Common use of Compliance with Law and Ethical Business Practices Clause in Contracts

Compliance with Law and Ethical Business Practices. In addition to the other representations, warranties and covenants made by each Party elsewhere in this Agreement, each Party (the “Compliant Party”) represents, warrants or covenants, as applicable, to the other Party that during the Term: 7.4.1. from the Effective Date until expiration or termination of this Agreement, it will perform its obligations under this Agreement in compliance with Applicable Laws; 7.4.2. it is, or will be at the applicable time, licensed, registered or qualified under Applicable Law to do business, and has obtained such licenses, consents, authorizations or completed such registrations or made such notifications as may be necessary or required by Applicable Law to provide the goods or services encompassed within this Agreement, and providing such goods or services is not inconsistent with any other obligation of the Compliant Party; 7.4.3. in conducting its activities under this Agreement, it will, will cause its Affiliates to and will use its Commercially Reasonable Efforts to cause other Representatives to comply in all material respects with Applicable Law and accepted pharmaceutical industry business practices, including, to the extent applicable to each Compliant Party and each such Current Licensor, Affiliate and other Representatives, the Federal Food, Drug, and Cosmetic Act (21 U.S.C. § 301, et seq.), the Anti-Kickback Statute (42 U.S.C. § 1320a-7b), Civil Monetary Penalty Statute (42 U.S.C. § 1320a-7a), the False Claims Act (31 U.S.C. § 3729 et seq.), comparable state statutes, the regulations promulgated under all such statutes and the regulations issued by the FDA, consistent with the Compliance Program Guidance for Pharmaceutical Manufacturers published by the Office of Inspector General, U.S. Department of Health and Human Services; 7.4.4. with respect to any Licensed Products, payments or services provided under this Agreement, it has not taken and will not during the Term take any action directly or indirectly to offer, promise or pay, or authorize the offer or payment of, any money or anything of value in order to improperly or corruptly seek to influence any Government Official or any other person in order to gain an improper advantage, and has not accepted, and will not accept in the future such payment; 7.4.5. it complies with the laws and regulations of the countries where it operates, including anti-bribery and anti-corruption laws, accounting and record keeping laws, and laws relating to interactions with healthcare professionals or healthcare providers and Government Officials; 7.4.6. to its knowledge, it and each of its Affiliates has been and will, for the Term, be in compliance with all applicable global trade laws, including those related to import controls, export controls or economic sanctions, and it will cause each of its Affiliates to remain in compliance with the same during the Term; 7.4.7. to its knowledge, except to the extent permissible under United States Law, neither it nor any of its Affiliates has, on its own behalf or in acting on behalf of any other Person, directly or indirectly engaged with, and will not for the Term, directly or indirectly engage in any transactions, or otherwise deal with, any country or Person targeted by United States, European Union, United Kingdom or other relevant economic sanctions laws in connection with any activities related to the Party’s interaction with the other Party, including those contemplated under this Agreement; and 7.4.8. it is, as between the Parties, solely responsible to ensure such compliance by it and its Affiliates.

Compliance with Law and Ethical Business Practices. In addition to the other representations, warranties and covenants made by each Party elsewhere in this Agreement, each Party (the “Compliant Party”) represents, represents and warrants or covenants, as applicable, to the other Party that during the Term: 7.4.1. from the Effective Date until expiration or termination of this Agreement, (a) it will perform its obligations under this Agreement in compliance with Applicable Laws; 7.4.2. it is, or will be at the applicable time, is licensed, registered registered, or qualified under Applicable applicable Law to do business, and has obtained such licenses, consents, authorizations or completed such registrations or made such notifications as may be necessary or required by Applicable applicable Law to provide the goods or services encompassed within this Agreement, and providing such goods or services is not inconsistent with any other obligation of the Compliant Party; 7.4.3. (b) in conducting its activities under this Agreementhereunder, it will, will and will cause its Affiliates to and will use its Commercially Reasonable Efforts to cause other Representatives to comply in all material respects with Applicable applicable Law and accepted pharmaceutical industry business practices, including, to the extent applicable to each Compliant Party and each such Current Licensor, Affiliate and other RepresentativesRepresentative, the United States Federal Food, Drug, and Cosmetic Act (21 U.S.C. § 301, et seq.), the Anti-Kickback Statute (42 U.S.C. § 1320a-7b), Civil Monetary Penalty Statute (42 U.S.C. § 1320a-7a), the False Claims Act (31 U.S.C. § 3729 et seq.), comparable state statutes, the regulations promulgated under all such statutes statutes, and the regulations issued by the FDA, consistent with the ‘Compliance Program Guidance for Pharmaceutical Manufacturers Manufacturers’ published by the Office of Inspector General, U.S. Department of Health and Human Services; 7.4.4. (c) with respect to any Licensed Products, payments or services provided under this Agreement, it has not taken and will not during the Term take any action directly or indirectly to unlawfully offer, promise or pay, or authorize the offer or payment of, any money or anything of value in order to improperly or corruptly seek to influence any Government Official or any other person in order to gain an improper advantage, and has not accepted, and will not accept in the future any such unlawful payment; 7.4.5. (d) it complies with the applicable laws and regulations of the countries where it operates, including anti-bribery and anti-corruption laws, accounting and record keeping laws, and laws relating to interactions with healthcare professionals or healthcare providers (collectively, “HCPs”) and Government Officials; 7.4.6(e) commencing promptly after the Effective Date, it will take steps toward adopting and implementing policies and procedures, and will adopt and implement such policies and procedures within six (6) months after the Effective Date, setting out rules governing [ * ] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. interactions with HCPs and Government Officials, engagement of Third Parties, including, where appropriate, due diligence (“Policies”), and its Policies will mandate a robust set of internal controls, including accounting controls, designed to ensure the making and keeping of fair and accurate books, records and accounts, on its operations around the world and apply worldwide to all its employees, subsidiaries, and Third Parties acting on its behalf, and which Policies will include (i) providing training to its officers, directors, employees and where appropriate, its other Representatives on such Policies, (ii) regular monitoring and auditing of activities to confirm compliance with such Policies and the adequacy of internal controls, and remediation of identified issues, and (iii) requirements for regular review as part of its internal processes of improvement, and, from time to time, benchmarking against the standards of the industry with the assistance of external counsel; (f) to its knowledge, it and each of its Affiliates has been and will, for the Term, be in compliance with all applicable global trade lawsGlobal Trade Control Laws (as defined in Section 12.8 below), including those related to to, import controls, export controls controls, or economic sanctions, and it will cause each of its Affiliates to remain in compliance with the same during the Term; 7.4.7. (g) to its knowledge, except to the extent permissible under United States Lawlaw, neither it nor any of its Affiliates has, on its own behalf or in acting on behalf of any other Person, directly or indirectly engaged with, and will not for the Term, without any required government authorization, directly or indirectly engage in any transactions, or otherwise deal with, any country or Person targeted by United States, European Union, United Kingdom or other relevant economic sanctions laws in connection with any activities related to the Party’s interaction with the other Party, including those contemplated under this Agreement; and 7.4.8. (h) it is, as between the Parties, solely responsible to ensure such compliance Compliance by it and its Affiliates.

Compliance with Law and Ethical Business Practices. In addition to the other representations, warranties and covenants made by each Party elsewhere in this Agreement, each Party (the “Compliant Party”) represents, represents and warrants or covenants, as applicable, to the other Party that during the Term: 7.4.1. from the Effective Date until expiration or termination of this Agreement, (a) it will perform its obligations under this Agreement in compliance with Applicable Laws; 7.4.2. it is, or will be at the applicable time, is licensed, registered registered, or qualified under Applicable applicable Law to do business, and has obtained such licenses, consents, authorizations or completed such registrations or made such notifications as may be necessary or required by Applicable applicable Law to provide the goods or services encompassed within this Agreement, and providing such goods or services is not inconsistent with any other obligation of the Compliant Party; 7.4.3. (b) in conducting its activities under this Agreementhereunder, it will, will and will cause its Affiliates to and will use its Commercially Reasonable Efforts to cause other Representatives to comply in all material respects with Applicable applicable Law and accepted pharmaceutical industry business practices, including, to the extent applicable to each Compliant Party and each such Current Licensor, Affiliate and other RepresentativesRepresentative, the United States Federal Food, Drug, and Cosmetic Act (21 U.S.C. § 301, et seq.), the Anti-Kickback Statute (42 U.S.C. § 1320a-7b), Civil Monetary Penalty Statute (42 U.S.C. § 1320a-7a), the False Claims Act (31 U.S.C. § 3729 et seq.), comparable state statutes, the regulations promulgated under all such statutes statutes, and the regulations issued by the FDA, consistent with the ‘Compliance Program Guidance for Pharmaceutical Manufacturers Manufacturers’ published by the Office of Inspector General, U.S. Department of Health and Human Services; 7.4.4. (c) with respect to any Licensed Products, payments or services provided under this Agreement, it has not taken and will not during the Term take any action directly or indirectly to unlawfully offer, promise or pay, or authorize the offer or payment of, any money or anything of [*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. value in order to improperly or corruptly seek to influence any Government Official or any other person in order to gain an improper advantage, and has not accepted, and will not accept in the future any such unlawful payment; 7.4.5. (d) it complies with the applicable laws and regulations of the countries where it operates, including anti-bribery and anti-corruption laws, accounting and record keeping laws, and laws relating to interactions with healthcare professionals or healthcare providers (collectively, “HCPs”) and Government Officials; 7.4.6. (e) commencing promptly after the Effective Date, it will take steps toward adopting and implementing policies and procedures, and will adopt and implement such policies and procedures within six (6) months after the Effective Date, setting out rules governing interactions with HCPs and Government Officials, engagement of Third Parties, including, where appropriate, due diligence (“Policies”), and its Policies will mandate a robust set of internal controls, including accounting controls, designed to ensure the making and keeping of fair and accurate books, records and accounts, on its operations around the world and apply worldwide to all its employees, subsidiaries, and Third Parties acting on its behalf, and which Policies will include (i) providing training to its officers, directors, employees and where appropriate, its other Representatives on such Policies, (ii) regular monitoring and auditing of activities to confirm compliance with such Policies and the adequacy of internal controls, and remediation of identified issues, and (iii) requirements for regular review as part of its internal processes of improvement, and, from time to time, benchmarking against the standards of the industry with the assistance of external counsel; (f) to its knowledge, it and each of its Affiliates has been and will, for the Term, be in compliance with all applicable global trade lawsGlobal Trade Control Laws (as defined in Section 16.8 below), including those related to to, import controls, export controls controls, or economic sanctions, and it will cause each of its Affiliates to remain in compliance with the same during the Term; 7.4.7. (g) to its knowledge, except to the extent permissible under United States Lawlaw, neither it nor any of its Affiliates has, on its own behalf or in acting on behalf of any other Person, directly or indirectly engaged with, and will not for the Term, without any required government authorization, directly or indirectly engage in any transactions, or otherwise deal with, any country or Person targeted by United States, European Union, United Kingdom or other relevant economic sanctions laws in connection with any activities related to the Party’s interaction with the other Party, including those contemplated under this Agreement; and 7.4.8. (h) it is, as between the Parties, solely responsible to ensure such compliance Compliance by it and its Affiliates.

Compliance with Law and Ethical Business Practices. In addition to the other representations, warranties and covenants made by each Party elsewhere in under this Agreement, each Party (the “Compliant Party”) hereby represents, warrants or covenants, as applicable, and covenants to the other Party that that, during the Term in the Territory: (a) it is, and will remain during the Term: 7.4.1. from the Effective Date until expiration or termination of this Agreement, it will perform its obligations under this Agreement in compliance with Applicable Laws; 7.4.2. it is, or will be at the applicable time, licensed, registered or and/or qualified under Applicable Law to do business, and has obtained such licenses, consents, authorizations or completed such registrations registration or made such notifications as may be necessary or required by Applicable Law to provide the goods or services encompassed within this Agreement, and providing such goods or services is not inconsistent with any other obligation of the Compliant Party; 7.4.3. in conducting perform its activities obligations under this Agreement; (b) it will perform its obligations under this Agreement in material compliance with this Agreement and any applicable Annual Marketing Plan, it will, will cause its Affiliates to Applicable Compliance/Review Policies and will use its Commercially Reasonable Efforts to cause other Representatives to comply in all material respects with Applicable Law and accepted pharmaceutical industry business practices, including, to Laws (including the extent applicable to each Compliant Party and each such Current Licensor, Affiliate and other Representatives, the Federal Food, Drug, and Cosmetic Act (21 U.S.C. § 301, et seq.)FD&C Act, the Anti-Kickback Statute (42 U.S.C. § 1320a-7b), Civil Monetary Penalty Statute (42 U.S.C. § 1320a-7a), the False Claims Act (31 U.S.C. § 3729 et seq.), comparable state statutes, the regulations promulgated under all such statutes statutes, and the regulations issued by the FDA, consistent ); (c) in connection with the Compliance Program Guidance for Pharmaceutical Manufacturers published activities contemplated by this Agreement, to each Party’s knowledge, it has been, and during the Office of Inspector GeneralTerm will be, in compliance with all applicable U.S. Department of Health and Human Servicestrade laws, including those related to, import controls, export controls, or economic sanctions; 7.4.4. (d) it will ensure its own compliance with all Applicable Laws; (e) with respect to the Product and any Licensed Products, payments or services provided under this Agreement, it such Party has not taken taken, and will not during the Term take will not take, any action action, directly or indirectly indirectly, to offer, promise or pay, or authorize the offer or payment of, any money or anything of value in order to improperly or corruptly seek to influence any Government Official or any other person in order to gain an improper advantage, and has not accepted, and will not accept in the future such payment; 7.4.5. (f) each Party hereby certifies that it complies with has implemented and will maintain and enforce a compliance and ethics program designed to prevent and detect violations of Applicable Laws throughout its operations (including Affiliates) and the laws and regulations operations of its Representatives that have responsibility for Product, payments, or services provided under the countries where it operatesAgreement, including anti-bribery by implementing policies and anti-corruption laws, accounting and record keeping laws, and laws relating to procedures setting out rules governing interactions with healthcare professionals or healthcare providers and Government Officials; the engagement of third parties, and where appropriate, due diligence; and the investigation, documentation, and remediation of any allegations, findings, or reports related to a potential violation of its Applicable Compliance/Review Policies. Such compliance program shall include at a minimum, compliance officer, compliance committee(s), policies and procedures relating to (i) sales, medical, Promotional and Marketing activities for the Product, (ii) regular auditing and monitoring, (iii) training on sales, medical, Promotional and Marketing activities and the relevant legal requirements regarding such activities, (iv) methods to raise questions or concerns internally (e.g., via a hotline) without fear of retribution or retaliation, (v) processes for investigating and documenting any compliance concerns or allegations raised, findings or reports related to a potential violation of Applicable Laws, and (vi) taking remedial, corrective action and/or disciplinary action, as appropriate; 7.4.6. (g) has implemented, and will maintain and enforce, a system of internal accounting controls designed to ensure the making and keeping of fair and accurate books, records, and accounts with respect to products, payments, or services provided under this Agreement, and regularly monitors and audits its knowledgebusiness activities to ensure compliance with its Applicable Compliance/Review Policies and the adequacy of internal controls, and implements remediation in response to identified issues; (h) it will (A) maintain truthful and each complete documentation supporting, in reasonable detail, the work performed and any expenses incurred in connection with this Agreement and any products, payments, or services provided under this Agreement and (B) maintain financial books and records that timely, fairly, accurately, and completely reflect all financial transactions, in accordance with all Applicable Laws (for example, invoices, reports, statements, books, and other records), and shall maintain such books and records during the Term of its Affiliates the Agreement and for three years after final payment has been made under the Agreement; (i) it provides, and willduring the Term will provide, for training to Representatives providing services in connection with this Agreement; (j) every year of this Agreement that coincides with the Termterm of the Corporate Integrity Agreement (“CIA”) entered into on May 23, be in 2018 between Pfizer and the United States Department of Health and Human Services, Office of Inspector General, Pfizer will send a letter to Exact that: (A) summarizes Pfizer’s obligations under the CIA, (B) expresses Pfizer’s commitment to full compliance with all applicable global trade lawsfederal health care program requirements, including those related (C) describes the Pfizer Compliance Program and (D) includes a copy of (or includes a link to) Pfizer’s code of conduct (referred to import controlsas the Blue Book). Within thirty (30) days of receipt of this letter, export controls or economic sanctions, Exact shall respond in writing to the contact information included in Pfizer’s letter that Exact shall: (1) make Pfizer’s code of conduct and it will cause each a description of its Affiliates to remain in compliance with the same during the Term; 7.4.7. Pfizer Compliance Program available to its knowledge, except to the extent permissible under United States Law, neither it nor any of its Affiliates has, on its own behalf or employees engaged in acting on behalf of any other Person, directly or indirectly engaged with, and will not for the Term, directly or indirectly engage in any transactions, or otherwise deal with, any country or Person targeted by United States, European Union, United Kingdom or other relevant economic sanctions laws in connection with any activities related to the Party’s interaction with Agreement or (2) represent to Pfizer that it has and enforces a substantially comparable code of conduct and compliance program for its employees who have responsibilities related to the other Party, including those contemplated under this Agreement; and 7.4.8. it is(k) with respect to the Product and any payments made or services provided under this Agreement: (i) in the event that such Party receives a report of or otherwise becomes aware of a potential violation of its Applicable Compliance/Review Policies, as between the PartiesParty will perform an investigation in accordance with its established policies and procedures and will take all necessary and appropriate responsive, solely responsible and corrective actions, including disciplinary actions (up to and including termination of any employee, contractor, agent, sub-contractor, customer, vendor or other Person that the Party believes was responsible); (ii) such Party has implemented, and will at all times during the Term maintain, adequate policies and procedures describing the materials and information that may be distributed or discussed by the Party’s Sales Representatives related to the Product and the manner in which such Persons should handle unsolicited requests for information related to off-label uses of the Product, which policies and procedures shall be designed to ensure compliance with Applicable Laws and regulations; (iii) such Party regularly reviews its Applicable Compliance/Review Policies as part of its internal processes of improvement, and, from time to time, benchmarks them against the standards of the industry; (iv) such Party has implemented, and will at all times during the Term maintain, adequate systems, policies, and procedures to screen before hire and annually thereafter all prospective and current Representatives conducting activities with respect to the Product against (A) the List of Excluded Individuals/Entities compiled by the Office of the Inspector General in the Department of Health and Human Services and (B) the General Services Administration’s List of Parties Excluded from Federal Programs, which policies and procedures require each Party’s prospective and current Representatives conducting activities with respect to the Product to disclose immediately to the Party that such Representative is or may become Debarred/Excluded; (v) neither Party shall provide funding to the other Party for charitable donations to independent charities that provide financial assistance to patients, including sharing costs associated with such donations; provide information to the other Party concerning its own such donations; or seek to obtain information about such donations from the other Party. Each Party shall have appropriate policies and procedures to ensure that such donations comply with Applicable Law and current government guidance, including without limitation guidance issued by the U.S. Department of Health and Human Services, Office of Inspector General, and shall operate consistent with those policies and procedures. Unless a Party does not and will not make such donations during the Term of the Agreement, if a Party does not have appropriate policies and procedures in place on the Effective Date, the Party must implement such policies and procedures within thirty (30) days of the Effective Date. Either Party may request copies of such policies and procedures of the other Party in order to confirm compliance by it with the requirements of this Section; (vi) certifies that in connection with this Agreement, such Party’s compensation system for its Representatives that perform any Marketing, Promotion, or sales activities related to the Product is designed to ensure that financial incentives do not inappropriately motivate such Representative to engage in improper or illegal Promotion, sales or Marketing of the Product (including off-label Promotion of the Product), and excludes from Incentive Compensation sales that may be attributable to the off-label use of the Product; and (vii) in connection with this Agreement, each Party’s call planning system for its AffiliatesSales Representatives that call upon health care professionals or health care institutions for any Promotional or sales activities related to the Product is designed to ensure that such Sales Representatives do not call upon health care professionals or health care institutions that are not likely to prescribe or use the Product for an on-label use.

Compliance with Law and Ethical Business Practices. In addition to the other representations, warranties and covenants made by each Party elsewhere in this Agreement, each Party (the “Compliant Party”) represents, represents and warrants or covenants, as applicable, to the other Party that during the Term:: 72 [*] = Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed. 7.4.1. from the Effective Date until expiration or termination of this Agreement, (a) it will perform its obligations under this Agreement in compliance with Applicable Laws; 7.4.2. it is, or will be at the applicable time, is licensed, registered registered, or qualified under Applicable applicable Law to do business, and has obtained such licenses, consents, authorizations or completed such registrations or made such notifications as may be necessary or required by Applicable applicable Law to provide the goods or services encompassed within this Agreement, and providing such goods or services is not inconsistent with any other obligation of the Compliant Party; 7.4.3. ; (b) in conducting its activities under this Agreementhereunder, it will, will and will cause its Affiliates to and will use its Commercially Reasonable Efforts to cause other Representatives to comply in all material respects with Applicable applicable Law and accepted pharmaceutical industry business practices, including, to the extent applicable to each Compliant Party and each such Current Licensor, Affiliate and other RepresentativesRepresentative, the United States Federal Food, Drug, and Cosmetic Act (21 U.S.C. § 301, et seq.), the Anti-Kickback Statute (42 U.S.C. § 1320a-7b), Civil Monetary Penalty Statute (42 U.S.C. § 1320a-7a), the False Claims Act (31 U.S.C. § 3729 et seq.), comparable state statutes, the regulations promulgated under all such statutes statutes, and the regulations issued by the FDA, consistent with the ‘Compliance Program Guidance for Pharmaceutical Manufacturers Manufacturers’ published by the Office of Inspector General, U.S. Department of Health and Human Services; 7.4.4. ; (c) with respect to any Licensed Products, payments or services provided under this Agreement, it has not taken and will not during the Term take any action directly or indirectly to unlawfully offer, promise or pay, or authorize the offer or payment of, any money or anything of value in order to improperly or corruptly seek to influence any Government Official or any other person in order to gain an improper advantage, and has not accepted, and will not accept in the future any such unlawful payment; 7.4.5. ; (d) it complies with the applicable laws and regulations of the countries where it operates, including anti-bribery and anti-corruption laws, accounting and record keeping laws, and laws relating to interactions with healthcare professionals or healthcare providers (collectively, “HCPs”) and Government Officials; 7.4.6. ; (e) commencing promptly after the Effective Date, it will take steps toward adopting and implementing policies and procedures, and will adopt and implement such policies and procedures within six (6) months after the Effective Date, setting out rules governing interactions with HCPs and Government Officials, engagement of Third Parties, including, where appropriate, due diligence (“Policies”), and its Policies will mandate a robust set of internal controls, including accounting controls, designed to ensure the making and keeping of fair and accurate books, records and accounts, on its operations around the world and apply worldwide to all its employees, subsidiaries, and Third Parties acting on its behalf, and which Policies will include (i) providing training to its officers, directors, employees and where appropriate, its other Representatives on such Policies, (ii) regular monitoring and auditing of activities to confirm compliance with such Policies and the adequacy of internal controls, and remediation of identified issues, and (iii) requirements for regular review as part of its internal processes of improvement, and, from time to time, benchmarking against the standards of the industry with the assistance of external counsel; (f) to its knowledge, it and each of its Affiliates has been and will, for the Term, be in compliance with all applicable global trade laws, including those related to import controls, export controls or economic sanctions, and it will cause each of its Affiliates to remain Global Trade Control Laws (as defined in compliance with the same during the Term; 7.4.7. to its knowledge, except to the extent permissible under United States Law, neither it nor any of its Affiliates has, on its own behalf or in acting on behalf of any other Person, directly or indirectly engaged with, and will not for the Term, directly or indirectly engage in any transactions, or otherwise deal with, any country or Person targeted by United States, European Union, United Kingdom or other relevant economic sanctions laws in connection with any activities related to the Party’s interaction with the other Party, including those contemplated under this Agreement; and 7.4.8. it is, as between the Parties, solely responsible to ensure such compliance by it and its Affiliates.Section 16.8

Compliance with Law and Ethical Business Practices. In addition to the other representations, warranties and covenants made by each Party elsewhere in this Agreement, each Party (the “Compliant Party”) represents, represents and warrants or covenantscovenants and agrees, as applicable, to with the other Party that during the Term: 7.4.1. from the Effective Date until expiration or termination of this Agreement, it will perform its obligations under this Agreement in compliance with Applicable Laws; 7.4.28.6.1. it is, or will be at the applicable time, is licensed, registered registered, or qualified under all Applicable Law Laws to do business, and has obtained such licenses, consents, authorizations or completed such registrations or made such notifications as may be necessary or required by Applicable Law to provide the any products, goods or services encompassed within this Agreement, and providing such products, goods or services is not inconsistent with any other obligation of the Compliant such Party; 7.4.38.6.2. in conducting its activities under this Agreementhereunder, it will, such Party will and will cause its Affiliates and, to and will the extent of its legal right to do so, use its Commercially Reasonable Efforts reasonable efforts to cause its other *** = Portions of this exhibit have been omitted pursuant to a request for confidential treatment. An unredacted version of this exhibit has been filed separately with the Commission. Representatives to comply in all material respects with all Applicable Law Laws and accepted pharmaceutical industry business practices, including, to the extent applicable to each Compliant such Party and each such Current Licensor, Affiliate of its Affiliates and other Representatives, : the Federal Food, Drug, and Cosmetic Act (21 U.S.C. § 301, et seq.), the Anti-Kickback Statute (42 U.S.C. § 1320a-7b), the Civil Monetary Penalty Statute (42 U.S.C. § 1320a-7a), the False Claims Act (31 U.S.C. § 3729 et seq.), comparable state statutes, the regulations promulgated under all such statutes statutes, and the regulations issued by the FDA, consistent with the Compliance Program Guidance for Pharmaceutical Manufacturers published by the Office of Inspector General, U.S. Department of Health and Human Services; 7.4.48.6.3. with respect to any Licensed Productsproducts, payments or services provided under this Agreement, it has not taken and will not during the Term take any action directly or indirectly to offer, promise or pay, or authorize the offer or payment of, any money or anything of value in order to improperly or corruptly seek to influence any Government Official or any other person in order to gain an improper advantage, and has not accepted, and will not accept in the future future, such payment; 7.4.58.6.4. it complies with the laws and regulations of the countries where it operates, including anti-bribery and anti-corruption laws, accounting and record keeping laws, and laws relating to interactions with healthcare professionals or healthcare providers and Government Officials; 7.4.68.6.5. to its knowledge, it and each of its Affiliates has been and will, for the Term, be in compliance with all applicable global trade laws, including those related to import controls, export controls or economic sanctions, and it such Party will cause each of its Affiliates to remain in compliance with the same during the Term; 7.4.78.6.6. to its knowledge, except to the extent permissible under United States Lawlaw, neither it nor any of its Affiliates has, on its own behalf or in acting on behalf of any other Person, directly or indirectly engaged with, and will not for the Term, directly or indirectly engage in any transactionstransactions with, or otherwise deal with, any country or Person targeted by United States, European Union, United Kingdom or other relevant economic sanctions laws in connection with any activities related to the such Party’s interaction with the other Party, including those contemplated under this Agreement; and 7.4.88.6.7. it is, as between the Parties, solely responsible to ensure such compliance for ensuring Compliance by it and its Affiliates.