Common use of Additional Warranties Clause in Contracts

Additional Warranties. Supplier represents and warrants, to the extent applicable to the Supplier that: (i) all Products and Services furnished hereunder shall be manufactured, inspected, and supplied in accordance with all domestic and foreign national, regional, provincial, state, and local laws, statutes, acts, ordinances, rules, codes, standards, guidelines, and regulations applicable to the labeling, re-labeling, packaging, processing, assembly, record creation, record retention, record modification, record transmission (including by electronic means), storage, handling, transport (including exportation and importation of Products within the United States, or to or from the United States and any other country), and reporting of medical devices, and, as applicable, human cells, tissues, or human cellular or tissue-based products (HCT/Ps, in accordance with 21 CFR 1271) in effect at a particular time and promulgated by the United States Food and Drug Administration (“FDA”) and any applicable regulatory body, foreign agency, or relevant competent regulatory authority; (ii) Supplier and any Supplier facility, equipment, employees, sub-suppliers, and agents shall comply with any requirements, obligations, standards, duties, or responsibilities pursuant to any environmental, product composition, and/or materials declaration laws, directives, or regulations, including international laws and treaties regarding such subject matter; and any regulations, interpretive guidance, or enforcement policies related to any of the foregoing; (iii) Supplier and its Affiliates and related entities are not debarred, suspended, proposed for debarment, or otherwise excluded from contracting with the United States Federal Government, or any national, regional, provincial, or state, domestic, foreign, or local government agency; and (iv) Supplier shall at all times comply with and provide Products and Services in accordance with any written Quality Agreement or Change Control Agreement issued by Stryker or agreed by the parties.

Additional Warranties. Supplier represents and warrants, to the extent applicable to the Supplier that: (i) all Products and Services furnished hereunder shall be manufactured, inspected, inspected and supplied in accordance with all domestic and foreign national, regional, provincialfederal, state, and local laws, statutes, acts, ordinances, rules, codes, standards, guidelines, guidelines and regulations applicable to the labeling, re-labeling, packaging, processing, assembly, record creation, record retention, record modification, record transmission (including by electronic means), storage, handling, transport (including exportation and importation of Products within the United States, or to or from the United States and any other country), and reporting of medical devices, and, as applicable, human cells, tissues, tissues or human cellular or tissue-based products (HCT/Ps, in accordance with 21 CFR 1271) in effect at a particular time and promulgated by the United States Food and Drug Administration (“FDA”) and any applicable regulatory body, foreign agency, agency or relevant competent regulatory authority;authority equivalent to the FDA; and (ii) Supplier and any Supplier facility, equipment, employees, sub-suppliers, suppliers and agents shall comply with any requirements, obligations, standards, duties, duties or responsibilities pursuant to any environmental, product composition, composition and/or materials declaration laws, directives, or regulations, including international laws and treaties regarding such subject matter; and any regulations, interpretive guidance, guidance or enforcement policies related to any of the foregoing;. (iii) Supplier and its Affiliates affiliates and related entities are not debarred, suspended, proposed for debarment, debarment or otherwise excluded from contracting with the United States Federal Government, Government or any national, regional, provincial, or state, domestic, foreign, State or local government agency; and (iv) Supplier shall at all times comply with and provide Products and Services in accordance with any written Quality Agreement or Change Control Agreement issued by Stryker or agreed by the parties.

Additional Warranties. Supplier represents and warrants, to the extent applicable to the Supplier that: (i) all Products and Services furnished hereunder shall be manufactured, inspected, and supplied in accordance with all domestic and foreign national, regional, provincial, state, state and local laws, statutes, acts, ordinances, rules, codes, standards, guidelines, and regulations applicable to the labeling, re-labeling, packaging, processing, assembly, record creation, record retention, record modification, record transmission (including by electronic means), storage, handling, transport (including exportation and importation of Products within the United States, or to or from the United States and any other country), and reporting of medical devices, and, as applicable, human cells, tissues, or human cellular or tissue-based products (HCT/Ps, in accordance with 21 CFR 12711271 or any local or regional equivalent thereof) in effect at a particular time and promulgated by the United States Food and Drug Administration (“FDA”) and any applicable regulatory body, foreign agency, or relevant competent regulatory authority; (ii) Supplier and any Supplier facility, equipment, employees, sub-suppliers, and agents shall comply with any requirements, obligations, standards, duties, or responsibilities pursuant to any environmental, product composition, and/or materials declaration laws, directives, or regulations, including international laws and treaties regarding such subject matter; and any regulations, interpretive guidance, or enforcement policies related to any of the foregoing; (iii) Supplier and its Affiliates and related entities are not debarred, suspended, proposed for debarment, or otherwise excluded from contracting with the United States Federal Government, Government or any national, regional, provincial, or state, domestic, foreign, or local government agency; and (iv) Supplier shall at all times comply with and provide Products and Services in accordance with any written Quality Agreement or Change Control Agreement issued by Stryker or agreed by the parties.