Common use of Commercialization Standards of Conduct Clause in Contracts

Commercialization Standards of Conduct. (a) Each Party shall, and shall cause its Affiliates and its subcontractors and distributors to, in all respects comply with all Applicable Law in Developing and Commercializing Collaboration Products, in the Field in the Territory, including to the extent applicable, the Foreign Corrupt Practices Act of 1977, as amended (“FCPA”); the UK Xxxxxxx Xxx 0000, Chapter 23, as amended (“UK Bribery Act”); the FD&C Act; the Public Health Service Act, as amended; the Prescription Drug Marketing Act of 1987, as amended; Federal Health Care Program Anti-Kickback Law (42 U.S.C. § 1320a-7b), as amended; the Health Insurance Portability and Accountability Act of 1996, as amended; the FDA Guidance for Industry-Supported Scientific and Educational Activities; and all federal, state and local “fraud and abuse,” consumer protection and false claims statutes and regulations, including the Medicare and State Health Programs Anti-Fraud and Abuse Amendments of the Social Security Act and the “Safe Harbor Regulations” found at 42 C.F.R. § 1001.952 et seq.; the Office of the Inspector General’s Compliance Guidance Program, the Pharmaceutical Research and Manufacturers of America Code on Interactions with Healthcare Professionals, as hereafter amended from time to time; the standards set forth by the Accreditation Council for Continuing Medical Education relating to educating the medical community in the Territory; 42 U.S.C. § 1320a-7h and its implementing regulations (also known as the National Physician Payment Transparency Program and the Open Payments Program) (“Sunshine Act”); and all foreign statutory and non-statutory equivalents in the Territory of any of the foregoing; provided that with respect to the Sunshine Act, each Party shall be responsible for reporting payments or other transfers of value actually made by such Party, and each Party shall use Commercially Reasonable Efforts to cooperate with the other Party to coordinate such disclosure. Each Party represents and warrants to the other Party that, as of the Effective Date, such Party and its Affiliates have adequate procedures in place to support their compliance with the FCPA and the UK Bribery Act in the Territory. Each Party and its Affiliates shall maintain such procedures throughout the Term and shall promptly notify the other Party in writing with respect to any material non-compliance with any Applicable Law regarding the Development or Commercialization of a Collaboration Product in the Field in the Territory. (b) Each Party and its Affiliates shall not, and shall use Commercially Reasonable Efforts to cause its subcontractors and distributors not to, directly or indirectly, promote or market any Collaboration Product (i) in any country in the Territory for which such Persons are not authorized to promote or market under or are not authorized to promote or market pursuant to this Agreement or (ii) for any use or indication not approved by the applicable Regulatory Authority in such country. (c) Each Party shall, and shall cause its Affiliates, subcontractors and distributors to, ensure that all of its and their Sales Representatives promoting Collaboration Products (i) have skills, training and experience generally consistent with industry standards in the applicable country in the Territory applicable to the promotion, marketing and sale of prescription pharmaceutical products in such country and (ii) have satisfactorily completed all Collaboration Product-specific training and ethics and compliance training required by such Party. (d) Each Party shall not, and shall cause its Affiliates, subcontractors and distributors, and its and their respective Sales Representatives not to, (i) make any statement, representation or warranty, oral or written, concerning any Collaboration Product in any country in the Territory, or use any labeling, literature or promotional or marketing material for any Collaboration Product in any country in the Territory that (A) is contrary to or inconsistent with Regulatory Approval for such Collaboration Product in such country in a manner that violates any Applicable Law in such country or (B) violates any Applicable Law in such country or (ii) make any arrangements with, make payments to or provide gifts or other incentives to any healthcare professionals in violation of Applicable Law in such country. Each Party shall, and shall cause its Affiliates and its subcontractors and distributors to, ensure that its and their Sales Representatives are familiar with the procedures, obligations, rights and responsibilities imposed by the terms of this Agreement as applicable to the performance of promotional activities hereunder. Each Party shall, and shall cause its Affiliates, subcontractors and distributors to, maintain records of its and their Sales Representatives’ activities.

Commercialization Standards of Conduct. (a) Each Party Eisai shall, and shall cause its Affiliates and its subcontractors and Sub-distributors to, in all respects comply with all Applicable Law Laws in Developing and Commercializing Collaboration Products, in the Field Products in the Territory, including to the extent applicable, the Foreign Corrupt Practices Act of 1977, as amended (“FCPA”); the UK Xxxxxxx Xxx 0000, Chapter 23, as amended (“UK Bribery Act”); the FD&C ActFFDCA; the Public Health Service Act, as amended; the Prescription Drug Marketing Act of 1987, as amended; Federal Health Care Program Anti-Kickback Law (42 U.S.C. §§ 1320a-7b), as amended; the Health Insurance Portability and Accountability Act of 1996, as amended; the FDA Guidance for Industry-Supported Scientific and Educational Activities; and all federal, state and local “fraud and abuse,” consumer protection and false claims statutes and regulations, including the Medicare and State Health Programs Anti-Fraud and Abuse Amendments of the Social Security Act and the “Safe Harbor Regulations” found at 42 C.F.R. § §1001.952 et seq.; the Office of the Inspector General’s Compliance Guidance Program, the Pharmaceutical Research and Manufacturers of America Code on Interactions with Healthcare Professionals, as hereafter amended from time to time; the standards set forth by the Accreditation Council for Continuing Medical Education relating to educating the medical community in the Territory; 42 U.S.C. § 1320a-7h and its implementing regulations (also known as the National Physician Payment Transparency Program and the Open Payments Program) (“Sunshine Act”); and all foreign statutory and non-statutory equivalents in the Additional Territory of any of the foregoing; provided that with respect to the Sunshine Act, each Party shall be responsible for reporting payments or other transfers of value actually made by such Party, and each Party shall use Commercially Reasonable Efforts to cooperate with the other Party to coordinate such disclosure. Each Party represents and warrants to the other Party that, as of the Amendment Effective Date, such first Party and its Affiliates have adequate procedures in place to support their compliance with the FCPA and the UK Bribery Act in the TerritoryFCPA. Each Party and its Affiliates (and, as to Eisai, its Sub-distributors) shall maintain such procedures throughout the Term and shall promptly notify the other Party in writing with respect to any material non-compliance with any Applicable Law regarding the Development development or Commercialization of a Collaboration Product in the Field in the TerritoryProducts. (b) Each Party and its Affiliates Eisai shall not, and shall use Commercially Reasonable Efforts to cause its subcontractors Affiliates and Sub-distributors not to, directly or indirectly, promote or market any Collaboration Product (i) in any country in the Territory for which such Persons are not authorized to promote or market under or are not authorized to promote or market pursuant to this Agreement or (ii) for any use or indication Indication not approved by the applicable Regulatory Authority in such country. (c) Each Party Eisai shall, and shall cause its Affiliates, subcontractors Affiliates and Sub-distributors to, ensure that all of its and their Sales Representatives sales representatives promoting Collaboration Products (i) have skills, training and experience generally consistent with industry standards in the applicable country in the Territory applicable to the promotion, marketing and sale of a prescription pharmaceutical products product in such country and (ii) have satisfactorily completed all Collaboration ProductProducts-specific training and ethics and compliance training required by such PartyEisai. (d) Each Party Eisai shall not, and shall cause its Affiliates, subcontractors Affiliates and distributors, Sub-distributors and its and their respective Sales Representatives sales representatives not to, (i) make any statement, representation or warranty, oral or written, concerning any Collaboration Product in any country in the Territory, or use any labeling, literature or promotional or marketing material for any Collaboration Product in any country in the Territory that (A) is contrary to or inconsistent with Regulatory Approval for such Collaboration Product in such country in a manner that violates any Applicable Law Laws in such country or (B) violates any Applicable Law Laws in such country or (ii) make any arrangements with, make payments to or provide gifts or other incentives to any healthcare professionals in violation of Applicable Law Laws in such countrycountry relating thereto. Each Party Eisai shall, and shall cause its Affiliates and its subcontractors and Sub-distributors to, ensure that its and their Sales Representatives sales representatives are familiar with the procedures, obligations, rights rights, and responsibilities imposed by the terms of this Agreement as applicable to the performance of promotional activities hereunder. Each Party shall, and shall cause its Affiliates, subcontractors and distributors to, maintain records of its and their Sales Representatives’ activities.

Commercialization Standards of Conduct. (a) Each Party Eisai shall, and shall cause its Affiliates Affiliates, Sub-distributors and its subcontractors and distributors Co-Promotion Partners to, in all respects comply with all Applicable Law Laws in Developing and Commercializing Collaboration Products, in the Field Products in the Territory, including to the extent applicable, the Foreign Corrupt Practices Act of 1977, as amended (“FCPA”); the UK Xxxxxxx Xxx 0000, Chapter 23, as amended (“UK Bribery Act”); the FD&C ActFFDCA; the Public Health Service Act, as amended; the Prescription Drug Marketing Act of 1987, as amended; Federal Health Care Program Anti-Kickback Law (42 U.S.C. §§ 1320a-7b), as amended; the Health Insurance Portability and Accountability Act of 1996, as amended; the FDA Guidance for Industry-Supported Scientific and Educational Activities; and all federal, state and local “fraud and abuse,” consumer protection and false claims statutes and regulations, including the Medicare and State Health Programs Anti-Fraud and Abuse Amendments of the Social Security Act and the “Safe Harbor Regulations” found at 42 C.F.R. § §1001.952 et seq.; the Office of the Inspector General’s Compliance Guidance Program, the Pharmaceutical Research and Manufacturers of America Code on Interactions with Healthcare Professionals, as hereafter amended from time to time; the standards set forth by the Accreditation Council for Continuing Medical Education relating to educating the medical community in the Territory; 42 U.S.C. § 1320a-7h and its implementing regulations (also known as the National Physician Payment Transparency Program and the Open Payments Program) (“Sunshine Act”); and all foreign statutory and non-statutory equivalents in the Additional Territory of any of the foregoing; provided that with respect to the Sunshine Act, each Party shall be responsible for reporting payments or other transfers of value actually made by such Party, and each Party shall use Commercially Reasonable Efforts to cooperate with the other Party to coordinate such disclosure. Each Party represents and warrants to the other Party that, as of the 2nd Amendment Effective Date, such first Party and its Affiliates have adequate procedures in place to support their compliance with the FCPA and the UK Bribery Act in the TerritoryFCPA. Each Party and its Affiliates (and, as to Eisai, its Sub-distributors and Co-Promotion Partners) shall maintain such procedures throughout the Term and shall promptly notify the other Party in writing with respect to any material non-compliance with any Applicable Law regarding the Development development or Commercialization of a Collaboration Product in the Field in the TerritoryProducts. (b) Each Party and its Affiliates shall not, and shall use Commercially Reasonable Efforts to cause its subcontractors and distributors not to, directly or indirectly, promote or market any Collaboration Product (i) in any country in the Territory for which such Persons are not authorized to promote or market under or are not authorized to promote or market pursuant to this Agreement or (ii) for any use or indication not approved by the applicable Regulatory Authority in such country. (c) Each Party shall, and shall cause its Affiliates, subcontractors and distributors to, ensure that all of its and their Sales Representatives promoting Collaboration Products (i) have skills, training and experience generally consistent with industry standards in the applicable country in the Territory applicable to the promotion, marketing and sale of prescription pharmaceutical products in such country and (ii) have satisfactorily completed all Collaboration Product-specific training and ethics and compliance training required by such Party. (d) Each Party shall not, and shall cause its Affiliates, subcontractors and distributors, and its and their respective Sales Representatives not to, (i) make any statement, representation or warranty, oral or written, concerning any Collaboration Product in any country in the Territory, or use any labeling, literature or promotional or marketing material for any Collaboration Product in any country in the Territory that (A) is contrary to or inconsistent with Regulatory Approval for such Collaboration Product in such country in a manner that violates any Applicable Law in such country or (B) violates any Applicable Law in such country or (ii) make any arrangements with, make payments to or provide gifts or other incentives to any healthcare professionals in violation of Applicable Law in such country. Each Party shall, and shall cause its Affiliates and its subcontractors and distributors to, ensure that its and their Sales Representatives are familiar with the procedures, obligations, rights and responsibilities imposed by the terms of this Agreement as applicable to the performance of promotional activities hereunder. Each Party shall, and shall cause its Affiliates, subcontractors and distributors to, maintain records of its and their Sales Representatives’ activities.

Commercialization Standards of Conduct. (a) Each Party 9.9.1 Fresenius shall, and shall cause its Affiliates and its subcontractors and distributors Related Parties to, in all material respects comply with all Applicable Law Laws in Developing and Commercializing Collaboration Productsthe Distribution Product hereunder, in the Field in the Territoryincluding, including to the extent applicable, the Foreign Corrupt Practices Act of 1977, as amended (“FCPA”); the UK Xxxxxxx Xxx 0000, Chapter 23, as amended (“UK Bribery Act”); the FD&C Act; the Public Health Service ActPHSA, as amended; the United States Prescription Drug Marketing Act of 1987, as amended; Federal Health Care Program US Anti-Kickback Law (42 U.S.C. § 1320a-7b), as amendedStatute; the United States Health Insurance Portability and Accountability Act of 1996, as amended; the FDA Guidance for Industry-Supported Scientific and Educational Activities; and all federal, state and local “fraud and abuse,” ”, consumer protection protection, and false claims statutes and regulationsregulations in the United States, including the Medicare and State Health Programs Program Anti-Fraud and Abuse Amendments of the Social Security Act and the “Safe Harbor Regulations” found at 42 C.F.R. § §1001.952 et seq.; the United States Office of the Inspector General’s Compliance Guidance Program, the Pharmaceutical Research and Manufacturers of America Code on Interactions with Healthcare Professionals, as hereafter amended from time to time; the standards set forth by the Accreditation Council for Continuing Medical Education relating to educating the medical community in the Territory; 42 U.S.C. § 1320a-7h and its implementing regulations (also known as the National Physician Payment Transparency Program and the Open Payments Program) (“Sunshine Act”); and all foreign statutory and non-statutory equivalents in the Territory of any of the foregoing; provided that with respect to the Sunshine Act, each Party shall be responsible for reporting payments foregoing in any Ex-US country or other transfers of value actually made by such Party, and each Party shall use Commercially Reasonable Efforts to cooperate with the other Party to coordinate such disclosure. Each Party represents and warrants to the other Party that, as of the Effective Date, such Party and its Affiliates have adequate procedures in place to support their compliance with the FCPA and the UK Bribery Act in the Territory. Each Party and its Affiliates shall maintain such procedures throughout the Term and shall promptly notify the other Party in writing with respect to any material non-compliance with any Applicable Law regarding the Development or Commercialization of a Collaboration Product in the Field in the Territoryterritory. (b) Each Party and its Affiliates 9.9.2 Fresenius shall not, and shall use Commercially Reasonable Efforts to cause its subcontractors and distributors Related Parties not to, directly or indirectly, promote or market any Collaboration Promote the Distribution Product (i) in any country in the Territory for which such Persons are not authorized to promote or market under or are not authorized to promote or market pursuant to this Agreement or (ii) for any use or indication not approved by the applicable Regulatory Authority Authorities in such countrycountry or otherwise in contravention of any Laws. (c) Each Party 9.9.3 Fresenius shall, and shall cause its Affiliates, subcontractors and distributors Related Parties to, ensure that all of its and their Sales Representatives promoting Collaboration Products sales representatives Promoting the Distribution Product in a country in the Territory (ia) have skills, training and experience generally consistent with industry standards in the applicable such country in the Territory applicable to the promotion, marketing and sale Promotion of a prescription pharmaceutical products biological product in such country and (iib) have satisfactorily completed all Collaboration Distribution Product-specific training and ethics and compliance training required by consistent with industry standards in such Partycountry and Fresenius’ internal practices, standard operating procedures, and standards. (d) Each Party 9.9.4 Fresenius shall not, and shall cause its Affiliates, subcontractors and distributors, and its and their respective Sales Representatives Related Parties not to, (ia) make any statement, representation representation, or warranty, oral or written, concerning any Collaboration the Distribution Product in any country in the Territory, or use any labeling, literature literature, Promotional Materials or promotional or other marketing material materials for any Collaboration the Distribution Product in any country in the Territory such country, that (Ai) is contrary to or inconsistent with the Regulatory Approval for such Collaboration the Distribution Product in such country in a manner that violates any Applicable Law in such country or (B) violates any Applicable Law Laws in such country or (ii) violates any Laws in such country, or (b) without limiting Fresenius’ obligations under Section 14.4, make any arrangements with, make payments to to, or provide gifts or other incentives to to, any healthcare professionals in any country in the Territory in violation of Applicable Law Laws in such country. Each Party country relating thereto. 9.9.5 Fresenius shall, and shall cause its Affiliates and its subcontractors and distributors Related Parties to, ensure that its and their Sales Representatives sales representatives are familiar with the procedures, obligations, responsibilities and rights and responsibilities imposed by the terms of for which provision is made in this Agreement as applicable to the performance of promotional Promotion activities hereunder. Each Party shall, and shall cause its Affiliates, subcontractors and distributors to, maintain records in respect of its and their Sales Representatives’ activitiesthe Distribution Product.

Commercialization Standards of Conduct. (a) Each Party shall use Commercially Reasonable Efforts to perform its Commercialization obligations in the Territory with respect to each Eisai Collaboration Product in accordance with the Global Branding Strategy and as set forth in the applicable Commercialization Plan. (b) Each Party shall, and shall cause its Affiliates and its subcontractors and distributors to, in all respects comply with all Applicable Law in Developing and Commercializing the Eisai Collaboration Products, in the Field in the Territory, including to the extent applicable, the Foreign Corrupt Practices Act of 1977, as amended (“FCPA”); ) and the UK Xxxxxxx Xxx 0000Bribery Act 2010, Chapter 23, as amended (“UK Bribery Act”); the FD&C Act; the Public Health Service Act, as amended; the Prescription Drug Marketing Act of 1987, as amended; Federal Health Care Program Anti-Kickback Law (42 U.S.C. §§ 1320a-7b), as amended; the Health Insurance Portability and Accountability Act of 1996, as amended; the FDA Guidance for Industry-Supported Scientific and Educational Activities; and all federal, state and local “fraud and abuse,” consumer protection and false claims statutes and regulations, including the Medicare and State Health Programs Anti-Anti- Fraud and Abuse Amendments of the Social Security Act and the “Safe Harbor Regulations” found at 42 C.F.R. § §1001.952 et seq.; the Office of the Inspector General’s Compliance Guidance Program, the Pharmaceutical Research and Manufacturers of America Code on Interactions with Healthcare Professionals, as hereafter amended from time to time; the standards set forth by the Accreditation Council for Continuing Medical Education relating to educating the medical community in the Territory; 42 U.S.C. § 1320a-7h and its implementing regulations (also known as the National Physician Payment Transparency Program and the Open Payments Program) (“Sunshine Act”); and all foreign statutory and non-statutory equivalents in the Territory of any of the foregoing; provided that with respect to the Sunshine Act, each Party shall be responsible for reporting relating to payments or other transfers of value actually made by such Party, and each Party shall use Commercially Reasonable Efforts to cooperate with the other Party to coordinate such disclosure. Each Party represents and warrants to the other Party that, as of the Effective Date, such first Party and its Affiliates have adequate procedures in place to support their compliance with the FCPA and the UK Bribery Act in the Territory. Each Party and its Affiliates shall maintain such procedures throughout the Term and shall promptly notify the other Party in writing with respect to any material non-compliance with any Applicable Law regarding the Development or Commercialization of a an Eisai Collaboration Product in the Field in the Territory. (bc) Each Party and its Affiliates shall not, not and shall use Commercially Reasonable Efforts to cause its subcontractors and distributors not to, to directly or indirectly, promote or market any Eisai Collaboration Product (i) in any country in the Territory for which such Persons are not authorized to promote or market under or are not authorized to promote or market pursuant to this Agreement or (ii) for any use or indication not approved by the applicable Regulatory Authority in such country. (cd) Each Party shall, and shall cause its Affiliates, Affiliates and its subcontractors and distributors to, ensure that all of its and their Sales sales Representatives promoting Eisai Collaboration Products (i) have skills, training and experience generally consistent with industry standards in the 132539616_1 applicable country in the Territory applicable to the promotion, marketing and sale of prescription pharmaceutical products in such country and (ii) have satisfactorily completed all Eisai Collaboration Product-specific training (including any such training set forth in the Commercialization Plan for such Eisai Collaboration Product) and ethics and compliance training required by such Party. (de) Each Party shall not, and shall cause its Affiliates, Affiliates and its subcontractors and distributors, and its and their respective Sales sales Representatives not to, (i) make any statement, representation or warranty, oral or written, concerning any Eisai Collaboration Product in any country in the Territory, or use any labeling, literature or promotional or marketing material for any Eisai Collaboration Product in any country in the Territory that (A) is contrary to or inconsistent with Regulatory Approval for such Eisai Collaboration Product in such country in a manner that violates any Applicable Law in such country or (B) violates any Applicable Law in such country or (ii) make any arrangements with, make payments to or provide gifts or other incentives to any healthcare professionals in violation of Applicable Law in such countrycountry relating thereto. Each Party shall, and shall cause its Affiliates and its subcontractors and distributors to, ensure that its and their Sales sales Representatives are familiar with the procedures, obligations, rights rights, and responsibilities imposed by the terms of this Agreement as applicable to the performance of promotional activities hereunder. Each Party shall, and shall cause its Affiliates, subcontractors and distributors to, maintain records of its and their Sales Representatives’ activities.