Compliance with Laws; Export Controls. Licensee shall comply with all applicable laws and regulations, including, without limitation, statutes and regulations affecting drug testing, development, marketing and distribution; laws and implementing regulations of the Department of Commerce governing intellectual property in federally-funded inventions; and Export Administration Regulations of the United States Department of Commerce issued pursuant to the Export Administration Act of 1979 (50 Xxx. X.X.X. §0000 et seq.). Licensee understands and acknowledges that transfer of certain technical data, computer software, laboratory prototypes and other commodities is subject to United States laws and regulations controlling their export, some of which prohibit or require a license for the export of certain types of technical data, to certain specified countries. CMCC neither represents that a license shall not be required, nor that if required, it shall be issued. Licensee hereby agrees and gives written assurance that it will comply with all United States laws and regulations, and any applicable similar laws and regulations of any other country, controlling the export of commodities and technical data, that it will be solely responsible for any violation of such by Licensee and/or its Affiliates and/or Sublicensees and that it will defend and hold CMCC, its Affiliates and their officers, directors, employees, agents, and medical staff harmless in accordance with the process set forth in Paragraphs B and C of ARTICLE VIII in the event of any legal action of any nature occasioned by such violation and any action by any governmental agency or authority, or any other party, relating to any asserted illegality or regulatory violation in the development, production, approval, marketing, sale, storage, manufacture, distribution, export or commercialization of Licensed Products or Licensed Processes by the Licensee, its Affiliates and/or its Sublicensees.
Appears in 4 contracts
Samples: Exclusive License Agreement (Genocea Biosciences, Inc.), Exclusive License Agreement (Genocea Biosciences, Inc.), Exclusive License Agreement (Genocea Biosciences, Inc.)
Compliance with Laws; Export Controls. A. Licensee shall comply with all applicable laws and regulations, including, without limitation, statutes and regulations affecting drug testing, development, marketing and distribution; laws and implementing regulations of the Department of Commerce governing intellectual property in federally-funded inventions; and Export Administration Regulations of the United States Department of Commerce issued pursuant to the Export Administration Act of 1979 (50 XxxApp. X.X.X. U.S.C. §0000 et 2401 et. seq.). Licensee understands and acknowledges that transfer of certain technical data, computer software, laboratory prototypes and other commodities is subject to United States laws and regulations controlling their export, some of which prohibit or require a license for the export of certain types of technical data, to certain specified countries. CMCC neither represents that a license shall not be required, nor that if required, it shall be issued. Licensee hereby agrees represents and gives written assurance warrants that it will comply with all United States laws and regulations, and any applicable similar laws and regulations of any other country, controlling the export of commodities and technical data, that it will be solely responsible for any violation of such by Licensee and/or its Affiliates and/or Sublicensees Sublicensees, and that it will defend and hold CMCC, its Affiliates and their officers, directors, employees, agents, and medical staff harmless in accordance with the process set forth in Paragraphs B and C of ARTICLE VIII in the event of any third party legal action of any nature occasioned by such violation violation, and any action by any governmental agency or authority, or any other party, relating to any asserted illegality or regulatory violation in the development, production, approval, marketing, sale, storage, manufacture, distribution, export or commercialization of Licensed Products or Licensed Processes by Processes.
B. It is the Licenseeintention of the Parties hereto to comply with all applicable laws, its Affiliates and/or its Sublicenseesrules, and regulations, including (i) the federal anti-kickback statute (42 U.S.C. §1320a-7b) and related safe harbor regulations, and (ii) the Limitation Certain Physician Referrals (42 U.S.C. §1395nn, the “Xxxxx Law”). Accordingly, the Parties agree and acknowledge that no consideration received under this Agreement is, or is intended to be, a prohibited payment for the recommending or arranging for the referral of business or ordering of items or services, nor is any such consideration intended to induce illegal referrals of business.
Appears in 3 contracts
Samples: Exclusive License Agreement (Morphic Holding, Inc.), Exclusive License Agreement (Morphic Holding, Inc.), Exclusive License Agreement (Morphic Holding, Inc.)
Compliance with Laws; Export Controls. Licensee shall comply with all applicable laws and regulations, including, without limitation, statutes and regulations affecting drug testing, development, marketing and distribution; laws and implementing regulations of the Department of Commerce governing intellectual property in federally-funded inventionsinventions when applicable; and Export Administration Regulations of the United States Department of Commerce issued pursuant to the Export Administration Act of 1979 (50 XxxApp. X.X.X. U.S.C. §0000 et 2401 et. seq.). Licensee understands and acknowledges that transfer of certain technical data, computer software, laboratory prototypes and other commodities is subject to United States laws and regulations controlling their export, some of which prohibit or require a license for the export of certain types of technical data, to certain specified countries. CMCC neither represents that a license shall not be required, nor that if required, it shall be issued. Licensee hereby agrees and gives written assurance that it will comply with all United States laws and regulations, and any applicable similar laws and regulations of any other country, controlling the export of commodities and technical data, that it will be solely responsible for any violation of such by Licensee and/or its Affiliates and/or Sublicensees sublicensees, and that it will defend and hold CMCC, its Affiliates affiliates and their officers, directors, employees, agents, and medical staff harmless in accordance with the process set forth in Paragraphs B and C of ARTICLE VIII in the event of any legal action of any nature occasioned by such violation violation, and any action by any governmental agency or authority, or any other party, relating to any asserted illegality or regulatory violation in the development, production, approval, marketing, sale, storage, manufacture, distribution, export or commercialization of Licensed Products or Licensed Processes by the Licensee, its Affiliates and/or its SublicenseesProducts.
Appears in 2 contracts
Samples: Exclusive License Agreement (Invivo Therapeutics Holdings Corp.), Exclusive License Agreement (Invivo Therapeutics Holdings Corp.)
Compliance with Laws; Export Controls. Licensee JBI shall comply with all applicable laws and regulations, including, without limitation, statutes and regulations affecting drug testing, development, marketing and distribution; laws and implementing regulations of the Department of Commerce governing intellectual property in federally-funded inventions; and Export Administration Regulations of the United States Department of Commerce issued pursuant to the Export Administration Act of 1979 (50 XxxApp. X.X.X. U.S.C. §0000 et 2401 et. seq.). Licensee JBI understands and acknowledges that transfer of certain technical data, computer software, laboratory prototypes and other commodities is subject to United States laws and regulations controlling their export, some of which prohibit or require a license for the export of certain types of technical data, to certain specified countries. JBI further acknowledges and agrees that CMCC neither represents that a license shall not be required, nor that if required, it shall be issued. Licensee hereby agrees and gives written assurance that it will JBI shall comply with all United States laws and regulations, and any applicable similar laws and regulations of any other country, controlling the export of commodities and technical data, that it will shall be solely responsible for any violation of such by Licensee and/or its Affiliates and/or Sublicensees and Sublicensees, and, subject to Paragraph 3 of this Exhibit I. that it will shall defend and hold CMCC, its Affiliates affiliates and their officers, directors, employees, agents, and medical staff harmless in accordance with the process set forth in Paragraphs B and C of ARTICLE VIII in the event of any legal action of any nature occasioned by such violation violation, and any action by any governmental agency or authority, or any other party, relating to any asserted illegality or regulatory violation in the development, production, approval, marketing, sale, storage, manufacture, distribution, export or commercialization of Licensed Products or Licensed Processes by the LicenseeProducts, its Affiliates and/or its Sublicensees.(see §XI (A))
Appears in 2 contracts
Samples: Option and License Agreement (Scholar Rock Holding Corp), Option and License Agreement (Scholar Rock Holding Corp)
Compliance with Laws; Export Controls. A. Licensee shall comply with all applicable laws and regulations, including, without limitation, statutes and regulations affecting drug testing, development, marketing and distribution; laws and implementing regulations of the Department of Commerce governing intellectual property in federally-funded inventions; and Export Administration Regulations of the United States Department of Commerce issued pursuant to the Export Administration Act of 1979 (50 XxxApp, U.S.C. §2401 et. X.X.X. §0000 et seq.). Licensee understands and acknowledges that transfer of certain technical data, computer software, laboratory prototypes and other commodities is subject to United States laws and regulations controlling their export, some of which prohibit or require a license for the export of certain types of technical data, to certain specified countries. CMCC neither represents that a license shall not be required, nor that if required, it shall be issued. Licensee hereby agrees represents and gives written assurance warrants that it will comply with all United States laws and regulations, and any applicable similar laws and regulations of any other country, controlling the export of commodities and technical data, that it will be solely responsible for any violation of such by Licensee and/or its Affiliates and/or Sublicensees Sublicensees, and that it will defend and hold CMCC, CMCC and its Affiliates and their officers, directors, employees, agents, and medical staff harmless in accordance with the process set forth in Paragraphs B and C of ARTICLE VIII in the event of any legal action of any nature occasioned by such violation violation, and any action by any governmental agency or authority, or any other party, relating to any asserted illegality or regulatory violation in the development, production, approval, marketing, sale, storage, manufacture, distribution, export or commercialization of Licensed Products or Licensed Processes by Processes.
B. It is the Licenseeintention of the Parties hereto to comply with all applicable laws, its Affiliates and/or its Sublicenseesrules, and regulations, including (i) the federal anti-kickback statute (42 U.S.C. §1320a-7b) and related safe harbor regulations, and (ii) the Limitation Certain Physician Referrals (42 U.S.C. §1395nn, the “Xxxxx Law”). Accordingly, the Parties agree and acknowledge that no consideration received under this Agreement is, or is intended to be, a prohibited payment for the recommending or arranging for the referral of business or ordering of Items or services, nor is any such consideration intended to induce illegal referrals of business.
Appears in 2 contracts
Samples: Exclusive License Agreement (Scholar Rock Holding Corp), Exclusive License Agreement (Scholar Rock Holding Corp)
Compliance with Laws; Export Controls. Licensee shall comply with all applicable laws and regulations, including, without limitation, statutes and regulations affecting drug testing, development, marketing and distribution; laws and implementing regulations of the Department of Commerce governing intellectual property in federally-funded inventions; and Export Administration Regulations of the United States Department of Commerce issued pursuant to the Export Administration Act of 1979 (50 XxxApp. X.X.X. §0000 et U.S.C. Section 2401 et. seq.). Licensee understands and acknowledges that transfer of certain technical data, computer software, laboratory prototypes and other commodities is subject to United States laws and regulations controlling their export, some of which prohibit or require a license for the export of certain types of technical data, to certain specified countries. CMCC neither represents that a license shall not be required, nor that if required, it shall be issued. Licensee hereby agrees and gives written assurance that it will comply with all United States laws and regulations, and any applicable similar laws and regulations of any other country, controlling the export of commodities and technical data, that it will be solely responsible for any violation of such by Licensee and/or its Affiliates and/or Sublicensees Sublicensees, and that it will defend and hold CMCC, its Affiliates affiliates and their officers, directors, employees, agents, and medical staff harmless in accordance with the process set forth in Paragraphs B and C of ARTICLE VIII in the event of any legal action of any nature occasioned by such violation violation, and any action by any governmental agency or authority, or any other party, relating to any asserted illegality or regulatory violation in the development, production, approval, marketing, sale, storage, manufacture, distribution, export or commercialization of Licensed Products or Licensed Processes by the Licensee, its Affiliates and/or its SublicenseesProcesses.
Appears in 2 contracts
Samples: Exclusive License Agreement (Boston Life Sciences Inc /De), Exclusive License Agreement (Boston Life Sciences Inc /De)
Compliance with Laws; Export Controls. Licensee shall comply with all applicable laws and regulations, including, without limitation, statutes and regulations affecting drug testing, development, marketing and distribution; laws and implementing regulations of the Department of Commerce governing intellectual property in federally-funded inventions; and Export Administration Regulations of the United States Department of Commerce issued pursuant to the Export Administration Act of 1979 (50 XxxApp. X.X.X. U.S.C. §0000 et 2401 et. seq.). Licensee understands and acknowledges that transfer of certain technical data, computer software, laboratory prototypes and other commodities is subject to United States laws and regulations controlling their export, some of which prohibit or require a license for the export of certain types of technical data, to certain specified countries. CMCC neither represents that a license shall not be required, nor that if required, it shall be issued. Licensee hereby agrees and gives written assurance that it will comply with all United States laws and regulations, and any applicable similar laws and regulations of any other country, controlling the export of commodities and technical data, that it will be solely responsible for any violation of such laws and regulations by Licensee and/or its Affiliates and/or Sublicensees Sublicensees, and that it will defend and hold CMCC, its Affiliates and their officers, directors, employees, agents, and medical staff harmless in accordance with the process set forth in Paragraphs B and C of ARTICLE VIII in the event of any legal action of any nature occasioned by such violation violation, and any action by any governmental agency or authority, authority or any other aggrieved party, relating to any asserted illegality or regulatory violation in the development, production, approval, marketing, sale, storage, manufacture, distribution, export or commercialization of Licensed Products or Licensed Processes by the Licensee, its Affiliates and/or its Sublicensees.Products. * Confidential Treatment Requested 33
Appears in 2 contracts
Samples: Exclusive License Agreement (Tengion Inc), Exclusive License Agreement (Tengion Inc)
Compliance with Laws; Export Controls. Licensee shall comply with all applicable laws and regulations, including, without limitation, statutes and regulations affecting drug testing, development, marketing and distribution; laws and implementing regulations of the Department of Commerce governing intellectual property in federally-funded inventions; and Export Administration Regulations of the United States Department of Commerce issued pursuant to the Export Administration Act of 1979 (50 XxxApp. X.X.X. U.S.C. §0000 et 2401 et. seq.). Licensee understands and acknowledges that transfer of certain technical data, computer software, laboratory prototypes and other commodities is subject to United States laws and regulations controlling their export, some of which prohibit or require a license for the export of certain types of technical data, to certain specified countries. CMCC neither represents that a license shall not be required, nor that if required, it shall be issued. Licensee hereby agrees and gives written assurance that it will comply with all United States laws and regulations, and any applicable similar laws and regulations of any other country, controlling the export of commodities and technical data, that it will be solely responsible for any violation of such by Licensee and/or its Affiliates and/or Sublicensees Sublicensees, and that it will defend and hold CMCC, its Affiliates affiliates and their officers, directors, employees, agents, and medical staff harmless in accordance with the process set forth in Paragraphs B and C of ARTICLE VIII in the event of any legal action of any nature occasioned by such violation violation, and any action by any governmental agency or authority, or any other party, relating to any asserted illegality or regulatory violation in the development, production, approval, marketing, sale, storage, manufacture, distribution, export or commercialization of Licensed Products or Licensed Processes by the Licensee, its Affiliates and/or its Sublicenseesunder this Agreement.
Appears in 2 contracts
Samples: Exclusive License Agreement (Fate Therapeutics Inc), Exclusive License Agreement (Fate Therapeutics Inc)