Trade Control Laws. In the performance of the Agreement, Company shall comply with all applicable export control and economic sanctions laws and regulations of the United States, European Union, EU member states, United Kingdom and other applicable government authorities including without limitation the U.S. Export Administration Regulations, the economic sanctions rules and regulations implemented under statutory authority and/or the President’s Executive Orders and administered by the U.S. Treasury Department’s Office of Foreign Assets Control, the International Traffic in Arms Regulation (“ITAR”), and the anti-boycott rules implemented by the Departments of Commerce and Treasury (collectively, “Trade Control Laws”). Company will not export, re-export, transfer, re-transfer or otherwise ship the Products except as authorized under applicable Trade Control Laws. Company hereby acknowledges and confirms that Company and any of its Resellers or Customers (i) are not included on, owned or controlled by an individual or entity included on, or acting on behalf of an individual or entity included on any of the restricted party lists maintained by the U.S. Government (e.g., Specially Designated Nationals List, Foreign Sanctions Evader List, Sectoral Sanctions Identification List, Denied Persons List, Unverified List, Entity List or List of Statutorily Debarred Parties) (collectively, “Restricted Parties”); (ii) will not export, re-export, transfer, re-transfer or otherwise ship, directly or indirectly, the Products or related technology to or for use by Restricted Parties; (iii) will not export, re-export, transfer, re-transfer or otherwise ship, directly or indirectly, the Products or related technology to or for use in or by countries or territories subject to U.S. economic sanctions (e.g., Crimea, Cuba, Iran, North Korea, or Syria); or (iv) will not use or sell the Products for nuclear end-uses, rocket systems, unmanned air vehicles, chemical or biological weapons, maritime nuclear propulsion, weapons of mass destruction or other restricted end-uses except to the extent consistent with Trade Control Laws. Company will require its Resellers and Customers to comply with this Trade Control Laws section. Violation of this section may result in immediate termination of the Agreement or other remedies at the discretion of Tenable.
Appears in 1 contract
Samples: Master Partner Agreement
Trade Control Laws. In the performance of the Agreement, Company shall (a) Each Party will fully comply with all applicable export control and control, economic sanctions laws and anti-boycott regulations of the United States, European Union, EU member states, United Kingdom States of America and other applicable government authorities governments, including without limitation but not limited to the U.S. Export Administration Regulations, Regulations (Title 15 of the U.S. Code of Federal Regulations Part 730 et seq.) and the economic sanctions rules and regulations implemented under statutory authority and/or the President’s 's Executive Orders and administered by the U.S. Treasury Department’s 's Office of Foreign Assets Control, Control (Title 31 of the International Traffic in Arms Regulation (“ITAR”), and the anti-boycott rules implemented by the Departments U.S. Code of Commerce and Treasury Federal Regulations Part 500 et seq.) (collectively, “"Trade Control Laws”"). Company will not export, re-export, transfer, re-transfer or otherwise ship the Products except as authorized under applicable Trade Control Laws. Company hereby .
(b) Each Party acknowledges and confirms that Company Trade Control Laws apply to its activities, its employees and Affiliates under this Agreement. ***CERTAIN INFORMATION HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.
(c) No API Compound or Licensed Product will be directly or indirectly shipped by the other Party to any country subject to U.S. or U.N. economic sanctions without the necessary licenses, even for transfer to non-sanctioned countries.
(d) Neither Party shall be required by the terms of its Resellers this Agreement to be directly or Customers indirectly involved in the provision of goods, services and/or technical data that may be prohibited by applicable Trade Control Laws if performed by such Party.
(ie) are Each Party hereby represents and warrants that it is not included on, owned or controlled by an individual or entity included on, or acting on behalf of an individual or entity included on any of the restricted party Party lists maintained by the U.S. Government (e.g.Government, including, but not limited to, the Specially Designated Nationals List, List administered by the U.S. Treasury Department's Office of Foreign Sanctions Evader List, Sectoral Sanctions Identification List, Assets Control; the Denied Persons List, Unverified List, List or Entity List maintained by the U.S. Commerce Department's Bureau of Industry and Security; or the List of Statutorily Debarred PartiesParties maintained by the U.S. State Department's Directorate of Defense Trade Controls.
(f) Each Party shall commit to maintaining awareness of the importance of Trade Control Laws throughout its organization. Each Party shall take such actions as are necessary and reasonable to prevent API Compound and Licensed Product from being exported or re-exported to any country, entity and/or individual subject to U.S. trade sanctions, unless prior approval of the other Party, and relevant permission and/or license from the U.S. government has been obtained.
(collectively, “Restricted Parties”); g) Each Party will keep accurate and consistent records of all transactions covered by the Trade Control Laws for a minimum of five (ii5) will not export, years from the date of export or re-export; the date of expiration of any applicable license; or, transfer, re-transfer other approval or otherwise ship, directly reliance on any application of license exception or indirectly, the Products or related technology to or for use by Restricted Parties; (iii) will not export, re-export, transfer, re-transfer or otherwise ship, directly or indirectly, the Products or related technology to or for use in or by countries or territories subject to U.S. economic sanctions (e.g., Crimea, Cuba, Iran, North Korea, or Syria); or (iv) will not use or sell the Products for nuclear end-uses, rocket systems, unmanned air vehicles, chemical or biological weapons, maritime nuclear propulsion, weapons of mass destruction or other restricted end-uses except to the extent consistent with Trade Control Laws. Company will require its Resellers and Customers to comply with this Trade Control Laws section. Violation of this section may result in immediate termination of the Agreement or other remedies at the discretion of Tenableexemption.
Appears in 1 contract
Samples: Development and Commercialization Agreement (Theravance Biopharma, Inc.)
Trade Control Laws. In the performance of the Agreement, Company shall (i) Each Party with respect to its rights and obligations arising from this Agreement will fully comply with all applicable export control and control, economic sanctions laws and anti-boycott regulations of the United States, European Union, EU member states, United Kingdom States of America and other applicable government authorities governments, including without limitation the U.S. Export Administration Regulations, Regulations (Title 15 of the U.S. Code of Federal Regulations Part 730 et seq.) and the economic sanctions rules and regulations implemented under statutory authority and/or the President’s Executive Orders and administered by the U.S. Treasury Department’s Office of Foreign Assets Control, Control (Title 31 of the International Traffic in Arms Regulation (“ITAR”), and the anti-boycott rules implemented by the Departments U.S. Code of Commerce and Treasury Federal Regulations Part 500 et seq.) (collectively, “Trade Control Laws”). Company will not export, re-export, transfer, re-transfer or otherwise ship the Products except as authorized under applicable Trade Control Laws. Company hereby .
(ii) Each Party acknowledges and confirms that Company Trade Control Laws apply to its activities, its employees and Affiliates under this Agreement.
(iii) No Compound or Product will be directly or indirectly shipped by the other Party to any country subject to U.S. or U.N. economic sanctions without the necessary licenses, even for transfer to non-sanctioned countries.
(iv) Neither Party shall be required by the terms of its Resellers this Agreement to be directly or Customers indirectly involved in the provision of goods, services and/or technical data that may be prohibited by applicable Trade Control Laws if performed by such Party.
(iv) are Each Party hereby represents and warrants that it is not included on, owned or controlled by an individual or entity included on, or acting on behalf of an individual or entity included on any of the restricted party Party lists maintained by the U.S. Government (e.g.Government, including the Specially Designated Nationals List, List administered by the U.S. Treasury Department’s Office of Foreign Sanctions Evader List, Sectoral Sanctions Identification List, Assets Control; the Denied Persons List, Unverified List, List or Entity List maintained by the U.S. Commerce Department’s Bureau of Industry and Security; or the List of Statutorily Debarred PartiesParties maintained by the U.S. State Department’s Directorate of Defense Trade Controls.
(vi) Each Party shall commit to maintaining awareness of the importance of Trade Control Laws throughout its organization. Each Party shall take such actions as are necessary and reasonable to prevent Compound and Product from being exported or re-exported to any country, entity and/or individual subject to U.S. trade sanctions, unless prior approval of the other Party, and relevant permission and/or license from the U.S. government has been obtained.
(collectively, “Restricted Parties”); vii) Each Party will keep accurate and consistent records with respect to its rights and obligations arising from this Agreement of all transactions covered by the Trade Control Laws for a minimum of five (ii5) will not export, years from the date of export or re-export; the date of expiration of any applicable license; or, transfer, re-transfer other approval or otherwise ship, directly reliance on any application of license exception or indirectly, the Products or related technology to or for use by Restricted Parties; (iii) will not export, re-export, transfer, re-transfer or otherwise ship, directly or indirectly, the Products or related technology to or for use in or by countries or territories subject to U.S. economic sanctions (e.g., Crimea, Cuba, Iran, North Korea, or Syria); or (iv) will not use or sell the Products for nuclear end-uses, rocket systems, unmanned air vehicles, chemical or biological weapons, maritime nuclear propulsion, weapons of mass destruction or other restricted end-uses except to the extent consistent with Trade Control Lawsexemption. Company will require its Resellers and Customers to comply with this Trade Control Laws section***CERTAIN INFORMATION HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. Violation of this section may result in immediate termination of the Agreement or other remedies at the discretion of TenableCONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.
Appears in 1 contract
Samples: License and Collaboration Agreement (Theravance Biopharma, Inc.)
Trade Control Laws. In the performance of the Agreement, Company shall (i) Each Party with respect to its rights and obligations arising from this Agreement will fully comply with all applicable export control and control, economic sanctions laws and anti-boycott regulations of the United States, European Union, EU member states, United Kingdom States of America and other applicable government authorities governments, including without limitation the U.S. Export Administration Regulations, Regulations (Title 15 of the U.S. Code of Federal Regulations Part 730 et seq.) and the economic sanctions rules and regulations implemented under statutory authority and/or the President’s 's Executive Orders and administered by the U.S. Treasury Department’s 's Office of Foreign Assets Control, Control (Title 31 of the International Traffic in Arms Regulation (“ITAR”), and the anti-boycott rules implemented by the Departments U.S. Code of Commerce and Treasury Federal Regulations Part 500 et seq.) (collectively, “"Trade Control Laws”"). Company will not export, re-export, transfer, re-transfer or otherwise ship the Products except as authorized under applicable Trade Control Laws. Company hereby .
(ii) Each Party acknowledges and confirms that Company Trade Control Laws apply to its activities, its employees and Affiliates under this Agreement.
(iii) No Compound or Product will be directly or indirectly shipped by the other Party to any country subject to U.S. or U.N. economic sanctions without the necessary licenses, even for transfer to non-sanctioned countries.
(iv) Neither Party shall be required by the terms of its Resellers this Agreement to be directly or Customers indirectly involved in the provision of goods, services and/or technical data that may be prohibited by applicable Trade Control Laws if performed by such Party.
(iv) are Each Party hereby represents and warrants that it is not included on, owned or controlled by an individual or entity included on, or acting on behalf of an individual or entity included on any of the restricted party Party lists maintained by the U.S. Government (e.g.Government, including the Specially Designated Nationals List, List administered by the U.S. Treasury Department's Office of Foreign Sanctions Evader List, Sectoral Sanctions Identification List, Assets Control; the Denied Persons List, Unverified List, List or Entity List maintained by the U.S. Commerce Department's Bureau of Industry and Security; or the List of Statutorily Debarred PartiesParties maintained by the U.S. State Department's Directorate of Defense Trade Controls.
(vi) Each Party shall commit to maintaining awareness of the importance of Trade Control Laws throughout its organization. Each Party shall take such actions as are necessary and reasonable to prevent Compound and Product from being exported or re-exported to any country, entity and/or individual subject to U.S. trade sanctions, unless prior approval of the other Party, and relevant permission and/or license from the U.S. government has been obtained.
(collectively, “Restricted Parties”); vii) Each Party will keep accurate and consistent records with respect to its rights and obligations arising from this Agreement of all transactions covered by the Trade Control Laws for a minimum of five (ii5) will not export, years from the date of export or re-export; the date of expiration of any applicable license; or, transfer, re-transfer other approval or otherwise ship, directly reliance on any application of license exception or indirectly, the Products or related technology to or for use by Restricted Parties; (iii) will not export, re-export, transfer, re-transfer or otherwise ship, directly or indirectly, the Products or related technology to or for use in or by countries or territories subject to U.S. economic sanctions (e.g., Crimea, Cuba, Iran, North Korea, or Syria); or (iv) will not use or sell the Products for nuclear end-uses, rocket systems, unmanned air vehicles, chemical or biological weapons, maritime nuclear propulsion, weapons of mass destruction or other restricted end-uses except to the extent consistent with Trade Control Lawsexemption. Company will require its Resellers and Customers to comply with this Trade Control Laws section***CERTAIN INFORMATION HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. Violation of this section may result in immediate termination of the Agreement or other remedies at the discretion of Tenable.CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.
Appears in 1 contract
Samples: License and Collaboration Agreement (Theravance Biopharma, Inc.)
Trade Control Laws. In the performance of the Agreement, Company shall 9.4.1 Each Party will fully comply with all applicable export control and control, economic sanctions laws and anti-boycott regulations of the United States, European Union, EU member states, United Kingdom States of America and other applicable government authorities governments, including without limitation the U.S. Export Administration Regulations, Regulations (Title 15 of the U.S. Code of Federal Regulations Part 730 et seq.) and the economic sanctions rules and regulations implemented under statutory authority and/or the or President’s Executive Orders and administered by the U.S. Treasury Department’s Office of Foreign Assets Control, Control (Title 31 of the International Traffic in Arms Regulation (“ITAR”), and the anti-boycott rules implemented by the Departments U.S. Code of Commerce and Treasury Federal Regulations Part 500 et seq.) (collectively, “Trade Control Laws”). Company will not export.
9.4.2 Each Party acknowledges and confirms that Trade Control Laws apply to its activities, re-export, transfer, re-transfer or otherwise ship its employees and Affiliates under this Agreement.
9.4.3 COMPANY acknowledges that it shall be solely and exclusively responsible for the Products except as authorized under preparation of all import and export documentation and compliance with all applicable Trade Control Laws, except as otherwise agreed by the Parties in writing. Company hereby acknowledges COMPANY represents and confirms warrants that Company and is shall not take any unilateral action to identify or otherwise name DPT as the importer or exporter of record for any of the aforementioned items.
9.4.4 No Product will be directly or indirectly shipped by the other Party to any country subject to U.S. or U.N. economic sanctions without the necessary licenses, even for transfer to non-sanctioned countries, and only after the express written consent of DPT, in its Resellers sole discretion.
9.4.5 DPT shall not be required by the terms of this Agreement to be directly or Customers (i) are indirectly involved in the provision of goods, services or technical data that may be prohibited by applicable Trade Control Laws if performed by DPT. It shall be in the sole discretion of DPT to refrain from being directly or indirectly involved in the provision of goods, services or technical data that may be prohibited by applicable Trade Control Laws.
9.4.6 Each Party hereby represents and warrants that it is not included on, owned or controlled by an individual or entity included on, or acting on behalf of an individual or entity included on any of the restricted party lists maintained by the U.S. Government (e.g.Government, including the Specially Designated Nationals List, List administered by the U.S. Treasury Department’s Office of Foreign Sanctions Evader List, Sectoral Sanctions Identification List, Assets Control; the Denied Persons List, Unverified List, List or Entity List maintained by the U.S. Commerce Department’s Bureau of Industry and Security; or the List of Statutorily Debarred PartiesParties maintained by the U.S. State Department’s Directorate of Defense Trade Controls.
9.4.7 Each Party shall commit to maintaining awareness of the importance of Trade Control Laws throughout its organization. Each Party shall take such actions as are necessary and reasonable to prevent Product from being exported or re-exported to any country, entity or individual subject to U.S. trade sanctions, unless prior approval of the other Party, and relevant permission or license from the U.S. government has been obtained.
9.4.8 Each Party will keep accurate and consistent records of all transactions under this Agreement covered by the Trade Control Laws for a minimum of five (5) (collectively, “Restricted Parties”); (ii) will not export, years from the date of export or re-export; the date of expiration of any applicable license; or, transfer, re-transfer other approval or otherwise ship, directly reliance on any application of license exception or indirectly, exemption.
9.4.9 COMPANY shall be the Products importer or related technology exporter of record for all such import or export activities. COMPANY shall cooperate with DPT as reasonably necessary to or for use by Restricted Parties; (iii) will not export, re-export, transfer, re-transfer or otherwise ship, directly or indirectly, the Products or related technology to or for use in or by countries or territories subject to U.S. economic sanctions (e.g., Crimea, Cuba, Iran, North Korea, or Syria); or (iv) will not use or sell the Products for nuclear end-uses, rocket systems, unmanned air vehicles, chemical or biological weapons, maritime nuclear propulsion, weapons of mass destruction or other restricted end-uses except to the extent consistent with Trade Control Laws. Company will require its Resellers and Customers permit DPT to comply with this the laws and regulations of the United States, including Trade Control Laws section. Violation and Anti-Corruption Laws, and the laws and regulations other country relating to the control of this section may result in immediate termination import or export of the Agreement Product, Active Pharmaceutical Ingredient, chemical, Labeling or other remedies at the discretion of TenablePackaging components (or related technical information or data).
Appears in 1 contract
Samples: Supply and Manufacturing Agreement (Evofem Biosciences, Inc.)
Trade Control Laws. In the performance of the Agreement, Company shall (a) Each Party will fully comply with all applicable export control and control, economic sanctions laws and anti-boycott regulations of the United States, European Union, EU member states, United Kingdom States of America and other applicable government authorities governments, including without limitation the U.S. Export Administration Regulations, Regulations (Title 15 of the U.S. Code of Federal Regulations Part 730 et seq.) and the economic sanctions rules and regulations implemented under statutory authority and/or the or President’s Executive Orders and administered by the U.S. Treasury Department’s Office of Foreign Assets Control, Control (Title 31 of the International Traffic in Arms Regulation (“ITAR”), and the anti-boycott rules implemented by the Departments U.S. Code of Commerce and Treasury Federal Regulations Part 500 et seq.) (collectively, “Trade Control Laws”).
(b) Each Party acknowledges and confirms that Trade Control Laws apply to its activities, its employees and Affiliates under this Agreement.
(c) No Product will be directly or indirectly shipped by the other Party to any country subject to U.S. or U.N. economic sanctions without the necessary licenses, even for transfer to non-sanctioned countries, and only after the express written consent of Mylan, [***].
(d) Neither Party shall be required by the terms of this Agreement to be directly or indirectly involved in the provision of goods, services or technical data that may be prohibited by applicable Trade Control Laws if performed by such Party. Company will not exportIt shall be [***] the [***] to refrain from being directly or indirectly involved in the provision of goods, re-export, transfer, re-transfer services or otherwise ship the Products except as authorized under technical data that may be prohibited by applicable Trade Control Laws. Company .
(e) Each Party hereby acknowledges represents and confirms warrants that Company and any of its Resellers or Customers (i) are it is not included on, owned or controlled by an individual or entity included on, or acting on behalf of an individual or entity included on any of the restricted party lists maintained by the U.S. Government (e.g.Government, including the Specially Designated Nationals List, List administered by the U.S. Treasury Department’s Office of Foreign Sanctions Evader List, Sectoral Sanctions Identification List, Assets Control; the Denied Persons List, Unverified List, List or Entity List maintained by the U.S. Commerce Department’s Bureau of Industry and Security; or the List of Statutorily Debarred PartiesParties maintained by the U.S. State Department’s Directorate of Defense Trade Controls.
(f) Each Party shall commit to maintaining awareness of the importance of Trade Control Laws throughout its organization. Each Party shall take such actions as are necessary and reasonable to prevent Product from being exported or re-exported to any country, entity or individual subject to U.S. trade sanctions, unless prior approval of the other Party, and relevant permission or license from the U.S. government has been obtained.
(collectively, “Restricted Parties”); g) Each Party will keep accurate and consistent records of all transactions covered by the Trade Control Laws for a minimum of [***] (ii[***]) will not export, [***] from the date of export or re-export; the date of expiration of any applicable license; or, transfer, re-transfer other approval or otherwise ship, directly reliance on any application of license exception or indirectly, the Products or related technology to or for use by Restricted Parties; (iii) will not export, re-export, transfer, re-transfer or otherwise ship, directly or indirectly, the Products or related technology to or for use in or by countries or territories subject to U.S. economic sanctions (e.g., Crimea, Cuba, Iran, North Korea, or Syria); or (iv) will not use or sell the Products for nuclear end-uses, rocket systems, unmanned air vehicles, chemical or biological weapons, maritime nuclear propulsion, weapons of mass destruction or other restricted end-uses except to the extent consistent with Trade Control Laws. Company will require its Resellers and Customers to comply with this Trade Control Laws section. Violation of this section may result in immediate termination of the Agreement or other remedies at the discretion of Tenableexemption.
Appears in 1 contract
Samples: Collaboration Agreement (Momenta Pharmaceuticals Inc)
Trade Control Laws. In the performance of the Agreement, Company shall 9.4.1 Each Party will fully comply with all applicable export control and control, economic sanctions laws and anti-boycott regulations of the United States, European Union, EU member states, United Kingdom States of America and other applicable government authorities governments, including without limitation the U.S. Export Administration Regulations, Regulations (Title 15 of the U.S. Code of Federal Regulations Part 730 et seq.) and the economic sanctions rules and regulations implemented under statutory authority and/or the or President’s Executive Orders and administered by the U.S. Treasury Department’s Office of Foreign Assets Control, Control (Title 31 of the International Traffic in Arms Regulation (“ITAR”), and the anti-boycott rules implemented by the Departments U.S. Code of Commerce and Treasury Federal Regulations Part 500 et seq.) (collectively, “Trade Control Laws”). Company will not export.
9.4.2 Each Party acknowledges and confirms that Trade Control Laws apply to its activities, re-export, transfer, re-transfer or otherwise ship its employees and Affiliates under this Agreement.
9.4.3 COMPANY acknowledges that it shall be solely and exclusively responsible for the Products except as authorized under preparation of all import and export documentation and compliance with all applicable Trade Control Laws, except as otherwise agreed by the Parties in writing. Company hereby acknowledges COMPANY represents and confirms warrants that Company and is shall not take any unilateral action to identify or otherwise name DPT as the importer or exporter of record for any of its Resellers the aforementioned items.
9.4.4 No Product will be directly or Customers (i) are indirectly shipped by the other Party to any country subject to U.S. or U.N. economic sanctions without the necessary licenses.
9.4.5 DPT shall not included onbe required by the terms of this Agreement to be directly or indirectly involved in the provision of goods, owned services or controlled technical data that may be prohibited by an individual applicable Trade Control Laws if performed by DPT. It shall be in the sole discretion of DPT to refrain from being directly or entity included onindirectly involved in the provision of goods, services or acting on behalf of an individual or entity technical data that may be prohibited by applicable Trade Control Laws.
9.4.6 Each Party hereby represents and warrants that it is not included on any of the restricted party lists maintained by the U.S. Government (e.g.Government, including the Specially Designated Nationals List, List administered by the U.S. Treasury Department’s Office of Foreign Sanctions Evader List, Sectoral Sanctions Identification List, Assets Control; the Denied Persons List, Unverified List, List or Entity List maintained by the U.S. Commerce Department’s Bureau of Industry and Security; or the List of Statutorily Debarred PartiesParties maintained by the U.S. State Department’s Directorate of Defense Trade Controls.
9.4.7 Each Party shall commit to maintaining awareness of the importance of Trade Control Laws throughout its organization. Each Party shall take such actions as are necessary and reasonable to prevent Product from being exported or re-exported to any country, entity or individual subject to U.S. trade sanctions, unless prior approval of the other Party, and relevant permission or license from the U.S. government has been obtained.
9.4.8 Each Party will keep accurate and consistent records of all transactions under this Agreement covered by the Trade Control Laws for a minimum of five (5) (collectively, “Restricted Parties”); (ii) will not export, years from the date of export or re-export; the date of expiration of any applicable license; or, transfer, re-transfer other approval or otherwise ship, directly reliance on any application of license exception or indirectly, exemption.
9.4.9 COMPANY shall be the Products importer or related technology exporter of record for all such import or export activities. COMPANY shall cooperate with DPT as reasonably necessary to or for use by Restricted Parties; (iii) will not export, re-export, transfer, re-transfer or otherwise ship, directly or indirectly, the Products or related technology to or for use in or by countries or territories subject to U.S. economic sanctions (e.g., Crimea, Cuba, Iran, North Korea, or Syria); or (iv) will not use or sell the Products for nuclear end-uses, rocket systems, unmanned air vehicles, chemical or biological weapons, maritime nuclear propulsion, weapons of mass destruction or other restricted end-uses except to the extent consistent with Trade Control Laws. Company will require its Resellers and Customers permit DPT to comply with this the laws and regulations of the United States, including Trade Control Laws section. Violation and Anti-Corruption Laws, and the laws and regulations other country relating to the control of this section may result in immediate termination import or export of the Agreement Product, Active Pharmaceutical Ingredient, chemical, Labeling or other remedies at the discretion of TenablePackaging components (or related technical information or data).
Appears in 1 contract
Samples: Supply and Manufacturing Agreement (Arcutis Biotherapeutics, Inc.)
Trade Control Laws. In the performance of the Agreement, Company shall (a) Each Party will fully comply with all applicable export control and control, economic sanctions laws and anti-boycott regulations of the United States, European Union, EU member states, United Kingdom States of America and other applicable government authorities governments, including without limitation but not limited to the U.S. Export Administration Regulations, Regulations (Title 15 of the U.S. Code of Federal Regulations Part 730 et seq.) and the economic sanctions rules and regulations implemented under statutory authority and/or the President’s Executive Orders and administered by the U.S. Treasury Department’s Office of Foreign Assets Control, Control (Title 31 of the International Traffic in Arms Regulation (“ITAR”), and the anti-boycott rules implemented by the Departments U.S. Code of Commerce and Treasury Federal Regulations Part 500 et seq.) (collectively, “Trade Control Laws”). Company will not export, re-export, transfer, re-transfer or otherwise ship the Products except as authorized under applicable Trade Control Laws. Company hereby .
(b) Each Party acknowledges and confirms that Company Trade Control Laws apply to its activities, its employees and Affiliates under this Agreement. ***CERTAIN INFORMATION HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.
(c) No API Compound or Licensed Product will be directly or indirectly shipped by the other Party to any country subject to U.S. or U.N. economic sanctions without the necessary licenses, even for transfer to non-sanctioned countries.
(d) Neither Party shall be required by the terms of its Resellers this Agreement to be directly or Customers indirectly involved in the provision of goods, services and/or technical data that may be prohibited by applicable Trade Control Laws if performed by such Party.
(ie) are Each Party hereby represents and warrants that it is not included on, owned or controlled by an individual or entity included on, or acting on behalf of an individual or entity included on any of the restricted party Party lists maintained by the U.S. Government (e.g.Government, including, but not limited to, the Specially Designated Nationals List, List administered by the U.S. Treasury Department’s Office of Foreign Sanctions Evader List, Sectoral Sanctions Identification List, Assets Control; the Denied Persons List, Unverified List, List or Entity List maintained by the U.S. Commerce Department’s Bureau of Industry and Security; or the List of Statutorily Debarred PartiesParties maintained by the U.S. State Department’s Directorate of Defense Trade Controls.
(f) Each Party shall commit to maintaining awareness of the importance of Trade Control Laws throughout its organization. Each Party shall take such actions as are necessary and reasonable to prevent API Compound and Licensed Product from being exported or re-exported to any country, entity and/or individual subject to U.S. trade sanctions, unless prior approval of the other Party, and relevant permission and/or license from the U.S. government has been obtained.
(collectively, “Restricted Parties”); g) Each Party will keep accurate and consistent records of all transactions covered by the Trade Control Laws for a minimum of five (ii5) will not export, years from the date of export or re-export; the date of expiration of any applicable license; or, transfer, re-transfer other approval or otherwise ship, directly reliance on any application of license exception or indirectly, the Products or related technology to or for use by Restricted Parties; (iii) will not export, re-export, transfer, re-transfer or otherwise ship, directly or indirectly, the Products or related technology to or for use in or by countries or territories subject to U.S. economic sanctions (e.g., Crimea, Cuba, Iran, North Korea, or Syria); or (iv) will not use or sell the Products for nuclear end-uses, rocket systems, unmanned air vehicles, chemical or biological weapons, maritime nuclear propulsion, weapons of mass destruction or other restricted end-uses except to the extent consistent with Trade Control Laws. Company will require its Resellers and Customers to comply with this Trade Control Laws section. Violation of this section may result in immediate termination of the Agreement or other remedies at the discretion of Tenableexemption.
Appears in 1 contract
Samples: Development and Commercialization Agreement (Theravance Biopharma, Inc.)
Trade Control Laws. In the performance of the Agreement, Company shall 9.4.1 Each Party will fully comply with all applicable export control and control, economic sanctions laws and anti-boycott regulations of the United StatesStates of America, European Union, EU member states, United Kingdom and other applicable government authorities including without limitation the U.S. Export Administration Regulations, Regulations (Title 15 of the U.S. Code of Federal Regulations Part 730 et seq.) and the economic sanctions rules and regulations implemented under statutory authority and/or the or President’s Executive Orders and administered by the U.S. Treasury Department’s Office of Foreign Assets Control, Control (Title 31 of the International Traffic in Arms Regulation (“ITAR”), and the anti-boycott rules implemented by the Departments U.S. Code of Commerce and Treasury Federal Regulations Part 500 et seq.) (collectively, “Trade Control Laws”).
9.4.2 Each Party acknowledges and confirms that Trade Control Laws apply to its activities, its employees and Affiliates under this Manufacturing Agreement.
9.4.3 No Product will be directly or indirectly shipped by the other Party to any country subject to U.S. or U.N. economic sanctions without the necessary licenses, even for transfer to non-sanctioned countries, and only after the express written consent of Buyer, in its sole discretion.
9.4.4 Buyer shall not be required by the terms of this Manufacturing Agreement to be directly or indirectly involved in the provision of goods, services or technical data that may be prohibited by applicable Trade Control Laws if performed by Buyer. Company will not exportIt shall be in the sole discretion of Buyer to refrain from being directly or indirectly involved in the provision of goods, re-export, transfer, re-transfer services or otherwise ship the Products except as authorized under technical data that may be prohibited by applicable Trade Control Laws. Company .
9.4.5 Each Party hereby acknowledges represents and confirms warrants that Company and any of its Resellers or Customers (i) are it is not included on, owned or controlled by an individual or entity included on, or acting on behalf of an individual or entity included on any of the restricted party lists maintained by the U.S. Government (e.g.Government, including the Specially Designated Nationals List, List administered by the U.S. Treasury Department’s Office of Foreign Sanctions Evader List, Sectoral Sanctions Identification List, Assets Control; the Denied Persons List, Unverified List, List or Entity List maintained by the U.S. Commerce Department’s Bureau of Industry and Security; or the List of Statutorily Debarred PartiesParties maintained by the U.S. State Department’s Directorate of Defense Trade Controls.
9.4.6 Each Party shall commit to maintaining awareness of the importance of Trade Control Laws throughout its organization. Each Party shall take such actions as are necessary and reasonable to prevent Product from being exported or re-exported to any country, entity or individual subject to U.S. trade sanctions, unless prior approval of the other Party, and relevant permission or license from the U.S. government has been obtained.
9.4.7 Each Party will keep accurate and consistent records of all transactions covered by the Trade Control Laws for a minimum of five (5) (collectively, “Restricted Parties”); (ii) will not export, years from the date of export or re-export; the date of expiration of any applicable license; or, transfer, re-transfer other approval or otherwise ship, directly reliance on any application of license exception or indirectly, the Products or related technology to or for use by Restricted Parties; (iii) will not export, re-export, transfer, re-transfer or otherwise ship, directly or indirectly, the Products or related technology to or for use in or by countries or territories subject to U.S. economic sanctions (e.g., Crimea, Cuba, Iran, North Korea, or Syria); or (iv) will not use or sell the Products for nuclear end-uses, rocket systems, unmanned air vehicles, chemical or biological weapons, maritime nuclear propulsion, weapons of mass destruction or other restricted end-uses except to the extent consistent with Trade Control Laws. Company will require its Resellers and Customers to comply with this Trade Control Laws section. Violation of this section may result in immediate termination of the Agreement or other remedies at the discretion of Tenableexemption.
Appears in 1 contract
Trade Control Laws. In the performance of the Agreement, Company shall (a) Each Party will fully comply with all applicable export control and control, economic sanctions laws and anti-boycott regulations of the United States, European Union, EU member states, United Kingdom States of America and other applicable government authorities governments, including without limitation the U.S. Export Administration Regulations, Regulations (Title 15 of the U.S. Code of Federal Regulations Part 730 et seq.) and the economic sanctions rules and regulations implemented under statutory authority and/or the or President’s Executive Orders and administered by the U.S. Treasury Department’s Office of Foreign Assets Control, Control (Title 31 of the International Traffic in Arms Regulation (“ITAR”), and the anti-boycott rules implemented by the Departments U.S. Code of Commerce and Treasury Federal Regulations Part 500 et seq.) (collectively, “Trade Control Laws”).
(b) Each Party acknowledges and confirms that Trade Control Laws apply to its activities, its employees and Affiliates under this Agreement.
(c) No Product will be directly or indirectly shipped by a Party to any country subject to U.S. or U.N. economic sanctions without the necessary licenses, even for transfer to non-sanctioned countries, and only after the express written consent of both Parties.
(d) Neither Party shall be required by the terms of this Agreement to be directly or indirectly involved in the provision of goods, services or technical data that may be prohibited by applicable Trade Control Laws if performed by such Party. Company will not exportIt shall be in the sole discretion of each Party [*] = Certain confidential information contained in this document, re-exportmarked by brackets, transferhas been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, re-transfer as amended to refrain from being directly or otherwise ship indirectly involved in the Products except as authorized under provision of goods, services or technical data that may be prohibited by applicable Trade Control Laws. Company .
(e) Each Party hereby acknowledges represents and confirms warrants that Company and any of its Resellers or Customers (i) are it is not included on, owned or controlled by an individual or entity included on, or acting on behalf of an individual or entity included on any of the restricted party lists maintained by the U.S. Government (e.g.Government, including the Specially Designated Nationals List, List administered by the U.S. Treasury Department’s Office of Foreign Sanctions Evader List, Sectoral Sanctions Identification List, Assets Control; the Denied Persons List, Unverified List, List or Entity List maintained by the U.S. Commerce Department’s Bureau of Industry and Security; or the List of Statutorily Debarred PartiesParties maintained by the U.S. State Department’s Directorate of Defense Trade Controls.
(f) Each Party shall commit to maintaining awareness of the importance of Trade Control Laws throughout its organization. Each Party shall take such actions as are necessary and reasonable to prevent Product from being exported or re-exported to any country, entity or individual subject to U.S. trade sanctions, unless prior approval of the other Party, and relevant permission or license from the U.S. government has been obtained.
(collectively, “Restricted Parties”); g) Each Party will keep accurate and consistent records of all transactions under this Agreement covered by the Trade Control Laws for a minimum of five (ii5) will not export, years from the date of export or re-export; the date of expiration of any applicable license; or, transfer, re-transfer other approval or otherwise ship, directly reliance on any application of license exception or indirectly, the Products or related technology to or for use by Restricted Parties; (iii) will not export, re-export, transfer, re-transfer or otherwise ship, directly or indirectly, the Products or related technology to or for use in or by countries or territories subject to U.S. economic sanctions (e.g., Crimea, Cuba, Iran, North Korea, or Syria); or (iv) will not use or sell the Products for nuclear end-uses, rocket systems, unmanned air vehicles, chemical or biological weapons, maritime nuclear propulsion, weapons of mass destruction or other restricted end-uses except to the extent consistent with Trade Control Laws. Company will require its Resellers and Customers to comply with this Trade Control Laws section. Violation of this section may result in immediate termination of the Agreement or other remedies at the discretion of Tenableexemption.
Appears in 1 contract
Samples: Collaboration and License Agreement (Revance Therapeutics, Inc.)
Trade Control Laws. In the performance of the Agreement, Company shall (a) Each Party will fully comply with all applicable export control and control, economic sanctions laws and anti-boycott regulations of the United States, European Union, EU member states, United Kingdom States of America and other applicable government authorities governments, including without limitation the U.S. Export Administration Regulations, Regulations (Title 15 of the U.S. Code of Federal Regulations Part 730 et seq.) and the economic sanctions rules and regulations implemented under statutory authority and/or the or President’s Executive Orders and administered by the U.S. Treasury Department’s Office of Foreign Assets Control, Control (Title 31 of the International Traffic in Arms Regulation (“ITAR”), and the anti-boycott rules implemented by the Departments U.S. Code of Commerce and Treasury Federal Regulations Part 500 et seq.) (collectively, “Trade Control Laws”).
(b) Each Party acknowledges and confirms that Trade Control Laws apply to its activities, its employees and Affiliates under this Agreement.
(c) No Product will be directly or indirectly shipped by the other Party to any country subject to U.S. or U.N. economic sanctions without the necessary licenses, even for transfer to non-sanctioned countries, and only after the express written consent of Mylan, [***].
(d) Neither Party shall be required by the terms of this Agreement to be directly or indirectly involved in the provision of goods, services or technical data that may be prohibited by applicable Trade Control Laws if performed by such Party. Company will not exportIt shall be [***] to refrain from being directly or indirectly involved in the provision of goods, re-export, transfer, re-transfer services or otherwise ship the Products except as authorized under technical data that may be prohibited by applicable Trade Control Laws. Company .
(e) Each Party hereby acknowledges represents and confirms warrants that Company and any of its Resellers or Customers (i) are it is not included on, owned or controlled by an individual or entity included on, or acting on behalf of an individual or entity included on any of the restricted party lists maintained by the U.S. Government (e.g.Government, including the Specially Designated Nationals List, List administered by the U.S. Treasury Department’s Office of Foreign Sanctions Evader List, Sectoral Sanctions Identification List, Assets Control; the Denied Persons List, Unverified List, List or Entity List maintained by the U.S. Commerce Department’s Bureau of Industry and Security; or the List of Statutorily Debarred PartiesParties maintained by the U.S. State Department’s Directorate of Defense Trade Controls. [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.
(f) Each Party shall commit to maintaining awareness of the importance of Trade Control Laws throughout its organization. Each Party shall take such actions as are necessary and reasonable to prevent Product from being exported or re-exported to any country, entity or individual subject to U.S. trade sanctions, unless prior approval of the other Party, and relevant permission or license from the U.S. government has been obtained.
(collectively, “Restricted Parties”); (iig) Each Party will not export, keep accurate and consistent records of all transactions covered by the Trade Control Laws for a minimum of [***] from the date of export or re-export; the date of expiration of any applicable license; or, transfer, re-transfer other approval or otherwise ship, directly reliance on any application of license exception or indirectly, the Products or related technology to or for use by Restricted Parties; (iii) will not export, re-export, transfer, re-transfer or otherwise ship, directly or indirectly, the Products or related technology to or for use in or by countries or territories subject to U.S. economic sanctions (e.g., Crimea, Cuba, Iran, North Korea, or Syria); or (iv) will not use or sell the Products for nuclear end-uses, rocket systems, unmanned air vehicles, chemical or biological weapons, maritime nuclear propulsion, weapons of mass destruction or other restricted end-uses except to the extent consistent with Trade Control Laws. Company will require its Resellers and Customers to comply with this Trade Control Laws section. Violation of this section may result in immediate termination of the Agreement or other remedies at the discretion of Tenableexemption.
Appears in 1 contract
Samples: Collaboration Agreement (Momenta Pharmaceuticals Inc)
Trade Control Laws. In the performance of the Agreement, Company shall (a) Each Party will fully comply with all applicable export control and control, economic sanctions laws and anti-boycott regulations of the United States, European Union, EU member states, United Kingdom States of America and other applicable government authorities governments, including without limitation the U.S. Export Administration Regulations, Regulations (Title 15 of the U.S. Code of Federal Regulations Part 730 et seq.) and the economic sanctions rules and regulations implemented under statutory authority and/or the or President’s Executive Orders and administered by the U.S. Treasury Department’s Office of Foreign Assets Control, Control (Title 31 of the International Traffic in Arms Regulation (“ITAR”), and the anti-boycott rules implemented by the Departments U.S. Code of Commerce and Treasury Federal Regulations Part 500 et seq.) (collectively, “Trade Control Laws”).
(b) Each Party acknowledges and confirms that Trade Control Laws apply to its activities, its employees and Affiliates under this Agreement.
(c) No Product will be directly or indirectly shipped by the other Party to any country subject to U.S. or U.N. economic sanctions without the necessary licenses, even for transfer to non-sanctioned countries, and only after the express written consent of Mylan, [***].
(d) Neither Party shall be required by the terms of this Agreement to be directly or indirectly involved in the provision of goods, services or technical data that may be prohibited by applicable Trade Control Laws if performed by such Party. Company will not exportIt shall be [***] to refrain from being directly or indirectly involved in the provision of goods, re-export, transfer, re-transfer services or otherwise ship the Products except as authorized under technical data that may be prohibited by applicable Trade Control Laws. Company .
(e) Each Party hereby acknowledges represents and confirms warrants that Company and any of its Resellers or Customers (i) are it is not included on, owned or controlled by an individual or entity included on, or acting on behalf of an individual or entity included on any of the restricted party lists maintained by the U.S. Government (e.g.Government, including the Specially Designated Nationals List, List administered by the U.S. Treasury Department’s Office of Foreign Sanctions Evader List, Sectoral Sanctions Identification List, Assets Control; the Denied Persons List, Unverified List, List or Entity List maintained by the U.S. Commerce Department’s Bureau of Industry and Security; or the List of Statutorily Debarred PartiesParties maintained by the U.S. State Department’s Directorate of Defense Trade Controls.
(f) Each Party shall commit to maintaining awareness of the importance of Trade Control Laws throughout its organization. Each Party shall take such actions as are necessary and reasonable to prevent Product from being exported or re-exported to any country, Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for confidential treatment and have been filed separately with the Securities and Exchange Commission. entity or individual subject to U.S. trade sanctions, unless prior approval of the other Party, and relevant permission or license from the U.S. government has been obtained.
(collectively, “Restricted Parties”); (iig) Each Party will not export, keep accurate and consistent records of all transactions covered by the Trade Control Laws for a minimum of [***] from the date of export or re-export; the date of expiration of any applicable license; or, transfer, re-transfer other approval or otherwise ship, directly reliance on any application of license exception or indirectly, the Products or related technology to or for use by Restricted Parties; (iii) will not export, re-export, transfer, re-transfer or otherwise ship, directly or indirectly, the Products or related technology to or for use in or by countries or territories subject to U.S. economic sanctions (e.g., Crimea, Cuba, Iran, North Korea, or Syria); or (iv) will not use or sell the Products for nuclear end-uses, rocket systems, unmanned air vehicles, chemical or biological weapons, maritime nuclear propulsion, weapons of mass destruction or other restricted end-uses except to the extent consistent with Trade Control Laws. Company will require its Resellers and Customers to comply with this Trade Control Laws section. Violation of this section may result in immediate termination of the Agreement or other remedies at the discretion of Tenableexemption.
Appears in 1 contract
Samples: Collaboration Agreement (Momenta Pharmaceuticals Inc)