and, with respect to any activities conducted outside the U.S., the Applicable Laws in such jurisdictionapplicable Laws. As of the date hereof, the Company Fortis has not received written or, [*], oral notice of and, 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 Entity alleging that any operation or activity of the Company Fortis is in violation of the FD&C Act, the PHSA FFDCA or any analogous Applicable applicable Laws promulgated by applicable Governmental Authorities Entities outside the U.S. 4.6.4. The Company (c) Fortis has made available to Buyer FibroGen a true, complete and correct copy of all material Regulatory Filings Materials submitted to any Regulatory Authority Entity by the Company Fortis or in the Company’s Fortis’ possession. All Regulatory Filings Materials submitted to any Regulatory Authority Entity by or on behalf of the Company, and to the knowledge of the Company, each Institution, Fortis were true and correct accurate in all material respectsrespects as of the date of submission to such Regulatory Entity. 4.6.5. All (d) To the extent required by applicable Laws, all preclinical research, clinical studies, and other studies and tests and Clinical Trials conducted by or on behalf of the Company, and to the knowledge of the Company, by or on behalf of each Institution Fortis with respect to ProductsProducts have been, have been conductedand if still pending are being, as applicable, conducted in material compliance with research protocols, GLP, GCP, and all Applicable Lawsapplicable Laws in the U.S., including the FD&C Act FFDCA (and 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 Fortis with respect to Products have been, or if 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. No preclinical research, clinical study or other study or test or Clinical Trial conducted by or on behalf of the Company, and to the knowledge of the Company, by or on behalf of each Institution, Fortis with respect to the Products has been terminated or suspended prior to completion. The Company, 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 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 omitted because it is both (i) not material and (ii) would likely cause competitive harm to the knowledge of the Company, each Institution, company if publicly disclosed. (e) Fortis has not, as of the date hereof, not received any written notice that any Regulatory Authority, investigatorEntity, 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 Institution, or (ii) initiated, or threatened to initiate, any action to (i) suspend any clinical study Clinical Trial conducted by or on behalf of the Company or any Institution, as applicableFortis, or suspend or terminate any IND sponsored by the Company or any Institution, as applicable, Fortis or otherwise restrict or delay the preclinical or nonclinical research on or clinical study study, in each case, of any Product, or (ii) recall, suspend or otherwise restrict the manufacture of any Product. 4.6.6. As (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 date hereof, neither FDA or (ii) 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. General or Department of Justice, or any other federal, state, local, or foreign Governmental Authority alleging that the Company, or any Institution as relates Justice pursuant to the Products, is in violation in any material respect of any Applicable Law, including Federal Healthcare Program Anti-Kickback Statute (42 U.S.C. §1320a-7b(b)) or the FD&C Act, the PHSA or any similar state, local or foreign equivalents to any of the foregoingFederal False Claims Act (31 U.S.C. §3729). 4.6.7. The Company, and to the knowledge of the Company, each Institution in relation to the Company and the Products, (h) Fortis has complied in all material respects with all applicable security and privacy standards regarding protected health information and personal data relating to the Products under (i) the Health Insurance Portability and Accountability Act of 1996, as amended by the Health Information Technology for Economic and Clinical Health Act of 2009, including the regulations promulgated thereunder, thereunder and (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 Regulation) and all national implementing legislation thereof, and (iii) any applicable national, state, provincial or local state privacy laws. 4.6.8. Neither (i) All manufacturing operations conducted by or for the Company norbenefit of Fortis with respect to the Products have been and are being conducted in material compliance with applicable Laws, including, to the knowledge of the Companyextent applicable, GMP. (j) Neither Fortis nor, [*], any Company Fortis Personnel or Affiliate has (i) made any materially false statement on, or material omission from, any notifications, applications, approvals, reports and other submission to any Governmental Authority or in any material legal proceeding; or (ii) 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 for the FDA or any other Governmental Authority to invoke such similar policies set forth in any similar policyapplicable Laws. Neither the Company nor Fortis nor, [*], any Company Fortis Personnel has been convicted of any crime or engaged in any conduct that has resulted, or would reasonably be expected to result, in debarment or exclusion under Applicable 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 the Company Fortis are pending or, to the knowledge of the Company[*], threatened, against the Company Fortis or, to the knowledge of the Company[*], any Company Fortis Personnel. 4.6.9. The Company, (k) There are no Actions pending with respect to which Fortis has been served and, [*], there are no other Actions pending, in each case, with respect to an alleged violation by Fortis of the FFDCA (or any regulations adopted thereunder), the Controlled Substances Act of 1970, as amended, or any other applicable Laws promulgated by any Regulatory Entity that applies to the knowledge regulatory status of the Company, each Institution as relates to the Products, any Product. (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 or notifications from any Regulatory Authority or other Governmental AuthorityEntity, or any institutional review board, independent ethics committee or similar body, alleging a lack of compliance by Fortis with any Applicable applicable Laws. The Company 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 knowledge of the Company, each Institution, (m) Fortis has not marketed, advertised, distributed (for commercialization purposes)distributed, sold, or commercialized any Product. 4.6.11. The Company (n) Fortis has provided or made available to Buyer true, complete and correct copies of FibroGen all adverse information with respect to the 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 material written preclinical (including research)preclinical, clinical and other material experimental data in the Company’s Fortis’ possession relating to the Products or the exploitation thereof relating to activities performed by or on behalf of the Company, and to the knowledge of the Company, by or on behalf of any InstitutionFortis, and has not intentionally concealed or withheld from Buyer FibroGen any such data. 4.6.13. To the Company’s knowledge(o) [*], there are no safety, efficacy, or regulatory issues issues, other than the information that has previously been made available to FibroGen, that would materially preclude Buyer FibroGen or the Surviving Corporation from exploiting the Products in compliance with Applicable applicable Laws. [*] = 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.