Commercialization Standards of Conduct. (a) Eisai shall, and shall cause its Affiliates, Sub-distributors and Co-Promotion Partners to, in all respects comply with all Applicable Laws in Commercializing the Products in the Territory, including to the extent applicable, the Foreign Corrupt Practices Act of 1977, as amended (“FCPA”); the FFDCA; 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; and all foreign equivalents in the Additional Territory of any of the foregoing. 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. 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 regarding the development or Commercialization of the Products.
Commercialization Standards of Conduct. Each Party shall, and shall cause its Affiliates to, comply with Applicable Law, the Pharmaceutical Research and Manufacturers of America (PhRMA) Code on Interactions with Healthcare Professionals, and other generally accepted industry codes with respect to the Commercialization of Joint Products in the Territory. In particular, and without limiting the foregoing, each Party shall in all respects comply with Applicable Law concerning the advertising, sales and marketing of prescription drug products in Commercializing Products in the Territory under this Agreement, including the Foreign Corrupt Practices Act of 1977, as amended (“FCPA”) and any applicable local Specific terms in this exhibit have been redacted because confidential treatment for those terms has been requested. These redacted terms have been marked in this exhibit with three asterisks [***]. An unredacted version of this exhibit has been separately filed with the Securities and Exchange Commission. 106 anti-bribery laws. Each Party and its Affiliates shall have a system of internal accounting controls in place that are sufficient to provide reasonable assurances of compliance as required by the FCPA, and shall obtain certification from any permitted sublicensee or distributor it or its Affiliates may engage with respect to Joint Products to do the same, to bring any material non-compliance therewith (should it ever occur) by any of the foregoing entities to its attention, and to promptly remedy any such non-compliance. Each Party and its Affiliates shall maintain such controls throughout the Term and shall promptly notify the JMC in writing with respect to any material non-compliance regarding Commercialization of Joint Products.
Commercialization Standards of Conduct. (a) On a Product-by-Product basis, each Party will use Commercially Reasonable Efforts to Commercialize such Product in the Shared Territory, and to carry out the tasks specified under the Joint Commercialization Plan in a timely and effective manner and in compliance in all material respects with Applicable Law and applicable codes of conduct.
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.
Commercialization Standards of Conduct. (a) Each Party and its Affiliates shall not, and shall ensure that its subcontractors and distributors shall not, directly or indirectly, promote, or market any product(s) within the FS Product Line and the External Products used in connection therewith, (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.
Commercialization Standards of Conduct. (a) Roivant shall, and shall cause its Sub-distributors and its and their Affiliates to, in all respects comply with all Applicable Laws in Commercializing Products, including to the extent applicable all federal, state and local “fraud and abuse,” consumer protection and false claims statutes and regulations.
Commercialization Standards of Conduct. CRXX shall in all respects comply with all applicable laws and regulations in Commercializing Products in the Territory under this 779758 v7/HN Agreement, including without limitation the Foreign Corrupt Practices Act of 1977, as amended (“FCPA”). CRXX represents and warrants to PGx that, as of the approval date for any Product, CRXX and its Affiliates will have adequate procedures in place to ensure their compliance with the FCPA, as well as the compliance therewith of any sublicensees and distributors it or its Affiliates may engage; to bring any non-compliance therewith (should it ever occur) by any of the foregoing entities to CRXX’s attention; and to promptly remedy any such non-compliance. CRXX and its Affiliates shall thereafter maintain such procedures throughout the Term and shall promptly notify PGx in writing with respect to any non-compliance regarding Commercialization of Products.
Commercialization Standards of Conduct. Eisai shall, and shall use Commercially Reasonable Efforts to cause the Eisai Related Parties and Co-Promotion Partners to, in all respects comply with all Applicable Laws in Commercializing the Products in the Territory.
Commercialization Standards of Conduct. 9.9.1 Fresenius shall, and shall cause its Related Parties to, in all material respects comply with all Laws in Commercializing the Distribution Product hereunder, including, to the extent applicable, the FD&C Act; the PHSA, as amended; the United States Prescription Drug Marketing Act of 1987, as amended; US Anti-Kickback Statute; the United States Health Insurance Portability and Accountability Act of 1996, as amended; and all federal, state and local “fraud and abuse”, consumer protection, and false claims statutes and regulations in the United States, including the Medicare and State Health 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; and all equivalents of the foregoing in any Ex-US country or territory.
Commercialization Standards of Conduct
